Objective To developapatient-reported outcomes scale of chronic obstructive pulmonary disease used for Chinese, thus offering tools for clinical efficacy assessment. Methods According to the development standard of International Patient-Reported Outcomes, the item pool was established and the preliminary scale was prepared. Then, 100 patients with chronic obstructive pulmonary disease and 50 healthy subjects were face-to-face interviewed with preliminary scale by well-trained investigators.Those copies were collected, surveys were analyzed and items were selected with 5 methods including measure of discrete tendency method, factor analysis, correlation coefficient method, Cronbach’s alpha coefficient method and item response Theory. Finally, the final scale was gained. Results The eventual scale contains 4 areas(physiological dimain, psychological dimension, social dimension, treatment), 11 dimensions(specific symptoms, general symptoms, individual, anxiety, depression, disease cognization, disease influence on social pctivity, social support, compliance, drug adverse reaction, satisfactory), and 52 items. Conclusion The ultimate scale coincides with the theoretical framework and reflects the connotation of the quality of life of patients with chronic obstructive pulmonary disease.
ObjectiveTo acquaint the development process and item composition of the appraisal tools and reporting standards of clinical pathways worldwide, in order to improve the development and evaluation of clinical pathways. MethodsWe searched databases including PubMed, EMbase, Web of Science, CBM, CNKI and WanFang Data for articles about the appraisal tools and reporting standards of clinical pathways from inception to Jan, 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and compared the difference in development process and item composition among included appraisal tools and reporting standards of clinical pathways. ResultsA total of 7 appraisal tools and reporting standards were included. Among them, 3 were from UK, 1 from China, 1 from Australia, 1 from Belgium, and 1 from Saudi Arabia. All included appraisal tools contained 4 to 15 domains and 14 to 99 items. Based on the comparison of different domains and items of included appraisal tools, "Clinical Pathway Management Guidelines" published by the National Health and Family Planning Commission of the People's Republic of China and the research of Vannhaecht, we identified 17 key elements of clinical pathway as follows:organizational commitment, pathway project management, format of doc, content of pathway, multidisciplinary involvement, variance management, EBM/guidelines, maintenance of pathway, accountability, patient involvement, development of pathway, additional support systems & documents, operational arrangement, implementation, outcome management, safety and organization of the care process. ConclusionCurrently, the appraisal tools and reporting standards of clinical pathways are rudimentary, so we desperately needs to establish mature appraisal tool and reporting standard of clinical pathways to guide the development and implementation of clinical pathway, so as to improve their application effects in clinical practice and medical quality.
The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.
ObjectiveThis study aimed to revise the perioperative recovery scale for integrative medicine (PRSIM) based on item response theory (IRT). MethodsUnder the guidance of IRT, a total of 349 patient data collected during the development of the original version of PRSIM at Guangdong Provincial Hospital of Chinese Medicine were used. Principal component analysis was performed using SPSS 18.0 software to test the unidimensionality. The R language was utilized for parameter estimation, including discrimination coefficient, difficulty parameters and information content, as well as drawing item characteristic curves to assess item quality and estimate item functioning differences. A comprehensive screening process was carried out by combining expert consultations, patient evaluations, and discussions within a core group. ResultsThe degree of discrimination of all items ranged from −0.535 to 2.195. The difficulty coefficient ranged from −10.343 to 5.461, and the average information content of all items ranged from 0.043 to 1.075. Based on the criteria for parameter selection, nine items were retained. The results of expert consultations indicated the removal of 5 items and the modification of 7 items. After discussion within the core group, a final decision was made to remove 5 items. ConclusionBased on a synthesis of IRT and expert consultation feedback, and following discussions within the core group, a revised version comprising 15 items is retained and modified from the original 20 items.