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Validation of an asthma knowledge questionnaire.

Asthma is responsible for much morbidity and mortality, which might be decreased by increasing parental and patient knowledge about asthma. This report describes the development and validation of an asthma knowledge questionnaire for use in the assessment of asthma knowledge. Two groups of respondents were examined. One group was designated 'high knowledge' and the other 'low knowledge'. The questionnaire had a maximum possible score of 31. The mean score of 69 'high' knowledge parents was 25.3 (median 25, range 18-31). By contrast, the mean score of 69 'low' knowledge parents was 13.0 (median 13, range 0-21). The difference between the two groups was statistically significant (P less than 0.0001). The questionnaire results were reproducible (tau = 0.94, P less than 0.01). Demographic characteristics such as education and socio-economic status were not important confounding variables. Face and content validity of the questionnaire were based on reference to published experience. Concurrent validity was demonstrated by the ability of the questionnaire to distinguish low from high knowledge parents. The questionnaire should prove to be a valuable research tool for the assessment of asthma knowledge either as part of an educational intervention or in a clinical situation.

Asthma↗

Threshold Assessment Grid (TAG): the development of a valid and brief scale to assess the severity of mental illness.

BACKGROUND: Lack of consensus about the meaning of severe mental illness makes it difficult to prioritise the severely mentally ill for specialist mental health care. The goal of this study was to develop a valid and brief assessment of severity of mental illness. METHOD: Six search workshops (n = 57) using consensus techniques developed a draft assessment acceptable to users, carers, practitioners and policy makers. A two-round Delphi consultation (n = 58) was held to identify consensus on this instrument. RESULTS: Search workshops agreed seven domains relevant to identifying the severely mentally ill: intentional and unintentional self-harm, risk from and to others, and survival, psychological, and social needs and disabilities. The Delphi consultation indicated at least agreement with all aspects in both rounds. CONCLUSIONS: The Threshold Assessment Grid (TAG) is a brief method of identifying the severely mentally ill, which has adequate face, concurrent, construct and content validity.

Delphi Technique↗

Psychometric properties of the Blood-borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ).

AIMS: To develop a standard measure of blood-borne virus transmission risk behaviour, and examine the underlying psychometric properties. DESIGN: The Blood-borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ) was developed over three consecutive phases of the original BBV-TRAQ study in adherence to classical scale development procedures, culminating in the recruitment of a development sample of current injecting drug users via convenience and snowball sampling. SETTING: Needle and syringe programmes (NSPs), medical clinics, alcohol/drug agencies, peer-based and outreach organizations across inner and outer metropolitan Melbourne. PARTICIPANTS: Two hundred and nine current injecting drug users. The mean age was 27 years, 68% were male, 65% unemployed, 36% with prison history and 25% in methadone maintenance. MEASUREMENTS: BBV-TRAQ items cover specific injecting, sexual and skin penetration risk practices. BBV-TRAQ characteristics were assessed via measures of internal and test-retest reliability; collateral validation; and principal components analyses. FINDINGS: The BBV-TRAQ has satisfactory psychometric properties. Internal (a=0.87), test-retest (r=0.84) and inter-observer reliability results were high, suggesting that the instrument provides a reliable measure of BBV risk behaviour and is reliable over time and across interviewers. A principal components analysis with varimax rotation produced a parsimonious factor solution despite modest communality, and indicated that three factors (injecting, sex and skin penetration/hygiene risks) are required to describe BBV risk behaviour. CONCLUSIONS: The BBV-TRAQ is reliable and represents the first risk assessment tool to incorporate sufficient coverage of injecting, sex and other skin penetration risk practices to be considered truly content valid. The questionnaire is indicated for use in addictions research, clinical, peer education and BBV risk behaviour surveillance settings.

Adolescent↗

[The dimensions of the organisational climate as seen by general practitioners].

