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1.  The Malawi Developmental Assessment Tool (MDAT): The Creation, Validation, and Reliability of a Tool to Assess Child Development in Rural African Settings 
PLoS Medicine  2010;7(5):e1000273.
Melissa Gladstone and colleagues evaluate the reliability and validity of an assessment tool for evaluating child development in rural African settings.
Background
Although 80% of children with disabilities live in developing countries, there are few culturally appropriate developmental assessment tools available for these settings. Often tools from the West provide misleading findings in different cultural settings, where some items are unfamiliar and reference values are different from those of Western populations.
Methods and Findings
Following preliminary and qualitative studies, we produced a draft developmental assessment tool with 162 items in four domains of development. After face and content validity testing and piloting, we expanded the draft tool to 185 items. We then assessed 1,426 normal rural children aged 0–6 y from rural Malawi and derived age-standardized norms for all items. We examined performance of items using logistic regression and reliability using kappa statistics. We then considered all items at a consensus meeting and removed those performing badly and those that were unnecessary or difficult to administer, leaving 136 items in the final Malawi Developmental Assessment Tool (MDAT). We validated the tool by comparing age-matched normal children with those with malnutrition (120) and neurodisabilities (80). Reliability was good for items remaining with 94%–100% of items scoring kappas >0.4 for interobserver immediate, delayed, and intra-observer testing. We demonstrated significant differences in overall mean scores (and individual domain scores) for children with neurodisabilities (35 versus 99 [p<0.001]) when compared to normal children. Using a pass/fail technique similar to the Denver II, 3% of children with neurodisabilities passed in comparison to 82% of normal children, demonstrating good sensitivity (97%) and specificity (82%). Overall mean scores of children with malnutrition (weight for height <80%) were also significantly different from scores of normal controls (62.5 versus 77.4 [p<0.001]); scores in the separate domains, excluding social development, also differed between malnourished children and controls. In terms of pass/fail, 28% of malnourished children versus 94% of controls passed the test overall.
Conclusions
A culturally relevant developmental assessment tool, the MDAT, has been created for use in African settings and shows good reliability, validity, and sensitivity for identification of children with neurodisabilities.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Babies can do very little when they are first born. But, gradually, over the first few years of life, they learn to walk and run (gross motor skills), they learn to manipulate objects with their hands (fine motor skills), they learn to communicate with words and gestures (language skills), and they learn how to interact with other people (social skills). For each of these skill “domains,” experts have identified “developmental milestones,” skills that are acquired by a specific age if development is proceeding normally. So, for example, by one year, a child should be able crawl, put objects into a container, respond to simple verbal requests, and enjoy imitating people during play. Every child attains the various developmental milestones at a slightly different age but their overall development can be monitored using a series of simple tests (items) covering each of the developmental domains. Clinicians and teachers can use these “developmental assessment tools” to identify children whose development deviates significantly from the norm. It is important to identify these children as young as possible because early intervention can help them reach their full developmental potential.
Why Was This Study Done?
In developing countries, poverty, poor health, and malnutrition are responsible for millions of children failing to reach their developmental potential. But because developmental assessment tools have mainly been designed and validated in western, developed countries, they contain many items that are alien to children in non-western cultures (for example, the use of knives and forks for eating and the use of specific gestures). They cannot, therefore, accurately assess whether a child living in, for example, a rural area of Africa, is developing normally. In this study, the researchers describe the creation and testing of a culturally appropriate developmental assessment tool for use in rural Africa—the Malawi Developmental Assessment Tool (MDAT)—from a 162-item draft tool (MDAT Draft I) that they previously developed from Denver II, an assessment tool widely used in developed countries.
What Did the Researchers Do and Find?
The researchers assessed the “face validity” (do the items look acceptable to untrained judges?) and “content validity” (does the tool examine all the domains it is meant to measure?) of MDAT Draft I and modified it to produce MDAT Draft II. After piloting this version on 80 children in rural Malawi, they modified it further to produce MDAT Draft III, which was used to assess 1,426 normal children aged 0–6 years from rural Malawi and to derive age-standardized norms for each item. After statistically analyzing the performance of each item in MDAT Draft III, all the items were considered at a consensus meeting, and items that were badly performing, unnecessary, and difficult to administer were removed, leaving 136 items (MDAT). The researchers then validated MDAT by using it to assess children with neurodisabilities (disorders of the nervous system that impair normal functioning) and children with delayed development because of malnutrition. The tool was reliable (different testers got similar results for individual children and individual testers got similar results when they retested specific children), sensitive (it correctly identified most children with a neurodisability or delayed development), and specific (it correctly identified most children who were developing normally; that is, it did not give false-positive results).
What Do These Findings Mean?
These findings show that MDAT is a culturally relevant assessment tool that reliably identifies children with neurodisabilities and delayed development in rural Malawi. Importantly, they also provide a detailed illustration of how to create and validate a culturally relevant assessment tool. Although MDAT is likely to be applicable in other similar settings, further research is needed to test its generalizability and to test whether it will work in children with more subtle developmental problems. MDAT, the researchers note, should be useful as a clinical tool for the early identification of neurodisabilities and as an outcome measure in clinical trials of interventions designed to improve child development. However, they stress, because developing countries have limited resources available for screening and for helping children whose development is delayed or disrupted, for now tools like MDAT are more likely to be used for research studies than for routine developmental assessments in Malawi and other African countries.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000273.
The World Health Organization has information on disability, prevention, and management in children and adults worldwide
UNICEF has a site on early childhood and in particular, provides information on programming experiences for early child intervention programs worldwide
Disability World is a website for international views and perspectives on disability worldwide. It provides information and links about the worldwide state of disability in children and adults in developing countries
Source, the International Information Support Centre has a good website of information about disability, inclusion, and development in children with links to many other sources of information
Wikipedia has a page on child development (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US Centers for Disease Control and Prevention provides information on developmental screening and on developmental milestones
The American Academy of Pediatrics also provides information on developmental stages and on developmental milestones
The UK National Health Service Choices site has an interactive guide to child development
MedlinePlus has links to further resources on infant and toddler development (in English and Spanish)
doi:10.1371/journal.pmed.1000273
PMCID: PMC2876049  PMID: 20520849
2.  The Caregiver Burden Questionnaire for Heart Failure (CBQ-HF): face and content validity 
Background
A new caregiver burden questionnaire for heart failure (CBQ-HF v1.0) was developed based on previously conducted qualitative interviews with HF caregivers and with input from HF clinical experts. Version 1.0 of the CBQ-HF included 41 items measuring the burden associated with caregiving in the following domains: physical, emotional/psychological, social, and impact on caregiver’s life. Following initial development, the next stage was to evaluate caregivers’ understanding of the questionnaire items and their conceptual relevance.
Methods
To evaluate the face and content validity of the new questionnaire, cognitive interviews were conducted with caregivers of heart failure patients. The cognitive interviews included a “think aloud” exercise as the patient completed the CBQ-HF, followed by more specific probing questions to better understand caregivers’ understanding, interpretation and the relevance of the instructions, items, response scales and recall period.
Results
Eighteen caregivers of heart failure patients were recruited. The mean age of the caregivers was 50 years (SD = 10.2). Eighty-three percent of caregivers were female and most commonly the patient was either a spouse (44%) or a parent (28%). Among the patients 55% were NYHA Class 2 and 45% were NYHA Class 3 or 4. The caregiver cognitive interviews demonstrated that the CBQ-HF was well understood, relevant and consistently interpreted. From the initial 41 item questionnaire, fifteen items were deleted due to conceptual overlap and/or item redundancy. The final 26-item CBQ-HF (v3.0) uses a 5-point Likert severity scale, assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens using a 4-week recall period.
