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1.  Psychometric Properties of Self-Report Concussion Scales and Checklists 
Journal of Athletic Training  2012;47(2):221-223.
Reference/Citation:
Alla S, Sullivan SJ, Hale L, McCrory P. Self-report scales/checklists for the measurement of concussion symptoms: a systematic review. Br J Sports Med. 2009;43 (suppl 1):i3–i12.
Clinical Question:
Which self-report symptom scales or checklists are psychometrically sound for clinical use to assess sport-related concussion?
Data Sources:
Articles available in full text, published from the establishment of each database through December 2008, were identified from PubMed, Medline, CINAHL, Scopus, Web of Science, SPORTDiscus, PsycINFO, and AMED. Search terms included brain concussion, signs or symptoms, and athletic injuries, in combination with the AND Boolean operator, and were limited to studies published in English. The authors also hand searched the reference lists of retrieved articles. Additional searches of books, conference proceedings, theses, and Web sites of commercial scales were done to provide additional information about the psychometric properties and development for those scales when needed in articles meeting the inclusion criteria.
Study Selection:
Articles were included if they identified all the items on the scale and the article was either an original research report describing the use of scales in the evaluation of concussion symptoms or a review article that discussed the use or development of concussion symptom scales. Only articles published in English and available in full text were included.
Data Extraction:
From each study, the following information was extracted by the primary author using a standardized protocol: study design, publication year, participant characteristics, reliability of the scale, and details of the scale or checklist, including name, number of items, time of measurement, format, mode of report, data analysis, scoring, and psychometric properties. A quality assessment of included studies was done using 16 items from the Downs and Black checklist1 and assessed reporting, internal validity, and external validity.
Main Results:
The initial database search identified 421 articles. After 131 duplicate articles were removed, 290 articles remained and were added to 17 articles found during the hand search, for a total of 307 articles; of those, 295 were available in full text. Sixty articles met the inclusion criteria and were used in the systematic review. The quality of the included studies ranged from 9 to 15 points out of a maximum quality score of 17. The included articles were published between 1995 and 2008 and included a collective total of 5864 concussed athletes and 5032 nonconcussed controls, most of whom participated in American football. The majority of the studies were descriptive studies monitoring the resolution of concussive self-report symptoms compared with either a preseason baseline or healthy control group, with a smaller number of studies (n = 8) investigating the development of a scale.
The authors initially identified 20 scales that were used among the 60 included articles. Further review revealed that 14 scales were variations of the Pittsburgh Steelers postconcussion scale (the Post-Concussion Scale, Post-Concussion Scale: Revised, Post-Concussion Scale: ImPACT, Post-Concussion Symptom Scale: Vienna, Graded Symptom Checklist [GSC], Head Injury Scale, McGill ACE Post-Concussion Symptoms Scale, and CogState Sport Symptom Checklist), narrowing down to 6 core scales, which the authors discussed further. The 6 core scales were the Pittsburgh Steelers Post-Concussion Scale (17 items), Post-Concussion Symptom Assessment Questionnaire (10 items), Concussion Resolution Index postconcussion questionnaire (15 items), Signs and Symptoms Checklist (34 items), Sport Concussion Assessment Tool (SCAT) postconcussion symptom scale (25 items), and Concussion Symptom Inventory (12 items). Each of the 6 core scales includes symptoms associated with sport-related concussion; however, the number of items on each scale varied. A 7-point Likert scale was used on most scales, with a smaller number using a dichotomous (yes/no) classification.
Only 7 of the 20 scales had published psychometric properties, and only 1 scale, the Concussion Symptom Inventory, was empirically driven (Rasch analysis), with development of the scale occurring before its clinical use. Internal consistency (Cronbach α) was reported for the Post-Concussion Scale (.87), Post-Concussion Scale: ImPACT 22-item (.88–.94), Head Injury Scale 9-item (.78), and Head Injury Scale 16-item (.84). Test-retest reliability has been reported only for the Post-Concussion Scale (Spearman r = .55) and the Post-Concussion Scale: ImPACT 21-item (Pearson r = .65). With respect to validity, the SCAT postconcussion scale has demonstrated face and content validity, the Post-Concussion Scale: ImPACT 22-item and Head Injury Scale 9-item have reported construct validity, and the Head Injury Scale 9-item and 16-item have published factorial validity.
Sensitivity and specificity have been reported only with the GSC (0.89 and 1.0, respectively) and the Post-Concussion Scale: ImPACT 21-item when combined with the neurocognitive component of ImPACT (0.819 and 0.849, respectively). Meaningful change scores were reported for the Post-Concussion Scale (14.8 points), Post-Concussion Scale: ImPACT 22-item (6.8 points), and Post-Concussion Scale: ImPACT 21-item (standard error of the difference = 7.17; 80% confidence interval = 9.18).
Conclusions:
Numerous scales exist for measuring the number and severity of concussion-related symptoms, with most evolving from the neuropsychology literature pertaining to head-injured populations. However, very few of these were created in a systematic manner that follows scale development processes and have published psychometric properties. Clinicians need to understand these limitations when choosing and using a symptom scale for inclusion in a concussion assessment battery. Future authors should assess the underlying constructs and measurement properties of currently available scales and use the ever-increasing prospective data pools of concussed athlete information to develop scales following appropriate, systematic processes.
PMCID: PMC3418135  PMID: 22488289
mild traumatic brain injuries; evaluation; reliability; validity; sensitivity; specificity
2.  The Validity and Utility of the M. D. Anderson Symptom Inventory in Patients With Breast Cancer: Evidence From the Symptom Outcomes and Practice Patterns Data From the Eastern Cooperative Oncology Group 
Clinical breast cancer  2013;13(5):325-334.
The M. D. Anderson Symptom Inventory assesses the severity and impact of multiple symptoms related to cancer and its treatment. Psychometric analysis of data from a national multicenter study of 1544 patients with breast cancer showed the M. D. Anderson Symptom Inventory to be a valid, reliable, sensitive symptom-assessment instrument that can enhance descriptive and clinical studies of symptom status in this patient population.
Background
The M. D. Anderson Symptom Inventory (MDASI) is a psychometrically validated patient-reported outcome measurement that assesses the severity and impact of multiple symptoms related to cancer and its treatment. With the MDASI, patients rate 13 common “core” symptoms and 6 items that reflect symptom interference with functioning. Several MDASI modules (core symptom and interference items plus additional symptoms specific to a particular cancer type or treatment modality) have been developed. Although the original MDASI validation study encompassed various cancer types, the instrument's psychometric properties have not been examined in a homogenous sample of patients with breast cancer in a national multicenter study.
Materials and Methods
We performed a secondary analysis of data from an Eastern Cooperative Oncology Group study to establish the reliability, validity, and sensitivity of the MDASI in a large sample of patients with breast cancer (n = 1544), 78% of whom were receiving treatment. The instrument was administered twice, approximately 1 month apart.
