Dorcas E. Beaton

GUIDELINES FOR THE PROCESS OF CROSS-CULTURAL ADAPTATION OF SELF-REPORT MEASURES

With the increase in the number of multinational and multicultural research projects, the need to adapt health status measures for use in other than the source language has also grown rapidly. 1,4,27 Most questionnaires were developed in English-speaking countries, 11 but even within these countries, researchers must consider immigrant populations in studies of health, especially when their exclusion could lead to a systematic bias in studies of health care utilization or quality of life. 9,11 The cross-cultural adaptation of a health status selfadministered questionnaire for use in a new country, culture, and/or language necessitates use of a unique method, to reach equivalence between the original source and target versions of the questionnaire. It is now recognized that if measures are to be used across cultures, the items must not only be translated well linguistically, but also must be adapted culturally to maintain the content validity of the instrument at a conceptual level across different cultures. 6,11‐13,15,24 Attention to this level of detail allows increased confidence that the impact of a disease or its treatment is described in a similar manner in multinational trials or outcome evaluations. The term “cross-cultural adaptation” is used to encompass a process that looks at both language (translation) and cultural adaptation issues in the process of preparing a questionnaire for use in another setting. Cross-cultural adaptations should be considered for several different scenarios. In some cases, this is more obvious than in others. Guillemin et al 11 suggest five different examples of when attention should be paid to this adaptation by comparing the target (where it is going to be used) and source (where it was developed) language and culture. The first scenario is that it is to be used in the same language and culture in which it was developed. No adaptation is necessary. The last scenario is the opposite extreme, the application of a questionnaire in a different culture, language and country—moving the Short Form 36-item questionnaire from the United States (source) to Japan (target) 7 which would necessitate translation and cultural adaptation. The other scenarios are summarized in Table 1 and reflect situations when some translation and/or adaptation is needed. The guidelines described in this document are based on a review of cross-cultural adaptation in the medical, sociological, and psychological literature. This review led to the description of a thorough adaptation process designed to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. 13 . Further experience in cross-cultural adaptation of generic and diseasespecific instruments and alternative strategies driven by different research groups 18 have led to some refinements

Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines

Clinicians and researchers without a suitable health-related quality of life (HRQOL) measure in their own language have two choices: (1) to develop a new measure, or (2) to modify a measure previously validated in another language, known as a cross-cultural adaptation process. We propose a set of standardized guidelines for this process based on previous research in psychology and sociology and on published methodological frameworks. These guidelines include recommendations for obtaining semantic, idiomatic, experiential and conceptual equivalence in translation by using back-translation techniques and committee review, pre-testing techniques and re-examining the weight of scores. We applied these guidelines to 17 cross-cultural adaptation of HRQOL measures identified through a comprehensive literature review. The reporting standards varied across studies but agreement between raters in their ratings of the studies was substantial to almost perfect (weighted kappa = 0.66-0.93) suggesting that the guidelines are easy to apply. Further research is necessary in order to delineate essential versus optional steps in the adaptation process.

Measuring the wole or the parts

UNLABELLED The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure was developed to evaluate disability and symptoms in single or multiple disorders of the upper limb at one point or at many points in time. PURPOSE The purpose of this study was to evaluate the reliability, validity, and responsiveness of the DASH in a group of diverse patients and to compare the results with those obtained with joint-specific measures. METHODS Two hundred patients with either wrist/hand or shoulder problems were evaluated by use of questionnaires before treatment, and 172 (86%) were re-evaluated 12 weeks after treatment. Eighty-six patients also completed a test-retest questionnaire three to five days after the initial (baseline) evaluation. The questionnaire package included the DASH, the Brigham (carpal tunnel) questionnaire, the SPADI (Shoulder Pain and Disability Index), and other markers of pain and function. Correlations or t-tests between the DASH and the other measures were used to assess construct validity. Test-retest reliability was assessed using the intraclass correlation coefficient and other summary statistics. Responsiveness was described using standardized response means, receiver operating characteristics curves, and correlations between change in DASH score and change in scores of other measures. Standard response means were used to compare DASH responsiveness with that of the Brigham questionnaire and the SPADI in each region. RESULTS The DASH was found to correlate with other measures (r > 0.69) and to discriminate well, for example, between patients who were working and those who were not (p<0.0001). Test-retest reliability (ICC = 0.96) exceeded guidelines. The responsiveness of the DASH (to self-rated or expected change) was comparable with or better than that of the joint-specific measures in the whole group and in each region. CONCLUSIONS Evidence was provided of the validity, test-retest reliability, and responsiveness of the DASH. This study also demonstrated that the DASH had validity and responsiveness in both proximal and distal disorders, confirming its usefulness across the whole extremity.

