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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.  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
7.  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
8.  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
9.  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
10.  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
11.  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
12.  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
13.  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
14.  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
15.  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
16.  Development of the Health Literacy of Caregivers Scale - Cancer (HLCS-C): item generation and content validity testing 
BMC Family Practice  2014;15(1):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
17.  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
18.  Better assessment of physical function: item improvement is neglected but essential 
Arthritis Research & Therapy  2009;11(6):R191.
Introduction
Physical function is a key component of patient-reported outcome (PRO) assessment in rheumatology. Modern psychometric methods, such as Item Response Theory (IRT) and Computerized Adaptive Testing, can materially improve measurement precision at the item level. We present the qualitative and quantitative item-evaluation process for developing the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function item bank.
Methods
The process was stepwise: we searched extensively to identify extant Physical Function items and then classified and selectively reduced the item pool. We evaluated retained items for content, clarity, relevance and comprehension, reading level, and translation ease by experts and patient surveys, focus groups, and cognitive interviews. We then assessed items by using classic test theory and IRT, used confirmatory factor analyses to estimate item parameters, and graded response modeling for parameter estimation. We retained the 20 Legacy (original) Health Assessment Questionnaire Disability Index (HAQ-DI) and the 10 SF-36's PF-10 items for comparison. Subjects were from rheumatoid arthritis, osteoarthritis, and healthy aging cohorts (n = 1,100) and a national Internet sample of 21,133 subjects.
Results
We identified 1,860 items. After qualitative and quantitative evaluation, 124 newly developed PROMIS items composed the PROMIS item bank, which included revised Legacy items with good fit that met IRT model assumptions. Results showed that the clearest and best-understood items were simple, in the present tense, and straightforward. Basic tasks (like dressing) were more relevant and important versus complex ones (like dancing). Revised HAQ-DI and PF-10 items with five response options had higher item-information content than did comparable original Legacy items with fewer response options. IRT analyses showed that the Physical Function domain satisfied general criteria for unidimensionality with one-, two-, three-, and four-factor models having comparable model fits. Correlations between factors in the test data sets were > 0.90.
Conclusions
Item improvement must underlie attempts to improve outcome assessment. The clear, personally important and relevant, ability-framed items in the PROMIS Physical Function item bank perform well in PRO assessment. They will benefit from further study and application in a wider variety of rheumatic diseases in diverse clinical groups, including those at the extremes of physical functioning, and in different administration modes.
doi:10.1186/ar2890
PMCID: PMC3003539  PMID: 20015354
19.  Multinational development of a questionnaire assessing patient satisfaction with anticoagulant treatment: the 'Perception of Anticoagulant Treatment Questionnaire' (PACT-Q©) 
Background
The side effects and burden of anticoagulant treatments may contribute to poor compliance and consequently to treatment failure. A specific questionnaire is necessary to assess patients' needs and their perceptions of anticoagulant treatment.
Methods
A conceptual model of expectation and satisfaction with anticoagulant treatment was designed by an advisory board and used to guide patient (n = 31) and clinician (n = 17) interviews in French, US English and Dutch. Patients had either atrial fibrillation (AF), deep venous thrombosis (DVT), or pulmonary embolism (PE). Following interviews, three PACT-Q language versions were developed simultaneously and further pilot-tested by 19 patients. Linguistic validations were performed for additional language versions.
Results
Initial concepts were developed to cover three areas of interest: 'Treatment', 'Disease and Complications' and 'Information about disease and anticoagulant treatment'. After clinician and patient interviews, concepts were further refined into four domains and 17 concepts; test versions of the PACT-Q were then created simultaneously in three languages, each containing 27 items grouped into four domains: "Treatment Expectations" (7 items), "Convenience" (11 items), "Burden of Disease and Treatment" (2 items) and "Anticoagulant Treatment Satisfaction" (7 items). No item was deleted or added after pilot testing as patients found the PACT-Q easy to understand and appropriate in length in all languages. The PACT-Q was divided into two parts: the first part to measure the expectations and the second to measure the convenience, burden and treatment satisfaction, for evaluation prior to and after anticoagulant treatment, respectively. Eleven additional language versions were linguistically validated.
