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PubMed2006

Translation and validation of the Dutch version of the International Knee Documentation Committee Subjective Knee Form.

BACKGROUND: For knee-related surgery, there is a great demand for internationally useable subjective scoring systems. Before such measurements can be used, they should be translated and validated for the population they are used on. For the Dutch population, only the Western Ontario and McMaster Universities Osteoarthritis Index and Oxford 12 Questionnaire have been validated. However, these scores can only be used regarding osteoarthritis of the knee. In 2001, the International Knee Documentation Committee presented the Subjective Knee Form, which is a knee-specific rather than a disease-specific questionnaire. STUDY DESIGN: Cohort study (diagnosis/symptom prevalence); Level of evidence, 2. METHODS: The authors describe the translation procedure and validation of the Dutch Subjective Knee Form. After a forward-backward translation protocol, the reliability, validity, and content validity were tested. The responses of 145 consecutive knee patients on 2 questionnaires containing the Short Form-36, Western Ontario and McMaster Universities Osteoarthritis Index, Oxford 12 Questionnaire score, a visual analog scale, and the Dutch International Knee Documentation Committee Subjective Knee Form were used. Reliability was tested by measuring the test-retest reliability and internal consistency. Validity was tested by correlating the questionnaire to the other outcome measurements, and content validity was tested by measuring the floor and ceiling effects. RESULTS: The reliability proved excellent with an intraclass coefficient of 0.96 for test-retest. Internal consistency was strong (Cronbach alpha, .92). The construct, convergent, and divergent validities were good. The content validity was good; no floor or ceiling effect occurred. CONCLUSION: The validation procedure shows that the Dutch International Knee Documentation Committee Subjective Knee Form is an excellent evaluation instrument for Dutch patients with knee-related injuries.

Adult↗
PubMed2003

Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity.

BACKGROUND: Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results) and internal validity (reliability or accuracy of the results) needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. DISCUSSION: External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. SUMMARY: Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results) and external validity (generalizability). The attempt to achieve methodological purity can result in clinically meaningless results, while attempting to achieve full generalizability can result in invalid and unreliable results. Achieving a creative tension between the two is crucial.

Blood Pressure↗
PubMed2005

Validation of psychoanalytic theories: towards a conceptualization of references.

The authors discuss criteria for the validation of psychoanalytic theories and develop a heuristic and normative model of the references needed for this. Their core question in this paper is: can psychoanalytic theories be validated exclusively from within psychoanalytic theory (internal validation), or are references to sources of knowledge other than psychoanalysis also necessary (external validation)? They discuss aspects of the classic truth criteria correspondence and coherence, both from the point of view of contemporary psychoanalysis and of contemporary philosophy of science. The authors present arguments for both external and internal validation. Internal validation has to deal with the problems of subjectivity of observations and circularity of reasoning, external validation with the problem of relevance. They recommend a critical attitude towards psychoanalytic theories, which, by carefully scrutinizing weak points and invalidating observations in the theories, reduces the risk of wishful thinking. The authors conclude by sketching a heuristic model of validation. This model combines correspondence and coherence with internal and external validation into a four-leaf model for references for the process of validating psychoanalytic theories.

Humans↗
PubMed2005

Development and validation of a lower-extremity activity scale. Use for patients treated with revision total knee arthroplasty.