OBJECTIVE: To create and validate a tool to assess the organizational climate (OC) perceived by general practitioners (GP). DESIGN: Descriptive, cross-sectional, and multi-site, study. SETTING: Health centres (HC) in Jaén and Málaga province Spain. PARTICIPANTS: Random sample of 38 HCs and 387 GPs. MAIN MEASUREMENTS: A self-administered questionnaire in March 2001, with the personal variables of sex, age, graduation date, specialty, kind of contract, time worked in primary care teams, time in current job, list size, case load, tutor of residents and academic qualification. HC variables: urban/rural, team structure, accreditation for teaching residents, service portfolio, out-patient care, and an OC scale of 40 Likert-like questions. We analysed the content validity of the scale by factorial analysis; and its reliability, by Cronbach's alpha and corrected scale-item correlation coefficients. RESULTS: Reply rate was 89.8%, 71% of the GPs were male, mean age was 44, 76% had tenure, and 37% were specialists in family medicine and 28% tutors, 17% with 3rd-year residents, 9% with doctors; 50% of HCs were rural and the mean team structure had 13 GPs and 4 paediatricians. We obtained 12 factors that explained 60% of variance, and 7 factors with reliability coefficients >0.50. We made an OC-positive scale (alpha=.82) with the dimensions for team-work, cohesion and social life; and another OC-negative scale (alpha=.78) composed of team conflict, perceived team failure, excess autonomy, authoritarian management, and GP-nurse tension. CONCLUSIONS: We found a questionnaire with good validity and reliability, which was useful for evaluating the OC perceived by GPs.

Adult↗

Development of an instrument to assess expectations of and preference for an insulin injection pen compared with the vial and syringe.

BACKGROUND: Before using a product, patients form expectations regarding the extent of a product's desirable attributes. These expectations can be used to understand their preference and anticipate potential satisfaction with the product. OBJECTIVE: The aim of this study was to produce a valid and reliable data collection instrument (the Insulin Injection Preference questionnaire [IIP-q]) to measure expectations of and preference for the insulin injection pen compared with the vial and syringe. METHODS: This study was initiated at the University of Mississippi (University, Mississippi). The IIP-q was developed to determine the extent to which respondents' prepurchase expectations of a product's attributes relate to preference for an insulin injection pen compared with the vial and syringe. Instrument development began with item generation related to product attributes important to patients who inject insulin. Items originated from an extensive search of the peer-reviewed Internet-based literature, marketing reports, clinical studies, and existing instruments. Content validity also was assessed using expert panel and focus group review. The resultant instrument (the IIP-q) was mailed to 1200 patients known to have type 1 or type 2 diabetes mellitus who either did or did not use insulin. Subscales were identified through exploratory factor analysis. Reliability and validity were assessed using Cronbach alpha for subscale items. Product-moment correlations between subscale dimensions and 2 global measures of preference were used to test the relationship between attribute expectations and preference. RESULTS: Seventeen of the questionnaires were returned as undeliverable, leaving 1183 in the sample population. Questionnaires were received from 302 individuals, 55 of whom failed to complete > or = 85% of the items and thus were not included in the final analysis. Of the 247 respondents (135 women, 112 men; mean [SD] age, 52.4 [13.2] years (range, 18-83 years]), 99 (40.1%) were current insulin users and 143 (57.9%) were not using insulin. Exploratory factor analysis resulted in a 13-item solution (Cronbach alpha = 0.92), accounting for 73.6% of the total explained variance. Ease of use, activity interference, and social acceptability emerged as expectation subscales from exploratory factor analysis. Cronbach alpha for items comprising the subscales ranged from 0.82 to 0.92. The 3 subscales were significantly correlated with patient preference (ease of use, r = 0.520, P < 0.001; activity interference, r = 0.570, p < 0.001; social acceptability, r = 0.602, p < 0.001). CONCLUSIONS: The results of the present study provide support for the IIP-q as a reliable and valid instrument to assess patient expectations of product attributes and preference. This instrument can be modified for use in clinical trials to determine the role of patient expectations and preference in their judgments regarding satisfaction with insulin delivery devices.

Cross-Sectional Studies↗

The development and use of the Verona Expectations for Care Scale (VECS) and the Verona Service Satisfaction Scale (VSSS) for measuring expectations and satisfaction with community-based psychiatric services in patients, relatives and professionals.