Conclusions
The CBQ-HF (v3.0) is a comprehensive and relevant measure of subjective caregiver burden with strong content validity. This study has established that the CBQ-HF (v3.0) has strong face and content validity and should be valuable as an outcomes measure to help understand and monitor the relationship between patient heart failure severity and caregiver burden. A Translatability AssessmentSM of the measure has since been performed confirming the cultural appropriateness of the measure and psychometric validation is planned for the future to further explore the reliability, and validity of the new questionnaire in a larger caregiver sample.
doi:10.1186/1477-7525-11-84
PMCID: PMC3673843  PMID: 23706131
Heart failure; Caregiver burden; Instrument development; Patient-reported outcome; Content validity; Face validity; Family
3.  Development of a new tool for assessing Health-Related Quality of Life in patients with primary hyperparathyroidism 
Background
Several studies in recent years have evaluated Health Related Quality of Life (HRQoL) of patients with primary hyperparathyroidism (PHPT). No disease specific questionnaires are available to assess the impact of the disease. The aim of this research is to describe the development of a new disease specific Quality of Life (QoL) questionnaire for use specifically with PHPT patients.
Methods
A conceptual model was developed describing the impact of the disease and its symptoms on QoL domains. A literature review was conducted to identify the most relevant domains. A focus group with experts was used to validate the domains; 24 patients were also interviewed to complement the information from the patient’s perspective. A content analysis of the interviews was performed to identify items related with the impact of the disease, leading to PHPQoL-V.1 which was presented to a sample of 67 patients. Reliability was assessed by Cronbach’s coefficient alpha and item-total score correlations. Validity was assessed by a factor analysis performed to determine the number of domains. Rasch analysis was carried out in order to refine the questionnaire items.
Results
259 items were extracted from the interviews that were subsequently reduced to 34 items. Cronbach’s coefficient alpha was 0.92. The factor analysis extracted two domains (physical and emotional). After Rasch analysis the questionnaire PHPQoL-V.2 kept 16 items (9 physical and 7 emotional). The questionnaire was developed in a Spanish population and the final version was translated to English through translation and back-translation.
Conclusion
The first disease specific HRQoL questionnaire for PHPT patients (PHPQoL-16) has been developed. Validation studies designed to assess measurement properties of this tool are currently underway.
doi:10.1186/1477-7525-11-97
PMCID: PMC3710251  PMID: 23777622
4.  The Psychometric Properties of the Generalized Anxiety Disorder-7 scale in Hispanic Americans with English or Spanish Language Preference 
The Generalized Anxiety Disorder-7 scale (GAD-7) is a self-report questionnaire that is widely used to screen for anxiety. The GAD-7 has been translated into numerous languages, including Spanish. Previous studies evaluating the structural validity of the English and Spanish versions indicate a uni-dimensional factor structure in both languages. However, the psychometric properties of the Spanish language version have yet to be evaluated in samples outside of Spain, and the measure has not been tested for use among Hispanic Americans. This study evaluated the reliability, structural validity, and convergent validity of the English and Spanish language versions of the GAD-7 for Hispanic Americans in the United States. A community sample of 436 Hispanic Americans with an English (n = 210) or Spanish (n = 226) language preference completed the GAD-7. Multiple-group confirmatory factor analysis (CFA) was used to examine the goodness of fit of the uni-dimensional factor structure of the GAD-7 across language-preference groups. Results from the multiple-group CFA indicated a similar unidimensional factor structure with equivalent response patterns and item intercepts, but different variances, across language-preference groups. Internal consistency was good for both English and Spanish language-preference groups. The GAD-7 also evidenced good convergent validity as demonstrated by significant correlations in expected directions with the Perceived Stress Scale, the Patient Health Questionnaire-9, and the Physical health domain of the World Health Organization Quality of Life-BREF assessment. The uni-dimensional GAD-7 is suitable for use among Hispanic Americans with an English or Spanish language preference.
doi:10.1037/a0036523
PMCID: PMC4129392  PMID: 25045957
generalized anxiety disorder; Hispanic Americans; multiple-group confirmatory factor analysis; GAD-7
5.  New English and Spanish Social Health Measures Will Facilitate Evaluating Health Determinants 
Objective
To develop psychometrically sound, culturally relevant and linguistically equivalent English and Spanish self-report measures of social health guided by a comprehensive conceptual model and applicable across chronic illnesses.
Methods
The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health Workgroup implemented a mixed methods approach to evaluate earlier results (v1.0); expand and refine domain definitions and items; translate items into Spanish; and obtain qualitative feedback. Computer-based and paper/pencil questionnaire administration was conducted with a variety of U.S. respondent samples during 2009–2012. Analyses included exploratory factor analysis (EFA), confirmatory factor analysis (CFA), two-parameter logistic item response theory (IRT) modeling, evaluation of differential item functioning (DIF), and evaluation of criterion and construct validity.
Results
Qualitative feedback supported the conceptualization of the Social Health domain framework (Social Function and Social Relationships sub-components). Validation testing participants (n=2,208 English; n=644 Spanish) were diverse in terms of gender, age, education and ethnicity/race. EFA, CFA and IRT identified seven unidimensional factors with good model fit. There was no DIF by language, and good evidence of criterion and construct validity.
Conclusions
PROMIS English and Spanish language instruments (v2.0), including computer-adaptive tests and fixed-length short forms, are publicly available for assessment of Social Function (Ability to Participate in Social Roles and Activities, and Satisfaction with Social Roles and Activities) and Social Relationships (Companionship; Emotional, Informational and Instrumental Support; and Social Isolation). Measures of social health will play a key role in applications that use ecologic (or determinants of health) models that emphasize how patients’ social environments influence their health.
doi:10.1037/hea0000055
PMCID: PMC4159098  PMID: 24447188
patient-reported outcomes; social health; social function; social relationships; Hispanic Americans; psychometrics
6.  Cross-cultural adaptation of the Schizophrenia Caregiver Questionnaire (SCQ) and the Caregiver Global Impression (CaGI) Scales in 11 languages 
Background
The Schizophrenia Caregiver Questionnaire (SCQ) was developed to provide a comprehensive view of caregivers’ subjective experiences of the impacts of caring for someone with schizophrenia. The Caregiver Global Impression (CaGI) scales were designed to assess their perception of the severity of the schizophrenia symptoms, of change in schizophrenia symptoms and in the experience of caring since the beginning of the study. The objectives of the study were to translate the SCQ and CaGI scales in 11 languages [French (Canada, France), English (Canada, UK, Australia), German (Germany), Italian (Italy), Spanish (Spain), Dutch (the Netherlands), Finnish (Finland), and Swedish (Sweden)], to present evidence that the translations capture the concepts of the original questionnaires and are well understood by caregivers of patients with schizophrenia in each target country.
Methods
The different language versions were developed using a standard or adjusted linguistic validation process fully complying with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommended procedures.
Results
Interviews were conducted with 55 caregivers of patients with schizophrenia from 10 countries representing the 11 different languages. Participants ranged in age from 28 to 84 years and had 5 to 16 years of education. Women represented 69.1 % (38/55) of the sample. Fourteen out of the 32 items of the SCQ generated difficulties which were mostly of semantic origin (13 items). The translation of the CaGI scales did not raise any major difficulty. Only five out of the 55 caregivers had difficulty understanding the meaning of the translations of “degree” in the expressions “degree of change in experience of caring” and “degree of change in symptoms”.
