Objective To investigate the incidence of urological malignancy in renal allograft recipients and explore the mechanism of increased incidence in China and the management. Methods A retrospective study was performed o...Objective To investigate the incidence of urological malignancy in renal allograft recipients and explore the mechanism of increased incidence in China and the management. Methods A retrospective study was performed on 22 patients with urological malignancy in renal allograft recipients between 1978 and 2010.展开更多
Majority of the patients with advanced non-small-cell lung cancer(NSCLC)experience two or more disease related symptoms,which may have a negative impact on their health-related quality of life(HR QOL).These patients p...Majority of the patients with advanced non-small-cell lung cancer(NSCLC)experience two or more disease related symptoms,which may have a negative impact on their health-related quality of life(HR QOL).These patients prefer a therapy that would improve disease related symptoms,as opposed or treatment that slightly prolongs their survival without improving symptoms.The improvements of the symptoms augment the significance of improved response rates or progression free survivals.The choice of the questionnaires to evaluate patients-reported outcomes(PROs)and HRQOL benefits and methods of collecting the data and their interpretations are very important and are discussed in this manuscript.PROs and HR QOL outcomes are important in patients with advanced NSCLC only when the data are collected and analyzed correctly.Then they can be viewed as components of the total value of a treatment,providing a comprehensive picture of the benefits and risks of anticancer therapies.Enabling the patients to feel during the last months of their lives more comfortable and not be dependent on their loved ones is a very important task in the treatment of advanced NSCLC.展开更多
BACKGROUND Synovial sarcoma(SS) is a rare type of soft tissue sarcoma that is usually developed from areas where synovial tissue exists, especially at the extremities.Nevertheless, several cases of retroperitoneal SS(...BACKGROUND Synovial sarcoma(SS) is a rare type of soft tissue sarcoma that is usually developed from areas where synovial tissue exists, especially at the extremities.Nevertheless, several cases of retroperitoneal SS(RSS) have been described. We herein report a case of RSS presented in our institution.CASE SUMMARY A 69-year-old female patient was admitted with a large, palpable, firm mass in the right abdominal space SS. Computerized tomography scan depicted a concentric, sharply marinated retro-peritoneal lesion which was displacing the right kidney and the lower edge of the liver. Subsequently, the patient underwent surgical excision of the mass with additional right nephrectomy and resection of the right adrenal gland and a part of the diaphragm. The final histological diagnosis of the tumour was grade II monophasic RSS.CONCLUSION RSS is encountered in the biphasic type, the monophasic fibrous, and the monophasic epithelial category as well. Relevant clinical manifestations are not always documented at early stages. Therefore, the final diagnosis is posed after complete histological examination taking into consideration the results of immunochemistry and genetic analysis. Therapeutic approach happens often late when metastases at the lungs and the liver are apparent. Thus, 5-year survival rates remain low.展开更多
BACKGROUND： Infective myositis is rare. The retrospective report of clinical data and symptoms from one patient with infective myositis will hopefully provide more information for clinicians in the diagnosis of this ...BACKGROUND： Infective myositis is rare. The retrospective report of clinical data and symptoms from one patient with infective myositis will hopefully provide more information for clinicians in the diagnosis of this disease. METHODS： A male patient, 65 years old, was admitted with ＂fever and muscle pain since four days ago, accompanied by inertia of all limbs for one day＂, to the First Department of Neurology, Guangdong Provincial Hospital of Traditional Chinese Medicine on April 25th, 2005. Following admission, a history of diseases was record, and detailed physical and neurological examinations were performed. During the examination, symmetrical myasthenia appeared, tendon reflex disappeared, and creatine kinase levels were increased 500 times higher than normal. The patient was primarily diagnosed with hypokalemic periodic paralysis, myositis, Guillain-Barre syndrome, and upper respiratory infection. Subsequently, the patient was treated with the following： cefuroxime