Results
Internal consistency and test-retest reliability were adequate, with Cronbach α values ≥ 0.85 and intraclass correlations ≥ 0.76 for all subscales. Known-group validity was evaluated by using performance status, tumor response, and disease stage. Sensitivity to change in patient-reported quality of life was established.
Conclusion
The MDASI is a valid, reliable, and sensitive symptom-assessment instrument that can enhance descriptive and clinical studies of symptom status in patients with breast cancer. Future studies might include cognitive debriefing and qualitative interviews to identify additional disease-specific items for inclusion in a MDASI breast cancer module.
doi:10.1016/j.clbc.2013.02.014
PMCID: PMC3775936  PMID: 23816985
Eastern Cooperative Oncology Group; M. D. Anderson Symptom Inventory; Patient-reported outcome; Symptom assessment; Validation
3.  The reliability, validity, and preliminary responsiveness of the Eye Allergy Patient Impact Questionnaire (EAPIQ) 
Background
The Eye Allergy Patient Impact Questionnaire (EAPIQ) was developed based on a pilot study conducted in the US and focus groups with eye allergy sufferers in Europe. The purpose of this study was to present the results of the psychometric validation of the EAPIQ.
Methods
One hundred forty six patients from two allergy clinics completed the EAPIQ twice over a two-week period during the fall and winter allergy seasons, along with concurrent measures of health status, work productivity, and utility. Construct validity, reliability (internal consistency and test-retest), concurrent, known-group, and clinical validities, and responsiveness of the EAPIQ were assessed. Known-group validity was assessed by comparing EAPIQ scale scores between patients grouped according to their self-rating of ocular allergy severity (no symptoms, very mild, mild, moderate, severe, very severe). Clinical validity was assessed by assessing differences in EAPIQ scores between groups of patients rated by their clinician as non-symptomatic, mild, moderate, and severe.
Results and Discussion
Results from the validation study suggested the deletion of 14 of 43 items (including embedded questions) that required patients to complete the percentage of time they were troubled by something (daily activity limitations/emotional troubles). These items yielded a significant amount of missing or inconsistent data (50%). The resulting factor analysis suggested four domains: symptoms, daily life impact, psychosocial impact, and treatment satisfaction. When included as separate scales, the symptom-bother and symptom-frequency scales were highly correlated (> 0.9). As a consequence, and due to superior discriminative validity, the symptom bother and frequency items were summed. All items met the tests for item convergent validity (item-scale correlation = 0.4). The success rate for item discriminant validity testing was 97% (item-scale correlation greater with own scale than with any other). The criterion for internal consistency reliability (alpha coefficient ≥ 0.70) was met for all EAPIQ scales (range 0.89–0.93), as was the criterion for test-retest reliability (intraclass correlation [ICC] ≥ 0.70). Largely moderate correlations between the scales of the EAPIQ and the mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) and low correlations with the Health Utilities Index 2/3 (HUI2/3) were indicative of satisfactory concurrent validity. The EAPIQ symptoms, Daily Life Impact, and Psychosocial Impact scales were able to distinguish between patients differing in eye allergy symptom severity, as rated by patients and clinicians, providing evidence of satisfactory known-group and clinical validities, respectively. Preliminary analyses indicated the EAPIQ Symptoms, Daily Life Impact, and Psychosocial Impact scales to be responsive to changes in eye allergies.
Conclusion
Following item reduction, construct validity, reliability, concurrent validity, known-group validity, and preliminary responsiveness were satisfactory for the EAPIQ in this population of ocular allergy patients.
doi:10.1186/1477-7525-3-67
PMCID: PMC1291386  PMID: 16259630
Patient functioning; ocular allergy; psychometric validation; EAPIQ; patient reported outcomes
4.  Cross-cultural adaptation and psychometric properties of the Brazilian-Portuguese version of the VSP-A (Vécu et Santé Perçue de l'Adolescent), a health-related quality of life (HRQoL) instrument for adolescents, in a healthy Brazilian population 
BMC Pediatrics  2011;11:8.
Background
Health-related quality of life (HRQoL) assessment, encompassing the adolescents' perceptions of their mental, physical, and social health and well-being is increasingly considered an important outcome to be used to identify population health needs and to provide targeted medical care. Although validated instruments are essential for accurately assessing HRQoL outcomes, there are few cross-culturally adapted tools for use in Brazil, and none designed exclusively for use among adolescents. The Vécu et Santé Perçue de l'Adolescent (VSP-A) is a generic, multidimensional self-reported instrument originally developed and validated in France that evaluates HRQoL of ill and healthy adolescents.
Purpose
To cross-culturally adapt and validate the Brazilian-Portuguese version of the VSP-A, a generic HRQoL measure for adolescents originally developed in France.
Methods
The VSP-A was translated following a well-validated forward-backward process leading to the Brazilian version. The psychometric evaluation was conducted in a sample of 446 adolescents (14-18 years) attending 2 public high schools of São Gonçalo City. The adolescents self-reported the Brazilian VSP-A, the validated Psychosomatic Symptom Checklist and socio-demographic information. A retest evaluation was carried out on a sub-sample (n = 195) at a two-week interval.
The internal construct validity was assessed through confirmatory factor analysis (CFA), multi-trait scaling analyses, Rasch analysis evaluating unidimensionality of each scale and Cronbach's alpha coefficients. The reproducibility was evaluated by intra-class correlation coefficients (ICC). Zumbo's ordinal logistic regression analysis was used to detect differential item functioning (DIF) between the Brazilian and the French items. External construct validity was investigated testing expected differences between groups using one-way analysis of variance (ANOVA), Mann-Whitney tests and the univariate general regression linear model.
Results
CFA showed an acceptable fit (RMSEA=0.05; CFI=0.93); 94% of scaling success was found for item-internal consistency and 98% for item discriminant validity. The items showed good fit to the Rasch model except 3 items with an INFIT at the upper threshold. Cronbach's Alpha ranged from 0.60 to 0.85. Test-retest reliability was moderate to good (ICC=0.55-0.82). DIF was evidenced in 4 out of 36 items. Expected patterns of differences were confirmed with significantly lower physical, psychological well being and vitality reported by symptomatic adolescents.
Conclusions
Although DIF in few items and responsiveness must be further explored, the Brazilian version of VSP-A demonstrated an acceptable validity and reliability in adolescents attending school and might serve as a starting point for more specific clinical investigations.
doi:10.1186/1471-2431-11-8
PMCID: PMC3042386  PMID: 21272317
5.  Validation of the Reflux Symptom Questionnaire Electronic Diary in Partial Responders to Proton Pump Inhibitor Therapy 
OBJECTIVES:
We aimed to develop and validate the Reflux Symptom Questionnaire electronic Diary (RESQ-eD) for use in clinical trials in patients with a partial response to proton pump inhibitor (PPI) therapy, using methods that meet US Food & Drug Administration (FDA) regulatory standards.