In this paper the global design of a research project aiming at measuring expectations and satisfaction of patients, relatives, and professionals with community-based psychiatric services (CPS) in a multidimensional, sensitive, valid and reliable way is described. Some psychometric properties of two newly developed instruments, partly adapted from the Service Satisfaction Scale (SSS), the Verona Expectations for Care Scale (VECS) and the Verona Service Satisfaction Scale (VSSS), are discussed. Three groups were selected for inclusion in the study: all patients living with their families who had more than 18 contacts in the last three years, according to the South-Verona Psychiatric Case Register; the relative who had been mainly caring for the patient; and all professionals working in the South-Verona CPS for at least one year. Data on 75 patients and 76 relatives are presented and show that VECS and VSSS have good content validity and test-retest reliability in both groups. Notwithstanding some differences, patients and relatives expressed similar expectations and were mostly satisfied. The current study is the first to provide a parallel measurement of expectations and satisfaction in all three above-mentioned groups; moreover, it is the first to investigate consumers' satisfaction with a CPS organized according to the principles of the Italian Psychiatric Reform.

Adult↗

Development of the Nursing Minimum Data Set for the Netherlands (NMDSN): identification of categories and items.

Development of the Nursing Minimum Data Set for the Netherlands (NMDSN): identification of categories and items Rationale Currently, there is no systematic collection of nursing care data in the Netherlands, while pressure is growing from the profession, policy-makers and society to justify the contribution of nursing and its costs. A nursing minimum data set can provide data to demonstrate nursing's contribution to health care as it can be used to describe the diversity of different patient populations and the variability of nursing activities, and to calculate the associated nursing workload. Objective To identify categories and items for inclusion in the Nursing Minimum Data Set for the Netherlands. Design A multimethod, exploratory approach was used. This included interviews, document analysis, consensus rounds, seeking validation in the literature, and drawing up lists of most frequently occurring patient problems, interventions and outcomes of care. Eight hospitals, with a total of 16 wards, participated in the study. Results Relevant categories and items emerged after analysis and grouping of the material and included: five hospital-related items, six patient demographics items, seven medical condition items, 10 nursing process items, 24 patient problems, 32 nursing interventions, four outcomes of nursing care, and three complexity of care items. Almost every item could be located in the existing documentation systems, the lists of patient problems, outcomes and interventions, or in the literature. Conclusion A set of categories and items of nursing data has been identified. The content validity of this set is partly supported by its consistency with the literature, findings from practice and the judgement of potential users. Nursing outcomes need further development. The data set will be tested in practice to find out whether the categories and items are useful, and whether they can be minimized.

Attitude of Health Personnel↗

Use of intuition by nursing students: instrument development and testing.

BACKGROUND: Intuition has been described as an important type of nursing knowledge and has gained acceptance as a valid way of knowing in clinical nursing. Use of intuition has become one way of explaining professional expertise. Measures of the use of intuition have been developed primarily for experienced nurses, but few measures of intuition use among nursing students exist. AIM: The aim of this paper is to describe the development and psychometric testing of an instrument to measure use of intuition by nursing students. METHODS: Instrument development consisted of concept clarification, item development, and psychometric testing. Intuition was defined as a non-linear process of knowing perceived through physical awareness, emotional awareness, and/or through physical or spiritual connections. Initial measurement items were derived inductively from the literature and informal interviews with senior nursing students. Seven content experts established a content validity index of 0.86 for the initial 33-item measure. It was pretested with a sample of 20 senior nursing students prior to its nationwide validation with a random sample of 1000 senior bachelor of science and associate degree nursing students. RESULTS: Postal mail data collection resulted in 349 responses (35% response rate). Principal component analysis with orthogonal varimax rotation resulted in seven factors accounting for 66.2% of the variance: physical sensations (28.4%); premonitions (9.7%); spiritual connections (7.7%); reading of cues (6.1%); sensing energy (5.7%); apprehension (4.3%); and reassuring feelings (4%). Eigenvalues ranged from 1 to 7.1 and factor loadings ranged from 0.534 to 0.858. The validation resulted in a revised 25-item measure that demonstrated an overall Cronbach's alpha of 0.89 and a range of 0.69-0.84 for each factor. The study is limited by the use of a self-report measure and the attrition in the randomized sample. CONCLUSIONS: The intuition measure for use with students showed evidence of construct validity and reliability. With further testing, the measure could serve as a stimulus to foster students' intuitive abilities.

