Validation of the Simplified Chinese version of the Core Outcome Measures Index (COMI)

Purpose

To translate the Core Outcome Measures Index (COMI) into Simplified Chinese and then validate it for Mainland Chinese patients with low back pain (LBP).

Methods

A total of 120 consecutive patients with LBP >3 months who visited our outpatient clinic from December 2011 to March 2012 were asked to complete a questionnaire booklet including the following: (1) the Roland Morris disability questionnaire (RMQ) (Fan et al. in Spine 37(10):875–880, 2012), (2) the Short Form Health Survey (SF-36) (Zhang et al. in Int J Med Sci 9(7):521–526, 2012), (3) the Oswestry Disability Index (ODI) (Liu et al. in Spine 34(11):1211–1216, 2009), (4) visual analogue scale (VAS) measure of pain, and (5) COMI. These patients were also asked to complete a second COMI questionnaire and a transition questionnaire (5-point Likert scale: better, a little better, no change, a little worse, worse) and to return the second COMI questionnaire via mail within 1 month.

Results

The floor effects for the COMI items ranged from 5.8 to 12.5 %. High values (28.3, 27.5, and 25.8 %, respectively) were found for symptom-specific quality of life, social disability, and work disability. Regarding the ceiling effects, the social and work disabilities were relatively high at 17.5 and 24.2 %, respectively. For other items, the values ranged from 0 to 14.2 %. Neither floor nor ceiling effects were found for the COMI summary score. Excellent correlations were found between the COMI pain scores and VAS scores (Rho = 0.89) and between the COMI pain and the SF-36 bodily pain domain (Rho = 0.84). Other individual items and summary scores showed a very good correlation (Rho = 0.54–0.72) with the corresponding questionnaires except for “symptom-specific well-being” (0.31–0.45). One-way repeated measures ANOVA was used to determine the intraclass correlation coefficient (ICC). The ICC for the entire COMI score was 0.91 (95 % CI 0.85–0.94) and 0.81–0.86 for the two pain scores (back and leg). The “minimum detectable change’’ (MDC 95 %) for the COMI summary score was 1.91 points. No significant difference in the mean values was found for the repeated scores of individual items or the summary score.

Conclusion

The Simplified Chinese version of COMI showed satisfactory reliability and good psychometric properties. This concise questionnaire is suitable for widespread use in Mainland China.     

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.     

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.     

Reliability and validity of the Polish version of the Core Outcome Measures Index for the neck

Purpose

Patient reported outcome measures play an increasingly important role in the outcomes research. The Core Outcome Measures Index (COMI) is a short, multidimensional instrument initially developed for the use by patients with low back pain. This study is an evaluation of a Polish version of COMI adapted for neck pain.

Methods

One hundred twenty-three patients complaining of neck pain were enrolled. All of them completed a questionnaire booklet containing COMI-neck, Neck Disability Index and Likert-type questions regarding the frequency of use of pain medications and pain frequency. Ninety-eight patients returned the retest questionnaire. Data quality was also assessed. Assessment of psychometric properties included examination of data quality, construct validity, test–retest reliability and factor analysis.

Results

The quality of data was good with no missing answers and a little floor effect. Exploratory factor analysis revealed a single-factor structure. Reliability expressed as intraclass correlation coefficient was 0.88 (95 % CI 0.84–0.92) for the overall COMI score and was generally good for most of individual core items. The minimum detectable change (MDC_95%) was 1.97.

Conclusion

This version of the COMI-neck is a valid and reliable instrument, with good psychometric properties. It can be recommended for Polish-speaking patients.     