METHODS:
Patient interviews were performed to elicit new items and evaluate existing items from the Reflux Disease Questionnaire. The instrument's measurement properties were evaluated, based on data from two clinical trials of patients with gastroesophageal reflux disease (GERD) with a partial response to PPIs who received lesogaberan or placebo as an add-on to PPI therapy.
RESULTS:
The content validity phase resulted in 13 RESQ-eD items. Principal component analysis supported a four-domain structure. All domains had a high inter-item correlation (Cronbach's alpha lower 95% confidence limit: 0.87–0.95). Test-retest reliability was good to excellent (intraclass correlation coefficient: 0.65–0.85). Convergent and discriminant validity was confirmed by correlation assessments referencing the Gastrointestinal Symptom Rating Scale. The RESQ-eD demonstrated a good ability to capture change in mean intensity and proportion of symptom-free days. Confirmatory psychometric evaluation verified internal consistency reliability, test-retest reliability, and ability to capture change.
CONCLUSIONS:
The RESQ-eD demonstrated good content validity and psychometric properties in the clinical trial setting in patients with GERD who have a partial response to PPI therapy. To our knowledge, the RESQ-eD is the first electronic symptom diary for use in partial responders to PPI that has been developed in line with the FDA guidance on patient-reported outcomes.
doi:10.1038/ctg.2012.1
PMCID: PMC3365670  PMID: 23238029
6.  A rapid screening tool for fatigue impact in multiple sclerosis 
BMC Neurology  2006;6:27.
Background
Fatigue is a common complaint in multiple sclerosis (MS) and often interferes with daily functioning. Both clinicians and researchers may need to detect high levels of fatigue impact using a time and effort efficient tool. This study evaluates the psychometric properties of a rapid screening instrument for fatigue impact in multiple sclerosis.
Methods
Three visual analogue scales (VAS) for assessing the impact of fatigue were developed. Sixty two subjects with definite MS (mean age 52 +/- 10.5 years; 29 women) and 24 healthy controls (mean age 52 +/- 14 years; 13 women) completed all VAS scales (range 0–100), the Fatigue Severity Scale (FSS) (range 7–63), the Modified Fatigue Impact Scale (MFIS) (range 0–84) and the Guy's Neurological Disability Scale (GNDS) (range 0–5). All tests were repeated with an interval of maximum three days.
To evaluate the reproducibility, intraclass correlations (ICC) were calculated, based on one-way analysis of variance for repeated measurements. Validity was considered by means of correlation coefficients. ROC analysis was used to determine the accuracy of the VAS scales.
Results
The ICC of the VAS scales ranged from 0.68 to 0.69. VAS scales showed low to moderate correlation with FSS, MFIS and GNDS (Kendall's tau 0.23–0.45) and were not related with physical or cognitive performance, or with depression. All VAS scales were able to discriminate between subjects with MS and controls. Twenty five subjects with MS had a Fatigue Severity Scale score of 36 or more and were classified into the "fatigue" group. ROC analysis showed that VAS_1 is most useful to classify subjects in the "fatigue" group. A cut-off value of VAS_1 of 59 displayed 76% sensitivity and 72% specificity. When using the MFIS score of 40 or more to classify the groups, VAS_1 remained the strongest tool, with 81% sensitivity and 77% specificity at a cut-off value of 59.
Conclusion
The VAS for the impact of fatigue on daily life (VAS_1) is a moderately reliable, though valid and useful tool to screen rapidly for fatigue impact in multiple sclerosis. A cut-off value of 59 satisfactorily classifies individuals having severe fatigue with a high impact on daily life. In clinical practice, a more comprehensive assessment of fatigue and the impact on daily life is recommended.
doi:10.1186/1471-2377-6-27
PMCID: PMC1579227  PMID: 16916440
7.  The PedsQL™ Oral Health Scale: feasibility, reliability and validity of the Brazilian Portuguese version 
Background
Oral and orofacial problems may cause a profound impact on children’s oral health-related quality of life (OHRQoL) because of symptoms associated with these conditions that may influence the physical, psychological and social aspects of their daily life. The OHRQoL questionnaires found in the literature are very specific and are not able to measure the impact of oral health on general health domains. Consequently, the objective of this study was to evaluate the psychometric properties of the Portuguese version for Brazilian translation of the Pediatric Quality of Life Inventory™ (PedsQL™) Oral Health Scale in combination with the PedsQL™ 4.0 Generic Core Scales.
Methods
The PedsQL™ Oral Health Scale was forward-backward translated and cross-culturally adapted for the Brazilian Portuguese language. In order to assess the feasibility, reliability and validity of the Brazilian version of the instrument, a study was carried out in Belo Horizonte with 208 children and adolescents between 2 and 18 years-of-age and their parents. Clinical evaluation of dental caries, socioeconomic information and the Brazilian versions of the PedsQL™ Oral Health Scale, PedsQL™ 4.0 Generic Core Scales, Child Perceptions Questionnaire (CPQ11-14 and CPQ8-10) and Parental-Caregiver Perception Questionnaire (P-CPQ) were administered. Statistical analysis included feasibility (missing values), confirmatory factor analysis (CFA), internal consistency reliability, and test-retest intraclass correlation coefficients (ICC) of the PedsQL™ Oral Health Scale.
Results
There were no missing data for both child self-report and parent proxy-report on the Brazilian version of the PedsQL™ Oral Health Scale. The CFA showed that the five items of child self-report and parent proxy-report loaded on a single construct. The Cronbach's alpha coefficients for child/adolescent and parent oral health instruments were 0.65 and 0.59, respectively. The test-retest reliability (ICC) for child self-report and parent proxy-report were 0.90 [95% confidence interval (CI) = 0.86-0.93] and 0.86 (95%CI = 0.81-0.90), respectively. The PedsQL™ Oral Health Scale demonstrated acceptable construct validity, convergent validity and discriminant validity.
Conclusions
These results supported the feasibility, reliability and validity of the Brazilian version of the PedsQL™ Oral Health Scale for child self-report for ages 5–18 years-old and parent proxy-report for ages 2–18 years-old children.
doi:10.1186/1477-7525-10-42
PMCID: PMC3425333  PMID: 22531004
Oral health; PedsQL; Quality of life; Validation; Child; Adolescent
8.  Cross-cultural adaptation of the Child Perceptions Questionnaire 11–14 (CPQ11–14) for the Brazilian Portuguese language 
Background
Oral-Health-Related Quality of Life (OHRQoL) instruments are being used with increasing frequency in oral health surveys. However, these instruments are not available in all countries or all languages. The availability of cross-culturally valid, multi-lingual versions of instruments is important for epidemiological research. The Child Perceptions Questionnaire 11–14 (CPQ11–14) is an OHRQoL instrument that assesses the impact of oral conditions on the quality of life of children and adolescents. The objective of the current study was to carry out the cross-cultural adaptation of CPQ11–14 for the Brazilian Portuguese language.