Development of the QuickDASH: Comparison of Three Item-Reduction Approaches

BACKGROUND The purpose of this study was to develop a short, reliable, and valid measure of physical function and symptoms related to upper-limb musculoskeletal disorders by shortening the full, thirty-item DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure. METHODS Three item-reduction techniques were used on the cross-sectional field-testing data derived from a study of 407 patients with various upper-limb conditions. These techniques were the concept-retention method, the equidiscriminative item-total correlation, and the item response theory (Rasch modeling). Three eleven-item scales were created. Data from a longitudinal cohort study in which the DASH questionnaire was administered to 200 patients with shoulder and wrist/hand disorders were then used to assess the reliability (Cronbach alpha and test-retest reliability) and validity (cross-sectional and longitudinal construct) of the three scales. Results were compared with those derived with the full DASH. RESULTS The three versions were comparable with regard to their measurement properties. All had a Cronbach alpha of > or = 0.92 and an intraclass correlation coefficient of > or = 0.94. Evidence of construct validity was established (r > or = 0.64 with single-item indices of pain and function). The concept-retention method, the most subjective of the approaches to item reduction, ranked highest in terms of its similarity to the original DASH. CONCLUSIONS The concept-retention version is named the QuickDASH. It contains eleven items and is similar with regard to scores and properties to the full DASH. A comparison of item-reduction approaches suggested that the retention of clinically sensible and important content produced a comparable, if not slightly better, instrument than did more statistically driven approaches.

Evaluating changes in health status : Reliability and responsiveness of five generic health status measures in workers with musculoskeletal disorders

OBJECTIVES To compare the measurement properties over time of five generic health status assessment techniques. METHODS Five health status measures were completed on two occasions by a sample of workers with musculoskeletal disorders. They included the SF-36, Nottingham Health Profile, Health Status Section of the Ontario Health Survey (OHS), Duke Health Profile, the Sickness Impact Profile and a self-report of change in health between tests. SETTING Subjects were accrued from a work site (within one week of injury) (n = 53), physiotherapy clinics (four weeks after injury), (n = 34), and a tertiary level rehabilitation center (more than four weeks after injury) (n = 40). ANALYSIS Intraclass correlation coefficients (ICC) derived from nonparametric one-way analysis of variance were used for test-retest reliability in those who had not changed (n = 49). Various responsiveness statistics were used to evaluate responsiveness in those who claimed they had a positive change in health (n = 45) and in those who would have been expected to have a positive change (n = 79). RESULTS Of the 127 subjects recruited, 114 completed both questionnaires (89.8%). In the subjects who reported no change in health, analysis of targeted dimensions (overall scores, physical function, and pain) demonstrated acceptable to excellent test-retest reliability in all but the Duke Health Profile. In subjects with change in health, the SF-36 was the most responsive measure (moderate to large effect sizes [0.55-0.97] and standardized response means ranging between 0.81 and 1.13). CONCLUSIONS The results suggest that the SF-36 was the most appropriate questionnaire to measure health changes in the population studied. The selection of a health status measure must be context-specific, taking into account the purpose and population of the planned research.

Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research.

The minimal clinically important difference (MCID) for an instrument is a much sought after, but elusive figure. In this review we will highlight new findings in this area, including taxonomy of MCID, methods used to ascertain MCID, the perspective taken for evaluating importance, and other sources of variation for MCID values. In the end we believe the MCID will be a context-specific value rather than a fixed number. The review highlights the need to do methodological research in this area, especially concurrent comparisons between approaches, or across different patient groups. There are many faces to the MCID, it is not a simple concept, nor simple to calculate.

