| Objective: To design the Gout Patient-Reported Outcomes Scale suitable for the patient with gout in China by taking patients as the center and according to the principles and process of designing the Patient-Reported Outcomes Scale released by the U.S.Food and Drug Administration(FDA);to better serve the evaluation of clinical curative effects and the health conditions of the patients with gout through clinical investigation and scientific evaluation of the reliability and validity of the scale and provide clinical doctors with tools to select better therapeutic regimens and guiding pharmacies.Methods: Based on the process of designing international PRO scales and through searching a lot of literature,making patient interviews,and referring to domestic and foreign scales,the main information of the patients with gout is obtained to form the conceptual framework and list the pool of items.By combining with expert opinions and patient feedback,the pool of items is revised and supplemented to form the preliminary scale.Later,the preliminary scale is used to make clinical investigations in the North Jiangsu People’s Hospital,the Second Hospital of Dalian Medical University and Qidong People’s Hospital,and five methods of the Classical Testing Theory are used to screen and modify the items of the scale collected for the generation of the final scale.Then,some statistical approaches such as Cronbach’s coefficient and factor analysis are adopted to test the related performance of the scale in the aspects of reliability,validity,and differentiation.At the end,the data materials obtained from the field investigation are used to evaluate the level of gout patient report outcomes,and the methods such as variance analysis and single factor t test are employed to explore and analyze the related influence factors such as sociodemographic characteristics,specificity of diseases and complications.Results: 1.The Gout Patient Report Outcome Scale including 40 items,4 fields and 12 dimensions was prepared at the end.Among them,there are 12 items in the field of physiology,including the dimensions of somatization,constitutional symptoms,and independence;there are 7 items in the field of psychology,including the dimensions of anxiety,depression and confidence;there are 8 items in the field of society,including the dimensions of social support and social adaptation;there are 13 items in the field of treatment including the dimensions of compliance,effectiveness,satisfaction,and side effects.2.The reliability,validity and differentiation of the scale were assessed.Reliability analysis: the total scale has the Cronbach’s α coefficient of 0.913,and the Cronbach’s α coefficients in the fields of physiology,psychology,society,and treatment are 0.907,0.812,0.658 and 0.758.Validity analysis: in the aspect of structural validity,except the RMSEA of more than 0.1 in the field of psychology,the RMSEAs in other fields are less than 0.1;except the CFI of 0.860 in the field of physiology,the CFI values in other fields are more than 0.90,indicating that the overall model has a high degree of fitting.In the scale,most dimensions have great structural validity.Reactivity analysis: the patients with gout are of statistical significance(P<0.05)before and after the treatment in the fields of physiology,psychology and treatment of the total scale and scale;the pre-treatment and post-treatment of patients can be distinguished through the total scores of the scale(P<0.05),indicating that the scale has a high degree of differentiation.3.Through the analysis of existing data materials,279 patients with gout obtained the total scores of 86.51±22.84 and the average scores of 2.15±0.57 in the PRO scale,showing a medium level.The elderly and undereducated gout patients with the bad habit of drinking obtained higher PRO scores than other subgroups,and the differences were of statistical significance(P<0.05).The patients who suffer from other disease complications,are at the stage of acute gout attacks,suffered from gout attacks in the last month,formed tophi on the affected joints and fail to realize the blood uric acid level of 360mmol/L showed higher PRO scores than other subgroups,and the differences were of statistical significance(P<0.05).Conclusion: 1.Guided by the process of designing international PRO scales,based on the clinical practices in China and adopting five methods of the Classical Testing Theory,the items of the scale are screened,and the final gout PRO scale suitable for the patients with gout in China is obtained.In the meantime,the Cronbach’s coefficient and factor analysis methods are used to assess the final scale scientifically,and the results show that the gout PRO scale is of ideal reliability and validity,and the results obtained according to the scale are effective and reliable.2.The patients with gout show a medium level in the PRO.Age,education level,history of drinking,complications,frequency of gout attacks,stage of gout,formation of tophi and level of blood uric acid are the related factors influencing the PRO of the patients with gout.3.The gout PRO scale can provide the patients with gout with a quantitative measuring tool for the life quality evaluation,clinical outcome explanation,curative effect evaluation and formulation of therapeutic regimens;due to its convenience and easy application,the scale can be further promoted and applied among the patients with gout. |
PDF Full Text Request