Methods
After translation and cross-cultural adaptation, the CPQ 11–14 was tested on 160 11-to-14-year-old children who were clinically and radiographically examined for the presence or absence of dental caries. The children were receiving dental care at the Pediatric Dental and Orthodontic clinics of the Federal University of Minas Gerais, Brazil. To test the quality of the translation, 17 children answered the questionnaire. The internal consistency of the instrument was assessed by Cronbach's Alpha Coefficient and the test-retest reliability by Intraclass Correlation Coefficient (ICC).
Results
The mean CPQ11–14 score were 24.5 [standard deviation (SD) 18.27] in the group with caries and 12.89 [SD 10.95] in the group without caries. Median scores were 20 and 10 in the groups with and without caries, respectively (p < 0.001). Significant associations were identified between caries status and all CPQ domains (p < 0.05). Internal reliability was confirmed by a Cronbach's alpha coefficient of 0.86. Test-retest reliability revealed satisfactory reproducibility (ICC = 0.85). The questionnaire proved to be a valid instrument. Construct validity was satisfactory, demonstrating highly significant correlations with global indicators for the total scale and subscales. The CPQ11–14 score was able to discriminate between different oral conditions (groups without and with untreated caries).
Conclusion
The present study demonstrated that the CPQ11–14 is applicable to children in Brazil. It has satisfactory psychometric properties, but further research is required to evaluate these properties in a population study.
doi:10.1186/1477-7525-6-2
PMCID: PMC2246108  PMID: 18194552
9.  The VSQ: a questionnaire to measure vulvovaginal symptoms in postmenopausal women 
Menopause (New York, N.Y.)  2013;20(9):973-979.
Objective
The purpose of this study was to develop a vulvovaginal symptoms questionnaire (VSQ) to study symptoms, emotions, life-impact, and sexual-impact of vulvovaginal symptoms in postmenopausal women.
Methods
We developed questionnaire focused on vulvovaginal symptoms based on modifications to the Skindex-16, a validated questionnaire to measure the impact of skin disease. We then recruited postmenopausal women seeking routine gynecologic care to test the psychometric properties of the VSQ. Test-retest reliability was assessed 2 to 4 weeks after their initial recruitment and measured utilizing intra-class coefficients. Four distinct a priori scales of the VSQ were developed: symptoms, emotions, life-impact, and sexual-impact. Confirmatory factor analysis was performed to verify the four a priori scales by evaluating the goodness-of-fit of a final confirmatory factor analysis model. The internal consistency of the scales was assessed through the calculation of Cronbach’s α coefficient.
Results
The VSQ is a 21-item written questionnaire with four scales, symptoms, emotions, life-impact, and sexual impact. One hundred twenty postmenopausal women participated in the psychometric validation of the VSQ. The test-retest reliability the four scales measured by intra-class coefficients were 0.75, 0.60, 0.55, and 0.65 for symptoms, emotions, life-impact and sexual-impact. The goodness-of –fit of the confirmatory factor response model was confirmed. Cronbach’s α coefficients were 0.76, 0.87, 0.83, and 0.82 for the scales.
Conclusion
The VSQ is a reliable and internal consistent instrument to measure vulvovaginal symptoms in postmenopausal women.
doi:10.1097/GME.0b013e318282600b
PMCID: PMC3695224  PMID: 23481118
atrophic vaginitis; menopause; vulvovaginal symptoms
10.  Psychometric properties of the CDC Symptom Inventory for assessment of Chronic Fatigue Syndrome 
Objectives
Validated or standardized self-report questionnaires used in research studies and clinical evaluation of chronic fatigue syndrome (CFS) generally focus on the assessment of fatigue. There are relatively few published questionnaires that evaluate case defining and other accompanying symptoms in CFS. This paper introduces the self-report CDC CFS Symptom Inventory and analyzes its psychometric properties.
Methods
One hundred sixty-four subjects (with CFS, other fatiguing illnesses and non fatigued controls) identified from the general population of Wichita, Kansas were enrolled. Evaluation included a physical examination, a standardized psychiatric interview, three previously validated self-report questionnaires measuring fatigue and illness impact (Medical Outcomes Survey Short-Form-36 [MOS SF-36], Multidimensional Fatigue Inventory [MFI], Chalder Fatigue Scale), and the CDC CFS Symptom Inventory. Based on theoretical assumptions and statistical analyses, we developed several different Symptom Inventory scores and evaluated them on their ability to differentiate between participants with CFS and non-fatigued controls.
Results
The Symptom Inventory had good internal consistency and excellent convergent validity. A Total score (all symptoms), Case Definition score (CFS case defining symptoms) and Short Form score (6 symptoms with minimal correlation) differentiated CFS cases from controls. Furthermore, both the Case Definition and Short Form scores distinguished people with CFS from fatigued subjects who did not meet criteria for CFS.
Conclusion
The Symptom Inventory appears to be a reliable and valid instrument to assess symptoms that accompany CFS. It is a positive addition to existing instruments measuring fatigue because it allows other dimensions of the illness to be assessed. Further research is needed to confirm and replicate the current findings in a normative population.
doi:10.1186/1478-7954-3-8
PMCID: PMC1183246  PMID: 16042777
11.  The Menopause-Specific Quality of Life (MENQOL) Questionnaire: Psychometric Evaluation among Breast Cancer Survivors 
Menopause (New York, N.Y.)  2011;18(3):289-295.
Objective
To evaluate the psychometric properties of the Menopause-Specific Quality of Life (MENQOL) Questionnaire in a sample of breast cancer survivors experiencing menopausal symptoms.
Methods
This was a secondary analysis of MENQOL psychometric data from two larger parent studies investigating acupuncture for the relief of menopausal symptoms among breast cancer survivors. Reliability was assessed for each subscale of the MENQOL via: 1) internal consistency reliability with Cronbach’s α, and 2) test-retest reliability at multiple follow-up points with intra-class correlation coefficients (ICCs) and r. Convergent and discriminant validity were assessed via correlations of the vasomotor and psychosocial MENQOL subscales with select items in the Kupperman Index and Daily Symptom Diary. A principal components analysis (PCA) was performed to determine construct validity.
Results
For each subscale, Cronbach’s α was ≥ 0.70. All subscale test-retest reliabilities at first follow-up were significant and at least moderately correlated ≥ 0.450 (r’s and ICCs). Convergent validity was moderate between the vasomotor and psychosocial subscales and the symptom diary (r’s ≥ 0.410, p’s < 0.001), and larger between these domains and the Kupperman Index (r’s ≥ 0.614, p’s < 0.001). In the same subscales, discriminant validity was supported by low, non-significant correlations (r’s ≤ 0.176, p’s > 0.05). The PCA revealed a latent structure nearly identical to the pre-specified instrument domains, with the exception of the physical domain.
