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Development of the Japanese Core Outcome Measures Index (COMI): cross-cultural adaptation and psychometric validation.

ABSTRACT: The patient-rated Core Outcome Measures Index (COMI) assesses the multidimensional impact of back problems on the sufferer. The brevity and comprehensibility of the tool make it practical for use in clinical and research settings. Although the COMI has been cross-culturally adapted in various languages worldwide, there is currently no Japanese version. The aim of this study was to develop a Japanese version of the COMI by: (1) performing a cross-cultural adaptation of the English version and (2) evaluating the psychometric properties of the Japanese version of the COMI in Japanese volunteers with chronic back problems.The English version of the COMI was cross-culturally adapted for the Japanese language using established guidelines. The pre-final version was pilot-tested in five Japanese-speaking patients with low back pain (LBP) and a history of spine surgery. The psychometric properties of the Japanese COMI were tested in a group of 1052 individuals with chronic LBP (LBP ?3 months), aged 20-69 years, who were recruited through a web-based survey. The psychometric properties that were evaluated included convergent and known-group validity, using the following reference questionnaires: EuroQol 5 Dimension, Roland Morris Disability Questionnaire, Short Form 8™ Health Survey, and the Keele STarT Back Screening Tool.The pre-final version of the cross-culturally adapted Japanese COMI was completed without any major problems of understanding or acceptability. For the evaluation of its psychometric properties, tests for convergent validity showed moderate correlations between COMI items and the respective reference questionnaires for symptom-specific well-being [-?0.33--0.48] and disability domains [0.48] and strong correlations (>?0.5) for the other domains and the COMI summary score. The analysis of known-group validity showed a linear trend for the COMI score in relation to prognostic risk (P?

SUBMITTER: Matsudaira K

PROVIDER: S-EPMC5834844 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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Development of the Japanese Core Outcome Measures Index (COMI): cross-cultural adaptation and psychometric validation.

Matsudaira Ko K Oka Hiroyuki H Oshima Yasushi Y Chikuda Hirotaka H Taniguchi Yuki Y Matsubayashi Yoshitaka Y Kawaguchi Mika M Sato Emiko E Murano Haruka H Laurent Thomas T Tanaka Sakae S Mannion Anne F AF

BMC musculoskeletal disorders 20180302 1

<h4>Background</h4>The patient-rated Core Outcome Measures Index (COMI) assesses the multidimensional impact of back problems on the sufferer. The brevity and comprehensibility of the tool make it practical for use in clinical and research settings. Although the COMI has been cross-culturally adapted in various languages worldwide, there is currently no Japanese version. The aim of this study was to develop a Japanese version of the COMI by: (1) performing a cross-cultural adaptation of the Engl ...[more]

PMID: 29499690

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Project description:IntroductionPatient-reported outcome measures (PROMs) are the preferred outcomes measured in patients with lumbar spinal degenerative diseases. As PROMs can be lengthy and therefore pose a burden to patients and researchers, short and standardized PROMs are needed, such as the Core Outcome Measures Index (COMI).Research questionIs the Dutch version of the COMI-back a reliable and responsive PROM to measure outcomes in lumbar degenerative spinal surgery?MethodsAfter translating and cross-cultural adapting the COMI-back into Dutch, patients who were on the waiting-list for lumbar decompression surgery in a secondary referral center, were enrolled in the validation study. Patients completed a baseline booklet consisting of the COMI-back, likert scales measuring back and leg pain, the Roland-Morris Disability questionnaire, the EuroQoL-5 dimensions and the WHO-Quality-of-Life-BREF questionnaire to test construct validity. Within 2 weeks and before undergoing surgery, patients completed the COMI-back again, to measure test-retest stability. Three months after surgery, a global treatment outcome (GTO) question and the COMI-back were completed to test responsiveness.ResultsThe COMI-back was successfully translated and adapted into Dutch. One-hundred-thirty-five patients completed the baseline booklet, 93 the test-retest questionnaire and 102 the responsiveness questionnaire. The COMI-summary score and four of five COMI-domains, showed good to very good correlation to the reference questionnaires (ρ > 0.41). The COMI-back showed a good test-retest stability with an intraclass correlation coefficient of 0.81 for the summary score. Furthermore, the standard error of agreement was 0.65 and the minimal detectable change was 1.8 points. The ROC-curve showed an area under the curve of 0.89 (95% CI 0.82 to 0.95).ConclusionThe Dutch version of the COMI-back has satisfactory psychometric properties and is a reliable and responsive patient-reported outcome measure in patients undergoing surgery for lumbar degenerative disease.

Project description:BackgroundMeasuring functional status in palliative care may help clinicians to assess a patient's prognosis, recommend adequate therapy, avoid futile or aggressive medical care, consider hospice referral, and evaluate provided rehabilitation outcomes. An optimized, widely used, and validated tool is preferable. The Palliative Performance Scale Version 2 (PPSv2) is currently one of the most commonly used performance scales in palliative settings. The aim of this study is the psychometric validation process of a Polish translation of this tool (PPSv2-Polish).MethodsTwo hundred patients admitted to a free-standing hospice were evaluated twice, on the first and third day, for test-retest reliability. In the first evaluation, two different care providers independently evaluated the same patient to establish inter-rater reliability values. PPSv2-Polish was evaluated simultaneously with the Karnofsky Performance Score (KPS), Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG PS), and Barthel Activities of Daily Living (ADL) Index, to determine its construct validity.ResultsA high level of full agreement between test and retest was seen (63%), and a good intra-class correlation coefficient of 0.85 (P?<?0.0001) was achieved. Excellent agreement between raters was observed when using PPSv2-Polish (Cohen's kappa 0.91; P?<?0.0001). Satisfactory correlations with the KPS and good correlations with ECOG PS and Barthel ADL were noticed. Persons who had shorter prognoses and were predominantly bedridden also had lower scores measured by the PPSv2-Polish, KPS and Barthel ADL. A strong correlation of 0.77 between PPSv2-Polish scores and survival time was noted (P?<?0.0001). Moderate survival correlations were seen between KPS, ECOG PS, and Barthel ADL of 0.41; -?0.62; and 0.58, respectively (P?<?0.0001).ConclusionPPSv2-Polish is a valid and reliable tool measuring performance status in a hospice population and can be used in daily clinical practice in palliative care and research.