BACKGROUND: Valid outcome measurement tools are required to reliably demonstrate the effectiveness and clinical outcomes of lower-extremity arthroplasty. Having ascertained a lack of a practical and valid measure of the change in actual daily physical activity that occurs prior to and following lower-limb arthroplasty, we developed and validated a lower-extremity activity scale. METHODS: The eighteen-level self-administered scale was developed with the aid of content experts to ensure face validity. Validity and reliability were assessed with the use of (1) pedometer measurements of seventy subjects over seven days; (2) next-of-kin proxy measurements of the activity levels of ninety patients before they underwent lower-limb arthroplasty; and (3) application, and correlation with the Western Ontario and McMaster Universities Osteoarthritis Index scores, in a prospective seventeen-center clinical study of 297 consecutive patients undergoing revision total knee arthroplasty. In this latter study, demographic and comorbidity data were also collected. Univariate and bivariate correlations were performed, and a multivariate structured equation modeling approach was used to further test responsiveness, reliability, and validity of the lower-extremity activity scale. RESULTS: Pedometer readings correlated with the activity levels derived with the lower-extremity activity scale (r = 0.79). Of note was the finding that age, weight, and body mass index did not correlate well with the average number of steps per day (r = -0.32, -0.32, and -0.25, respectively). A significant correlation was found between the lower-extremity activity scores recorded by the patients and those reported by their next of kin (Pearson correlation, r = 0.715; p = 0.0001) and between the initial lower-extremity activity scores and two-week-retest scores (intraclass correlation = 0.9147; p < 0.0001), demonstrating the validity and reliability of the scale. The lower-extremity activity scale was responsive, accurately reflecting changes in the patient's condition between baseline and the time of follow-up (p < 0.001), and it was reliable, with baseline values correlating with follow-up scores (p < 0.001). The convergent validity of the lower-extremity activity scale was established by correlations with the function scores (r = -0.301, p < 0.001) and pain scores (r = -0.241, p < 0.001) derived with the Western Ontario and McMaster Universities Osteoarthritis Index and with a higher number of comorbidities (r = -0.244, p < 0.001). Multivariate path modeling further demonstrated diminished activity in patients who had more difficulty in functioning and a greater number of comorbidities. CONCLUSIONS: We developed a lower-extremity activity scale and validated that it was an effective instrument for the assessment of patients' actual activity levels. It is easy to apply and interpret, and it is valid and ready for use in the clinical setting. This scale will allow more accurate analysis and prediction of outcomes. Consequently, it will become a useful, practical adjunct to objective clinical decision-making and intervention for patients undergoing arthroplasty.

Activities of Daily Living↗
PubMedDate not supplied

[Clinical assessment of schizophrenic syndrome (CASS): validity evaluation of the new diagnostic tool].

AIM: The aim of the study was an evaluation of validity measures of the CASS (Clinical Assessment of Schizophrenic Syndromes)--a new multi-purpose and multi-level clinical diagnostic instrument consisting of a diagnostic questionnaire (CASS-D) allowing to analyze a diagnosis of schizophrenia according to DSM-IV and ICD-10 criteria as well as of three rating scales designed for description and intensity evaluation of schizophrenic syndromes on the global (CASS-G), dimensional (CASS-P, a profile of 13 basic dimensions) or symptomatological (CASS-S, a set of 31 symptoms) level. SUBJECTS: 194 inpatients consecutively admitted to the Department within approximately 6 months were assessed twice (at the start and end of their hospitalization) by 12 trained diagnosticians. METHOD: Several measures of validity were analyzed. Results obtained by means of CASS were compared with results of the SANS/SAPS, BPRS, and PANSS as reference rating scales (diagnostic validity). Characteristics of frequency, intensity, dynamics and specificity of scale items were used to analyze content validity. Factorial structure of CASS scales was applied as a measure of construct validity. FINDINGS: Diagnostic validity of the new instrument seems to be confirmed by its very high correlation coefficients with rating scales recognized as international standards: BPRS, PANSS, and SANS/SAPS. Reasonable characteristics of frequency, intensity, dynamics and specificity of individual items (dimensions, symptoms) and sum scores of CASS scales and relationships between their values strongly suggest their content validity. Both sum (CASS-P, CASS-S) and global (CASS-G) scores of scales under study revealed some specificity--they had significantly higher values in patients with schizophrenia than in patients with other diagnoses. It allows to distinguish in a schizophrenic syndrome described by CASS components which are specific and not specific for this disorder. The latter have been left also in the final version for their practical and clinical importance. Construct validity of the CASS was studied separately for different scales (CASS-P, CASS-S) and different groups (all or only schizophrenic patients) by means of several factor analyses, and performed along identical statistical procedure (principal component method of extraction with criterion eigenvalue > 1, followed by Equamax rotation). Resulting solutions could be interpreted reasonably and consistently with contemporary attempts to find adequate factorial models of intrinsic structure of schizophrenic syndrome. Thus they support confidence for constructive aspect of the CASS validity. CONCLUSIONS: Ultimately, results obtained in the study suggest that the CASS may be considered as an instrument with some promising indices of diagnostic, content and construct validity, which may be potentially useful for clinical and research purposes.