Conclusions
With results comparable to those obtained in previous psychometric work, the MENQOL appears to be a reliable and valid instrument to assess quality of life in post-menopausal breast cancer survivors.
doi:10.1097/gme.0b013e3181ef975a
PMCID: PMC3017657  PMID: 20881889
menopause; quality of life; breast cancer; psychometrics; factor analysis
12.  Psychometric properties of the Brazilian version of the Child Perceptions Questionnaire (CPQ11–14) – short forms 
Background
The need to evaluate the impact of oral health has led to the development of instruments for measuring oral health-related quality of life (OHQoL). One such instrument is the Child Perceptions Questionnaire (CPQ11–14), developed specifically for 11-to-14-year-old children. As this questionnaire was considered long (37 items), shorter forms were developed with 8 (Impact Short Form: 8 – ISF:8) and 16 items (Impact Short Form: 16 – ISF:16) to facilitate use in the clinical setting and population-based health surveys. The aim of the present study was to translate and cross-culturally adapt these CPQ11–14 short forms for Brazilian Portuguese and evaluate the measurement properties of these versions for use on Brazilian children.
Methods
Following translation and cross-cultural adaptation, the ISF:8 and ISF:16 were tested on 136 children from 11 to 14 years of age in the city of Belo Horizonte, Brazil. The instrument was administered by a trained researcher who also performed clinical examinations. The measurement properties (i.e. criterion validity, construct validity, internal consistency reliability, test-retest reliability) were determined. Discriminant validity was tested between groups, which were divided into children with no cavities and no malocclusion; children with cavities and without malocclusion; and children with malocclusion and without cavities.
Results
The mean total score was 6.8 [standard deviation (SD) 4.2] for the ISF:8 and 11.9 (SD 7.6) for the ISF:16 (p < 0.001). Statistically significant associations were found between oral abnormalities and the subscales of the ISF:8 and ISF:16 (p < 0.05). Both test-retest stability and internal consistency, as measured by the intra-class correlation coefficient (ICC) (ISF:8 = 0.98 and ISF:16 = 0.97) and Cronbach's alpha (ISF:8 = 0.70 and ISF:16 = 0.84) proved to be adequate. Construct validity was confirmed from the correlation between the short form scores and oral health and overall well-being ratings. The score on the short forms of the CPQ11–14 was able to discriminate between different oral conditions. Criterion validity was satisfactory (p < 0.05).
Conclusion
The Brazilian versions of CPQ11–14 ISF:8 and ISF:16 have satisfactory psychometric properties, similar to those of the original instrument.
doi:10.1186/1477-7525-7-43
PMCID: PMC2689176  PMID: 19445725
13.  Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample 
Quality of Life Research  2006;16(3):445-460.
Objective
To evaluate feasibility, internal consistency, test–retest reliability, and concurrent and discriminative validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) for parents of pre-school children with 12 scales (103-items) covering physical and psychosocial domains and impact of child health on parents, in comparison with the TNO-AZL Pre-school Children Quality of Life Questionnaire (TAPQOL).
Methods
Parents of children from a random general population sample (2 months–4 years old; n = 500) and of an outpatient clinic sample of children with respiratory disease (5 months–5 1/2 years old; n = 217) were mailed ITQOL and TAPQOL questionnaires; a retest was sent after two weeks.
Results
Feasibility: The response was ≥80% with few missing and non-unique ITQOL-answers (<2%) in both study populations. Some ITQOL-scales (3–4 scales) showed a ceiling effect (>25% at maximum score). Internal consistency: All Cronbach’s α >0.70. Test–retest Intraclass Correlation Coefficients (ICCs) were moderate or adequate (≥0.50; p lt; 0.01) for 10 ITQOL-scales. Validity: ITQOL-scales, with a few exceptions, correlated better with predefined parallel TAPQOL scales than with non-parallel scales. Five to eight ITQOL-scales discriminated clearly between children with few and with many parent-reported chronic conditions, between children with and without doctor-diagnosed respiratory disease and with a low and a high parent-reported medical consumption (p <0.05).
Conclusions
This study supported the evidence that the ITQOL is a feasible instrument with adequate psychometric properties. The study provided reference ITQOL scores for gender/age subgroups. We recommend repeated evaluations of the ITQOL in varied populations, especially among very young children, including repeated assessments of test–retest characteristics and evaluations of responsiveness to change. We recommend developing and evaluating a shortened ITQOL version.
doi:10.1007/s11136-006-9134-8
PMCID: PMC2792359  PMID: 17111231
Asthma; General population; Health-related quality of life; Infant and Toddler Quality of Life Questionnaire (ITQOL); Pre-school children; Reference/norm scores; Reliability; TNO-AZL Pre-school Children Quality of Life Questionnaire (TAPQOL); Validity
14.  Can the Fatigue Severity Scale 7-item version be used across different patient populations as a generic fatigue measure - a comparative study using a Rasch model approach 
Background
Fatigue is a disabling symptom associated with reduced quality of life in various populations living with chronic illnesses. The transfer of knowledge about fatigue from one group to another is crucial in both research and healthcare. Outcomes should be validly and reliably comparable between groups and should not be unduly influenced by diagnostic variations. The present study evaluates whether the Fatigue Severity Scale 7-item version (FSS-7) demonstrates similar item hierarchy across people with multiple sclerosis, stroke or HIV/AIDS to ensure valid comparisons between groups, and provide further evidence of internal scale validity.
Methods
A secondary comparative analysis was performed using data from three different studies of three different chronic illnesses: multiple sclerosis, stroke and HIV/AIDS. Each of these studies had previously concluded that the FSS-7 has better psychometric properties than the original FSS for measuring fatigue interference. Data from 224 people with multiple sclerosis, 104 people with stroke and 316 people with HIV/AIDS were examined. Item response theory and a Rasch model were chosen to analyze the similarity of the FSS-7 item hierarchy across the three diagnostic groups
Results
Cross-sample differences were found for items #3, #5, #6 and #9 for two of the three samples, which raise questions about item validity across groups. However, disease-specific and disease-generic Rasch measures were similar across samples, indicating that individual fatigue interference measures in these three chronic illnesses might still be reliably comparable using the FSS-7.