for infection, potassium supplements, breviscapin for promoting blood circulation through the removal of stasis, and ATP/CO-A for myocardial nutrition. Antiviral drugs were not administered. However, laboratory samples were continuously monitored. Creatine kinase levels decreased to normal, and muscle pain was obviously relieved following antibiotics treatment. The results led to a final diagnosis of infective myositis. RESULTS： Four days after treatment （April 29th）, muscular tenderness and throat congestion were obviously improved （＋/-）. The neurological examination showed the patient was conscious, cooperated with treatment, and had normal intellect. No abnormalities of the cranial nerve were observed upon examination. Proximal and distal muscle strength and muscular tensions of the four limbs were all normal. Reflexes of the right biceps brachii muscle and its tendon were decreased, and knee tendon and Achilles tendon reflex were not induced. A Babinski reflex was not detected. The neurological examination presented no abnormalities, and the related creatine kinases were within normal range by re-examination at 2 weeks, and l and 3 months after discharge. CONCLUSION： A diagnosis of infective myositis should be considered for patients with clear prodromes of infection, that include symptoms of periodic paralysis and elevated creatine kinase levels. Treatment with sufficient antibiotics can obtain good results.展开更多
BACKGROUND Checkpoint-Inhibition has revolutionized the treatment for several entities such as melanoma and renal cell carcinoma.The first encouraging experience in ovarian cancer was reported for nivolumab,a fully hu...BACKGROUND Checkpoint-Inhibition has revolutionized the treatment for several entities such as melanoma and renal cell carcinoma.The first encouraging experience in ovarian cancer was reported for nivolumab,a fully humanized anti-programmed death-1 antibody.Pseudoprogression is a new phenomenon associated with these novel immuno-oncologic agents.It can be explained by infiltrating leucocytes and edema that result in a temporary increase in tumor size and delayed subsequent shrinkage due to tumor cell destruction.CASE SUMMARY We report on a 47-year old patient with platinum-resistant ovarian cancer that was treated off-label with nivolumab 3mg/kg iv d1q14d.She first experienced classic pseudoprogression with inguinal lymph node swelling after cycle two and subsequent shrinkage.After 6 cycles she presented with rectal bleeding and progressive disease was diagnosed due to new tumor infiltration into the rectum.CONCLUSION Clinicians should be aware of pseudoprogression,its underlying mechanisms and strategies to discriminate pseudo-from real progression in ovarian cancer.展开更多
For cancer patients on Phase I trials, one of the most important physician decisions is whether or not patients are deriving benefit from therapy. With an increasing number of cytostatic treatment agents, the criteria...For cancer patients on Phase I trials, one of the most important physician decisions is whether or not patients are deriving benefit from therapy. With an increasing number of cytostatic treatment agents, the criteria to determine patient response to Phase I treatment has become harder to define. Physicians are increasingly looking to patient-reported outcomes (PROs) such as quality of life (QOL) to help evaluate treatment response. Electronic daily diary (EDD) devices can be used by patients to report their QOL over extended periods of time, thereby providing a more accurate picture of how patients are affected by treatment on a daily basis. However, questions remain about how to integrate this patient-reported information into decisions about Phase I treatment. This study investigated how physicians use patients’ daily QOL reports to evaluate patient response to Phase I treatment. Data were collected over a 4-month period from Phase I patients (N = 30) and physicians (N = 3) in an NCI-designated comprehensive cancer center. Patients completed daily QOL reports using EDD devices and physicians were provided with a summary of patients’ QOL before each visit. After the visit, doctors recorded their treatment decision and also rated the importance of four biomedical factors (Toxicity, Imaging, Labs, and Performance Status) and QOL in their treatment decision for that visit. Although physicians rated QOL as being very important in evaluating treatment response, in practice, when predictors of their decisions were analyzed, results showed they relied exclusively on biomedical data (Toxicity, Imaging) to make Phase I treatment decisions. Questions remain about the utility and effective integration of QOL and biomedical data in clinical decision-making processes in Phase I clinical trials.展开更多