Humans↗
PubMed1996

[OECD ist accepting test guidelines for validated in vitro toxicity tests in 1996]

Since 1990 in Europe a scientific concept for the validation of in vitro toxicity tests has been developed to facilitate regulatory acceptance of the new methods at the international level. ERGATT and ECVAM have promoted the concept of validation on two workshops in 1990 and 1994. A pre-validation stage is an essential part of this validation concept to achieve a better standardisation of in vitro tests before entering formal validation. Within the NTP in 1995/96 Federal Agencies of the USA represented by the validation center ICCVAM have accepted a validation concept, which basically agrees with the essentials of ECVAM"s European validation concept. Subsequently, in January of 1996 the major industrial nations have at the OECD level agreed to the European/US validation concept. This will at the international level allow mutual acceptance of data obtained with in vitro toxicity tests rather than with animal tests. It seems very likely that in 1996 in vitro testing for skin penetration with human skin will be the first in vitro toxicity test accepted by the OECD. Several in vitro tests for local irritancy testing will follow in 1997/98, since they are currently undergoing validation according to OECD criteria.

Journal Article↗
PubMed2001

Establishing the internal and external validity of experimental studies.

The information needed to determine the internal and external validity of an experimental study is discussed. Internal validity is the degree to which a study establishes the cause-and-effect relationship between the treatment and the observed outcome. Establishing the internal validity of a study is based on a logical process. For a research report, the logical framework is provided by the report's structure. The methods section describes what procedures were followed to minimize threats to internal validity, the results section reports the relevant data, and the discussion section assesses the influence of bias. Eight threats to internal validity have been defined: history, maturation, testing, instrumentation, regression, selection, experimental mortality, and an interaction of threats. A cognitive map may be used to guide investigators when addressing validity in a research report. The map is based on the premise that information in the report evolves from one section to the next to provide a complete logical description of each internal-validity problem. The map addresses experimental mortality, randomization, blinding, placebo effects, and adherence to the study protocol. Threats to internal validity may be a source of extraneous variance when the findings are not significant. External validity is addressed by delineating inclusion and exclusion criteria, describing subjects in terms of relevant variables, and assessing generalizability. By using a cognitive map, investigators reporting an experimental study can systematically address internal and external validity so that the effects of the treatment are accurately portrayed and generalization of the findings is appropriate.

Double-Blind Method↗
PubMed1999

Validity of work-related assessments.

Insufficient evidence of the validity of work-related assessments is frequently reported as a major concern in occupational rehabilitation. Despite this concern, and the continuing development of new and old assessments, no comprehensive evaluation of the evidence has been conducted. OBJECTIVES: The purpose of this study was to first determine the extent and quality of available evidence for the validity of work-related assessments, and then where sufficient evidence was available, determine the level of validity. STUDY DESIGN: This study examined available literature and sources in order to review the extent to which validity has been established for 28 work-related assessments. RESULTS: The levels of evidence and validity are presented for each assessment. Most work-related assessments have limited evidence of validity. Of those that had adequate evidence, validity ranged from poor to good. There was no instrument that demonstrated moderate to good validity in all areas. Very few work-related assessments were able to demonstrate adequate validity in more than one area, or with more than one study, even when contributory evidence was included. CONCLUSION: With this study clinicians will be able to examine their options with regard to the validity of the assessments they choose to use.

Journal Article↗
PubMed2001

Development and validation of the Observation List for early signs of Dementia (OLD).

