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Psychometric evaluation and adaptation of the Spine Oncology Study Group Outcomes Questionnaire to evaluate health-related quality of life in patients with spinal metastases.

ABSTRACT: BACKGROUND:The Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) was developed as the first spine oncology-specific health-related quality of life (HRQOL) measure. This study evaluated the psychometric properties and clinical validity of the SOSGOQ in a diverse cohort of patients with spinal metastases. METHODS:An international, multicenter, prospective observational cohort study including patients with spinal metastases who underwent surgery and/or radiotherapy was conducted by the AOSpine Knowledge Forum Tumor. Demographic, tumor, and treatment data were collected. HRQOL was evaluated using the SOSGOQ and Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) at baseline and fixed follow-up times. Construct validity was assessed using multitrait scaling analyses, confirmatory factor analyses, and correlation with the SF-36 and NRS pain score. Test-retest reliability was assessed in a subgroup of patients between 12 weeks after treatment and the retest 4 to 9 days later. RESULTS:A total of 238 patients were enrolled at 9 centers across North America; 153 of these patients had HRQOL data available at 12 weeks after treatment. Multitrait scaling analyses and confirmatory factor analyses resulted in a refined version of the SOSGOQ with 4 domains and 4 single items. The revised SOSGOQ (SOSGOQ2.0) demonstrated strong correlations with SF-36 and the ability to discriminate between clinically distinct patient groups. Reliability of the SOSGOQ2.0 was demonstrated to be good, with an intraclass correlation coefficient ranging from 0.58 to 0.92 for the different domains. CONCLUSIONS:The SOSGOQ2.0 is a reliable and valid measure with which to evaluate HRQOL in patients with spinal metastases. It is recommended to use the SOSGOQ2.0 together with a generic HRQOL outcome measure to comprehensively assess HRQOL and increase sensitivity and specificity. Cancer 2018;124:1828-38. © 2018 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

SUBMITTER: Versteeg AL

PROVIDER: S-EPMC5900572 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Psychometric evaluation and adaptation of the Spine Oncology Study Group Outcomes Questionnaire to evaluate health-related quality of life in patients with spinal metastases.

Versteeg Anne L AL Sahgal Arjun A Rhines Laurence D LD Sciubba Daniel M DM Schuster James M JM Weber Michael H MH Varga Peter Pal PP Boriani Stefano S Bettegowda Chetan C Fehlings Michael G MG Clarke Michelle J MJ Arnold Paul M PM Gokaslan Ziya L ZL Fisher Charles G CG

Cancer 20180206 8

<h4>Background</h4>The Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) was developed as the first spine oncology-specific health-related quality of life (HRQOL) measure. This study evaluated the psychometric properties and clinical validity of the SOSGOQ in a diverse cohort of patients with spinal metastases.<h4>Methods</h4>An international, multicenter, prospective observational cohort study including patients with spinal metastases who underwent surgery and/or radiotherapy was condu ...[more]

PMID: 29409108

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Project description:BACKGROUND:Quality of life (QoL) is considered a key treatment outcome in bipolar disorder (BD) across research, clinical, and self-management contexts. Web-based assessment of patient-reported outcomes offer numerous pragmatic benefits but require validation to ensure measurement equivalency. A web-based version of the Quality of Life in Bipolar Disorder (QoL.BD) questionnaire was developed (QoL Tool). OBJECTIVE:This study aimed to evaluate the psychometric properties of a web-based QoL self-report questionnaire for BD (QoL Tool). Key aims were to (1) characterize the QoL of the sample using the QoL Tool, (2) evaluate the internal consistency of the web-based measure, and (3) determine whether the factor structure of the original version of the QoL.BD instrument was replicated in the web-based instrument. METHODS:Community-based participatory research methods were used to inform the development of a web-based adaptation of the QoL.BD instrument. Individuals with BD who registered for an account with the QoL Tool were able to opt in to sharing their data for research purposes. The distribution of scores and internal consistency estimates, as indicated by Cronbach alpha, were inspected. An exploratory factor analysis using maximum likelihood and oblique rotation was conducted. Inspection of the scree plot, eigenvalues, and minimum average partial correlation were used to determine the optimal factor structure to extract. RESULTS:A total of 498 people with BD (349/498, 70.1% female; mean age 39.64, SD 12.54 years; 181/498, 36.3% BD type I; 195/498, 39.2% BD type II) consented to sharing their QoL Tool data for the present study. Mean scores across the 14 QoL Tool domains were, in general, significantly lower than that of the original QoL.BD validation sample. Reliability estimates for QoL Tool domains were comparable with that observed for the QoL.BD instrument (Cronbach alpha=.70-.93). Exploratory factor analysis supported the extraction of an 11-factor model, with item loadings consistent with the factor structure suggested by the original study. Findings for the sleep and physical domains differed from the original study, with this analysis suggesting one shared latent construct. CONCLUSIONS:The psychometric properties of the web-based QoL Tool are largely concordant with the original pen-and-paper QoL.BD, although some minor differences in the structure of the sleep and physical domains were observed. Despite this small variation from the factor structure identified in the QoL.BD instrument, the latent factor structure of the QoL Tool largely reproduced the original findings and theoretical structure of QoL areas relevant to people with BD. These findings underscore the research and clinical utility of this instrument, but further comparison of the psychometric properties of the QoL Tool relative to the QoL.BD instrument is warranted. Future adaptations of the QoL Tool, including the production of an app-based version of the QoL Tool, are also discussed.

