Reliability and validity of the cross-culturally adapted French version of the Core Outcome Measures Index (COMI) in patients with low back pain

Purpose  

To conduct a cross-cultural adaptation of the Core Outcome Measures Index (COMI) into French according to established guidelines.     

Cross-cultural adaptation and assessment of the reliability and validity of the Core Outcome Measures Index (COMI) for the Brazilian-Portuguese language

Purpose

The use of patient-orientated questionnaires is of utmost importance in assessing the outcome of spine surgery. Standardisation, using a common set of outcome measures, is essential to aid comparisons across studies/in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders. This study aimed to produce a Brazilian-Portuguese version of the COMI.

Methods

A cross-cultural adaptation of the COMI into Brazilian-Portuguese was carried out using established guidelines. 104 outpatients with chronic LBP (>3 months) were recruited from a Public Health Spine Medical Care Centre. They completed a questionnaire booklet containing the newly translated COMI, and other validated symptom-specific questionnaires: Oswestry Disability Index (ODI) and Roland Morris disability scale (RM), and a pain visual analogue scale. All patients completed a second questionnaire within 7–10 days to assess reproducibility.

Results

The COMI summary score displayed minimal floor and ceiling effects. On re-test, the responses for each individual domain of the COMI were within 1 category in 98% patients for the domain ‘function’, 96% for ‘symptom-specific well-being’, 97% for ‘general quality of life’, 99% for ‘social disability’ and 100% for ‘work disability’. The intraclass correlation coefficients (ICC_2,1) for COMI pain and COMI summary scores were 0.91–0.96, which compared favourably with the corresponding values for the RM (ICC, 0.99) and ODI (ICC, 0.98). The standard error of measurement for the COMI was 0.6, giving a “minimum detectable change” (MDC95%) of approximately 1.7 points i.e., the minimum change to be considered “real change” beyond measurement error. The COMI scores correlated as hypothesised (Rho, 0.4–0.8) with the other symptom-specific questionnaires.

Conclusions

The reproducibility of the Brazilian-Portuguese version of the COMI was comparable to that of other language versions. The COMI scores correlated in the expected manner with existing but longer symptom-specific questionnaires suggesting good convergent validity for the COMI. The Brazilian-Portuguese COMI represents a valuable tool for Brazilian study-centres in future multicentre clinical studies and surgical registries.     

Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck

Purpose  

Patient-orientated outcome questionnaires are essential to evaluate treatment success. To compare different treatments, hospitals, and surgeons, standardised questionnaires are required. The present study examined the validity and responsiveness of the Core Outcome Measurement Index for neck pain (COMI-neck), a short, multidimensional outcome instrument.     

Cross-cultural adaptation and validation of the Norwegian version of the Core Outcome Measures Index for low back pain

Purpose

The Core Outcome Measures Index (COMI) is a short multidimensional scale covering all domains recommended to be included as outcome measures for patients with low back pain (LBP). The purpose of the present study was to translate and cross-culturally adapt the COMI into Norwegian and to test clinimetric properties of the Norwegian COMI version in patients with non-specific LBP recruited from various clinical settings.

Methods

Ninety patients with non-specific LBP from primary care and hospital settings participated in the validation part and 61 also in the reproducibility part of the study (1 week apart). Acceptability, data quality, reproducibility and construct validity were investigated.

Results

The questionnaire was well accepted and with little missing data and end effects. Reliability in terms of intraclass correlations (ICC) was satisfactory for the COMI index [0.89 (95 % CI 0.82–0.94)] and most single-core items. Agreement was acceptable for the COMI index [standard error of measurement (SEM_agreement) 0.80, minimal detectable change (MDC_individual) 2.21], but exceeded the minimal standard of acceptability in some of the individual core items. Construct validity was acceptable for the COMI index.

Conclusion

The Norwegian version of the COMI index shows acceptable clinimetric properties in our patient population, but some of the sub-items had shortcomings. Our study, however, support the usefulness of the COMI index as an applicable stand-alone global scale when a light respondent burden is advisable.     