Conclusions
Some items performed differently between the three samples but did not bias person measures, thereby indicating that fatigue interference in these illnesses might still be reliably compared using FSS-7 scores. However, caution is warranted when comparing fatigue raw sum scores directly across diagnostic groups using the FSS-7. Further studies of the scale are needed in other types of chronic illnesses.
doi:10.1186/1477-7525-12-24
PMCID: PMC3936846  PMID: 24559076
Acquired immunodeficiency syndrome; Fatigue; HIV; Multiple sclerosis; Rasch analysis; Questionnaire; Stroke
15.  Development and Psychometric Properties of the OCD Family Functioning (OFF) Scale 
Obsessive–compulsive disorder (OCD) influences not only patients but also family members. Although the construct of family accommodation has received attention in OCD literature, no measures of overall family functioning are currently available. The OCD Family Functioning (OFF) Scale was developed to explore the context, extent, and perspectives of functional impairment in families affected by OCD. It is a three-part, self-report measure capturing independent perspectives of patients and relatives. A total of 400 subjects were enrolled between 2008 and 2010 from specialized OCD clinics and OCD research studies. Psychometric properties of this scale were examined including internal consistency, test–retest reliability, convergent and divergent validity, and exploratory factor analyses. Both patient and relative versions of the OFF Scale demonstrated excellent internal consistency (Cronbach’s alpha coefficient = 0.96). The test–retest reliability was also adequate (ICC = 0.80). Factor analyses determined that the OFF Scale comprises a family functioning impairment factor and four OCD symptom factors that were consistent with previously reported OCD symptom dimension studies. The OFF Scale demonstrated excellent convergent validity with the Family Accommodation Scale and the Work and Social Adjustment Scale. Information gathered regarding emotional impact and family role-specific impairment was novel and not captured by other examined scales. The OFF Scale is a reliable and valid instrument for the clinical and research assessment of family functioning in pediatric and adult OCD. This will facilitate the exploration of family functioning impairment as a potential risk factor, as a moderator and as a treatment outcome measure in OCD.
doi:10.1037/a0023735
PMCID: PMC3752992  PMID: 21553962
obsessive–compulsive disorder; family; accommodation; functioning; scale
16.  The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients 
Background
The Anti-Clot Treatment Scale (ACTS) is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Its role in clinical trials and other settings should be supported by evidence that it is both clinically meaningful and scientifically sound. The aim of the study was to evaluate the measurement performance of the ACTS (Dutch, Italian, French, German and English language versions) in patients with venous thromboembolism based on traditional psychometric methods.
Methods
ACTS Burdens and Benefits scale data from a large clinical trial (EINSTEIN DVT) involving 1336 people with venous thromboembolism were analysed at both the scale and item level. Five key psychometric properties were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (including internal consistency reliability, test-retest reproducibility); validity (including known groups and discriminant validity); and responsiveness. These methods of examination underpin the US Food and Drug Administration recommendations for patient-reported outcome instrument evaluation.
Results
Overall, the 12-item ACTS Burdens scale and 3-item ACTS Benefits scale met the psychometric criteria evaluated at both item and scale levels, with the exception of some relatively minor issues in the Dutch language version, which were just below reliability criteria (i.e. alpha = 0.72, test-retest intraclass correlation = 0.79). A consistent finding from item-level evaluations of aggregate endorsement frequencies and skewness suggested that response scales may be improved by reducing the number of response options from five to four.
Conclusions
Both the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language datasets, supporting it as a clinically useful patient-reported instrument of satisfaction with anticoagulant treatment in clinical trials.
Trial registration number
NCT00440193
doi:10.1186/1477-7525-10-120
PMCID: PMC3478969  PMID: 23013426
PRO instruments; Rating scales; Reliability; Validity; Venous thromboembolism
17.  The Chinese version of the world health organization quality of life instrument-older adults module (WHOQOL-OLD): psychometric evaluation 
Background
Under the circumstance of global population aging, the issue on how to facilitate the quality of life (QOL) for older people brings us grand challenge. On the way to solve this problem, it is inextricable to measure QOL for older people accurately at onset. This study is aimed at evaluating the reliability and validity of the Chinese version of the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD).
Methods
We received 1005 valid WHOQOL-OLD questionnaires from 1050 respondents who were 60 and older by quota sampling method. To calculate the test-retest correlation coefficient we re-interviewed 101 participants from the community. Psychometric properties were evaluated from the aspect of feasibility, internal consistency reliability, test-retest reliability, content validity, construct validity and discriminant validity.
Results
Missing item responses took up 0.0%-2.7% in the scale. The WHOQOL-OLD showed satisfactory reliability with Cronbach’s Alpha coefficients ranging from 0.711 (Social participation) to 0.842 (Sensory ability) for each domain. The intra-class correlation coefficients (ICC) presenting test-retest reliability were all over 0.7. In Confirmatory Factor Analysis (CFA), Root Mean Square Error of Approximation (RMSEA) was 0.084 (a little more than 0.08) and comparative fit index (CFI) 0.95 (>0.90) which meant acceptable construct validity. There were higher correlation coefficients between items and their hypothesized domains than other domains (P < 0.001), indicating good content validity. The results of t-test showed good discriminant validity of the WHOQOL-OLD between the healthy group and the unhealthy group (P < 0.0083).
Conclusion
The Chinese version of WHOQOL-OLD showed good feasibility, reliability and validity in this study. However, before it can be used national-widely, further research should be conducted in other areas of China.
doi:10.1186/1477-7525-11-156
PMCID: PMC3847352  PMID: 24034698
Elderly; Quality of life; Reliability; Validity; WHOQOL-OLD
18.  The Chinese version of the Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module: cross-cultural adaptation and psychometric evaluation 
Background
A pediatric chronic health condition not only influences a child's life, but also has impacts on parent health-related quality of life (HRQOL) and family functioning. To provide care and social support to these families, a psychometrically well-developed instrument for measuring these impacts is of great importance. The present study is aimed to evaluate the psychometric properties of the Chinese version of the PedsQL™ Family Impact Module.
Methods
The cross-cultural adaptation of the PedsQL™ Family Impact Module was performed following the PedsQL™ Measurement Model Translation Methodology. The Chinese version of the PedsQL™ Family Impact Module was administered to 136 parents of children with asthma and 264 parents of children with heart disease from four Triple A hospitals. The psychometric properties such as feasibility, internal consistency reliability, item-subscale correlations and construct validity were evaluated.
Results
The percentage of missing item responses was less than 0.1% for both asthma and heart disease sample groups. The Chinese version of the PedsQL™ Family Impact Module showed ceiling effects but had acceptable reliability (Cronbach's Alpha Coefficients were higher than 0.7 in all the subscales except "Daily Activities" in the asthma sample group). There were higher correlation coefficients between items and their hypothesized subscales than those with other subscales. The asthma sample group reported higher parent HRQOL and family functioning than the heart disease sample group. In the heart disease sample group, parents of outpatients reported higher parent HRQOL and family functioning than parents of inpatients. Confirmatory factor analysis showed that the instrument had marginally acceptable construct validity with some Goodness-of-Fit indices not reaching the standard indicating acceptable model fit.