Clinical Competence↗

The Pediatric Rheumatology International Trials Organization/American College of Rheumatology provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus: prospective validation of the definition of improvement.

OBJECTIVE: To use the Pediatric Rheumatology International Trials Organization (PRINTO) core set of outcome measures to develop a validated definition of improvement for the evaluation of response to therapy in juvenile systemic lupus erythematosus (SLE). METHODS: Thirty-seven experienced pediatric rheumatologists from 27 countries, each of whom had specific experience in the assessment of juvenile SLE patients, achieved consensus on 128 patient profiles as being clinically improved or not improved. Using the physicians' consensus ratings as the gold standard measure, the chi-square, sensitivity, specificity, false-positive and false-negative rates, area under the receiver operating characteristic curve, and kappa level of agreement for 597 candidate definitions of improvement were calculated. Only definitions with a kappa value greater than 0.7 were retained. The top definitions were selected based on the product of the content validity score multiplied by its kappa statistic. RESULTS: The definition of improvement with the highest final score was at least 50% improvement from baseline in any 2 of the 5 core set measures, with no more than 1 of the remaining worsening by more than 30%. CONCLUSION: PRINTO proposes a valid and reproducible definition of improvement that reflects well the consensus rating of experienced clinicians and that incorporates clinically meaningful change in core set measures in a composite end point for the evaluation of global response to therapy in patients with juvenile SLE. The definition is now proposed for use in juvenile SLE clinical trials and may help physicians to decide whether a child with SLE responded adequately to therapy.

Child↗

Nursing documentation in patient records: experience of the use of the VIPS model.

The VIPS model for the documentation of nursing care in patient records was scientifically developed and published in 1991, with the aim of supporting the systematic documentation of nursing care and promoting individualized care. As the model seemed to be accepted and used in many parts of Sweden, a study was conducted in order to gather further information on the validity of the model, to describe the clinical and educational experience of its use and to refine it. Experience of the use of the model was gathered from a review of the scientific papers and other reports on it, from questionnaires addressed to nurses (n = 514), from comments by key informants, and from interviews with faculty members at all the nursing schools in the country. The findings showed that an intense process of change and development was occurring regarding nursing documentation. However, there were limitations in the use of the entire nursing process, especially in the specification of patient problems and the formulation of nursing diagnoses and nursing interventions. The keywords (Swedish spelling) of the VIPS model had good content validity in different areas of nursing care. The findings also indicated the need for further elaboration and revision of some of the keywords. A revised version of the VIPS model based on these findings is presented.

Health Knowledge, Attitudes, Practice↗

Assuring the quality of high-stakes undergraduate assessments of clinical competence.

In the UK, and in many Commonwealth countries, a university degree is accepted by registration bodies as an indication of competence to practice as a PRHO or intern. Concerns have been raised that the quality of university examinations may not always be sufficient for such high-stakes decision-making. Assessments of clinical competence are subject to many potential sources of error. The search for standardization, and high validity and reliability, demands the identification and reduction of measurement errors and biases due to poor test design or variation in test items, judges, patients or examination procedures. Generalizability and other research studies have identified where the likely sources of error might arise and have been taken into account in the development of published guidelines on international best practice, which institutions should strive to follow. The purpose of this paper is to describe the development of the integrated final-year assessment of clinical competence at the University of Sheffield. The aim was to introduce a range of strategies to ensure the examination met the best practice guidelines. These included blueprinting the assessment to achieve a high degree of content validity; lengthening the examination by adding a written component to the OSCE component to ensure an adequate level of reliability; providing training and feedback for examiners and simulated patients; paying attention to item development; and providing statistical information to assist the examination committee in standard setting and decision-making. This evidence-based approach should be readily achievable by all medical schools.

Clinical Competence↗

Is the Harris hip score system useful to study the outcome of total hip replacement?

