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      GC-PROM: validation of a patient-reported outcomes measure for Chinese patients with gastric cancer

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          Abstract

          Background

          There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer.

          Method

          Following the FDA’s draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method.

          Results

          The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains.

          Conclusions

          The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.

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          Most cited references24

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          Reliability and factor analysis of the Epworth Sleepiness Scale.

          The Epworth Sleepiness Scale (ESS) is a self-administered eight-item questionnaire that has been proposed as a simple method for measuring daytime sleepiness in adults. This investigation was concerned with the reliability and internal consistency of the ESS. When 87 healthy medical students were tested and retested 5 months later, their paired ESS scores did not change significantly and were highly correlated (r = 0.82). By contrast, ESS scores that were initially high in 54 patients suffering from obstructive sleep apnea syndrome returned to more normal levels, as expected, after 3-9 months' treatment with nasal continuous positive airway pressure. The questionnaire had a high level of internal consistency as measured by Cronbach's alpha (0.88). Factor analysis of item scores showed that the ESS had only one factor for 104 medical students and for 150 patients with various sleep disorders. The ESS is a simple and reliable method for measuring persistent daytime sleepiness in adults.
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            Applying item response theory (IRT) modeling to questionnaire development, evaluation, and refinement.

            Health outcomes researchers are increasingly applying Item Response Theory (IRT) methods to questionnaire development, evaluation, and refinement efforts. To provide a brief overview of IRT, to review some of the critical issues associated with IRT applications, and to demonstrate the basic features of IRT with an example. Example data come from 6,504 adolescent respondents in the National Longitudinal Study of Adolescent Health public use data set who completed to the 19-item Feelings Scale for depression. The sample was split into a development and validation sample. Scale items were calibrated in the development sample with the Graded Response Model and the results were used to construct a 10-item short form. The short form was evaluated in the validation sample by examining the correspondence between IRT scores from the short form and the original, and by comparing the proportion of respondents identified as depressed according to the original and short form observed cut scores. The 19 items varied in their discrimination (slope parameter range: .86-2.66), and item location parameters reflected a considerable range of depression (-.72-3.39). However, the item set is most discriminating at higher levels of depression. In the validation sample IRT scores generated from the short and long forms were correlated at .96 and the average difference in these scores was -.01. In addition, nearly 90% of the sample was classified identically as at risk or not at risk for depression using observed score cut points from the short and long forms. When used appropriately, IRT can be a powerful tool for questionnaire development, evaluation, and refinement, resulting in precise, valid, and relatively brief instruments that minimize response burden.
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              Carcinoma of the stomach: A review of epidemiology, pathogenesis, molecular genetics and chemoprevention.

              Carcinoma of the stomach is still the second most common cause of cancer death worldwide, although the incidence and mortality have fallen dramatically over the last 50 years in many regions. The incidence of gastric cancer varies in different parts of the world and among various ethnic groups. Despite advances in diagnosis and treatment, the 5-year survival rate of stomach cancer is only 20 per cent. Stomach cancer can be classified into intestinal and diffuse types based on epidemiological and clinicopathological features. The etiology of gastric cancer is multifactorial and includes both dietary and nondietary factors. The major diet-related risk factors implicated in stomach cancer development include high content of nitrates and high salt intake. Accumulating evidence has implicated the role of Helicobacter pylori (H. pylori) infection in the pathogenesis of gastric cancer. The development of gastric cancer is a complex, multistep process involving multiple genetic and epigenetic alterations of oncogenes, tumor suppressor genes, DNA repair genes, cell cycle regulators, and signaling molecules. A plausible program for gastric cancer prevention involves intake of a balanced diet containing fruits and vegetables, improved sanitation and hygiene, screening and treatment of H. pylori infection, and follow-up of precancerous lesions. The fact that diet plays an important role in the etiology of gastric cancer offers scope for nutritional chemoprevention. Animal models have been extensively used to analyze the stepwise evolution of gastric carcinogenesis and to test dietary chemopreventive agents. Development of multitargeted preventive and therapeutic strategies for gastric cancer is a major challenge for the future.
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                Author and article information

                Contributors
                zxr610624@163.com
                sxmuzyb@126.com
                Journal
                BMC Cancer
                BMC Cancer
                BMC Cancer
                BioMed Central (London )
                1471-2407
                16 January 2020
                16 January 2020
                2020
                : 20
                : 41
                Affiliations
                [1 ]ISNI 0000 0004 1798 4018, GRID grid.263452.4, Department of Health Statistics, School of Public Health, , Shanxi Medical University, ; 56 South XinJian Road, Taiyuan, 030001 Shanxi Province China
                [2 ]GRID grid.464423.3, Department of Internal Medicine, , Shanxi Provincial Peoples Hospital, ; 29 Twin Towers Temple Street, Taiyuan, 030012 Shanxi Province China
                [3 ]ISNI 0000 0004 1762 8478, GRID grid.452461.0, Department of Internal Medicine, , First Hospital of Shanxi Medical University, ; 85 South JieFang Road, Taiyuan, 030001 Shanxi Province China
                Article
                6518
                10.1186/s12885-020-6518-z
                6966844
                31948422
                3208399c-4f81-41e4-bae9-276bfe9498fa
                © The Author(s). 2020

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 30 August 2019
                : 6 January 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001809, National Natural Science Foundation of China;
                Award ID: 81273180
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100013317, Shanxi Provincial Key Research and Development Project;
                Award ID: 201603D321101
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2020

                Oncology & Radiotherapy
                gastric cancer,patient-reported outcome,classical test theory,item response theory,minimal clinically important difference

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