OBJECTIVE: Development and validation of a short Observation List of possible early signs of Dementia (OLD) for use in general practice. DESIGN: Stepwise development using reviews of publications and expert consensus. Field study for evaluation of reliability. Validation study (interviews, family forms) using existing valid and reliable measures. Use of data reduction techniques to construct a short version. Setting of field study Twenty-two GPs in 19 Dutch practices. PARTICIPANTS: The first two patients seen on 15 working days (n = 470) were observed. Inclusion: age > 75, without a known diagnosis of dementia. Exclusion: psychiatric treatment, severe depression, acute illness with confusion. Division of patients into three groups with no, intermediate, and the most signs (total of interviewed patients, n = 60; family forms, n = 39). Outcome measures Reliability (Cronbach's alpha and factor-analysis). Convergent validity using the Cognitive Screening Test (CST), the Word Learning Test (WLT, total and retention), the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), the Groningen Activities Restriction Scale (GARS), and an IADL scale. Discriminant validity using the geriatric depression scale (GDS). Construct validity using a Principal Component Analysis (PRINCALS). Incremental validity using the intuitive opinion of the GP (McNemar test). RESULTS: Reliability in the total group 0.88, first factor explained variance 42.5%. Convergent validity (two-way ANOVA) results: CST (p = 0.00), WLT-total (p = 0.001), WLT retention (p = 0.00), IQCODE (p = 0.09). No statistically significant differences for GARS and IADL. GDS (p = 0.30) not different. PRINCALS first factor explained 48% of variance. The OLD added to the GP opinion (McNemar p = 0.00). Reliability short version 0.89 (interviewed group), 0.86 (total group). CONCLUSIONS: The OLD is a valid and reliable method to detect early signs of dementia in general practice that can indicate when it may be useful to employ existing screening instruments.

Aged↗
PubMed2007

Development of a content-valid standardized orthopedic assessment tool (SOAT).

INTRODUCTION: Content validation of an instrument that measures student performance in OSCE-type practical examinations is a critical step in a tool's overall validity and reliability [Hopkins (1998), Educational and Psychological Measurement and Evaluation (8th ed.). Toronto: Allyn & Bacon]. PURPOSE: The purpose of the paper is to outline the process employed to create a content-valid Standardized Orthopedic Assessment Tool (SOAT). Orthopedic assessment skills are employed by athletic therapists, physiotherapists and physicians. All follow very similar diagnostic algorithms and that system was used to develop the original SOAT [Cyriax (1982). Textbook of Orthopaedic Medicine, (vol. 1) Bailliere Tindall]. METHODS: To validate the tool, the study followed procedures outlined by Violato, Salami, and Muiznieks (2002), Journal of Manipulative Physiological Therapeutics, 25, 111-115, and Butterwick, Paskevich, Vallevand and Lafave (2006), Journal of Allied Health: a modified Ebel procedure. An expert group of athletic therapists from across Canada were chosen to create the content valid tool. Representation from all accredited athletic therapy programs in Canada was sought. Experts participated in three stages of content validation: Stage one consisted of individuals grading tasks on difficulty (hard, medium, easy) and importance (essential, important, not important) for 8 body regions (cervical spine, lumbar spine, shoulder, elbow, wrist/hand/thumb, hip, knee and lower leg/foot/ankle) and three diagnoses for each body region (24 total). If 80% consensus was not achieved in the first stage, then in stage two, face to face discussion is meant to clarify positions and achieved consensus, if possible. RESULTS: The history component, the observation component, scanning exams, clearing joints above and below the lesion site and active range of motion, passive range of motion and isometric resisted testing all yielded 80% consensus in the first two stages of development. A third stage was added to this process because a new model of measurement was conceptualized during the second stage due to a lack of consensus on two orthopedic assessment categories: special testing and palpation. The new model consisted of a ;;clinical reasoning" metric that tied each section of an orthopedic assessment (history; observation; scanning and clearing; examination, special testing; palpation; conclusion) together and would permit the expert rater to evaluate the student performance based on the student's rationale for tests chosen rather than the traditionally rigid checklists. At least 80% consensus was achieved with the new ;;clinical reasoning" metric and the originally contentious special testing and palpation categories. CONCLUSIONS: The new SOAT that underwent content validation may be a hybrid between the traditional OSCE-type checklists and global scales that provide a more realistic and thus more valid depiction of orthopedic assessment clinical competence. Now that content validation has been established, the next steps include inter-rater reliability testing.

Algorithms↗
PubMed2004

[Translation and construct validity of the Lequesne index for Arab speaking North African patients with osteoarthritis of the knee].