Although the Harris hip score frequently is used to assess the outcome of total hip replacement, only a few minor validity tests have been presented. The aim of this study was to perform a validity test of the Harris hip score and to test its reliability. Two cohorts were studied. First, 58 patients who had undergone total hip replacement 2 to 10 years earlier were evaluated by an orthopaedic surgeon and an experienced physiotherapist using the Harris hip score. The patients also answered the Western Ontario and McMaster University Osteoarthritis Index and the Medical Outcomes Study 36-Item Short-Form Health Survey. Second, 1,056 patients answered the Western Ontario and McMaster University Osteoarthritis Index and the Medical Outcomes Study 36-Item Short-Form Health Survey questionnaires. The results were compared with those of a subcohort of 344 patients who were evaluated using the Harris hip score. The following items were tested: content validity, convergent and divergent construct validity, criterion validity, test and retest reliability, internal consistency reliability, and interobserver reliability. The Medical Outcomes Study 36-Item Short-Form Health Survey, Western Ontario and McMaster University Osteoarthritis Index, and the Harris hip score showed high validity and reliability. The Harris hip score can be used by a physician or a physiotherapist to study the clinical outcome of hip replacement.

Activities of Daily Living↗

Development and psychometric properties of the Individualized Care Scale.

RATIONALE, AIMS AND OBJECTIVES: In this study we describe the development of the Individualized Care Scale (ICS) and evaluate its validity, psychometric properties and feasibility. The ICS was designed to measure patients' views on how individuality is supported through specific nursing interventions (ICA) and how they perceive individuality in their own care (ICB) during hospitalization. METHOD: Three different data sets were collected among patients being discharged from hospital (n1 = 203, n2 = 279, n3 = 454). This bipartite 38-item ICS promises to be a brief, timely, easy to administer and useful self-completion measure for evaluating clinical nursing practice from the patient's point of view. RESULTS: The findings supported the internal consistency reliability of the ICS (alpha 0.94 for ICA and ICB 0.93) and the three subscales (alphas 0.85-0.90). Item analysis supported the item construction of each scale. Content validity was furthered by a critical literature review and four expert analyses. Principal component analysis (Promax with Kaiser normalization) among earlier factor analyses supported construct validity by generating a three-factor solution which accounted for 65% of the variance in the ICA and 61% in the ICB. Pearson's correlation coefficients were at least 0.88 between the subscales and the total domain ICA or ICB. CONCLUSIONS: The ICS has demonstrated promise as a tool for measuring patients' evaluations of their hospital experience and individuality in care.

Female↗

Development and validation of a new treatment outcome score for men with LUTS.

AIMS: To develop, validate, and test elements of a new outcome score for men with lower urinary tract symptoms (LUTS). METHODS: Elements of well-established questions from the International Prostate Symptom Score (IPSS) assessment were combined with both established noninvasive objective determinants of voiding function including maximum uroflow (Qmax), postvoid residual urine volume (PVR), total number voids, maximum voided volume (MVV) as well as a subjective patient assessment parameter, to create a new LUTS treatment outcome instrument which we have termed the "LUTS outcome score" (LOS). The LOS is comprised of eight items; each assigned a score of 0, 1, or 2. Thus, the score ranges from 0 (best) to 16 (worst). Patients were divided into surgical/non- surgical (pharmacologic or behavior modification) treatment groups. Content validity and cutoff values for cure/improve/fail were established by an expert panel. Criterion validity was established by comparison to the IPSS. Internal reliability analysis was performed to obtain information about the relationships between individual items in the scale. Individual LOS items were correlated with the subjective outcome score. We also calculated the correlations between the LOS, IPSS, subjective post-treatment response, and age. Internal consistency, based on the average inter-item correlation was calculated using Cronbach's alpha statistic. Associations between continuous variables were examined by calculating the Pearson correlation coefficient, and between ordinal variables, using Spearman's rho. Test-retest analysis was recorded to determine reproducibility of the patient subjective outcome score. Seventy-seven men who underwent treatment for LUTS for at least 6 months participated in the study. All completed a detailed pretreatment and post-treatment clinical evaluation consisting of history/physical, questionnaire, voiding diary, urinalysis, Q, PVR, and videourodynamic study. Subjective responses of cured/improved/failed status following treatment were assessed by independent investigators. RESULTS: A high level of internal consistency was observed among the LOS symptom questions, Cronbach's alpha = 0.81 for the total cohort. The LOS correlated directly and significantly with the patient's subjective post-treatment response (r = 0.75, P < 0.001), age (r = 0.27, P = 0.02), and with the total IPSS (r = 0.62, P < 0.001). The IPSS also correlated directly and significantly with the patient's subjective post-treatment response (r = 0.48, P < 0.001) but did not correlate with the patient's age (r = 0.10, P = 0.41). When the subjective parameter for post-treatment response was subtracted from the LOS, the resulting correlation (r = 0.52, P < 0.001) approximated that obtained using the IPSS. CONCLUSIONS: The LOS is valid and internally consistent. Unlike the IPSS, it combines subjective, semisubjective, and objective parameters. Because of the objective components, it diminishes the possibility of overestimating cure and underestimating improvement relying only on patient's symptoms. Further, we believe it will prove to be useful for post hoc analysis in patients who have not had pre-treatment assessment.