Conclusions
Translations of the SCQ and CaGI scales into 11 languages adequately captured the concepts in the original English versions of the questionnaires, thereby demonstrating the conceptual, semantic, and cultural equivalence of each translation.
doi:10.1186/s12955-015-0264-y
PMCID: PMC4459060  PMID: 26050597
Schizophrenia; Caregiver; Clinical outcome assessment; Translation; Cross-cultural adaptation
7.  Evaluating Psychometric Properties of the Spanish-version of the Pediatric Functional Assessment of Chronic Illness Therapy-Perceived Cognitive Function (pedsFACIT-PCF) 
Purpose
The pediatric Functional Assessment of Chronic Illness Therapy-Perceived Cognitive Function (pedsFACIT-PCF) is a 13-item short-form derived from the pediatric Perceived Cognitive Function item bank (pedsPCF), which was developed to measure children’s daily cognitive behaviors and was validated on the US general population and children with cancer. This study evaluated the psychometric properties of Spanish language pedsFACIT-PCF and the measurement equivalence between Spanish and English versions.
Methods
pedsFACIT-PCF items were translated into Spanish using a standard iterative methodology. A total of 1358 English- and 604 Spanish-speaking children aged 8–17 years who completed English and Spanish versions of pedsFACIT-PCF, respectively, were administered through an Internet survey company. Unidimensionality was evaluated using confirmatory factor analysis. Item responses were modeled using item response theory. The presence and impact of differential item functioning (DIF) were evaluated using ordinal logistic regression.
Results
Unidimensionality of the pedsFACIT-PCF was supported. One of the 13 items demonstrated statistically significant DIF by language; however, impacts of language DIF on both individual scores and at the test level were negligible. No Spanish items showed DIF with respect to age and gender.
Conclusions
The 13-item pedsFACIT-PCF demonstrated stable measurement properties on language, gender and age and can be used for future trials.
doi:10.1007/s11136-015-0949-z
PMCID: PMC4531106  PMID: 25749924
Perceived Cognitive Function; Children; Differential item functioning; Language; Age; Gender
8.  Accounting for the effect of GERD symptoms on patients’ health-related quality of life: supporting optimal disease management by primary care physicians 
Aim
To review, from a primary care physician (PCP) perspective, the use of patient-reported outcome (PRO) instruments for assessment of gastro-oesophageal reflux disease (GERD) symptoms, their impact on health-related quality of life (HRQL) and the effectiveness of therapy.
Results
While generic and disease-specific PRO instruments have been used in the assessment of GERD, the latter can be considered to be more appropriate as they focus only on problems relevant to the disease in question (and therefore tend to be more responsive to change). Such instruments include the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and the Gastrointestinal Symptom Rating Scale and the Reflux Disease Questionnaire (RDQ). Their use indicates that GERD symptoms are troublesome and significantly reduce patients’ HRQL, and that effective treatment of GERD improves HRQL. The GERD Impact Scale (GIS) questionnaire, primarily developed for use within primary care, can also help to determine the impact of symptoms on patients’ everyday lives and, in turn, the benefit of appropriately targeted therapy. Notably, these PRO instruments were developed from focus groups of GERD patients, and only aspects rated of highest importance are used in the final instruments. Consequently, PCPs can feel confident that these questionnaires encompass the most relevant points that they are likely to ask in terms of how symptoms affect patients’ everyday lives.
Conclusions
Primary care physicians are encouraged to make wider use of PRO instruments within routine practice to improve communication with their GERD patients that, in turn, could lead to improved clinical outcomes and greater patient satisfaction.
Review CriteriaWe conducted a review of validated patient-reported outcome (PRO) instruments used in gastro-oesophageal reflux disease (GERD), based on the authors’ expertise in the field and a supplementary MEDLINE search with the terms ‘health-related quality of life’, ‘quality of life questionnaire’, ‘patient-reported outcomes’, ‘patient satisfaction’ and ‘gastro-oesophageal reflux disease’.We reviewed papers reporting health-related quality of life (HRQL) data in patients with GERD, including the effect of GERD on HRQL, treatment efficacy and HRQL, patient satisfaction and physician-patient agreement, to help primary care physicians to incorporate PRO instruments into their day-to-day management of patients with GERD.Message for the ClinicAn evidence-based review shows that PRO instruments can accurately assess the nature of GERD symptoms, their impact on HRQL and the efficacy of treatment.Primary care physicians are encouraged to make wider use of PRO instruments as part of their management of patients with GERD, given that such questionnaires can facilitate patient communication and help physicians understand and satisfy the therapeutic needs of their patients.Among validated PRO instruments, the GERD Impact Scale represents a practical tool that is easy for primary care physicians to incorporate into their everyday practice.
doi:10.1111/j.1742-1241.2007.01586.x
PMCID: PMC2228387  PMID: 17927764
9.  Using Qualitative Methods to Improve Questionnaires for Spanish Speakers: Assessing Face Validity of a Food Behavior Checklist 
Development of outcome measures relevant to health nutrition behaviors requires a rigorous process of testing and revision. Whereas researchers often report performance of quantitative data collection to assess questionnaire validity and reliability, qualitative testing procedures are often overlooked. This report outlines a procedure for assessing face validity of a Spanish-language dietary assessment tool. Reviewing the literature produced no rigorously validated Spanish-language food behavior assessment tools for the US Department of Agriculture’s food assistance and education programs. In response to this need, this study evaluated the face validity of a Spanish-language food behavior checklist adapted from a 16-item English version of a food behavior checklist shown to be valid and reliable for limited-resource English speakers. The English version was translated using rigorous methods involving initial translation by one party and creation of five possible versions. Photos were modified based on client input and new photos were taken as necessary. A sample of low-income, Spanish-speaking women completed cognitive interviews (n=20). Spanish translation experts (n=7) fluent in both languages and familiar with both cultures made minor modifications but essentially approved client preferences. The resulting checklist generated a readability score of 93, indicating low reading difficulty. The Spanish-language checklist has adequate face validity in the target population and is ready for further validation using convergent measures. At the conclusion of testing, this instrument may be used to evaluate nutrition education interventions in California. These qualitative procedures provide a framework for designing evaluation tools for low-literate audiences participating in the US Department of Agriculture food assistance and education programs.
doi:10.1016/j.jada.2009.10.002
PMCID: PMC4671629  PMID: 20102831
10.  Assessment of the Equivalence of the Spanish and English Versions of the CAHPS® Hospital Survey on the Quality of Inpatient Care 
Health Services Research  2005;40(6 Pt 2):2140-2161.
Objective
To describe translation and cultural adaptation procedures, and examine the degree of equivalence between the Spanish and English versions of the Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessments of Healthcare Providers and Systems (CAHPS®) Hospital Survey (H-CAHPS®) of patient experiences with care.
Data Sources
Cognitive interviews on survey comprehension with 12 Spanish-speaking and 31 English-speaking subjects. Psychometric analyses of 586 responses to the Spanish version and 19,134 responses to the English version of the H-CAHPS survey tested in Arizona, Maryland, and New York in 2003.
Study Design
A forward/backward translation procedure followed by committee review and cognitive testing was used to ensure a translation that was both culturally and linguistically appropriate. Responses to the two language versions were compared to evaluate equivalence and assess the reliability and validity of both versions.
Data Collection/Extraction Methods
Comparative analyses were carried out on the 32 items of the shortened survey version, focusing on 16 items that comprise seven composites representing different aspects of hospital care quality (communication with nurses, communication with doctors, communication about medicines, nursing services, discharge information, pain control, and physical environment); three items that rate the quality of the nursing staff, physician staff, and the hospital overall; one item on intention to recommend the hospital. The other 12 items used in the analyses addressed mainly respondent characteristics. Analyses included item descriptives, correlations, internal consistency reliability of composites, factor analysis, and regression analysis to examine construct validity.
Principal Findings
Responses to both language versions exhibit similar patterns with respect to item–scale correlations, factor structure, content validity, and the association between each of the seven qualities of care composites with both the hospital rating and intention to recommend the hospital. Internal consistency reliability was slightly, yet significantly lower for the Spanish-language respondents for five of the seven composites, but overall the composites were generally equivalent across language versions.