In the last decade, evidence-based medical practice has been supported on a large scale by computerized decision support tools, aiming to reduce diagnostic and therapeutic uncertainty, complementing the actions of the...In the last decade, evidence-based medical practice has been supported on a large scale by computerized decision support tools, aiming to reduce diagnostic and therapeutic uncertainty, complementing the actions of the health professional. With technological developments, it is now possible to consider these systems as part of clinical intervention, both for the diagnosis and treatment of diseases. The literature has described the implementation of e-health tools, that is, technological innovations in the health area such as software, applications, serious games, among others, as a strategy to improve the process and adherence to treatment. However, there is still no standardized instrument in Brazil that can be used to guide the development, from the research phase, and the implementation of these tools as a health intervention, also impacting patient outcomes. With the objective of investigating a new therapeutic and preventive form, based on intervention with a computerized system, this work proposes the creation of guidelines for the registration and implementation of e-health tools as a clinical intervention. The proposal aims to be able to assist in the reporting standardization from the development stage to the application of the e-health tool helping in the treatment of diseases, registering all the experience lived in the research and applying it in different contexts of health.展开更多
目的观察卵巢-附件报告和数据系统超声2022版(O-RADS US v2022)及其联合恶性风险指数4(RMI4)鉴别附件良、恶性肿瘤的价值。方法回顾性分析126例手术病理诊断为附件肿瘤患者,根据O-RADS US v2022将1~3类归为良性病变、4~5类归为恶性病变,...目的观察卵巢-附件报告和数据系统超声2022版(O-RADS US v2022)及其联合恶性风险指数4(RMI4)鉴别附件良、恶性肿瘤的价值。方法回顾性分析126例手术病理诊断为附件肿瘤患者,根据O-RADS US v2022将1~3类归为良性病变、4~5类归为恶性病变,以450为RMI4分类的临界值,基于二者进行联合分类。以病理结果为金标准,绘制受试者工作特征(ROC)曲线,计算曲线下面积(AUC),评估单一O-RADS US v2022、RMI4及其联合鉴别附件良、恶性肿瘤的效能。结果126例附件肿瘤中,良性94例、恶性32例。O-RADS US v2022鉴别附件良、恶性肿瘤的敏感度、特异度、准确率及AUC分别为78.13%、80.85%和80.16%、0.795,RMI4分别为71.88%、84.04%和80.95%、0.780;二者联合的特异度及准确率(93.62%、92.06%)均高于单一O-RADS US v2022(χ^(2)=7.322、5.967,P=0.007、0.015)或RMI4(χ^(2)=4.625、5.331,P=0.032、0.021),而敏感度及AUC(87.50%、0.906)差异均无统计学意义(P均>0.05)。结论O-RADS US v2022能有效鉴别附件良、恶性肿瘤,联合RMI4可提高鉴别特异度及准确率。展开更多
目的分析目前中医患者报告结局(PRO)量表的研究现状及存在的问题,为中医PRO量表研制提供参考。方法在中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、PubMed、Embase及Web of Science中检索中医...目的分析目前中医患者报告结局(PRO)量表的研究现状及存在的问题,为中医PRO量表研制提供参考。方法在中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、PubMed、Embase及Web of Science中检索中医PRO量表研究文献,收集量表相关信息,抽取量表相关的12个数据元素进行统计,分析中医PRO量表的开发情况及测评情况等。结果共纳入88篇文献,涉及50个量表。研究集中在2008-2022年,涉及疾病种类以消化系统最多;中医PRO量表设置以3~4个维度最多,其中有9个量表设置了中医特色维度;条目池的构建多采用专家咨询法、文献研究法及访谈法相结合;条目筛选方面,运用客观方法的较多,其次为主观德尔菲法及主客观方法结合;量表测评方面,27个量表进行了信度测评,24个量表进行了效度测评,9个量表进行了反应度测评,16个量表进行了可行性测评。结论中医PRO量表的研究整体处于起步阶段,其研制的规范度及完整度仍存在不足,信效度等指标测评需引起重视,维度和条目设置方面需注重结合中医自身治疗特色,后续学者需更加完善中医PRO量表研制过程,丰富中医临床诊疗评价体系。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
文摘Objective To investigate the incidence of urological malignancy in renal allograft recipients and explore the mechanism of increased incidence in China and the management. Methods A retrospective study was performed on 22 patients with urological malignancy in renal allograft recipients between 1978 and 2010.
文摘Majority of the patients with advanced non-small-cell lung cancer(NSCLC)experience two or more disease related symptoms,which may have a negative impact on their health-related quality of life(HR QOL).These patients prefer a therapy that would improve disease related symptoms,as opposed or treatment that slightly prolongs their survival without improving symptoms.The improvements of the symptoms augment the significance of improved response rates or progression free survivals.The choice of the questionnaires to evaluate patients-reported outcomes(PROs)and HRQOL benefits and methods of collecting the data and their interpretations are very important and are discussed in this manuscript.PROs and HR QOL outcomes are important in patients with advanced NSCLC only when the data are collected and analyzed correctly.Then they can be viewed as components of the total value of a treatment,providing a comprehensive picture of the benefits and risks of anticancer therapies.Enabling the patients to feel during the last months of their lives more comfortable and not be dependent on their loved ones is a very important task in the treatment of advanced NSCLC.