Italian version of the Roland Disability Questionnaire,specific for low back pain: cross-cultural adaptation and validation

Over the last 10 years, patient-oriented evaluations using questionnaires have become an important aspect of clinical spinal outcome studies. Any questionnaire must be translated and culturally adapted in order to be used with different language groups, and the translated version must then be evaluated for reliability and validity, which are fundamental attributes of any measurement tool. The Roland Disability Questionnaire, a low back pain disease-specific tool, was submitted to translation into Italian and to cross-cultural adaptation following the Guillemin criteria. It was then validated on 70 patients (37 male and 33 female; mean age 58, range: 28-67) suffering from low back pain as assessed by clinical examination, imaging and also electromyography in cases of suspected neurological impairment. The test-retest reliability, assessed with intraclass correlation, was 0.92 and the internal consistency reached a Cronbach's alpha of 0.82. The Italian version of the Roland Disability Questionnaire satisfied the validation criteria, showing characteristics of reliability and validity similar to previously published versions translated and adapted for other countries.     

Validation of the Japanese version of the Roland-Morris Disability Questionnaire

The study was designed to validate a translated, culturally adapted questionnaire. We examined the reliability, validity, and responsiveness of the Japanese version of the Roland-Morris Questionnaire (RDQ) when assessing disability in Japanese patients with low back pain. The RDQ is a reliable, validated scale used to measure disability caused by low back pain. However, no validated Japanese version of this questionnaire is available. A series of 214 outpatients with low back pain participated in this validation study. The patients were given the RDQ and the SF-36, and assessed their pain and global rating of health. Among them, 57 who were clinically stable were given the RDQ again 2 weeks later. The reliability was examined based on the test-retest method and internal consistency. Sufficient reliability was demonstrated with a Chronbach's · coefficient of 0.85, and the reproducibility for the 30 patients was r = 0.91. The principal component analysis showed unidimensionality. The RDQ score of the 133 patients was significantly improved after treatment. The Japanese version of the RDQ is a useful scale that is easy to use with reliability, validity, and responsiveness when assessing patients with low back pain.     

Validation of Portuguese version of Quality of Erection Questionnaire (QEQ) and comparison to International Index of Erectile Function (IIEF) and RAND 36-Item Health Survey

Purpose

To validate the Quality of Erection Questionnaire (QEQ) considering Brazilian social-cultural aspects.

Materials and Methods

To determine equivalence between the Portuguese and the English QEQ versions, the Portuguese version was back-translated by two professors who are native English speakers. After language equivalence had been determined, urologists considered the QEQ Portuguese version suitable. Men with self-reported erectile dysfunction (ED) and infertile men who had a stable sexual relationship for at least 6 months were invited to answer the QEQ, the International Index of Erectile Function (IIEF) and the RAND 36-Item Health Survey (RAND-36). The questionnaires were presented together and answered without help in a private room. Internal consistency (Cronbach’s α), test-retest reliability (Spearman), convergent validity (Spearman correlation) coefficients and known-groups validity (the ability of the QEQ Portuguese version to differentiate erectile dysfunction severity groups) were assessed.

Results

We recruited 197 men (167 ED patients and 30 non-ED patients), mean age of 53.3 and median of 55.5 years (23-82 years). The Portuguese version of the QEQ had high internal consistency (Cronbach α=0.93), high stability between test and retest (ICC 0.83, with IC 95%: 0.76-0.88, p<0.001) and Spearman correlation coefficient r=0.82 (p<0.001), which demonstrated the high correlation between the QEQ and IIEF results. The correlations between the QEQ and RAND-36 were significantly low in ED (r=0.20, p=0.01) and non-ED patients (r=0.37, p=0.04).

Conclusion

The QEQ Portuguese version presented good psychometric properties and high convergent validity in relation to IIEF. The low correlations between the QEQ and the RAND-36, as well as between the IIEF and the RAND-36 indicated IIEF and QEQ specificity, which may have resulted from the patients’ psychological adaptations that minimized the impact of ED on Quality of Life (QoL) and reestablished the well-being feeling.     