Conclusions
The results provide preliminary evidence of the equivalence between the Spanish and English versions of H-CAHPS. The translated Spanish version can be used to assess hospital quality of care for Spanish speakers, and compare results across these two language groups.
doi:10.1111/j.1475-6773.2005.00469.x
PMCID: PMC1361240  PMID: 16316442
Survey translation and adaptation; patient survey; language equivalence; hospital care quality; Spanish-language survey
11.  Acromegaly Quality of Life Questionnaire (AcroQoL) 
Acromegaly is a chronic disease with an important impact on patients, Health Related Quality of Life (HRQoL). The ability to effectively measure Health Related Quality of Life is central to describing the impacts of disease or treatment upon the patient, therefore the importance of having a disease specific questionnaire for acromegaly. For the development of the AcroQoL questionnaire different sources of information were used: first a literature search was performed to identify relevant papers describing the impact of acromegaly in HRQoL, second the main domains of impact on HRQoL were identified by 10 experts endocrinologists, and third ten in-depth semi-structured interviews were conducted in acromegalic patients to identify domains and items related to the self-perceived impact of acromegaly in patients' life. After a proper qualitative analysis a preliminary 38 item questionnaire was obtained. Rasch analysis concluded with a final 22 item questionnaire. The measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbach's Alpha and item-total correlation). The evaluation of the item parameters confirmed the construct validity of the new instrument. Responsiveness to change was assessed in a small sample of 32 acromegalic patients with active disease in Spain who were administered the AcroQoL and the generic questionnaire EuroQoL 5-D. The results showed a statistically significant relationship between all the dimensions of AcroQoL and the VAS (visual analogic scale) of EQ-5D. An improvement in the global score of AcroQoL was related to a global improvement in the VAS of the EQ-5D.
Following the current recommended standard methodology the Spanish questionnaire was translated into eleven other languages.
doi:10.1186/1477-7525-2-13
PMCID: PMC404471  PMID: 14987332
12.  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
13.  Caregiver- and Patient-Directed Interventions for Dementia 
Executive Summary
In early August 2007, the Medical Advisory Secretariat began work on the Aging in the Community project, an evidence-based review of the literature surrounding healthy aging in the community. The Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the ministry’s newly released Aging at Home Strategy.
After a broad literature review and consultation with experts, the secretariat identified 4 key areas that strongly predict an elderly person’s transition from independent community living to a long-term care home. Evidence-based analyses have been prepared for each of these 4 areas: falls and fall-related injuries, urinary incontinence, dementia, and social isolation. For the first area, falls and fall-related injuries, an economic model is described in a separate report.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html, to review these titles within the Aging in the Community series.
Aging in the Community: Summary of Evidence-Based Analyses
Prevention of Falls and Fall-Related Injuries in Community-Dwelling Seniors: An Evidence-Based Analysis
Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors: An Evidence-Based Analysis
Caregiver- and Patient-Directed Interventions for Dementia: An Evidence-Based Analysis
Social Isolation in Community-Dwelling Seniors: An Evidence-Based Analysis
The Falls/Fractures Economic Model in Ontario Residents Aged 65 Years and Over (FEMOR)
This report features the evidence-based analysis on caregiver- and patient-directed interventions for dementia and is broken down into 4 sections:
Introduction
Caregiver-Directed Interventions for Dementia
Patient-Directed Interventions for Dementia
Economic Analysis of Caregiver- and Patient-Directed Interventions for Dementia
Caregiver-Directed Interventions for Dementia
Objective
To identify interventions that may be effective in supporting the well-being of unpaid caregivers of seniors with dementia living in the community.
Clinical Need: Target Population and Condition
Dementia is a progressive and largely irreversible syndrome that is characterized by a loss of cognitive function severe enough to impact social or occupational functioning. The components of cognitive function affected include memory and learning, attention, concentration and orientation, problem-solving, calculation, language, and geographic orientation. Dementia was identified as one of the key predictors in a senior’s transition from independent community living to admission to a long-term care (LTC) home, in that approximately 90% of individuals diagnosed with dementia will be institutionalized before death. In addition, cognitive decline linked to dementia is one of the most commonly cited reasons for institutionalization.
Prevalence estimates of dementia in the Ontario population have largely been extrapolated from the Canadian Study of Health and Aging conducted in 1991. Based on these estimates, it is projected that there will be approximately 165,000 dementia cases in Ontario in the year 2008, and by 2010 the number of cases will increase by nearly 17% over 2005 levels. By 2020 the number of cases is expected to increase by nearly 55%, due to a rise in the number of people in the age categories with the highest prevalence (85+). With the increase in the aging population, dementia will continue to have a significant economic impact on the Canadian health care system. In 1991, the total costs associated with dementia in Canada were $3.9 billion (Cdn) with $2.18 billion coming from LTC.
Caregivers play a crucial role in the management of individuals with dementia because of the high level of dependency and morbidity associated with the condition. It has been documented that a greater demand is faced by dementia caregivers compared with caregivers of persons with other chronic diseases. The increased burden of caregiving contributes to a host of chronic health problems seen among many informal caregivers of persons with dementia. Much of this burden results from managing the behavioural and psychological symptoms of dementia (BPSD), which have been established as a predictor of institutionalization for elderly patients with dementia.
It is recognized that for some patients with dementia, an LTC facility can provide the most appropriate care; however, many patients move into LTC unnecessarily. For individuals with dementia to remain in the community longer, caregivers require many types of formal and informal support services to alleviate the stress of caregiving. These include both respite care and psychosocial interventions. Psychosocial interventions encompass a broad range of interventions such as psychoeducational interventions, counseling, supportive therapy, and behavioural interventions.
Assuming that 50% of persons with dementia live in the community, a conservative estimate of the number of informal caregivers in Ontario is 82,500. Accounting for the fact that 29% of people with dementia live alone, this leaves a remaining estimate of 58,575 Ontarians providing care for a person with dementia with whom they reside.
Description of Interventions
The 2 main categories of caregiver-directed interventions examined in this review are respite care and psychosocial interventions. Respite care is defined as a break or relief for the caregiver. In most cases, respite is provided in the home, through day programs, or at institutions (usually 30 days or less). Depending on a caregiver’s needs, respite services will vary in delivery and duration. Respite care is carried out by a variety of individuals, including paid staff, volunteers, family, or friends.
Psychosocial interventions encompass a broad range of interventions and have been classified in various ways in the literature. This review will examine educational, behavioural, dementia-specific, supportive, and coping interventions. The analysis focuses on behavioural interventions, that is, those designed to help the caregiver manage BPSD. As described earlier, BPSD are one of the most challenging aspects of caring for a senior with dementia, causing an increase in caregiver burden. The analysis also examines multicomponent interventions, which include at least 2 of the above-mentioned interventions.
Methods of Evidence-Based Analysis
A comprehensive search strategy was used to identify systematic reviews and randomized controlled trials (RCTs) that examined the effectiveness of interventions for caregivers of dementia patients.
Questions
Section 2.1
Are respite care services effective in supporting the well-being of unpaid caregivers of seniors with dementia in the community?
Do respite care services impact on rates of institutionalization of these seniors?
Section 2.2
Which psychosocial interventions are effective in supporting the well-being of unpaid caregivers of seniors with dementia in the community?
Which interventions reduce the risk for institutionalization of seniors with dementia?
Outcomes of Interest
any quantitative measure of caregiver psychological health, including caregiver burden, depression, quality of life, well-being, strain, mastery (taking control of one’s situation), reactivity to behaviour problems, etc.;
rate of institutionalization; and
cost-effectiveness.
Assessment of Quality of Evidence
The quality of the evidence was assessed as High, Moderate, Low, or Very low according to the GRADE methodology and GRADE Working Group. As per GRADE the following definitions apply:
Summary of Findings
Conclusions in Table 1 are drawn from Sections 2.1 and 2.2 of the report.