Practice patterns in the diagnosis and treatment of osteoporosis after a fragility fracture: a systematic review

Fragility fractures are a strong indicator of underlying osteoporosis (OP). With the risk of future fracture being increased 1.5- to 9.5-fold following a fragility fracture, the diagnosis and treatment of OP in men and women with fragility fractures provides the opportunity to prevent future fragility fractures. This review describes the current status of practice in investigation and diagnosis of OP in men and women with fragility fractures, the rates and types of postfracture treatment in patients with fragility fractures and OP, interventions undertaken in this population, and the barriers to OP identification and treatment. A literature search performed in Medline, Healthstar, CINAHL, EMBASE, PreMedline, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews identified 37 studies on OP diagnosis, treatment, and interventions. The studies varied in design methodology, study facilities, types of fractures, and pharmacological treatments. Some studies revealed that no patients with fragility fractures received investigation or treatment for underlying OP. Investigation of OP by bone mineral density was low: 14 of 16 studies reported investigation of less than 32% of patients. Investigation by bone mineral density resulted in high rates of OP diagnosis (35–100%), but only moderate use of calcium and vitamin D (8–62%, median 18%) and bisphosphoates (0.5–38%) in patients investigated postfracture. Studies on barriers to OP identification and treatment focused on various groups of health practitioners. Barriers included the cost of therapies, time and cost of resources for diagnosis, concerns about medications, and the lack of clarity regarding the responsibility to undertake this care.

Assessing the reliability and responsiveness of 5 shoulder questionnaires

The purpose of this study was to compare the test-retest reliability and responsiveness of 5 different shoulder questionnaires in a sample of patients with shoulder pain. Ninety-nine patients completed the following shoulder questionnaires on 2 occasions: Subjective Shoulder Rating Scale, Simple Shoulder Test, Modified-American Shoulder and Elbow Surgeons Form, Shoulder Severity Index, and the Shoulder Pain and Disability Index. The Short Form-36 was also included. Test-retest reliability was assessed with intraclass correlation coefficients. Standardized response means were calculated to assess responsiveness. This procedure was done on 33 subjects who underwent rotator cuff surgery or total shoulder arthroplasty and who believed that they had improved between testings. All questionnaires had acceptable reliability (coefficients > 0.75) except the Subjective Shoulder Rating Scale (coefficient = 0.71) and were more responsive (0.65 < Standardized response mean < 1.23) than the Short Form-36 (0.08 < Standardized response mean < 0.43) except for pain (0.91). In this longitudinal study a direct comparison of 5 shoulder questionnaires was carried out. We found the Subjective Shoulder Rating Scale to have lower reliability and responsiveness. The other 4 questionnaires including 1 developed to measure whole extremity function (Modified American Shoulder and Elbow Surgeons Form) rather than the shoulder only were comparable with good reliability and responsiveness. The results indicate that the shoulder questionnaires were more sensitive to change in patients with shoulder pain than the generic questionnaire (Short Form-36), and both types of questionnaires should be used in outcome evaluations.

Validity of observer-based aggregate scoring systems as descriptors of elbow pain, function, and disability.