Erratum to: Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck

European Spine Journal -     

Reliability,validity and responsiveness of the cross-culturally adapted Italian version of the core outcome measures index (COMI) for the neck

Purpose

Evaluation of the psychometric properties of a cross-culturally adapted questionnaire, the Core Outcome Measurement Index for neck pain (COMI-neck).

Methods

The COMI-neck was cross-culturally adapted for the Italian language using established procedures. The following psychometric properties of the instrument were then assessed in patients with chronic neck pain undergoing rehabilitation: test–retest reliability (intraclass correlation coefficient, ICC); construct validity by comparing COMI-neck with the Neck Pain and Disability Scale, a numerical pain rating scale, and the EuroQol-Five Dimension (Pearson’s correlations); and responsiveness by means of Standardized Response Mean (SRM), unpaired t tests, and Receiver Operating Characteristics (ROC) curves.

Results

The questionnaire was completed by 103 subjects. The COMI-neck summary score displayed no relevant floor or ceiling effects. Test–retest reliability was excellent (ICC = 0.87). With one exception (symptom-specific well-being), the individual COMI items and the COMI summary score correlated to the expected extent with the scores of the reference questionnaires (r = 0.40–0.80). The mean change scores for the Italian COMI-neck differed significantly between patients with a good global outcome and those with a poor outcome (p = 0.002); SRM for the good outcome group was 1.23, and for the poor outcome group 0.40. ROC analysis revealed an area under the curve of 0.73 (95 % CI: 0.62–0.85).

Conclusions

This study provides evidence that the Italian version of the COMI-neck is a valid and responsive questionnaire in the population of patients examined. Its use is recommended for clinical and research purposes.     

Reliability and validity of Punjabi version of Oswestry Disability Index in patients with mechanical low back pain

ObjectiveOswestry disability Index(ODI) is the commonest patient reported outcome for assessment of disability due to low back pain. Its application to non-English speaking Punjabi population is limited as a validated and cross culturally adapted Punjabi version of ODI is not available. The purpose of the study was to analyse the psychometric properties of Punjabi version of Oswestry disability index (ODI-P) in patients with mechanical low back pain.Materials and methodsThe translation and cross-cultural adaptation of Punjabi version of ODI was done according to well recommended guidelines. The prefinal version was tested on a set of 15 patients and suitable modifications were made. The final version was administered to 113 patients with mechanical low back pain of more than two weeks duration. Psychometric properties comprising of internal consistency, test retest reliability, floor and ceiling effect, construct validity and factorial structure of the questionnaire were determined.ResultsODI-P showed excellent internal consistency (Chronbach alpha of ODI-P is 0.72), test retest reliability (ICC 0.891) and construct validity (Spearman correlation coefficient with VAS 0.424). Factor analysis proved the questionnaire to be having a 1-factor structure with a total variance of 48.61%.ConclusionsODI (P) is a reliable and valid instrument for measurement of disability related to mechanical low back pain in Punjabi population. It can be used both in research and clinical care settings in future.     

Development of a German version of the Oswestry Disability Index. Part 1: cross-cultural adaptation, reliability, and validity

Patient-orientated assessment methods are of paramount importance in the evaluation of treatment outcome. The Oswestry Disability Index (ODI) is one of the condition-specific questionnaires recommended for use with back pain patients. To date, no German version has been published in the peer-reviewed literature. A cross-cultural adaptation of the ODI for the German language was carried out, according to established guidelines. One hundred patients with chronic low-back pain (35 conservative, 65 surgical) completed a questionnaire booklet containing the newly translated ODI, along with a 0-10 pain visual analogue scale (VAS), the Roland Morris Disability Questionnaire, and Likert scales for disability, medication intake and pain frequency [to assess ODI's construct (convergent) validity]. Thirty-nine of these patients completed a second questionnaire within 2 weeks (to assess test-retest reliability). The intraclass correlation coefficient for the test-retest reliability of the questionnaire was 0.96. In test-retest, 74% of the individual questions were answered identically, and 21% just one grade higher or lower. The standard error of measurement (SEM) was 3.4, giving a "minimum detectable change" (MDC(95%)) for the ODI of approximately 9 points, i.e. the minimum change in an individual's score required to be considered "real change" (with 95% confidence) over and above measurement error. The ODI scores correlated with VAS pain intensity (r = 0.78, P < 0.001) and Roland Morris scores (r = 0.80, P < 0.001). The mean baseline ODI scores differed significantly between the surgical and conservative patients (P < 0.001), and between the different categories of the Likert scales for disability, medication use and pain frequency (in each case P < 0.001). Our German version of the Oswestry questionnaire is reliable and valid, and shows psychometric characteristics as good as, if not better than, the original English version. It should represent a valuable tool for use in future patient-orientated outcome studies in German-speaking lands.     