Summary of Conclusions on Caregiver-Directed Interventions
There is limited evidence from RCTs that respite care is effective in improving outcomes for those caring for seniors with dementia.
There is considerable qualitative evidence of the perceived benefits of respite care.
Respite care is known as one of the key formal support services for alleviating caregiver burden in those caring for dementia patients.
Respite care services need to be tailored to individual caregiver needs as there are vast differences among caregivers and patients with dementia (severity, type of dementia, amount of informal/formal support available, housing situation, etc.)
There is moderate- to high-quality evidence that individual behavioural interventions (≥ 6 sessions), directed towards the caregiver (or combined with the patient) are effective in improving psychological health in dementia caregivers.
There is moderate- to high-quality evidence that multicomponent interventions improve caregiver psychosocial health and may affect rates of institutionalization of dementia patients.
RCT indicates randomized controlled trial.
Patient-Directed Interventions for Dementia
Objective
The section on patient-directed interventions for dementia is broken down into 4 subsections with the following questions:
3.1 Physical Exercise for Seniors with Dementia – Secondary Prevention
What is the effectiveness of physical exercise for the improvement or maintenance of basic activities of daily living (ADLs), such as eating, bathing, toileting, and functional ability, in seniors with mild to moderate dementia?
3.2 Nonpharmacologic and Nonexercise Interventions to Improve Cognitive Functioning in Seniors With Dementia – Secondary Prevention
What is the effectiveness of nonpharmacologic interventions to improve cognitive functioning in seniors with mild to moderate dementia?
3.3 Physical Exercise for Delaying the Onset of Dementia – Primary Prevention
Can exercise decrease the risk of subsequent cognitive decline/dementia?
3.4 Cognitive Interventions for Delaying the Onset of Dementia – Primary Prevention
Does cognitive training decrease the risk of cognitive impairment, deterioration in the performance of basic ADLs or instrumental activities of daily living (IADLs),1 or incidence of dementia in seniors with good cognitive and physical functioning?
Clinical Need: Target Population and Condition
Secondary Prevention2
Exercise
Physical deterioration is linked to dementia. This is thought to be due to reduced muscle mass leading to decreased activity levels and muscle atrophy, increasing the potential for unsafe mobility while performing basic ADLs such as eating, bathing, toileting, and functional ability.
Improved physical conditioning for seniors with dementia may extend their independent mobility and maintain performance of ADL.
Nonpharmacologic and Nonexercise Interventions
Cognitive impairments, including memory problems, are a defining feature of dementia. These impairments can lead to anxiety, depression, and withdrawal from activities. The impact of these cognitive problems on daily activities increases pressure on caregivers.
Cognitive interventions aim to improve these impairments in people with mild to moderate dementia.
Primary Prevention3
Exercise
Various vascular risk factors have been found to contribute to the development of dementia (e.g., hypertension, hypercholesterolemia, diabetes, overweight).
Physical exercise is important in promoting overall and vascular health. However, it is unclear whether physical exercise can decrease the risk of cognitive decline/dementia.
Nonpharmacologic and Nonexercise Interventions
Having more years of education (i.e., a higher cognitive reserve) is associated with a lower prevalence of dementia in crossectional population-based studies and a lower incidence of dementia in cohorts followed longitudinally. However, it is unclear whether cognitive training can increase cognitive reserve or decrease the risk of cognitive impairment, prevent or delay deterioration in the performance of ADLs or IADLs or reduce the incidence of dementia.
Description of Interventions
Physical exercise and nonpharmacologic/nonexercise interventions (e.g., cognitive training) for the primary and secondary prevention of dementia are assessed in this review.
Evidence-Based Analysis Methods
A comprehensive search strategy was used to identify systematic reviews and RCTs that examined the effectiveness, safety and cost effectiveness of exercise and cognitive interventions for the primary and secondary prevention of dementia.
Questions
Section 3.1: What is the effectiveness of physical exercise for the improvement or maintenance of ADLs in seniors with mild to moderate dementia?
Section 3.2: What is the effectiveness of nonpharmacologic/nonexercise interventions to improve cognitive functioning in seniors with mild to moderate dementia?
Section 3.3: Can exercise decrease the risk of subsequent cognitive decline/dementia?
Section 3.4: Does cognitive training decrease the risk of cognitive impairment, prevent or delay deterioration in the performance of ADLs or IADLs, or reduce the incidence of dementia in seniors with good cognitive and physical functioning?
Assessment of Quality of Evidence
The quality of the evidence was assessed as High, Moderate, Low, or Very low according to the GRADE methodology. As per GRADE the following definitions apply:
Summary of Findings
Table 2 summarizes the conclusions from Sections 3.1 through 3.4.
Summary of Conclusions on Patient-Directed Interventions*
Previous systematic review indicated that “cognitive training” is not effective in patients with dementia.
A recent RCT suggests that CST (up to 7 weeks) is effective for improving cognitive function and quality of life in patients with dementia.
Regular leisure time physical activity in midlife is associated with a reduced risk of dementia in later life (mean follow-up 21 years).
Regular physical activity in seniors is associated with a reduced risk of cognitive decline (mean follow-up 2 years).
Regular physical activity in seniors is associated with a reduced risk of dementia (mean follow-up 6–7 years).
Evidence that cognitive training for specific functions (memory, reasoning, and speed of processing) produces improvements in these specific domains.
Limited inconclusive evidence that cognitive training can offset deterioration in the performance of self-reported IADL scores and performance assessments.
1° indicates primary; 2°, secondary; CST, cognitive stimulation therapy; IADL, instrumental activities of daily living; RCT, randomized controlled trial.
Benefit/Risk Analysis
As per the GRADE Working Group, the overall recommendations consider 4 main factors:
the trade-offs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates, and the relative value placed on the outcome;
the quality of the evidence;
translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise; and
uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of health care alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 reflects the overall trade-off between benefits and harms (adverse events) and incorporates any risk/uncertainty (cost-effectiveness).
Overall Summary Statement of the Benefit and Risk for Patient-Directed Interventions*
Economic Analysis
Budget Impact Analysis of Effective Interventions for Dementia
Caregiver-directed behavioural techniques and patient-directed exercise programs were found to be effective when assessing mild to moderate dementia outcomes in seniors living in the community. Therefore, an annual budget impact was calculated based on eligible seniors in the community with mild and moderate dementia and their respective caregivers who were willing to participate in interventional home sessions. Table 4 describes the annual budget impact for these interventions.
Annual Budget Impact (2008 Canadian Dollars)
Assumed 7% prevalence of dementia aged 65+ in Ontario.
Assumed 8 weekly sessions plus 4 monthly phone calls.
Assumed 12 weekly sessions plus biweekly sessions thereafter (total of 20).
Assumed 2 sessions per week for first 5 weeks. Assumed 90% of seniors in the community with dementia have mild to moderate disease. Assumed 4.5% of seniors 65+ are in long-term care, and the remainder are in the community. Assumed a rate of participation of 60% for both patients and caregivers and of 41% for patient-directed exercise. Assumed 100% compliance since intervention administered at the home. Cost for trained staff from Ministry of Health and Long-Term Care data source. Assumed cost of personal support worker to be equivalent to in-home support. Cost for recreation therapist from Alberta government Website.
Note: This budget impact analysis was calculated for the first year after introducing the interventions from the Ministry of Health and Long-Term Care perspective using prevalence data only. Prevalence estimates are for seniors in the community with mild to moderate dementia and their respective caregivers who are willing to participate in an interventional session administered at the home setting. Incidence and mortality rates were not factored in. Current expenditures in the province are unknown and therefore were not included in the analysis. Numbers may change based on population trends, rate of intervention uptake, trends in current programs in place in the province, and assumptions on costs. The number of patients was based on patients likely to access these interventions in Ontario based on assumptions stated below from the literature. An expert panel confirmed resource consumption.