OBJECTIVE: To translate in Arabic and validate the Lequesne index for use in Tunisian. BACKGROUND: No instrument wording in Arabic language and validated in an Arab population to measure lower limb functional disability caused by OA. DESIGN: Arab translation was obtained using the "forward translation/backward translation" method. Adaptations were made after a pilot study. Patients with symptomatic knee osteoarthritis fulfilling the revised criteria of the American College of Rheumatology were included. Impairment outcome measures (VAS pain; knee mobility; Kellgren's radiological score); disability (the maximum distance walked; WOMAC index) and Beck depression scale were recorded. Inter rater reliability was assessed using the intra-class correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated using the Spearman rank correlation coefficient (convergent and divergent validities) and a factor analysis was performed. Internal consistency of each factor was assessed by Crohnbach alpha coefficient. RESULTS: One hundred and three patients were included. All questions were acceptable and retained. Inter rater reliability was excellent with ICC = 0.91. The Bland and Altman method showed distribution of differences homogenous and no systematic trend. Expected divergent validity and convergent validity were observed, suggested good construct validity. Two main factors were extracted by factor analysis of the Lequesne, and explained more than 55% of the cumulative variance, the first factor represents disability and the second represents pain and stiffness. Crohnbach alpha coefficient was, respectively, 0.68 for factor 1 and 0.54 for factor 2. In conclusion, we translated and adapted the Lequesne index into Arabic to suit Tunisian people. Translated questionnaire is reliable and valid. Although the scale was validated in a Tunisian population, we expect that it can suit other Arab populations especially North Africans. Further studies are needed to confirm such hypothesis.

Adult↗
PubMed2005

[The Oswestry index for low back pain translated into Arabic and validated in a Arab population].

OBJECTIVE: To translate into Arabic and validate the Oswestry index for low back pain in an Arab population. BACKGROUND: No functional disability index to assess low back pain written in the Arabic language and validated in an Arab population is available. DESIGN: Arabic translation of the Oswestry index was obtained by the "forward translation/backward translation" method. Adaptations were made after a pilot study involving ten patients aged 18 to 65 years old. Impairment outcome measures (pain as measured on a visual analog scale [VAS], Schober-McRae, index, duration of morning stiffness and number of night awakenings), disability (Quebec index, Waddell index), handicap (as measured on a VAS) and Beck depression scale scores were recorded. Inter-rater reliability was assessed by use of the intra-class correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated with use of the Spearman rank correlation coefficient (convergent and divergent validity), and factor analysis was performed. Internal consistency was assessed by use of the Cronbach alpha coefficient. RESULTS: Eighty Tunisian patients with low back pain were included in the validation study. Two items were excluded. Inter-rater reliability was excellent (ICC = 0.98). Expected divergent and convergent validity results suggested good construct validity. Two main factors were extracted by factor analysis and explained 58.19% of the cumulative variance: the first factor represented discomfort in dynamic activities, the second discomfort in static activities. The Cronbach alpha coefficient was 0.76 for factor 1 and 0.70 for factor 2. CONCLUSION: We translated into and adapted the Oswestry index for the Arabic language in a population of Tunisian women? with low back pain. The 8-item version is reliable and valid. Although the scale was validated in a Tunisian population, we expect that it is suitable for other Arab populations, especially North Africans. Further study is needed to confirm such a hypothesis.

Adolescent↗
PubMedDate not supplied

Content validity and the language of breathing.

OBJECTIVE: The study objective was to validate the content validity of natural language words and phrases selected from participant logs as breathing-intensity descriptors. DESIGN AND SETTING: A descriptive design was implemented using data collected in a prior study in which the breathing-intensity descriptors had been identified. METHODS: Content validity was used to rate natural language breathing-intensity descriptors. Six seasoned nurses with a minimum of master's preparation served as the expert panel. On the basis of a 4-point (0-3) scale, mean scores were calculated for natural language breathing-intensity descriptors. Content validity was established for mean scores greater than 1.0. RESULTS: A total of 66 (89%) natural language breathing-intensity descriptors were validated. The experts did not validate eight descriptors that described the lower end of breathing intensity. CONCLUSIONS: Natural language breathing-intensity descriptors were validated. The highest validation scores were achieved with breathing-intensity descriptors at the upper end of the breathing-intensity spectrum. However, words and phrases that aligned with the lower end of the spectrum generated lower content validity scores. This was an unexpected finding on the full spectrum of breathing intensity that raised questions about differences in language, meaning, and significance between participants and experts.