文摘BACKGROUND Synovial sarcoma(SS) is a rare type of soft tissue sarcoma that is usually developed from areas where synovial tissue exists, especially at the extremities.Nevertheless, several cases of retroperitoneal SS(RSS) have been described. We herein report a case of RSS presented in our institution.CASE SUMMARY A 69-year-old female patient was admitted with a large, palpable, firm mass in the right abdominal space SS. Computerized tomography scan depicted a concentric, sharply marinated retro-peritoneal lesion which was displacing the right kidney and the lower edge of the liver. Subsequently, the patient underwent surgical excision of the mass with additional right nephrectomy and resection of the right adrenal gland and a part of the diaphragm. The final histological diagnosis of the tumour was grade II monophasic RSS.CONCLUSION RSS is encountered in the biphasic type, the monophasic fibrous, and the monophasic epithelial category as well. Relevant clinical manifestations are not always documented at early stages. Therefore, the final diagnosis is posed after complete histological examination taking into consideration the results of immunochemistry and genetic analysis. Therapeutic approach happens often late when metastases at the lungs and the liver are apparent. Thus, 5-year survival rates remain low.
文摘BACKGROUND： Infective myositis is rare. The retrospective report of clinical data and symptoms from one patient with infective myositis will hopefully provide more information for clinicians in the diagnosis of this disease. METHODS： A male patient, 65 years old, was admitted with ＂fever and muscle pain since four days ago, accompanied by inertia of all limbs for one day＂, to the First Department of Neurology, Guangdong Provincial Hospital of Traditional Chinese Medicine on April 25th, 2005. Following admission, a history of diseases was record, and detailed physical and neurological examinations were performed. During the examination, symmetrical myasthenia appeared, tendon reflex disappeared, and creatine kinase levels were increased 500 times higher than normal. The patient was primarily diagnosed with hypokalemic periodic paralysis, myositis, Guillain-Barre syndrome, and upper respiratory infection. Subsequently, the patient was treated with the following： cefuroxime for infection, potassium supplements, breviscapin for promoting blood circulation through the removal of stasis, and ATP/CO-A for myocardial nutrition. Antiviral drugs were not administered. However, laboratory samples were continuously monitored. Creatine kinase levels decreased to normal, and muscle pain was obviously relieved following antibiotics treatment. The results led to a final diagnosis of infective myositis. RESULTS： Four days after treatment （April 29th）, muscular tenderness and throat congestion were obviously improved （＋/-）. The neurological examination showed the patient was conscious, cooperated with treatment, and had normal intellect. No abnormalities of the cranial nerve were observed upon examination. Proximal and distal muscle strength and muscular tensions of the four limbs were all normal. Reflexes of the right biceps brachii muscle and its tendon were decreased, and knee tendon and Achilles tendon reflex were not induced. A Babinski reflex was not detected. The neurological examination presented no abnormalities, and the related creatine kinases were within normal range by re-examination at 2 weeks, and l and 3 months after discharge. CONCLUSION： A diagnosis of infective myositis should be considered for patients with clear prodromes of infection, that include symptoms of periodic paralysis and elevated creatine kinase levels. Treatment with sufficient antibiotics can obtain good results.
文摘BACKGROUND Checkpoint-Inhibition has revolutionized the treatment for several entities such as melanoma and renal cell carcinoma.The first encouraging experience in ovarian cancer was reported for nivolumab,a fully humanized anti-programmed death-1 antibody.Pseudoprogression is a new phenomenon associated with these novel immuno-oncologic agents.It can be explained by infiltrating leucocytes and edema that result in a temporary increase in tumor size and delayed subsequent shrinkage due to tumor cell destruction.CASE SUMMARY We report on a 47-year old patient with platinum-resistant ovarian cancer that was treated off-label with nivolumab 3mg/kg iv d1q14d.She first experienced classic pseudoprogression with inguinal lymph node swelling after cycle two and subsequent shrinkage.After 6 cycles she presented with rectal bleeding and progressive disease was diagnosed due to new tumor infiltration into the rectum.CONCLUSION Clinicians should be aware of pseudoprogression,its underlying mechanisms and strategies to discriminate pseudo-from real progression in ovarian cancer.