PMCID: PMC3377513  PMID: 23074509
14.  Validation of a Spanish language version of the pain self-perception scale in patients with fibromyalgia 
Background
The Pain Self-Perception Scale (PSPS) is a 24-item questionnaire used to assess mental defeat in chronic pain patients. The aim of this study was to develop a Spanish language version of the PSPS (PSPS-Spanish), to assess the instrument's psychometric properties in a sample of patients with fibromyalgia and to confirm a possible overlapping between mental defeat and pain catastrophizing.
Methods
The PSPS was translated into Spanish by three bilingual content and linguistic experts, and then back-translated into English to assess for equivalence. The final Spanish version was administered, along with the Hospital Anxiety Depression Scale (HADS), Pain Visual Analogue Scale (PVAS), Pain Catastrophizing Scale (PCS) and Fibromyalgia Impact Questionnaire (FIQ), to 250 Spanish patients with fibromyalgia.
Results
PSPS-Spanish was found to have high internal consistency (Cronbach's α = 0.90 and the item-total r correlation coefficients ranged between 0.68 and 0.86). Principal components analysis revealed a one-factor structure which explained 61.4% of the variance. The test-retest correlation assessed with the intraclass correlation coefficient, over a 1-2 weeks interval, was 0.78. The total PSPS score was significantly correlated with all the questionnaires assessed (HADS, PVAS, PCS, and FIQ).
Conclusions
The Spanish version of the PSPS appears to be a valid tool in assessing mental defeat in patients with fibromyalgia. In patients with fibromyalgia and Post-Traumatic Stress Disorder (PTSD), PSPS-Spanish correlates more intensely with FIQ than in patients without PTSD. Mental defeat seems to be a psychological construct different to pain catastrophizing.
doi:10.1186/1471-2474-11-255
PMCID: PMC2991283  PMID: 21050485
15.  Perceptions of the Pediatric Hospice Experience among English- and Spanish-Speaking Families 
Journal of Palliative Medicine  2016;19(1):30-41.
Abstract
Objective: Many children who die are eligible for hospice enrollment but little is known about parental perceptions of the hospice experience, the benefits, and disappointments. The objective of this study was to explore parental perspectives of the hospice experience in children with cancer, and to explore how race/ethnicity impacts this experience.
Study Design: We held 20 semistructured interviews with 34 caregivers of children who died of cancer and used hospice. Interviews were conducted in the caregivers' primary language: 12 in English and 8 in Spanish. Interviews were recorded, transcribed, and analyzed using accepted qualitative methods.
Results: Both English and Spanish speakers described the importance of honest, direct communication by medical providers, and anxieties surrounding the expectation of the moment of death. Five English-speaking families returned to the hospital because of unsatisfactory symptom management and the need for additional supportive services. Alternatively, Spanish speakers commonly stressed the importance of being at home and did not focus on symptom management. Both groups invoked themes of caregiver appraisal, but English-speaking caregivers more commonly discussed themes of financial hardship and fear of insurance loss, while Spanish-speakers focused on difficulties of bedside caregiving and geographic separation from family.
Conclusions: The intense grief associated with the loss of a child creates shared experiences, but Spanish- and English-speaking parents describe their hospice experiences in different ways. Additional studies in pediatric hospice care are warranted to improve the care we provide to children at the end of life.
doi:10.1089/jpm.2015.0137
PMCID: PMC4692131  PMID: 26618809
16.  Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing 
Purpose
Neuro-QOL provides a clinically relevant and psychometrically robust health-related quality of life (HRQL) assessment tool for both adults and children with common neurological disorders. We now report the psychometric results for the adult tools.
Methods
An extensive research, survey and consensus process was used to produce a list of 5 priority adult neurological conditions (stroke, multiple sclerosis, Parkinson’s disease, epilepsy and ALS). We identified relevant health related quality of life (HRQL) domains through multiple methods and data sources including a comprehensive review of the literature and literature search, expert interviews and surveys and patient and caregiver focus groups. The final domain framework consisted of 17 domains of Physical, Mental and Social health. There were five phases of item development: (1) identification of 3,482 extant items, (2) item classification and selection, (3) item review and revision, (4) cognitive interviews with 63 patients to assess their understanding of individual items and (5) field testing of 432 representative items.
Participants and Procedures
Participants were drawn from the US general population and clinical settings, and included both English and Spanish speaking subjects (N = 3,246). Confirmatory factor analysis (CFA) was used to evaluate the dimensionality of unidimensional domains. Where the domain structure was previously unknown, the dataset was split and first analyzed with exploratory factor analysis and then CFA. Samejima’s graded response model (GRM) was used to calculate IRT parameters. We further evaluated differential item functioning (DIF) on gender, education and age.
Results
Thirteen unidimensional calibrated item banks consisting of 297 items were developed. All of the tested item banks had high reliability and few or no locally dependent items. The range of item slopes and thresholds with good information are reported for each of the item banks. The banks can support CAT and the development of short forms.
Conclusion
The Neuro-QOL measurement system provides item banks and short forms that enable PRO measurement in neurological research, minimizes patient burden and can be used to create multiple instrument types minimizing standard error. The 17 adult measures include 13 calibrated item banks, 3 item pools available for calibration work by others, and 1 stand-alone scale (index). The Neuro-QOL instruments provide a “common metric” of representative concepts for use across patient groups in different studies.
doi:10.1007/s11136-011-9958-8
PMCID: PMC3889669  PMID: 21874314
Outcome measures; Quality of life; Neurological disorders; Computerized adaptive testing, item banking
17.  Validation and Diagnostic Usefulness of Gastroesophageal Reflux Disease Questionnaire in a Primary Care Level in Mexico 
Background/Aims
Different non-invasive diagnostics strategies have been used to assess patients with gastroesophageal reflux. Gastroesophageal reflux disease (GERD) questionnaire (GerdQ) is a 6-item, easy to use questionnaire that was developed primarily as a diagnostic tool for GERD in primary care. Our aim was to validate and assess diagnostic utility of GerdQ questionnaire in Mexican patients in the primary care setting.
Methods
The study was performed in 3 phases: (1) a questionnaire translation and comprehension study (n = 20), (2) are a reproducibility and validation study (50 patients and 50 controls) and (3) a study to assess the clinical utility in 252 subjects with GERD symptoms. Diagnostic accuracy was calculated using endoscopy and/or pH-metry as the gold standard.
Results
Internal consistency measured by the Cronbach’s α coefficient was 0.81 for patients and 0.90 for healthy controls, with a mixed coefficient of 0.93. Reproducibility for GerdQ was very good and its discriminating validity was 88%. Most of the patients with erosive reflux and non-erosive reflux with abnormal pH-metry had scores > 8, meanwhile most of the patients with functional heartburn and hypersensitive esophagus had < 8. Sensitivity, specificity and positive predictive value of GerdQ com -pared to the gold standard were 72%, 72% and 87%, respectively.
Conclusions
In Mexico, the GerdQ questionnaire Spanish validated version is useful for GERD diagnosis in the primary care setting.
doi:10.5056/jnm14014
PMCID: PMC4204416  PMID: 25273118
Gastroesophageal reflux; Mexico; Questionnaires; Sensitivity and specificity
18.  The Pediatric Asthma Control and Communication Instrument asthma questionnaire: For use in diverse children of all ages 
Background
National Institutes of Health asthma guidelines recommend questionnaires to assess asthma control, but these questionnaires are not useable across the entire pediatric age spectrum and have not been validated among significant numbers of minority or Spanish-speaking children.