Humans↗
PubMed2005

Model to predict prostate biopsy outcome in large screening population with independent validation in referral setting.

OBJECTIVES: To develop a model capable of predicting prostate biopsy outcomes in a large screening population, with independent validation in the referral setting. METHODS: Data from 3814 men participating in the Tyrol screening project were used to develop the model. Prospectively collected data from two independent sites in the United States (Virginia Mason Clinic, Seattle, Wash and Stanford University, Stanford, Calif) were used to validate the model independently. The Tyrol data was split randomly into three cross-validation sets, and a feed-forward, back error-propagation artificial neural network (ANN) was alternately trained on a combination of two of these data sets and validated on the remaining data set. Similarly, three logistic regression (LR) models were produced and validated using identical cross-validation data sets. The Tyrol model with the median area under receiver operating characteristic curve (AUROC) was then validated against the Virginia Mason (n = 491) and Stanford University (n = 483) data sets. RESULTS: The AUROCs for the three cross-validations were 0.74, 0.76, and 0.75 for the ANN and 0.75, 0.76, and 0.75 for the LR models. The mean AUROC for both ANN and LR was 0.75 with a standard deviation of 0.009 for ANN and 0.006 for LR. The AUROCs for the Virginia Mason and Stanford University data were 0.74 (both ANN and LR) and 0.73 (ANN) and 0.72 (LR), respectively. CONCLUSIONS: This model, designed to predict the prostate biopsy outcome, performed accurately and consistently when validated with data from two independent referral centers in the United States, suggesting that it generalizes well and may be of clinical utility to a broad range of patients.

Aged↗
PubMed2001

The community integration measure: development and preliminary validation.

OBJECTIVE: To present a new measure of community integration, the Community Integration Measure (CIM), and to offer preliminary information about its psychometric properties. DESIGN: Validation study. SETTING: Community. PARTICIPANTS: Ninety-two participants placed in 3 subgroups (brain injury survivors, n = 41; significant others, n = 36; college students, n = 15). MAIN OUTCOME MEASURES: The distributional properties, factor structure, internal consistency reliability, content validity, discriminant validity, concurrent validity, and construct validity of the CIM. RESULTS: All items correlated positively with each other and with the total score. Principal components factor analysis confirmed a 1-factor structure, which explained 44.1% of the variance. Internal consistency reliability, using Cronbach's alpha, was.87. Content validity was assured by the development procedure, correspondence with the theoretical model, and direct use of consumer language. Discriminant validity was supported by the CIM's ability to differentiate between subsamples. Criterion validity was supported by using correlations with the Community Integration Questionnaire. Construct validity was supported by correlations with the Interpersonal Support Evaluation List. CONCLUSION: The CIM offers a brief, easily administered measure of community integration that conforms to an empirically derived theoretical model and is psychometrically sound.

Activities of Daily Living↗
PubMed2005

Validity of the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire.

STUDY DESIGN: A cross-sectional multicenter study was performed to validate the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. OBJECTIVES: To determine the construct validity and convergent validity of the instrument. METHODS: The Spanish version of the SRS-22 was given to 175 patients with scoliosis (mean age, 19 years old and 86% women). A subgroup of 31 patients also received the Quality of Life for Spine Deformities Profile (QLSDP). Construct validity was studied by factor analysis. Discriminant validity was assessed analyzing the relation between SRS-22 scores and the variables of deformity severity. Convergent validity as related to the QLSDP was studied with a multitrait-multimethod matrix analysis. RESULTS: Factor analysis offered a solution of four factors coherent with the dimensions of the original instrument. SRS-22 scores were worse in older patients (r = -0.34); patients using analgesics demonstrated lower scores (P < 0.001). Patients treated with a brace had a poorer self-image and were less satisfied with their treatment (P < 0.001) than the other treatment groups. Angular improvement of the curves was associated with better self-image scores (r = 0.34). The SRS-22 and QLSDP demonstrated high correlation coefficients in the convergent validity tests (r = 0.84). CONCLUSION: The Spanish version of the SRS-22 is valid. It has a factorial structure similar to that of the original questionnaire. Moreover, it relates to known severity characteristics of the disease, distinguishes among scoliosis patient groups, and shows concordant values with another valid instrument for measuring self-perceived health.