Conclusions
The Chinese version of the PedsQL™ Family Impact Module has adequate psychometric properties and could be used to assess the impacts of pediatric asthma or pediatric heart disease on parent HRQOL and family functioning in China. This instrument should be field tested on parents of children with other chronic medical conditions in other areas. Construct validity tested by confirmatory factor analysis and test-retest reliability should be further assessed.
doi:10.1186/1477-7525-9-16
PMCID: PMC3072920  PMID: 21429195
19.  Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module 
Background
Generic utility instruments may not fully capture the impact and consequences of urinary problems. Condition-specific preference-based measures, developed from previously validated disease-specific patient-reported outcomes instruments, may add relevant information for economic evaluations. The aim of this study was to develop a condition-specific preference-based measure, the Incontinence Utility Index (IUI), for valuing health states associated with urinary problems.
Methods
A two-step process was implemented. First, an abbreviated health state classification system was developed from the Incontinence Quality of Life Questionnaire (I-QOL) and Neurogenic Module by applying Rasch modelling, classical psychometrical testing and expert criteria to data from two pivotal trials comprised of neurogenic detrusor overactivity (NDO) patients. Criterion, convergent validity and concordance with the original instrument was assessed in the abbreviated version. Then, a multi-attribute utility function (MAUF) was estimated from a representative sample of the UK non-institutionalized adult general population. Visual analogue and time-trade off (TTO) evaluations were applied in the elicitation process. Predictive validity of the MAUF was tested comparing estimated and direct utility scores.
Results
The abbreviated health state classification system generated from the NDO sample contained 5 attributes with 3 levels of response and had adequate psychometrical properties: significant differences in scores according to the reduction in the frequency of urinary incontinence episodes [UIE] (p < 0.001); Spearman correlation coefficient with number of daily UIE = −0.43; p < 0.01 and Intraclass Correlation Coefficient (ICC, 95% CI) with the original version = 0.90 (0.89-0.91; p < 0.001). Next, 442 participants were interviewed (398 cases were valid, generating 2,388 TTO evaluations) to estimate the social preferences for derived health states. Mean age was 44.75 years (interquartile range 33.5-55.5) and 60.1% were female. An overall algorithm for the IUI was estimated and transformed onto a dead = 0.00 and full health = 1.00 scale. Model fits were acceptable (R-squared = 0.923 and 0.978). Predictive validity was adequate: ICC (95% CI) = 0.928 (0.648-0.985) and Mean of Absolute Differences = 0.038.
Conclusions
The newly developed IUI is a preference-based measure for urinary problems related to NDO that provides general population-based utility scores with adequate predictive validity.
Trial registration
ClinicalTrials.gov: NCT00461292, NCT00311376.
Electronic supplementary material
The online version of this article (doi:10.1186/s12955-014-0147-7) contains supplementary material, which is available to authorized users.
doi:10.1186/s12955-014-0147-7
PMCID: PMC4196092  PMID: 25288099
Overactive bladder; Urinary incontinence; Utility; Preference; Quality of life; Multi-attribute theory
20.  Validity and reliability of a new, short symptom rating scale in patients with persistent atrial fibrillation 
Background
Symptoms related to atrial fibrillation and their impact on health-related quality of life (HRQoL) are often evaluated in clinical trials. However, there remains a need for a properly validated instrument. We aimed to develop and validate a short symptoms scale for patients with AF.
Methods
One hundred and eleven patients with a variety of symptoms related to AF were scheduled for DC cardioversion. The mean age was 67.1 ± 12.1 years, and 80% were men. The patients completed the new symptoms scale, the Toronto Symptoms Check List (SCL) and the generic Short Form 36 (SF-36) the day before the planned DC cardioversion. Compliance was excellent, with only 1 of 666 answers missing.
Results
One item, 'limitations in working capability', was deleted because of a low numerical response rate, as many of the patients were retired. The internal consistency reliability of the remaining six items was 0.81 (Cronbach's α). Patients scored highest in the items of 'dyspnoea on exertion', 'limitations in daily life due to AF' and 'fatigue due to AF', with scores of 4.5, 3.3 and 4.5, respectively. There was a good correlation to all relevant SF-36 domains and to the relevant questions of the SCL. The Rasch analyses showed that the items are unidimensional and that they are clearly separated and cover an adequate range. Test-retest reliability was performed in patients who failed DC and was adequate for three of six items, >0.70.
Conclusion
The psychometric characteristics of the new short symptoms scale were found to have satisfactory reliability and validity.
doi:10.1186/1477-7525-7-65
PMCID: PMC2717073  PMID: 19604399
21.  The WHO-DAS II: Psychometric Properties in the Measurement of Functional Health Status in Adults With Acquired Hearing Loss 
Trends in Amplification  2005;9(3):111-126.
The World Health Organization's (WHO) Disability Assessment Scale II (WHO-DAS II) is a generic health-status instrument firmly grounded in the WHO's International Classification of Functioning, Disability and Health (WHO-ICF). As such, it assesses functioning for six domains: communication, mobility, self-care, interpersonal, life activities, and participation. Domain scores aggregate to a total score. Because the WHO-DAS II contains questions relevant to hearing and communication, it has good face validity for use as an outcome measure for audiologic intervention. The purpose of the present study was to determine the psychometric properties of the WHO-DAS II on a sample of individuals with adult-onset hearing loss, including convergent validity, internal consistency, and test-retest stability. Convergent validity was established by examining correlations between the WHO-DAS II (domain and total scores) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Hearing Aid Handicap for the Elderly (HHIE), two disease-specific measures, as well as with the Short Form-36 for veterans (SF-36V), a second generic measure. Data on all four measures were collected from 380 older individuals with adult-onset hearing loss who were not hearing aid users. The results of the convergent validity analysis revealed that the WHO-DAS II communication domain score was moderately and significantly correlated with scores on the APHAB and the HHIE. WHO-DAS II interpersonal and participation domain scores and the total scores were also moderately and significantly correlated with HHIE scores. These findings support the validity of using the WHO-DAS II for assessing activity limitations and participation restrictions of adult-onset hearing loss. Several WHO-DAS II domain scores and the total score were also significantly and moderately-markedly correlated with scores from the SF-36V. These findings support the validity of the WHO-DAS II as a generic health-status instrument. Internal consistency reliability for all the domain scores was adequate for all but the interpersonal domain. Test-retest stability for all the domain scores was adequate. Critical difference values were calculated for use in clinical application of the WHO-DAS II. From these findings, we concluded that the WHO-DAS II communication, participation, and total scores can be used to examine the effects of adult-onset hearing loss on functional health status. Further work examining the utility of the WHO-DAS II as an outcome measure for hearing aid intervention is warranted.
doi:10.1177/108471380500900303
PMCID: PMC4111522  PMID: 16244758
22.  Validation of a specific measure to assess health-related quality of life in patients with schizophrenia and bipolar disorder: the 'Tolerability and quality of life' (TOOL) questionnaire 
Background
Perception of quality of life may differ depending on the perspective. The aim of the study was to assess the psychometric properties of the Spanish version of the 'TOlerability and quality Of Life' (TOOL) questionnaire, a specific self-rated instrument to evaluate the impact of side effects of antipsychotic drugs on health-related quality of life (HRQoL). The questionnaire consists of eight items answered on a four-point Likert scale.