文摘For cancer patients on Phase I trials, one of the most important physician decisions is whether or not patients are deriving benefit from therapy. With an increasing number of cytostatic treatment agents, the criteria to determine patient response to Phase I treatment has become harder to define. Physicians are increasingly looking to patient-reported outcomes (PROs) such as quality of life (QOL) to help evaluate treatment response. Electronic daily diary (EDD) devices can be used by patients to report their QOL over extended periods of time, thereby providing a more accurate picture of how patients are affected by treatment on a daily basis. However, questions remain about how to integrate this patient-reported information into decisions about Phase I treatment. This study investigated how physicians use patients’ daily QOL reports to evaluate patient response to Phase I treatment. Data were collected over a 4-month period from Phase I patients (N = 30) and physicians (N = 3) in an NCI-designated comprehensive cancer center. Patients completed daily QOL reports using EDD devices and physicians were provided with a summary of patients’ QOL before each visit. After the visit, doctors recorded their treatment decision and also rated the importance of four biomedical factors (Toxicity, Imaging, Labs, and Performance Status) and QOL in their treatment decision for that visit. Although physicians rated QOL as being very important in evaluating treatment response, in practice, when predictors of their decisions were analyzed, results showed they relied exclusively on biomedical data (Toxicity, Imaging) to make Phase I treatment decisions. Questions remain about the utility and effective integration of QOL and biomedical data in clinical decision-making processes in Phase I clinical trials.
文摘In the last decade, evidence-based medical practice has been supported on a large scale by computerized decision support tools, aiming to reduce diagnostic and therapeutic uncertainty, complementing the actions of the health professional. With technological developments, it is now possible to consider these systems as part of clinical intervention, both for the diagnosis and treatment of diseases. The literature has described the implementation of e-health tools, that is, technological innovations in the health area such as software, applications, serious games, among others, as a strategy to improve the process and adherence to treatment. However, there is still no standardized instrument in Brazil that can be used to guide the development, from the research phase, and the implementation of these tools as a health intervention, also impacting patient outcomes. With the objective of investigating a new therapeutic and preventive form, based on intervention with a computerized system, this work proposes the creation of guidelines for the registration and implementation of e-health tools as a clinical intervention. The proposal aims to be able to assist in the reporting standardization from the development stage to the application of the e-health tool helping in the treatment of diseases, registering all the experience lived in the research and applying it in different contexts of health.
文摘目的观察卵巢-附件报告和数据系统超声2022版(O-RADS US v2022)及其联合恶性风险指数4(RMI4)鉴别附件良、恶性肿瘤的价值。方法回顾性分析126例手术病理诊断为附件肿瘤患者,根据O-RADS US v2022将1~3类归为良性病变、4~5类归为恶性病变,以450为RMI4分类的临界值,基于二者进行联合分类。以病理结果为金标准,绘制受试者工作特征(ROC)曲线,计算曲线下面积(AUC),评估单一O-RADS US v2022、RMI4及其联合鉴别附件良、恶性肿瘤的效能。结果126例附件肿瘤中,良性94例、恶性32例。O-RADS US v2022鉴别附件良、恶性肿瘤的敏感度、特异度、准确率及AUC分别为78.13%、80.85%和80.16%、0.795,RMI4分别为71.88%、84.04%和80.95%、0.780;二者联合的特异度及准确率(93.62%、92.06%)均高于单一O-RADS US v2022(χ^(2)=7.322、5.967,P=0.007、0.015)或RMI4(χ^(2)=4.625、5.331,P=0.032、0.021),而敏感度及AUC(87.50%、0.906)差异均无统计学意义(P均>0.05)。结论O-RADS US v2022能有效鉴别附件良、恶性肿瘤,联合RMI4可提高鉴别特异度及准确率。
文摘目的分析目前中医患者报告结局(PRO)量表的研究现状及存在的问题,为中医PRO量表研制提供参考。方法在中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、PubMed、Embase及Web of Science中检索中医PRO量表研究文献,收集量表相关信息,抽取量表相关的12个数据元素进行统计,分析中医PRO量表的开发情况及测评情况等。结果共纳入88篇文献,涉及50个量表。研究集中在2008-2022年,涉及疾病种类以消化系统最多;中医PRO量表设置以3~4个维度最多,其中有9个量表设置了中医特色维度;条目池的构建多采用专家咨询法、文献研究法及访谈法相结合;条目筛选方面,运用客观方法的较多,其次为主观德尔菲法及主客观方法结合;量表测评方面,27个量表进行了信度测评,24个量表进行了效度测评,9个量表进行了反应度测评,16个量表进行了可行性测评。结论中医PRO量表的研究整体处于起步阶段,其研制的规范度及完整度仍存在不足,信效度等指标测评需引起重视,维度和条目设置方面需注重结合中医自身治疗特色,后续学者需更加完善中医PRO量表研制过程,丰富中医临床诊疗评价体系。
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.