Conclusion
The PACT-Q has been rigorously developed and linguistically validated. It is available in 14 languages for use with thromboembolic patients, including AF, PE and DVT patients. Its validation and psychometric properties have been tested and are presented in a separate manuscript.
doi:10.1186/1477-7525-7-9
PMCID: PMC2654430  PMID: 19196486
20.  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
21.  Development of the conceptual framework for the Eye-Drop Satisfaction Questionnaire (EDSQ©) in glaucoma using a qualitative study 
Background
Compliance is a major issue in glaucoma care. It is usually poor in glaucomatous patients, and may ultimately result in an acceleration of the disease progression and a risk of blindness. Reasons for this poor compliance are complex and multifactorial, amongst which patient satisfaction can be counted. The objective of this study was to develop a questionnaire to assess patient satisfaction and compliance with eye-drop treatment.
Methods
A qualitative study was carried out to develop the questionnaire. An interview guide was developed based on a literature review. Structured interviews of fifteen French and English patients with primary open-angle glaucoma or intraocular hypertension were conducted by trained interviewers of the native language of the interviewees. General concepts and subconcepts were identified from the transcripts. The questionnaire was developed using the patient verbatim, and submitted to six patients (French and English) for cognitive debriefing. Following patients' comments, items were modified and restructured, and a pilot questionnaire was designed.
Results
Analysis of data from the interviews with patients and clinicians resulted in the elicitation of concepts related to patient satisfaction and compliance with glaucomatous treatment. These were further refined and used to generate a test questionnaire, which consisted of 46 items grouped into 6 domains: patient characteristics, treatment characteristics, patient-clinician relationship, patient experience with the disease and the treatment, interaction between the patient and the treatment, and patient knowledge of the disease and the treatment.
Conclusion
The Eye-Drop Satisfaction Questionnaire (EDSQ) conceptual framework and items were developed simultaneously in French and in English. This questionnaire could be used to evaluate patient satisfaction and compliance with eye-drop treatment and would facilitate the identification of patients at risk of being non-compliant prior to clinical trials or innovative device tests. A psychometric study is under way to validate the questionnaire.
doi:10.1186/1472-6963-7-124
PMCID: PMC1973077  PMID: 17683594
22.  Translation and validation of non-English versions of the Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire 
Background
The Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire is a unidimensional, disease-specific measure developed in the UK and the Netherlands. This study describes its adaptation into other languages.
Methods
The UK English ASQOL was translated into US English; Canadian French and English; French; German; Italian; Spanish; and Swedish (dual-panel methods). Cognitive debriefing interviews were conducted with AS patients. Psychometric/scaling properties were assessed using data from two Phase III studies of adalimumab. Baseline and Week-2 data were used to assess test-retest reliability. Validity was determined by correlation of ASQOL with SF-36 and BASFI and by discriminative ability of ASQOL based on disease severity. Item response theory (Rasch model) was used to test ASQOL's scaling properties.
Results
Cognitive debriefing showed the new ASQOL versions to be clear, relevant and comprehensive. Sample sizes varied, but were sufficient for: psychometric/scaling assessment for US English and Canadian English; psychometric but not scaling analyses for German; and preliminary evidence of these properties for the remaining languages. Test-retest reliability and Cronbach's alpha coefficients were high: US English (0.85, 0.85), Canadian English (0.87, 0.86), and German (0.77, 0.79). Correlations of ASQOL with SF-36 and BASFI for US English, Canadian English, and German measures were moderate, but ASQOL discriminated between patients based on perceived disease severities (p < 0.01). Results were comparable for the other languages. US English and Canadian English exhibited fit to the Rasch model (non-significant p-values: 0.54, 0.68), confirming unidimensionality.
Conclusion
The ASQOL was successfully translated into all eight languages. Psychometric properties were excellent for US English, Canadian English, and German, and extremely promising for the other languages.
doi:10.1186/1477-7525-5-7
PMCID: PMC1808053  PMID: 17274818
23.  Does the Consumer Assessment of Healthcare Providers and Systems Cultural Competence Survey provide equivalent measurement across English and Spanish versions? 
Medical care  2012;50(9 Suppl 2):S37-S41.
BACKGROUND
The English and Spanish versions of the Consumer Assessments of Healthcare Providers and Systems (CAHPS®) Cultural Competence Survey (CAHP-CC) assess patients’ experiences with culturally competent care. The possibility exists that even when Spanish and an English speakers experience the same levels of culturally competent care, responses describing their care may differ. This is called measurement bias. To deliver reliable and valid information across language, responses must provide equivalent measurement across versions. In this study, we examined whether measurement bias on the CAHPS-CC impedes valid measurement across the English and Spanish versions.