Validity of the Japanese Core Outcome Measures Index (COMI)-Back for thoracic and lumbar spine surgery: a prospective cohort study

European Spine Journal - To investigate the psychometric properties of the Japanese version of the Core Outcome Measures Index-Back (COMI-Back), only recently published according to the established...     

Validation and cross-cultural adaptation of the Korean version of the Core Outcome Measures Index in patients with degenerative lumbar disease

Purpose

To translate and cross-culturally adapt the Core Outcome Measures Index (COMI) into the Korean language and to test the psychometric properties of the Korean COMI in patients with degenerative lumbar spine diseases.

Methods

A cross-cultural adaptation of the COMI into Korean was carried out using established guidelines. A total of 117 patients with lumbar spinal diseases were recruited from the spinal center of a tertiary care teaching institution and completed a baseline questionnaire including the newly translated COMI, the visual analog scale for back pain and for leg pain, the Oswestry Disability Index (ODI), and the EuroQOL-5 dimensions (EQ-5D). Within 2 weeks after the first assessment, 83 (71%) completed a second COMI questionnaire and a transition question (no change, slight change, moderate change, a lot of change) by phone to assess reproducibility.

Results

COMI summary scores displayed 1.7% floor effects and no ceiling effect. For construct validity, each COMI item and COMI summary score well correlated with its corresponding reference questionnaire. Therefore, the predefined hypotheses for the construct validities of each COMI item (ρ?>?0.4 with the corresponding questionnaire) and the COMI summary score (ρ?>?0.6 with both ODI and EQ-5D) were confirmed. Intraclass correlation coefficients of each COMI item and summary score ranged from 0.93 to 0.98. Therefore, the hypothesis for reliability (ICC?>?0.8) was confirmed.

Conclusions

The present study highlights that the Korean version of the COMI is a reliable and valid outcome tool for use in Korean-speaking patients with degenerative lumbar spinal disease.

Graphical abstract

These slides can be retrieved under Electronic Supplementary Material.

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Responsiveness of the Brazilian–Portuguese version of the Oswestry Disability Index in subjects with low back pain

When quality of life questionnaires are used as measures of treatment outcomes, it is essential to know how well these can respond to clinical changes. The objective of this study is to examine the responsiveness of the Brazilian–Portuguese version of the Oswestry Disability Index (ODI-Brazil) in subjects with chronic low back pain submitted to a physical therapy program. Thirty subjects with chronic low back pain completed the ODI-Brazil questionnaire, along with an 11-point pain visual analogue scale (Pain VAS), and the Brazilian–Portuguese version of Roland–Morris disability questionnaire before and after the program. All patients also completed a global perception of change Likert scale in condition after the program. This scale was collapsed to produce a dichotomous variable outcome: improved and non-improved. Responsiveness was determined using effect size statistics and receiver operating characteristic curve (ROC curve), with best cut-point analysis. The best change score cut-off was identified when equally balanced sensitivity and specificity was found, as an expression of the minimum clinically important difference (MCID). After treatment, 19 patients considered themselves improved. Both the effect size (0.37) and the area under the ROC curve (0.73) for ODI-Brazil score in relation to global outcome after program indicated that the ODI-Brazil showed responsiveness. The ROC curve for ODI-Brazil was distributed at the upper corners of the diagonal line, indicating that the questionnaire presents discriminative ability. The best cut-off point for ODI-Brazil was approximately 4.45 points (63.2% sensitivity, 81.8% specificity). The Brazilian–Portuguese version of ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in chronic low back pain patients receiving conservative care.     