&NA; Current elbow-scoring systems are based on the observer-derived assessment of a variety of clinical and functional criteria, which are scored separately and then aggregated. The aggregate score then is assigned a categorical ranking that ranges from excellent to poor. The developers of different elbow-scoring systems have chosen different outcome criteria, assigned different weights to each criterion, and accorded different ranges of values to each categorical ranking. Five different elbow-scoring systems (the Mayo elbow-performance index and the systems of Broberg and Morrey, Ewald et al., The Hospital for Special Surgery, and Pritchard) were used to evaluate the same group of patients. The validity of the scoring systems was determined with use of visual-analog scales for the assessment of pain and function, patient and physician-derived ratings of the severity of impairment of the elbow, and two functional questionnaires completed by the patient (the Disabilities of the Arm, Shoulder and Hand questionnaire and the Modified American Shoulder and Elbow Surgeons patient self-evaluation form). The study sample consisted of sixty-nine patients who had sought treatment at one of two tertiary referral clinics because of problems related to the elbow. Pearson product-moment correlation coefficients were used to compare the raw aggregate scores, and kappa statistics were used to determine the level of agreement among the categorical rankings (excellent, good, fair, and poor). Examination of the five scoring systems revealed a remarkable lack of concordance with regard to the aspects of elbow function that were assessed.Good correlation was observed when the systems were compared on the basis of raw scores (Pearson product-moment correlation coefficients, 0.79 to 0.90), but only slight-to-moderate correlation was noted when the systems were compared on the basis of categorical rankings (quadratic weighted kappa coefficients, 0.18 to 0.49). Validity testing showed the system of Ewald et al. and the Mayo elbow-performance index to be the most discriminating, the system of Pritchard to be the least discriminating, and the system of The Hospital for Special Surgery and the system of Broberg and Morrey to be intermediate. The scores determined with the elbow-scoring systems demonstrated only moderate correlation with the score for function on the visual analog scale (Pearson product-moment correlation coefficients, 0.44 to 0.66), whereas those derived from the functional questionnaires completed by the patient demonstrated moderate-to-good correlation with the score for function (Pearson product-moment correlation coefficients, 0.72 and 0.80). Clinical Relevance We observed a remarkable lack of agreement when five different elbow-scoring systems were used to determine categorical rankings for the same cohort of patients. The correlations between the raw aggregate scores were better. On the basis of these findings, we believe that outcomes should be expressed as raw scores rather than as categorical rankings. We also found that scores derived from patient-completed functional questionnaires correlated more closely with perceived functional loss than did those determined with aggregate elbow-scoring systems. It must be recognized that comparisons between studies that are based on different scoring systems are not valid and that the categorical rankings of different systems are not interchangeable. The outcome of therapies designed for the treatment of the elbow should be determined on the basis of a patient-derived assessment of function, a clinical examination, and an assessment of pain.

Effective initiation of osteoporosis diagnosis and treatment for patients with a fragility fracture in an orthopaedic environment

BACKGROUND Fragility fractures resulting from osteoporosis are common injuries. However, the identification and treatment of osteoporosis in these high-risk patients are widely reported to be inadequate. The goals of this study were to determine how many patients receiving inpatient or outpatient treatment for a fragility fracture could be identified and enrolled in a program for osteoporosis education, investigation, and treatment and receive appropriate osteoporosis care within the program. METHODS An Osteoporosis Exemplary Care Program was implemented to identify, educate, evaluate, refer, and treat patients considered to be at risk for osteoporosis because of a typical fragility fracture. System modifications included coordination among the orthopaedic unit, Metabolic Bone Disease Clinic, and nuclear medicine unit to provide a continuum of care for these patients. Barriers were addressed through ongoing education of physicians, staff, and patients to increase knowledge and awareness of osteoporosis. The percentages of patients previously diagnosed and treated for osteoporosis, referred for investigation of osteoporosis, treated by the orthopaedic team, and receiving appropriate attention for osteoporosis were calculated. Risk factors for osteoporosis were also assessed. RESULTS Three hundred and forty-nine patients with a fragility fracture (221 outpatients and 128 inpatients) who met the inclusion criteria and an additional eighty-one patients with a fracture (fifty-five outpatients and twenty-six inpatients) who did not meet the inclusion criteria but were suspected by their orthopaedic surgeons of having underlying osteoporosis were enrolled in the Osteoporosis Exemplary Care Program. More than 96% (414) of these 430 patients received appropriate attention for osteoporosis. Approximately one-third (146) of the 430 patients had been diagnosed and treated for osteoporosis before the time of recruitment. Two hundred and twenty-two of the remaining patients were referred to the Metabolic Bone Disease Clinic or to their family physician for further investigation and treatment for osteoporosis. Treatment was initiated by the orthopaedic team for another twenty-three patients. Many patients had risk factors for osteoporosis in addition to the fragility fracture; these included a previous fracture (forty-nine of 187; 26%), a mother who had had a fragility fracture (forty-two of 188; 22%), or a history of smoking (105 of 188; 56%). CONCLUSIONS In a coordinated post-fracture osteoporosis education and treatment program directed at patients with a fragility fracture and their caregivers, >95% of patients were appropriately diagnosed, treated, or referred for osteoporosis care. To accomplish this, a dedicated coordinator and the full cooperation of orthopaedic surgeons and residents, orthopaedic technologists, allied health-care professionals (nurses, physical and occupational therapists, and social workers), and administrative staff were required.