METHODS
We used multiple group (MG) confirmatory factor analyses (CFA) to examine measurement bias across English (n = 851) and Spanish (n = 113) speakers. Participants came from a 2008 sample of two Medicaid managed care plans, in New York and California.
RESULTS
MG-CFA provided general support for the equivalence of the CAHPS-CC in measuring Doctor Communication-Positive Behaviors, Doctor Communication-Negative Behaviors, Doctor Communication-Preventative Care, Equitable Treatment, and Trust. We did observe statistically significant differences in the thresholds associated with the item asking whether a doctor gave easier to understand instructions. However, analyses indicated that bias did not meaningfully influence conclusions about average experiences using the English and Spanish versions of the CAHPS-CC.
CONCLUSIONS
Our results support the use of the English and Spanish versions of the CAHPS-CC. Though we found some bias, analyses demonstrated that it did not substantively impact conclusions for the studied domains. Health providers can place confidence in the two different CAHPS-CC translations.
doi:10.1097/MLR.0b013e3182665189
PMCID: PMC3443872  PMID: 22895229
Cultural competence; CAHPS®; Spanish; translation; ethnicity; measurement equivalence
24.  Content Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Framework in Women With Urinary Incontinence 
Neurourology and urodynamics  2011;30(4):503-509.
Aims
To assess whether the existing National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) conceptual framework and item banks sufficiently capture the concerns of women with urinary incontinence (UI).
Methods
Thirty-five women with UI were recruited between February-April 2009 for 4 structured focus groups to develop and assess the content validity of a conceptual framework for the impact of UI. This framework included domains from the NIH PROMIS framework and item banks including broad domains of physical and social function and mental health. All sessions were transcribed, coded, and qualitatively and quantitatively analyzed using analytic induction and deductive analysis to identify new themes and domains relevant to women with UI.
Results
The focus groups provided information that confirmed the relevance of existing PROMIS domains and identified new outcome domains that are important to this patient population. The groups confirmed the relevance of the physical and social functioning, and mental health domains. Additional themes that emerged included the distinction between ability versus participation and satisfaction, role functioning, external mediators, re-calibration/coping, cognitive function and new possibilities. Participants also felt strongly that not all domains and items apply to all women with UI and an option to tailor questionnaires and skip non-relevant items was important.
Conclusions
The PROMIS framework domains are relevant to women with UI, but additional patient-important themes are identified that may improve the comprehensiveness of this assessment framework for measuring outcomes important to women with UI. These results will inform future item content development for UI.
doi:10.1002/nau.21048
PMCID: PMC4116099  PMID: 21400574
content validity; conceptual framework; incontinence; patient outcomes; quality of life; tailored outcomes
25.  Linguistic validation of translation of the self-assessment goal achievement (saga) questionnaire from English 
Background
A linguistic validation of the Self-Assessment Goal Achievement (SAGA) questionnaire was conducted for 12 European languages, documenting that each translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population.
Methods
Native-speaking residents of the target countries who reported urinary problems/lower urinary tract problems were asked to review a translation of the SAGA questionnaire, which was harmonized among 12 languages: Danish, Dutch, English (UK), Finnish, French, German, Greek, Icelandic, Italian, Norwegian, Spanish, and Swedish. During a cognitive debriefing interview, participants were asked to identify any words that were difficult to understand and explain in their own words the meaning of each sentence in the questionnaire. The qualitative analysis was conducted by local linguistic validation teams (original translators, back translator, project manager, interviewer, and survey research expert).
Results
Translations of the SAGA questionnaire from English to 12 European languages were well understood by the participants with an overall comprehension rate across language of 98.9%. In addition, the translations retained the original meaning of the SAGA items and instructions. Comprehension difficulties were identified, and after review by the translation team, minor changes were made to 7 of the 12 translations to improve clarity and comprehension.
Conclusions
Conceptual, semantic, and cultural equivalence of each translation of the SAGA questionnaire was achieved thus confirming linguistic validation.
doi:10.1186/1477-7525-10-40
PMCID: PMC3349573  PMID: 22525050
SAGA; Validation; Lower urinary tract symptoms; Overactive bladder; Goal achievement; Patient-reported questionnaire

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