Objective
We sought to evaluate a questionnaire designed to assess asthma control across a broad age range of minority and Spanish-speaking children cared for in an outpatient setting.
Methods
Between July 1, 2007, and September 30, 2010, we collected information using the Pediatric Asthma Control and Communication Instrument (PACCI), the Asthma Control Test (ACT; or the childhood ACT for children 4–11 years old), the Pediatric Asthma Caregiver Quality of Life Questionnaire, and lung function and clinicians’ ratings of asthma status among a population of children presenting for routine asthma specialist care. The PACCI measure of asthma control was validated by evaluating accuracy, internal reliability, and concurrent, discriminative, and known-groups validity.
Results
We collected information on 265 English- and 52 Spanish-speaking children (mean age, 8.2 years; 58% male; 44% African American). Across all age groups and in both languages, PACCI control showed good internal reliability and strong concurrent, discriminative, and known-groups validity with ACT and Pediatric Asthma Caregiver Quality of Life Questionnaire scores and clinicians’ ratings of asthma control. The accuracy of the PACCI in classifying children with uncontrolled asthma was good (area under the curve, 0.83; 95% CI, 0.79–0.88).
Conclusions
The PACCI accurately measures asthma control in English- and Spanish-speaking children. The PACCI should be useful to clinicians to assess and classify asthma according to National Institutes of Health asthma guidelines.
doi:10.1016/j.jaci.2013.01.007
PMCID: PMC4297654  PMID: 23434285
Impairment; control; children; assessment; accuracy; survey; validation; Pediatric Asthma Control and Communication Instrument; Spanish
19.  Psychometric properties of a culture-adapted Spanish version of AIDA (Assessment of Identity Development in Adolescence) in Mexico 
Background
The construct “identity” was discussed to be integrated as an important criterion for diagnosing personality disorders in DSM-5. According to Kernberg, identity diffusion is one of the relevant underlying structures in terms of personality organization for developing psychopathology, especially borderline personality disorder. Therefore, it would be important to differentiate healthy from pathological development already in adolescence. With the questionnaire termed AIDA (Assessment of Identity Development in Adolescence), a reliable and valid self-rating inventory was introduced by Goth, Foelsch, Schlueter-Mueller, & Schmeck (2012) to assess pathology-related identity development in healthy and disturbed adolescents. To test the usefulness of the questionnaire in Mexico, we contributed to the development of a culture-specific Spanish translation of AIDA and tested the reliability and aspects of validity of the questionnaire in a juvenile Mexican sample.
Methods
An adapted Spanish translation of AIDA was developed by an expert panel from Chile, Mexico, and Spain in cooperation with the original authors, focusing on content equivalence and comprehensibility by considering specific idioms, life circumstances, and culture-specific aspects. The psychometric properties of the Spanish version were first tested in Mexico. Participants were 265 students from a state school (N = 110) and private school (N = 155), aged between 12 and 19 years (mean 14.15 years). Of these, 44.9% were boys and 55.1% were girls. Item characteristics were analyzed by several parameters, scale reliability by Cronbach’s Alpha, and systematic effects of gender, age, and socioeconomics by an analysis of variance (ANOVA). We evaluated aspects of criterion validity in a juvenile justice system sample (N = 41) of adolescent boys in conflict with the law who displayed various types of behavioral problems by comparing the AIDA scores of a subgroup with signs for borderline pathology (N = 14) with the scores obtained in the student sample using T-tests.
Results
The psychometric properties of the Spanish version of AIDA proved satisfactory in the Mexican sample for items as well as scales. The reliability coefficients were α = .94 for the total scale “Identity Diffusion”, α = .85 and .92 for the two primary scales “Discontinuity” and “Incoherence”, and between α = .70 and .83 for the subscales. However, some items of the item pool in the Spanish version of AIDA did not meet all criteria for test equivalence and should thus be reformulated, taking the Mexican culture into account. Significant effects for gender and age were found. In line with our theory, the AIDA scores in the domains “Discontinuity” (high effect size) and “Incoherence” (medium effect size) were markedly higher in the delinquent boys than in the student group.
Conclusion
The Spanish version of AIDA can be used in Mexico with satisfying psychometric properties, with only minor adaptions required. Our study contributes to the intercultural applicability of the AIDA instrument using the construct “identity integration vs. diffusion” as it was defined in the AIDA model for diagnostic purposes. Cultural differences, even those present in the various Spanish-speaking countries, should be modeled carefully.
doi:10.1186/1753-2000-7-25
PMCID: PMC3765088  PMID: 23899385
Identity; Questionnaire; Psychometrics; Adolescence; Cultural test adaption; Cross-cultural
20.  Assessing the quality of life of health-referred children and adolescents with short stature: development and psychometric testing of the QoLISSY instrument 
Background
When evaluating the outcomes of treatment in paediatric endocrinology, the health-related quality of life (HrQoL) of the child is to be taken into consideration. Since few self–reported HrQoL instruments exist for children with diagnosed short stature (dSS), the objective of this study was to develop and psychometrically test a targeted HrQoL instrument for use in multinational clinical research.
Methods
The target population were short stature (height < −2 SDS) children and adolescents (age 8–12 and 13–18 years) with a diagnosis of growth hormone deficiency (GHD) or idiopathic short stature (ISS), differing in growth hormone treatment status. Focus group discussions for concept and item generation, piloting of the questionnaire with cognitive debriefing, and instrument field testing with a retest were conducted simultaneously in five countries. After qualitative and preliminary quantitative analyses, psychometric testing of field test data in terms of reliability and validity including confirmatory factor analyses (CFA) was performed.
Results
Following item generation from focus group discussions, 124 items were included in a pilot test with a cognitive debriefing exercise providing preliminary feedback on item and domain operating characteristics. A field test with 268 participants showed high internal consistency reliabilities (alpha 0.82 – 0.95), good correlations with generic measures (up to r = .58), significant known group differences (e.g. in height: F = 32, df 244, p < 0.001) and an acceptable CFA model fit suggesting construct validity of the three-domain core structure with 22 items, supplemented by three mediator domains with 28 items.
Conclusions
The QoLISSY questionnaire is a promising step forward in assessing the impact of dSS on HrQoL. It is based on items generated from the subjective experience of short stature children referred for endocrine investigation, is validated for use in five languages and it is easy to administer in clinical and research settings.
doi:10.1186/1477-7525-11-76
PMCID: PMC3666886  PMID: 23648112
Health-related quality of life; Short stature; Growth hormone deficiency; Assessment in children; Idiopathic short stature; Outcomes research; Patient reported outcomes
21.  Patient-reported outcome measures for cancer caregivers: a systematic review 
Quality of Life Research  2016;25:1859-1876.
Purpose
Informal caregivers provide invaluable help and support to people with cancer. As treatments extend survival and the potential burdens on carers increase, there is a need to assess the impact of the role. This systematic review identified instruments that measure the impact of caregiving, evaluated their psychometric performance specifically in cancer and appraised the content.
Methods
A two-stage search strategy was employed to: (1) identify instruments that measure the impact of caregiving, and (2) run individual searches on each measure to identify publications evaluating psychometric performance in the target population. Searches were conducted in MEDLINE, EMBASE, CINAHL and PsycINFO and restricted to English for instrument used and article language. Psychometric performance was evaluated for content and construct validity, internal consistency, test–retest reliability, precision, responsiveness and acceptability. Individual scale items were extracted and systematically categorised into conceptual domains.
Results
Ten papers were included reporting on the psychometric properties of eight measures. Although construct validity and internal consistency were most frequently evaluated, no study comprehensively evaluated all relevant properties. Few studies met our inclusion criteria so it was not possible to consider the psychometric performance of the measures across a group of studies. Content analysis resulted in 16 domains with 5 overarching themes: lifestyle disruption; well-being; health of the caregiver; managing the situation and relationships.
