Objective: To compare patient-reported outcomes after implantation of the ZA9003 intraocular lens(IOLs), or the MCX11 ASP IOLs or the spherical IOLs(HQ-201HEP). Methods: Prospective nonrandomized controlled trial was ...Objective: To compare patient-reported outcomes after implantation of the ZA9003 intraocular lens(IOLs), or the MCX11 ASP IOLs or the spherical IOLs(HQ-201HEP). Methods: Prospective nonrandomized controlled trial was used. A total of 105 patients(210 eyes) were divided into three groups according to the type of IOLs: ZA9003(35 patients, 70 eyes), MCX11 ASP(35 patients, 70 eyes) or HQ-201HEP(35 patients, 70 eyes). The main outcome was scores of Catquest nine-item short-form questionnaire. Additional outcome was best corrected visual acuities, spherical aberration(SA) and total higher-order aberrations(HOAs). Results: The global score was significantly lower in the spherical IOL group than the aspherical IOL group of-020 μm SA(P < 0.05) and the aspherical IOL group of-027 μm SA(P < 0.05), and no significant difference was found in the global score between the aspherical IOL group of-020 μm SA than the aspherical IOL group of-027 μm SA(P > 0.05). Significant differences were also found in question 2, question 5, question 6 and question 8 between the spherical IOLs and the aspherical IOLs. Conclusion: Implantation of an aspherical IOL could improve vision-related quality of life compared with a spherical IOL. However, there were no statistically significant differences in vision-related quality of life between aspheric IOLs with different negative spherical aberrations.展开更多
Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content...Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content. The objective of this study was to compare the combined measurement properties of two fatigue scales, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and SF-36 vitality (VT) scale using item response theory (IRT). Methods: The FACIT-Fatigue and SF-36v2 were administered at baseline and weeks 2, 4, 7, 12, and 16 to rheumatoid arthritis (RA) patients (n = 237) enrolled in a 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy and safety of subcutaneous secukinumab administered to pa- tients with active RA. Confirmatory factor analysis (CFA) was used to investigate unidimensionality among FACIT- Fatigue and VT items. A generalized partial credit IRT model was used to cross-calibrate the FACIT-Fatigue and VT items and weighted maximum-likelihood estimation was used to score a composite fatigue index. Analysis of variance was used to compare the composite fatigue index with the original scales in responding to ACR improvement and treatment effects. Results: CFA found less than adequate fit to a unidimensional model. However, specifications of alternative multidimensional models were insufficient in explaining the common variance among items. An IRT model was successfully fitted and the composite fatigue index score was found to be more responsive than the original scales to ACR improvement and treatment effects. Effect sizes and significance tests for changes in scores on the composite index were generally larger than those observed with the original scales. Conclusion: IRT methods offer a promising approach to combining items from different scales measuring the same concept that could improve the detection of treatment effects in clinical studies of RA.展开更多
Objective： To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients （MG-PRO） in China. Methods： A total of 100 MG patients were interviewed for the field testing. Another 5...Objective： To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients （MG-PRO） in China. Methods： A total of 100 MG patients were interviewed for the field testing. Another 56 MG patients were selected and assessed with the MG-PRO scale before treatment and at 1, 2 and 4 weeks after treatment. The classical test theory and item response theory （IRT） were used to assess the psychometric characteristics of the MG-PRO scale, Results： The MG-PRO scale included 4 dimensions： physical, psychological, social environment, and treatment. Confirmatory factor analysis showed that each dimension was consistent with the theoretical construct. The scores of the physical and psychological dimensions increased significantly at 1 week after treatment （P〈0.05）. All the dimension scores and the MG-PRO score increased significantly at 2 and 4 weeks after treatment （P〈0.05）. IRT showed that person separation indices were greater than 0.8, most of the item fit residual statistics were within ＋ 2.5, and no item had uniform or non-uniform differential item functioning （DIF） between gender and age （〈40, 〉140）. Conclusions： The MG-PRO scale is valid for measuring the quality of life （QOL） of MG patients, with good reliability, validity, responsiveness, and good psychometric characteristics from IRT. It can be applied to evaluate the QOL of MG patients and to assess treatment effects in clinical trials.展开更多
目的建立基于冠心病心绞痛患者报告临床结局评价量表(patient-reported outcomes of coronaryheart disease,CHD-PRO)的原始条目池,并对条目池进行初步筛选。方法结合中医理论,参照国际PRO量表的研制方法和冠心病心绞痛疾病特点建立量...目的建立基于冠心病心绞痛患者报告临床结局评价量表(patient-reported outcomes of coronaryheart disease,CHD-PRO)的原始条目池,并对条目池进行初步筛选。方法结合中医理论,参照国际PRO量表的研制方法和冠心病心绞痛疾病特点建立量表的原始条目池,通过核心小组讨论、半开放式问卷调查等方法进行条目的初步筛选。结果原始的条目池由41个条目组成,经过初步筛选后,剩余36个条目,其中生理领域14条,心理领域8条,独立性领域4条,社会关系领域3条,社会环境领域6条,总体评价条目1条。结论初筛后的条目覆盖地冠心病心绞痛常见的生理领域、心理领域、独立性领域、社会关系领域及社会环境领域5个方面,比较全面地反映了冠心病心绞痛的内涵,且语言通俗易懂,容易理解和回答,具有较好的内容效度。展开更多