Project description:BackgroundHand osteoarthritis (OA) has a wide spectrum of clinical presentations and physical function is one of the core domains where patients suffer. The Functional Index for Hand Osteoarthritis (FIHOA) is a leading assessment tool for hand OA-related functional impairment. Our objective was to make a Japanese version of FIHOA (J-FIHOA) and validate it among Japanese hand OA patients.MethodsForward and backward translation processes were completed to create a culturally adapted J-FIHOA. A prospective, observational multicenter study was undertaken for the validation process. Seventeen collaborating hospitals recruited Japanese hand OA patients who met the American College of Rheumatology criteria. A medical record review and responses to the following patient-rated questionnaires were collected: J-FIHOA, Hand20, Health Assessment Questionnaire (HAQ), numerical rating scale for pain (NRS pain) and Short Form 36 Health Survey (SF-36). We explored the structure of J-FIHOA using factor analysis. Cronbach's alpha coefficients and item-total correlations were calculated. Correlations between J-FIHOA and other questionnaires were evaluated for construct validity. Participants in clinically stable conditions repeated J-FIHOA at a one- to two-week interval to assess test-retest reliability. To evaluate responsiveness, symptomatic patients who started new pharmacological treatments had a 1-month follow-up visit and completed the questionnaires twice. Effect size (ES) and standardized response mean (SRM) were calculated with pre- and post-treatment data sets. We assessed responsiveness, comparing ES and SRM of J-FIHOA with other questionnaires (construct approach).ResultsA total of 210 patients participated. J-FIHOA had unidimensional structure. Cronbach's alphas (0.914 among females and 0.929 among males) and item-total correlations (range, 0.508 to 0.881) revealed high internal consistency. Hand20, which measures upper extremity disability, was strongly correlated with J-FIHOA (r = 0.82) while the mental and role-social components of SF-36 showed no correlations (r = - 0.24 and - 0.26, respectively). Intraclass correlation coefficient for test-retest reliability was 0.83 and satisfactory. J-FIHOA showed the highest ES and SRM (- 0.68 and - 0.62, respectively) among all questionnaires, except for NRS pain.ConclusionsOur results showed J-FIHOA had good measurement properties to assess physical function in Japanese hand OA patients both for ambulatory follow-up in clinical practice, and clinical research and therapeutic trials.

Project description:BackgroundThe rapid proliferation of web-based information on health and health care has profoundly changed individuals' health-seeking behaviors, with individuals choosing the internet as their first source of information on their health conditions before seeking professional advice. However, barriers to the evaluation of people's eHealth literacy present some difficulties for decision makers with respect to encouraging and empowering patients to use web-based resources.ObjectiveThis study aims to examine the psychometric properties of a simplified Chinese version of the eHealth Literacy Scale (SC-eHEALS).MethodsData used for analysis were obtained from a cross-sectional multicenter survey. Confirmatory factor analysis (CFA) was used to examine the structure of the SC-eHEALS. Correlations between the SC-eHEALS and ICEpop capability measure for adults (ICECAP-A) items and overall health status were estimated to assess the convergent validity. Internal consistency reliability was confirmed using Cronbach alpha (α), McDonald omega (ω), and split-half reliability (λ). A general partial credit model was used to perform the item response theory (IRT) analysis. Item difficulty, discrimination, and fit were reported. Item-category characteristic curves (ICCs) and item and test information curves were used to graphically assess the validity and reliability based on the IRT analysis. Differential item functioning (DIF) was used to check for possible item bias on gender and age.ResultsA total of 574 respondents from 5 cities in China completed the SC-eHEALS. CFA confirmed that the one-factor model was acceptable. The internal consistency reliability was good, with α=0.96, ω=0.92, and λ=0.96. The item-total correlation coefficients ranged between 0.86 and 0.91. Items 8 and 4 showed the lowest and highest mean scores, respectively. The correlation coefficients between the SC-eHEALS and ICECAP-A items and overall health status were significant, but the strength was mild. The discrimination of SC-eHEALS items ranged between 2.63 and 5.42. ICCs indicated that the order of categories' thresholds for all items was as expected. In total, 70% of the information provided by SC-eHEALS was below the average level of the latent trait. DIF was found for item 6 on age.ConclusionsThe SC-eHEALS has been demonstrated to have good psychometric properties and can therefore be used to evaluate people's eHealth literacy in China.

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Development of the Japanese Core Outcome Measures Index (COMI): cross-cultural adaptation and psychometric validation.

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Development of the Japanese Core Outcome Measures Index (COMI): cross-cultural adaptation and psychometric validation.

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