Aged↗

The McCanse Readiness for Death Instrument (MRDI): a reliable and valid measure for hospice care.

The purpose of this study was to establish whether or not readiness for death, as an indicator of healthy dying, is a measurable concept. Review of relevant literature revealed consensus regarding the universality of a human need for healthy dying. A theory of healthy dying was derived from the Rogerian paradigm. The McCanse Readiness for Death Instrument (MRDI) was constructed, which included indicators of physiological, psychological, sociological, and spiritual aspects of "healthy" field pattern as death is developmentally approached. The MRDI was a 26-item structured interview questionnaire which generated interval-ratio data through a visual analog scale. A pretest was conducted with a sample of 9 volunteer patients drawn from a small suburban outpatient hospice. The MRDI was concurrently administered to dying individuals, their primary caregivers, and their primary hospice nurses. Correlations between dying individuals' scores and their primary caregivers' estimates of patient death readiness as well as between patients and their primary hospice nurses were very encouraging. Cronbach's coefficient alpha for internal consistency reliability was .59. Content validity was supported by consensus of an expert panel of practicing hospice nurses. Construct validity was demonstrated through legitimate placement of the concept, healthy death readiness, within the theoretical web which supported it. The MRDI was then administered to a sample of 31 terminally-ill individuals, their primary caregivers, and their primary hospice nurses drawn from larger, urban hospice populations in three geographic areas of the United States. The MRDI was also administered to a contrast group of 39 cardiac-impaired individuals who were not terminally-ill. Overall internal consistency of the MRDI was found to be quite favorable (alpha = .76). Debilitating illness and actual mortality in the study sample precluded and/or confounded estimates of test-retest reliability. Convergent validity of the MRDI was indicated by significant correlations between patients' scores and primary caregivers' estimates (r = .35, p < .05) and between patients' scores and primary hospice nurses' estimates (r = .53, p < .01). Discriminant validity of the MRDI was demonstrated by a significant mean difference between the group of terminally-ill patients and the group of non-terminal, cardiac-impaired patients (t = 1.76, p < .01).

Aged↗

Use of an objective structured clinical examination in evaluating student performance.

BACKGROUND AND OBJECTIVES: The objective structured clinical exam (OSCE) is increasingly being used to evaluate student clinical performance. However, scant literature exists pertinent to this approach in evaluating family medicine clerkship performance. In this study, we assess 8 years' experience with a family medicine clerkship OSCE. METHODS: Eight annual clerkship OSCEs and the performance of 696 students are described. Comparisons of faculty evaluation, written exam, and OSCE performance are made for 335 students. Post-OSCE student and faculty feedback regarding OSCE validity and utility is also presented. RESULTS: Student performance is highest in medical history taking and physical examination and lowest in information-sharing stations. OSCE results appear to be relatively consistent on a year-to-year basis. OSCE, faculty evaluation, and written exam results have low overall levels of correlation, particularly in assessing performance that differs substantially from the mean. Students and faculty agree that the OSCE experience reflects skills that students should possess, but there is less agreement that the OSCE reflects clerkship-related learning and actual student performance. Both students and faculty derive insight from the OSCE regarding the definition of specific learning needs. CONCLUSIONS: The family medicine clerkship OSCE we describe appears to provide consistent measures of student performance. Although content validity is high, further assessment is needed to assure construct validity. The OSCE experience provides students with a rich resource for defining clerkship-related learning needs. Study results strongly suggest that OSCEs, faculty evaluations, and written exams provide differing measures of student performance. The reasons for these differences merit further exploration.