Responsiveness of the Chinese version of the Oswestry disability index in patients with chronic low back pain

The Oswestry Disability Index (ODI) is one of the most widely used questionnaires that assess disability in patients with low back pain (LBP). Responsiveness is both an important psychometric property of an instrument and a key issue for clinicians when choosing suitable outcome measures. The objective of this study was to examine the responsiveness of the Chinese version of the ODI (ODI-Chinese) for subjects with chronic LBP following a physical therapy program. In total, 76 patients with chronic LBP completed the ODI-Chinese, a visual analog scale (VAS) of pain, and the Chinese version of Short Form-36 (SF-36) before and after treatment. All patients also completed a global perception of change Likert scale in condition after the program. The scale was collapsed to produce a dichotomous variable outcome, improved or non-improved. The responsiveness of the instruments was determined using the standardized response means (SRM) and receiver operating characteristics (ROC). After treatment, 56 patients considered themselves to be improved. The SRM of the ODI-Chinese was −1.2 in the improved group and −0.4 in the non-improved group. The area of the ROC curve for the ODI-Chinese was 0.77 (95% CI 0.66–0.89). Therefore, the Chinese version of the ODI is both responsive and appropriate for use in chronic LBP patients after conservative therapy.     

汉译Roland-Morris功能障碍调查表评估下腰痛患者的可靠性

目的:探讨应用汉译Roland-Morris功能障碍调查表评定下腰痛患者的可靠性。方法:将Roland-Morris功能障碍调查表按一定的要求翻译成中文调查表(CRMDQ),对48例住院拟手术的下腰痛患者(男30例,女18例;年龄26～73岁,平均38.5岁),用CRMDQ、中文版Oswestry功能障碍指数(CODI)、视觉模拟评分(VAS)先后进行两次测试,间隔期2d,检测CRMDQ的可重复性;对门诊158例下腰痛患者在就诊时行CRMDQ、CODI、VAS测试,对CRMDQ与CODI、VAS测试结果进行Spearman秩相关分析。结果:CRMDQ具有良好的可重复性(r=0.945,P<0.01);在CRMDQ有效性测试中,与CODI、VAS比较显示出显著的相关性(CRMDQ-CODI:r=0.386;CRMDQ-VAS:r=0.478,P<0.05)。结论:CRMDQ测试具有良好的可重复性和有效性,可用于对下腰痛患者的功能障碍评估。     

The cross-cultural adaptation of the DASH questionnaire in Thai (DASH-TH)

Study designClinical measurement.IntroductionCurrently there are no self-report questionnaires in Thai to evaluate disability levels in patients suffering from upper extremity musculoskeletal disorders.Purpose of the studyTo translate and cross-cultural adaptation the disabilities of the arm, shoulder and hand (DASH) questionnaire to Thai version and to evaluate content validity, construct validity and internal consistency of the questionnaire.MethodsThe DASH-TH was produced by following cross-cultural adaptation guidelines stated by the Institute for Work and Health (IWH). Forty Thai patients with arm, shoulder or hand problems participated in field testing of the questionnaire. Content validity was determined by obtaining the item-objective congruence (IOC) value for each questionnaire item. Correlation between the DASH-TH score and numeric rating scale was used to assess construct validity. Internal consistency of DASH-TH was measured using Cronbach's alpha coefficient.ResultsForty patients (14 males, 26 females) with arm, shoulder or hand problems enrolled in the present study. The average age of patients was 44.8 years. The index of item-objective congruence (IOC) of each item ranged from 0.7 to 1.0. The Cronbach's alpha coefficient of the questionnaire was 0.938. There was no correlation between DASH-TH score and numeric rating scale.ConclusionThe DASH-TH has high content validity and internal consistency.Level of evidenceN/A.