Methods
A psychometric study was conducted with clinically stable outpatients with schizophrenia and bipolar disorder under antipsychotic treatment. The translation and cultural adaptation of the questionnaire was performed according to international standards. Internal consistency using the Cronbach α coefficient and test-retest reliability using the intraclass correlation coefficient (ICC) was used to assess the reliability of the instrument. Patients completed generic and specific measures of quality of life and clinical severity.
Results
A total of 238 patients were analysed, with a mean age of 42 years (SD 10.9). The mean completion time was 4.9 min (SD 4.4). Internal consistency and intraclass correlation coefficient were adequate (Cronbach α = 0.757 and ICC = 0.90). Factorial analysis showed a unidimensional structure (a single eigenvalue >1, accounting for 39.1% of variance). Significant Spearman's rank correlations between the TOOL and both generic and specific measures were found. The questionnaire was able to discriminate among the Clinical Global Impression - Severity scores (Mann-Whitney U test, P < 0.001).
Conclusions
The TOOL questionnaire shows appropriate feasibility, reliability, and discriminative performance as a patient-reported outcome. TOOL constitutes a valuable addition to measure the impact of adverse events of antipsychotic drugs from the patient perspective.
doi:10.1186/1744-859X-10-6
PMCID: PMC3062605  PMID: 21396102
23.  The Barretos short instrument for assessment of quality of life (BSIqol): development and preliminary validation in a cohort of cancer patients undergoing antineoplastic treatment 
Background
To be clinically useful, an instrument assessing health-related quality of life (HRQOL) should be easy to understand and quick to answer. Few instruments have been designed to be short, simple, and easily understandable by patients from all educational levels. The aim of the present study was to evaluate the psychometric properties of a brief general instrument developed to assess HRQOL.
Methods
Results from a preliminary study regarding the initial development of the Barretos Short Instrument for Assessment of Quality of Life (BSIqol) with 80 cancer patients are presented. Out of all the patients, 59 completed the BSIqol on two occasions in order to evaluate the reproducibility test-retest. Validity analyses were done comparing scores from BSIqol with EORTC QLQ-C30 and Edmonton Symptom Assessment System (ESAS). In addition, BSIqol scores were analyzed in function of ECOG-PS, work activity, and financial income.
Results
BSIqol demonstrated good internal consistency (Cronbach's α = 0.79) and adequate test-retest reliability, with intraclass coefficient correlation (ICC) varying from 0.736 to 0.946. There were adequate correlations between scores of BSIqol, EORTC QLQ-C30 and ESAS. The BSIqol was capable of discriminating between clinical subgroups, with different ECOG-PS and work activity. Patients completed the BSIqol in a median time <2 min. Only one patient reported some difficulty to answer the instrument.
Conclusions
BSIqol seems to be a straightforward and useful instrument for rapidly assessing HRQOL from cancer patients. Further studies are necessary to evaluate BSIqol in different populations and also to assess its responsiveness and define its minimal clinically important differences.
doi:10.1186/1477-7525-10-144
PMCID: PMC3541104  PMID: 23192011
Quality of life; Questionnaire development; Reliability; Validity; Cancer
24.  The merits and problems of Neuropsychiatric Inventory as an assessment tool in people with dementia and other neurological disorders 
Objective
The Neuropsychiatric Inventory (NPI) is one of the most commonly used assessment scales for assessing symptoms in people with dementia and other neurological disorders. This paper analyzes its conceptual framework, measurement mode, psychometric properties, and merits and problems.
Method
All articles discussing the psychometric properties and factor structure of the NPI were searched for in Medline via Ovid. The abstracts of these papers were read to determine their relevance to the purpose of this paper. If deemed appropriate, a full paper was then obtained and read.
Results
The NPI has reasonably good content validity and internal consistency, and good test–retest and interrater reliability. There is limited information about its sensitivity, specificity, positive and negative predictive values, and, in particular, responsiveness. Merits of the NPI include being comprehensive, avoiding symptom overlap, ease of use, and flexibility. It has problems in scoring (no multiples of 5, 7, and 11) and, therefore, analysis using parametric tests may not be appropriate. The use of individual subscales also warrants further investigation.
Conclusion
In terms of its content and concurrent validity, intra- and interrater reliability, test–retest reliability, and internal consistency, the NPI can be considered as valid and reliable, and can be used across different ethnic groups. The tool is most likely unable to deliver as good a performance in terms of discriminating between different disorders. More studies are required to further evaluate its psychometric properties, particularly in the areas of factor structure and responsiveness. The clinical utility of the NPI also needs to be further explored.
doi:10.2147/CIA.S63504
PMCID: PMC4099101  PMID: 25031530
measurement; neuropsychiatric symptoms; outcome assessment
25.  A comparison of EQ-5D index scores using the UK, US, and Japan preference weights in a Thai sample with type 2 diabetes 
Background
Data are scarce on the comparison of EQ-5D index scores using the UK, US, and Japan preference weights in other populations. This study was aimed to examine the differences and agreements between these three weights, psychometric properties including test-retest reliability, convergent and known-groups validity, and the impact of differences in the EQ-5D scores on the outcome of cost-utility analysis in Thai people.
Methods
A convenience sample of 303 type 2 diabetic outpatients (18 years or older) from a cross-sectional study was examined. ANOVA and pos-hoc Bonferroni tests were used to determine the differences among the three EQ-5D scores. The agreements among the EQ-5D scores were assessed employing intraclass correlations coefficients (ICCs) and Bland-Altman plots. The ICCs were utilized to examine the test-retest reliability. Spearman's rho correlation coefficients were used to assess the convergent validity between the EQ-5D scores and sociodemographic & clinical data, and health status. Mann-Whitney U tests were used to test the differences in EQ-5D scores between the known groups including HbA1c level (cut point of 7%), and the presence of diabetic complications namely neuropathy, retinopathy, nephropathy and cardiovascular diseases. Seven hypothetical decision trees were created to evaluate the impact of differences in the EQ-5D scores on the incremental cost-utility ratio (ICUR).
Results
The US weights yielded higher scores than those of the UK and the Japan weights (p < 0.001, both), while the UK and the Japan weighted scores did not differ (p > 0.05). Both UK and US scores had more agreement with each other than with the Japan scores. Regarding psychometric properties, the Japan scheme provided better test-retest reliability, convergent and known-groups validity than both UK and US schemes. The variation in EQ-5D scores estimated from UK, US, and Japan preference weights had a marginal impact on ICUR (range: 1.23–6.32%).
Conclusion
Since the Japan model showed more preferable psychometric properties than the UK and the US models and the differences in these EQ-5D scores had a small impact on ICUR, we recommended that for both clinical and policy purposes the Japan scheme should be used in Thai people. However, more research needs to be done.
doi:10.1186/1477-7525-6-71
PMCID: PMC2559828  PMID: 18811935

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