Clinical Clerkship↗

[Validation of the functional assessment of multiple sclerosis quality of life instrument in a Portuguese language].

The objective of the present study was to translate, to do cultural equivalence and validation of the Functional Assessment of Multiple Sclerosis quality of life instrument (FAMS) to Portuguese. The database analyzed is longitudinal, with 143 patients with clinically defined multiple sclerosis (MS). The validity of the scale was established by correlating total FAMS scores and sub-scales scores to EDSS and EAN. The internal consistency reliability were similar to those of the original FAMS. All sub-scales correlated with each other (0.35 to 0.71). Total FAMS score correlated significantly with EDSS, and EAN. All sub-scales correlated to EDSS. Kendall's Tau coefficient, showed significant associations between basal and first visit. Responsiveness was investigated considering two groups: patients with EDSS < 3.5 and with EDSS > 3.5. There was significantly higher score in the group with light EDSS when compared to the group of patients with moderate EDSS. One can conclude, based on this retrospective study that FAMS instrument translated to Brazilian Portuguese can be considered reliable, responsive and content valid.

Disability Evaluation↗

Reliability and validity of the American Orthopaedic Foot and Ankle Society Clinical Rating Scale: a pilot study for the hallux and lesser toes.

BACKGROUND: The use of clinical outcomes instruments is essential for the effective interpretation of individual patient progress as well as the comparison of treatment groups. An outcomes instrument must be reliable and valid to obtain any meaningful data. The purpose of the present study was to examine the reliability and validity of the American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating scale for the hallux metatarsophalangeal-interphalangeal and lesser toes metatarsophalangeal-interphalangeal joints. METHODS: Eleven patients (one man, 10 women) with an average age of 54 (range 40 to 72) years and with classic rheumatoid arthritis not currently treated for foot complaints were enrolled in the present study. The average duration of rheumatoid arthritis was 14 years. Each patient completed a set of two outcomes instruments and had a physical examination by a single clinician at the initial visit and returned at 1 week for completion of the same scales and examination. The outcomes scales used were the AOFAS clinical rating scale for the hallux, the AOFAS clinical rating scale for the lesser toes, and the previously validated Foot Function Index (FFI). Test-retest reliability was evaluated using intraclass correlation coefficients between week 1 and week 2 for the summary scores as well as for the subscales of pain and activity. Consistency between the two instruments was evaluated with Pearson correlation coefficients. RESULTS: The AOFAS clinical rating scale for the hallux and lesser toes is repeatable between 1-week trials (ICC 0.95; p < 0.05; ICC 0.80; p < 0.05, respectively). Moderately strong correlations were found between the mean values for the AOFAS hallux and FFI (r = -0.81; p < 0.05). Weaker correlations were seen between the mean values for the AOFAS lesser toes and FFI scales (r = -0.69; p < 0.05). CONCLUSIONS: The hallux subscale for pain correlates strongly with the FFI subscale for pain, suggesting high content validity (r = -0.94; p < 0.001). Ceiling effects were seen with the AOFAS lesser toe subscale for activity, limiting its usefulness in a general patient population. The AOFAS lesser toe subscale for pain and the AOFAS hallux subscale for activity correlated weakly with the FFI values (r = -0.31; r = -0.37; p > 0.05, respectively). CONCLUSIONS: Although the AOFAS hallux and lesser toe scales were found to be reliable in a rheumatoid patient population, their validity remains in question. These findings must be confirmed with larger subject numbers, with the inclusion of symptomatic patients before recommended routine use of the hallux clinical rating and lesser toe clinical rating scales.

Adult↗