基金supported by the Health Bureau of Shanghai City(201440029)
文摘Objective: To compare patient-reported outcomes after implantation of the ZA9003 intraocular lens(IOLs), or the MCX11 ASP IOLs or the spherical IOLs(HQ-201HEP). Methods: Prospective nonrandomized controlled trial was used. A total of 105 patients(210 eyes) were divided into three groups according to the type of IOLs: ZA9003(35 patients, 70 eyes), MCX11 ASP(35 patients, 70 eyes) or HQ-201HEP(35 patients, 70 eyes). The main outcome was scores of Catquest nine-item short-form questionnaire. Additional outcome was best corrected visual acuities, spherical aberration(SA) and total higher-order aberrations(HOAs). Results: The global score was significantly lower in the spherical IOL group than the aspherical IOL group of-020 μm SA(P < 0.05) and the aspherical IOL group of-027 μm SA(P < 0.05), and no significant difference was found in the global score between the aspherical IOL group of-020 μm SA than the aspherical IOL group of-027 μm SA(P > 0.05). Significant differences were also found in question 2, question 5, question 6 and question 8 between the spherical IOLs and the aspherical IOLs. Conclusion: Implantation of an aspherical IOL could improve vision-related quality of life compared with a spherical IOL. However, there were no statistically significant differences in vision-related quality of life between aspheric IOLs with different negative spherical aberrations.
文摘Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content. The objective of this study was to compare the combined measurement properties of two fatigue scales, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and SF-36 vitality (VT) scale using item response theory (IRT). Methods: The FACIT-Fatigue and SF-36v2 were administered at baseline and weeks 2, 4, 7, 12, and 16 to rheumatoid arthritis (RA) patients (n = 237) enrolled in a 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy and safety of subcutaneous secukinumab administered to pa- tients with active RA. Confirmatory factor analysis (CFA) was used to investigate unidimensionality among FACIT- Fatigue and VT items. A generalized partial credit IRT model was used to cross-calibrate the FACIT-Fatigue and VT items and weighted maximum-likelihood estimation was used to score a composite fatigue index. Analysis of variance was used to compare the composite fatigue index with the original scales in responding to ACR improvement and treatment effects. Results: CFA found less than adequate fit to a unidimensional model. However, specifications of alternative multidimensional models were insufficient in explaining the common variance among items. An IRT model was successfully fitted and the composite fatigue index score was found to be more responsive than the original scales to ACR improvement and treatment effects. Effect sizes and significance tests for changes in scores on the composite index were generally larger than those observed with the original scales. Conclusion: IRT methods offer a promising approach to combining items from different scales measuring the same concept that could improve the detection of treatment effects in clinical studies of RA.
基金Supported by the Major State Basic Research Development Program of China(973 Program,No.2005CB523500)the Key Project of the National 11th Five Year Research Program of China(No.2006BAI04A12)
文摘Objective： To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients （MG-PRO） in China. Methods： A total of 100 MG patients were interviewed for the field testing. Another 56 MG patients were selected and assessed with the MG-PRO scale before treatment and at 1, 2 and 4 weeks after treatment. The classical test theory and item response theory （IRT） were used to assess the psychometric characteristics of the MG-PRO scale, Results： The MG-PRO scale included 4 dimensions： physical, psychological, social environment, and treatment. Confirmatory factor analysis showed that each dimension was consistent with the theoretical construct. The scores of the physical and psychological dimensions increased significantly at 1 week after treatment （P〈0.05）. All the dimension scores and the MG-PRO score increased significantly at 2 and 4 weeks after treatment （P〈0.05）. IRT showed that person separation indices were greater than 0.8, most of the item fit residual statistics were within ＋ 2.5, and no item had uniform or non-uniform differential item functioning （DIF） between gender and age （〈40, 〉140）. Conclusions： The MG-PRO scale is valid for measuring the quality of life （QOL） of MG patients, with good reliability, validity, responsiveness, and good psychometric characteristics from IRT. It can be applied to evaluate the QOL of MG patients and to assess treatment effects in clinical trials.
文摘目的建立基于冠心病心绞痛患者报告临床结局评价量表(patient-reported outcomes of coronaryheart disease,CHD-PRO)的原始条目池,并对条目池进行初步筛选。方法结合中医理论,参照国际PRO量表的研制方法和冠心病心绞痛疾病特点建立量表的原始条目池,通过核心小组讨论、半开放式问卷调查等方法进行条目的初步筛选。结果原始的条目池由41个条目组成,经过初步筛选后,剩余36个条目,其中生理领域14条,心理领域8条,独立性领域4条,社会关系领域3条,社会环境领域6条,总体评价条目1条。结论初筛后的条目覆盖地冠心病心绞痛常见的生理领域、心理领域、独立性领域、社会关系领域及社会环境领域5个方面,比较全面地反映了冠心病心绞痛的内涵,且语言通俗易懂,容易理解和回答,具有较好的内容效度。