Project description:BackgroundThe recently developed Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) was proven a valid and reliable instrument measuring health-related quality of life (HRQOL) for patients with spinal malignancies. A German version was not available.ObjectiveA cross-cultural adaptation of the SOSGOQ2.0 to the German language and its multicenter evaluation.MethodsIn a multistep process, a cross-cultural adaptation of the SOSGOQ2.0 was conducted. Subsequently, a multicenter, prospective observational cohort study was initiated to assess the reliability and validity of the German adaptation. To assess external construct validity of the cross-cultural adapted questionnaire, a comparison to the established questionnaire QLQ-C30 from the European Organisation for Research and Treatment of Cancer was conducted. Mean-difference plots were used to measure the agreement between the questionnaires in total score and by domain (deviation from mean up to 10% allowed). Further reliability and validity tests were carried out. Change to baseline was analysed 3-16 weeks later after different interventions occurred. Clinically relevant thresholds in comparison to the EORTC QLQ-C30 questionnaire were evaluated by ROC curve analysis.ResultsWe could enroll 113 patients from four different university hospitals (58 females, 55 males). Mean age was 64.11 years (sd 11.9). 80 patients had an ECOG performance status of 2 or higher at baseline. External construct validity in comparison to the EORTC QLQ-C30 questionnaire in total score and by domain was confirmed (range of deviation 4.4 to 9.0%). Good responsiveness for the domains Physical Functioning (P < .001) and Pain (P < .001) could be shown. The group mean values also displayed a difference in the domains of Social Functioning (P = .331) and Mental Health (P = .130), but not significant. The minimum clinically relevant threshold values for the questionnaire ranged from 4.0 to 7.5 points.ConclusionsAccording to our results, the cross-cultural adapted questionnaire is a reliable and valid tool to measure HRQOL in German speaking patients with spinal malignancies. Especially the domains Physical Functioning and Pain showed overall good psychometric characteristics. In this way, a generic questionnaire, such as the EORTC QLQ-C30, can be usefully supplemented by spine-specific questions to increase the overall accuracy measuring HRQOL in patients with spinal malignancies.

Project description:BACKGROUND:Patient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties. METHODS:A mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain's internal consistency was measured using Cronbach's ?. RESULTS:The literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (??>?0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity. CONCLUSIONS:The ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making. TRIAL REGISTRATION:NCT03357471.

Project description:BackgroundThe Extended Nordic Musculoskeletal Questionnaire (NMQ-E) had never been adapted into Arabic. We culturally adapted the NMQ-E to Arabic in five stages and investigated its psychometric properties.MethodsAfter translating and cross-culturally adapting the NMQ-E into Arabic, through forward translation, translation synthesis, backward translation, expert committee review, and pilot testing, the psychometric properties were investigated. The construct validity was assessed by having the participants completing the Arabic version of the NMQ-E with four Arabic scales that measured musculoskeletal pain in all regions covered in the NMQ-E. Participants' baseline records were also used to evaluate internal consistency (Cronbach's α). Seven days later, participants completed the Arabic NMQ-E again to evaluate its test-retest reliability employing intraclass correlation coefficient (ICC) and standard error of measurement (SEM) for the age questions, and Cohen's kappa coefficient (κ), the proportion of observed agreement (Po), the proportion of positive agreement (Ppos), and the proportion of negative agreement (Pneg) for the dichotomous items.ResultsA total of 127 participants, 70 males and 57 females with mean age 32.5 ± 12.2 years, were included. Significant differences were found between participants with and without musculoskeletal pain in the corresponding scales, signifying the content validity of the questionnaire. Cronbach's α for both the prevalence and consequences pain sections combined ranged from 0.30 to 1.00. The test-retest reliability of the age questions was excellent, with ICC values ranging between 0.995 and 1.00. The SEM was 0.77 for the neck region and 0 for the rest of the regions. The prevalence questions demonstrated almost perfect agreement, with κ values ranging between 0.82 and 1.00, the Po between 0.94 and 1.00, the Ppos between 0.80 and 1.00, and the Pneg between 0.93 and 1.00. The consequences of pain questions showed moderate-to-perfect agreement, with κ values ranging between 0.57 and 1.00, between 0.83 and 1.00 for the Po, between 0.50 and 1.00 for the Ppos, and between 0.86 and 1.00 for the Pneg.ConclusionsThe results suggest that the Arabic NMQ-E is a valid and reliable tool that can be used to screen Arab adults for the prevalence and consequences of musculoskeletal pain.

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Psychometric evaluation and adaptation of the Spine Oncology Study Group Outcomes Questionnaire to evaluate health-related quality of life in patients with spinal metastases.

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Psychometric evaluation and adaptation of the Spine Oncology Study Group Outcomes Questionnaire to evaluate health-related quality of life in patients with spinal metastases.

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