A Core Outcome Measures Index (COMI) for Patients Undergoing Hip Arthroplasty

Outcome is best assessed with both generic and disease-specific instruments, but using many, lengthy questionnaires increases the burden, quality, and cost of data collection.We evaluated a short, hip-oriented Core Outcome Measures Index (COMI-hip), comprising six items (pain, function, symptom-specific well-being, quality of life, and disability) extracted from established full-length questionnaires; 214 consecutive total hip arthroplasty (THA) patients participated. Scores for the single items and sum-score of COMI-hip correlated well with those of the full-length instruments (r = − 0.56 to − 0.88). At 6 and 12 months’ follow-up, the COMI-hip showed similar responsiveness (Cohen’s d for effect size, 1.36–3.08) to the full-length questionnaires (1.65-2.34). The COMI-hip proved a simple but valid outcome instrument in THA patients. Its brevity renders it a potentially valuable instrument for routine use.     

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.     

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.     

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

European Spine Journal -     

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

Purpose

The Core Outcome Measures Index (COMI) is a short, multidimensional outcome scale validated for the use by patients with spinal disorders. It is a recommended instrument in the Spine Society of Europe Spine Tango Registry. The purpose of this study was to produce a cross-culturally adapted and validated Polish COMI.

Methods

The cross-cultural adaptation was carried out using the established guidelines. One-hundred and sixty-nine patients with chronic low back pain were enrolled, 89 took part in the reproducibility part of the study. Data quality, construct validity and reproducibility were assessed.

Results

The quality of data was very good with very few missing answers and modest floor effect. Reliability expressed as intraclass correlation coefficient (ICC) was 0.90 (95 % CI 0.85–0.93) for the overall COMI score and for most of the individual core items. The minimum detectable change (MDC_95%) was 1.79.

Conclusions

The Polish version of COMI showed a favorable reproducibility similar to that of previously tested language versions. The COMI scores correlated sufficiently with existing measures. This version of the COMI is a valuable instrument for the use by Polish-speaking patients with spinal disorders.     

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.     

护士长工作环境量表的跨文化调试与信效度评价

目的对英文版护士长工作环境(NMPE)量表进行跨文化调试和信效度检验,为我国护士长工作环境评测提供测量工具。方法遵循量表的跨文化调试指南,对源量表进行翻译、回译和跨文化调试;对100名护士长进行测试,检验中文版NMPE量表的信效度。结果中文版NMPE量表包括8个维度45个条目,内部一致性Cronbach′sα系数为0.931,分半信度为0.812,重测信度为0.968。内容效度(CVI)为0.96;探索性因素分析提取8个公因子,累积方差贡献率为73.69%。结论中文版NMPE量表具有良好的信效度,可用于我国护士长工作环境的测评。     

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...     

Cross-cultural adaptation and validation of the Traditional Chinese version of the Core Outcome Measures Index in patients with low back pain

Purpose

This study aimed to carry out a cross-cultural adaptation of the Core Outcome Measures Index (COMI) for use in Traditional Chinese-speaking patients with low back pain (LBP) and to investigate its psychometric properties.

Methods

A total of 224 patients with LBP > 6 weeks who visited our spine center from May 2018 to May 2019 were included in the study. Patients completed a booklet of questionnaires including the following: (1) pain Numeric Rating Scale, (2) Oswestry Disability Index, (3) Roland–Morris Disability Questionnaire, (4) EuroQol-five dimension (EQ-5D), and (5) COMI. Patients were sent a second booklet (also containing a transition question to indicate any change in condition) to be completed again within one month after the first. Fifty-two patients did not receive any intervening treatment (group 1), while the other 172 patients received medical treatment (group 2) between the two questionnaires.

Results

The intraclass correlation coefficient (ICC) for the COMI summary score was 0.94 (95% CI 0.89–0.97); the standard error of measurement (SEM) was 0.41 and the minimum detectable change (MDC) score was 1.14. The COMI summary scores showed a low floor effect (1.8%) and ceiling effect (0.4%). All COMI item scores demonstrated the hypothesized correlations with their corresponding full-length questionnaires except for the pain item (correlation stronger than hypothesized). Standardized response means (SRM) for the COMI items in the treated group were between 0.58 and 1.30. Regarding the ability of the COMI change score to differentiate between good and poor outcomes, the area under the receiver operating characteristic (AUROC) curve was 0.77 [standard error (SE) 0.07, 95% confidence interval (CI) 0.68–0.84] and the minimal clinically important change (MCIC) score was ≥ 1.85 points.