Adult↗
PubMed2005

Validation of performance indicators for rehabilitation of workers with mental health problems.

OBJECTIVE: The objective of this study was to evaluate content validity and predictive validity of 11 performance indicators for the rehabilitation of workers with mental health problems. RESEARCH DESIGN AND SUBJECTS: Content validity was assessed by experts who evaluated the validity of the performance indicators in 2 Delphi rounds. Predictive validity was evaluated by relating the performance indicators and their sum score to the outcome of a cohort of 191 employees absent from work as a result of mental health problems. Scores for the performance indicators were obtained by processing registration forms of consultations filled out by occupational physicians. MAIN OUTCOME MEASURES: Three outcome measures were used: time to return to work, change in level of fatigue, and patient satisfaction. RESULTS: Ten of the 11 performance indicators showed adequate content validity according to the expert panel. The evaluation of predictive validity yielded mixed results. One performance indicator did not show sufficient variability and was excluded from further analysis. The sum score of 9 performance indicators and performance on the evaluation of work disabilities were significantly related to a shorter time to return to work (hazard ratio [HR], respectively, 0.7; confidence interval [CI], 0.7-0.9 and 0.5; CI, 0.2-0.9). Adequate care regarding interventions aimed at providers of care in the curative sector was related to a longer time to return to work (HR, 1.8; CI, 1.1-3.0). The linear regression revealed that the sum score was not significantly related to a change in level of fatigue. However, lower quality of overall care was significantly related to moderately higher patient satisfaction (beta=0.18; P<0.05). CONCLUSIONS: The evaluated performance indicators showed sufficient content validity and overall predictive validity, but no clear relation could be established between individual performance indicators and outcome.

Adult↗
PubMed2005

Validation of a short questionnaire in English and French for use in patients with persistent upper gastrointestinal symptoms despite proton pump inhibitor therapy: the PASS (Proton pump inhibitor Acid Suppression Symptom) test.

BACKGROUND: The management of persistent symptoms during acid suppression therapy in patients with gastroesophageal reflux disease or dyspepsia might be improved if patient-physician communication regarding the presence and character of these persistent symptoms were facilitated. AIM: To validate a short, simple questionnaire (the Proton pump inhibitor [PPI] Acid Suppression Symptom [PASS] test), in English and French, to identify patients with persistent acid-related symptoms during PPI therapy and document their response to a change in therapy. METHODS: Patients with persistent acid-related symptoms on PPI therapy were interviewed to produce a draft, five-item questionnaire; content validity was evaluated by focus groups comprising English- and French-speaking patients. Psychometric validity was subsequently evaluated in a multicentre, family practice-based study of English- and French-speaking patients with persistent acid-related upper gastrointestinal symptoms despite PPI therapy. The PASS test, Global Overall Symptom scale, Gastrointestinal Symptom Rating Scale (GSRS), Quality of Life in Reflux and Dyspepsia questionnaire and Reflux Disease Questionnaire were completed at baseline and repeated after one week while patients continued their original PPI therapy. All patients then received esomeprazole 40 mg once daily for four weeks, after which all questionnaires and an evaluation of overall treatment effect were completed. RESULTS: Content validity was established in 20 English- and 16 French-speaking patients. Psychometric validation in 158 English- and 113 French-speaking patients revealed good-to-excellent test-retest reliability coefficients: 0.76 for English; 0.68 for French. For construct validity, the PASS test showed moderate-to-high correlation with the GSRS scale (0.51 for English; 0.43 for French). After four weeks of therapy, the PASS test score fell to zero in 30% of English- and 33% of French-speaking patients, while the Global Overall Symptom score fell to one (no symptoms) in 32% of patients (English- and French-speaking); the PASS test demonstrated good responsiveness in comparison with the GSRS, Reflux Disease Questionnaire and Quality of Life in Reflux and Dyspepsia questionnaire. CONCLUSION: The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy.

Dyspepsia↗