Conclusions
Few measures of caregiver impact have been subject to psychometric evaluation in cancer caregivers. Those that have do not capture well changes in roles and responsibilities within the family and career, indicating the need for a new instrument.
Electronic supplementary material
The online version of this article (doi:10.1007/s11136-016-1239-0) contains supplementary material, which is available to authorized users.
doi:10.1007/s11136-016-1239-0
PMCID: PMC4945691  PMID: 26872911
Caregivers; Cancer; Outcome measures; Impact; Burden; Psychometric performance
22.  Development of the Health Literacy of Caregivers Scale - Cancer (HLCS-C): item generation and content validity testing 
BMC Family Practice  2014;15:202.
Background
Health literacy refers to an individual’s ability to engage with health information and services. Cancer caregivers play a vital role in the care of people with cancer, and their capacity to find, understand, appraise and use health information and services influences how effectively they are able to undertake this role. The aim of this study was to develop an instrument to measure health literacy of cancer caregivers.
Method
Content areas for the new instrument were identified from a conceptual model of cancer caregiver health literacy. Item content was guided by statements provided by key stakeholders during consultation activities and selected to be representative across the range of cancer caregiver experiences. Content validity of items was assessed through expert review (n = 7) and cognitive interviews with caregivers (n = 16).
Results
An initial pool of 82 items was generated across 10 domains. Two categories of response options were developed for these items: agreement with statements, and difficulty undertaking presented tasks. Expert review revealed that the majority of items were relevant and clear (Content Validity Index > 0.78). Cognitive interviews with caregivers suggested that all except three items were well understood.
Conclusion
A resultant 88 item questionnaire was developed to assess cancer caregiver health literacy. Further work is required to assess the construct validity and reliability of the new measure, and to remove poorly performing and redundant items, which will result in a shorter, final measure. The new measure has the potential to inform the development and evaluation of interventions and the improvement of health service delivery to cancer caregivers.
doi:10.1186/s12875-014-0202-9
PMCID: PMC4269846  PMID: 25491883
Cancer; Caregivers; Health literacy; Information needs; Questionnaire development
23.  Development of six PROMIS pediatrics proxy-report item banks 
Background
Pediatric self-report should be considered the standard for measuring patient reported outcomes (PRO) among children. However, circumstances exist when the child is too young, cognitively impaired, or too ill to complete a PRO instrument and a proxy-report is needed. This paper describes the development process including the proxy cognitive interviews and large-field-test survey methods and sample characteristics employed to produce item parameters for the Patient Reported Outcomes Measurement Information System (PROMIS) pediatric proxy-report item banks.
Methods
The PROMIS pediatric self-report items were converted into proxy-report items before undergoing cognitive interviews. These items covered six domains (physical function, emotional distress, social peer relationships, fatigue, pain interference, and asthma impact). Caregivers (n = 25) of children ages of 5 and 17 years provided qualitative feedback on proxy-report items to assess any major issues with these items. From May 2008 to March 2009, the large-scale survey enrolled children ages 8-17 years to complete the self-report version and caregivers to complete the proxy-report version of the survey (n = 1548 dyads). Caregivers of children ages 5 to 7 years completed the proxy report survey (n = 432). In addition, caregivers completed other proxy instruments, PedsQL™ 4.0 Generic Core Scales Parent Proxy-Report version, PedsQL™ Asthma Module Parent Proxy-Report version, and KIDSCREEN Parent-Proxy-52.
Results
Item content was well understood by proxies and did not require item revisions but some proxies clearly noted that determining an answer on behalf of their child was difficult for some items. Dyads and caregivers of children ages 5-17 years old were enrolled in the large-scale testing. The majority were female (85%), married (70%), Caucasian (64%) and had at least a high school education (94%). Approximately 50% had children with a chronic health condition, primarily asthma, which was diagnosed or treated within 6 months prior to the
interview. The PROMIS proxy sample scored similar or better on the other proxy instruments compared to normative samples.
Conclusions
The initial calibration data was provided by a diverse set of caregivers of children with a variety of common chronic illnesses and racial/ethnic backgrounds. The PROMIS pediatric proxy-report item banks include physical function (mobility n = 23; upper extremity n = 29), emotional distress (anxiety n = 15; depressive symptoms n = 14; anger n = 5), social peer relationships (n = 15), fatigue (n = 34), pain interference (n = 13), and asthma impact (n = 17).
doi:10.1186/1477-7525-10-22
PMCID: PMC3312870  PMID: 22357192
PROMIS; HRQOL; PRO; Scale development; Parent Proxy; Pediatrics
24.  Development and Validation of the Biobanking Attitudes and Knowledge Survey (BANKS) 
Background
No validated multi-scale instruments exist that measure community members’ views on biobanking and biospecimen donation. This study describes the development and psychometric properties of the English-language BANKS (Biobanking Attitudes aNd Knowledge Survey).
Methods
The BANKS was created by item generation through review of scientific literature, focus groups with community members, and input from a community advisory board. Items were refined through cognitive interviews. Content validity was assessed through an expert panel review. Psychometric properties of the BANKS were assessed in a sample of 85 community members.
Results
The final BANKS includes 3 scales: Attitudes, Knowledge, and Self-Efficacy; as well as 3 single items, which evaluated receptivity and intention to donate a biospecimen for research. Cronbach's alpha coefficients for two scales that use Likert response format indicated high internal consistency (Attitudes: α=.88; Self-Efficacy: α=.95). Content validity indices were moderate, ranging from 0.69 to 0.89. Intention to donate blood and intention to donate urine were positively correlated with attitudes, knowledge, self-efficacy, and receptivity to learning more about biobanking (p's range from .029 to <.001).
Conclusions
The final BANKS shows evidence of satisfactory reliability and validity, is easy to administer, and is a promising tool to inform biospecimen research. Additional studies should be conducted with larger samples considering biospecimen donation to further assess the instrument's reliability and validity.
Impact
A valid and reliable instrument measuring community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation. A Spanish-language BANKS is under development.
doi:10.1158/1055-9965.EPI-13-0746
PMCID: PMC3955026  PMID: 24609846
Biobanking; tissue banking; survey; reliability; validity
25.  Study protocol of psychometric properties of the Spanish translation of a competence test in evidence based practice: The Fresno test 
Background
There are few high-quality instruments for evaluating the effectiveness of Evidence-Based Practice (EBP) curricula with objective outcomes measures. The Fresno test is an instrument that evaluates most of EBP steps with a high reliability and validity in the English original version. The present study has the aims to translate the Fresno questionnaire into Spanish and its subsequent validation to ensure the equivalence of the Spanish version against the English original.
Methods and design
The questionnaire will be translated with the back translation technique and tested in Primary Care Teaching Units in Catalonia (PCTU). Participants will be: (a) tutors of Family Medicine residents (expert group); (b) Family Medicine residents in their second year of the Family Medicine training program (novice group), and (c) Family Medicine physicians (intermediate group). The questionnaire will be administered before and after an educational intervention. The educational intervention will be an interactive four half-day sessions designed to develop the knowledge and skills required to EBP. Responsiveness statistics used in the analysis will be the effect size, the standardised response mean and Guyatt's method. For internal consistency reliability, two measures will be used: corrected item-total correlations and Cronbach's alpha. Inter-rater reliability will be tested using Kappa coefficient for qualitative items and intra-class correlation coefficient for quantitative items and the overall score. Construct validity, item difficulty, item discrimination and feasibility will be determined.
Discussion
The validation of the Fresno questionnaire into different languages will enable the expansion of the questionnaire, as well as allowing comparison between countries and the evaluation of different teaching models.
doi:10.1186/1472-6963-9-37
PMCID: PMC2660898  PMID: 19239704

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