Conclusion

The Traditional Chinese COMI represents a practical and reliable tool for the assessment of Traditional Chinese-speaking patients with back problems.

     

The assessment of symptoms and functional limitations in low back pain patients: validity and reliability of a new questionnaire

Many of the existing low back pain (LBP) questionnaires of function and symptoms have a content of different domains of disability presented as a single sum score, making it difficult to derive changes within a specific domain. The present study describes the development of a clinically derived back-specific questionnaire incorporating both a functional limitation and a symptom scale, with a further subdivision of the symptom scale in separate indices for severity and temporal aspects. The aims of the study were to assess the overall reliability and validity of the new questionnaire, named the Profile Fitness Mapping questionnaire (PFM). A total of 193 chronic LBP patients answered the PFM together with five validated criterion questionnaires. For the internal consistency of the questionnaires, the three indices of the PFM had the highest Cronbach’s alpha (0.90–0.95) and all items had item–total correlations above 0.2. The correlation coefficients between the PFM and the back-specific criterion questionnaires ranged between 0.61 and 0.83, indicating good concurrent criterion validity. The best discriminative ability between patients with different pain severities was demonstrated by the functional limitation scale of the PFM. Well centered score distribution with no patient’s score at the floor or the ceiling level indicates that the PFM has the potential to detect the improvement or worsening of symptoms and functional limitations in chronic LBP patients. Classification according to the International Classification of Functioning, Disability and health (ICF) of WHO revealed a high degree of homogeneous item content of the symptom scale to the domain of impairments, and of the functional limitation scale to the domain of activity limitations. The present study suggests that the PFM has a high internal consistency and is a valid indicator of symptoms and functional limitations of LBP patients. It offers the combination of a composite total score and the possibility of evaluations within specific domains of disability. Complementary evaluation of test–retest reliability and responsiveness to change is warranted.     

Danish version of the Oswestry Disability Index for patients with low back pain. Part 1: Cross-cultural adaptation, reliability and validity in two different populations

Over the past 10 years, a plethora of back-specific patient-orientated outcome measures have appeared in the literature. Standardisation has been advocated by an expert panel of researchers proposing a core set of instruments. Of the condition-specific questionnaires the Oswestry Disability Index (ODI) is recommended for use with low back pain (LBP) patients. To date, no Danish version of the ODI exists which has been cross-culturally adapted, validated and published in the peer-reviewed literature. A cross-cultural adaptation and validation of the ODI for the Danish language was carried out according to established guidelines: 233 patients [half of the patients were seen in the primary sector (PrS) and half in the secondary sector (SeS) of the Danish health care system] with LBP and/or leg pain completed a questionnaire booklet at baseline, 1 day or 1 week and 8 weeks follow-up. The booklet contained the Danish version of the ODI, along with the Roland Morris Disability Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. For the ODI test–retest analysis (93 stable patients) resulted in an intraclass correlation coefficient of 0.91, a mean difference of 0.8 and 95% limits of agreements of − 11.5 to + 13. Thus, a worsening greater than 12 points and improvement greater than 13 points can be considered a “real” change above the measurement error. A substantial floor effect was found in PrS patients (14.1%). The ODI showed satisfactory cross-sectional discriminant validity when compared to the external measures. Concurrent validity of the ODI revealed: (a) a 10% and 21% lower ODI score compared to the disability and pain measures, respectively, (b) a poorer differentiation of patient disabilities and (c) an acceptable individual ODI score level compared to the external measures. Longitudinal external construct validity showed moderate correlations (range 0.56–0.78). We conclude that the Danish version of the ODI is both a valid and reliable outcome instrument in two LBP patient populations. The ODI is probably most appropriate for use in SeS patients.Part 2 of this article is available at: