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Evaluation of A Scale of patient-reported outcomes for the Assessment of Myasthenia Gravis patients in China

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Chinese Journal of Integrative Medicine 2012年第10期18卷 737-745页

作者：刘凤斌陈新林郭丽刘小斌 Department of Internal Medicine The First Affiliated HospitalGuangzhou University of Chinese Medicine College of Basic Medical Science Guangzhou University of Chinese Medicine The Second Hospital Liwan District of Guangzhou The DENG Tietao Institute Guangzhou University of Chinese Medicine

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.

关键词： myasthenia gravis quality of life patient-reported outcome classical test theory item response theory

Factors affecting the quality of life of patients after gastrectomy as assessed using the newly developed PGSAS-45 scale: A nationwide multi-institutional study

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World Journal of Gastroenterology 2016年第40期22卷 8978-8990页

作者： Koji Nakada Masazumi Takahashi Masami Ikeda Shinichi Kinami Masashi Yoshida Yoshikazu Uenosono Yoshiyuki Kawashima Sayumi Nakao Atsushi Oshio Yoshimi Suzukamo Masanori Terashima Yasuhiro Kodera Department of Laboratory Medicine Daisan Hospital Jikei University School of MedicineTokyo 201-8601Japan Division of Gastroenterological Surgery Yokohama Municipal Citizen’s HospitalYokohama 240-8555Japan Department of Surgery Asama General HospitalSaku 085-0022Japan Department of Surgical Oncology Kanazawa Medical SchoolKanazawa 920-0293Japan Department of Surgery International University of Health and Welfare HospitalTochigi 329-2763Japan Department of Digestive Surgery Breast and Thyroid SurgeryKagoshima University Graduate School of MedicineKagoshima 890-8620Japan Division of Gastroenterological Surgery Saitama Cancer CenterSaitanna 362-0806Japan Department of Surgery 2 Tokyo Women’s Medical UniversityTokyo 162-8666Japan Faculty of Letters Arts and SciencesWaseda UniversityTokyo 169-8050Japan Department of Physical Medicine and Rehabilitation Tohoku University Graduate School of MedicineSendai 980-8575Japan Division of Gastric Surgery Shizuoka Cancer CenterShizuoka 411-8777Japan Department of Gastroenterological Surgery Nagoya University Graduate School of MedicineNagaya 466-8550Japan

AIM To identify certain clinical factors other than the type of gastrectomy which affect the postoperative quality of life(QOL) of patients after *** The postgastrectomy syndrome assessment scale(PGSAS)-45 was designed to assess the severity of symptoms, the living status and the QOL of gastrectomized patients. It consists of 45 items, of which 22 are original items while 23 were retrieved from the SF-8 and Gastrointestinal Symptoms Rating Scale questionnaires with permission. A nationwide surveillance study to validate PGSAS was conducted and 2368 gastric cancer patients who underwent various types of gastrectomy at 52 medical institutions were enrolled. Of these, 1777 patients who underwent total gastrectomy(TG) reconstructed with Roux-Y(n = 393), distal gastrectomy(DG) reconstructed with Billroth-I(n = 909), or DG reconstructed with Roux-Y(n = 475) were evaluated in the current study. The influence of the type of gastrectomy and other clinical factors such as age, sex, duration after surgery, the symptom severity, the degree of weight loss, dietary intake, and the ability for working on the postoperative QOL(i.e., dissatisfaction for daily life subscale, physical component summary and mental component summary of the SF-8) were examined by multiple regression analysis(MRA). In addition, importance of various symptoms such as esophageal reflux, abdominal pain, meal-related distress, indigestion, diarrhea, constipation and dumping on the postoperative living status and QOL were also appraised by *** The postoperative QOL were significantly deteriorated in patients who underwent TG compared to those after DG. However, the extent of gastrectomy was not an influential factor on patients' QOL when adjusted by the MRA. Among various clinical factors, the symptom severity, ability for working, and necessity for additional meals were the most influential factorsto the postoperative QOL. As for the individual symptoms, meal-related distress, dumping,

关键词： Postgastrectomy syndrome Quality of life patient-reported outcome Effect size Gastrectomy

Development and validation of a simple and multifaceted instrument,GERD-TEST,for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms

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World Journal of Gastroenterology 2017年第28期23卷 5216-5228页

作者： Koji Nakada Nobuyuki Matsuhashi Katsuhiko Iwakiri Atsushi Oshio Takashi Joh Kazuhide Higuchi Ken Haruma Department of Laboratory Medicine Daisan Hospital Jikei University School of Medicine Department of Gastroenterology NTT Medical Center Tokyo Department of Gastroenterology Nippon Medical School Graduate School of Medicine Faculty of Letters Arts and SciencesWaseda University Department of Gastroenterology and Metabolism Nagoya City University Graduate School of Medical Sciences Second Department of Internal Medicine Osaka Medical College Department of General Internal Medicine 2 Kawasaki Medical School Kawasaki Hospital

To evaluate the psychometric properties of a newly developed questionnaire, known as the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST), in patients with *** patients with predominant GERD symptoms recruited according to the Montreal definition were treated for 4 wk using a standard dose of proton pump inhibitor (PPI). The GERD-TEST and the Medical outcome Study Short Form-8 Health Survey (SF-8) were administered at baseline and after 4 wk of treatment. The GERD-TEST contains three domains: the severity of GERD and functional dyspepsia (FD) symptoms (5 items), the level of dissatisfaction with daily life (DS) (4 items), and the therapeutic efficacy as assessed by the patients and medication compliance (4 items).RESULTSA total of 290 patients were eligible at baseline; 198 of these patients completed 4 wk of PPI therapy. The internal consistency reliability as evaluated using the Cronbach’s α values for the GERD, FD and DS subscales ranged from 0.75 to 0.82. The scores for the GERD, FD and DS items/subscales were significantly correlated with the physical and mental component summary scores of the SF-8. After 4 wk of PPI treatment, the scores for the GERD items/subscales were greatly reduced, ranging in value from 1.51 to 1.87 and with a large effect size (P patients.

关键词： Gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test patient-reported outcome Gastroesophageal reflux disease Validity Reliability

Quality of life after total vs distal gastrectomy with Rouxen-Y reconstruction: Use of the Postgastrectomy Syndrome Assessment Scale-45

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World Journal of Gastroenterology 2017年第11期23卷 2068-2076页

作者： Masazumi Takahashi Masanori Terashima Hiroshi Kawahira Eishi Nagai Yoshikazu Uenosono Shinichi Kinami Yasuhiro Nagata Masashi Yoshida Keishiro Aoyagi Yasuhiro Kodera Koji Nakada Division of Gastroenterological Surgery Yokohama Municipal Citizen’s Hospital Division of Gastric Surgery Shizuoka Cancer Center Center for Frontier Medical Engineering Chiba University Department of Surgery and Science Graduate school of medicine Kyushu University Department of Digestive Surgery Kagoshima University Graduate School of Medicine Department of Surgical Oncology Kanazawa Medical School Center for Comprehensive Community Care Education Graduate School of Biomedical Sciences Nagasaki University Department of Surgery International University of Health and Welfare Hospital Department of Surgery Kurume University School of Medicine Department of Gastroenterological Surgery Nagoya University Graduate School of Medicine Department of Laboratory Medicine The Jikei University School of Medicine

AIM To investigate the detrimental impact of loss of reservoir capacity by comparing total gastrectomy(TGRY) and distal gastrectomy with the same Rouxen-Y(DGRY) reconstruction. The study was conducted using an integrated questionnaire, the Postgastrectomy Syndrome Assessment Scale(PGSAS)-45, recently developed by the Japan Postgastrectomy Syndrome Working *** The PGSAS-45 comprises 8 items from the Short Form-8, 15 from the Gastrointestinal Symptom Rating Scale, and 22 newly selected items. Uni-and multivariate analysis was performed on 868 questionnaires completed by patients who underwent either TGRY(n = 393) or DGRY(n = 475) for stage I gastric cancer(52 institutions). Multivariate analysis weighed of six explanatory variables, including the type of gastrectomy(TGRY/DGRY), interval after surgery, age, gender, surgical approach(laparoscopic/open), and whether the celiac branch of the vagus nerve was preserved/divided on the quality of life(QOL).RESULTS The patients who underwent TGRY experienced the poorer QOL compared to DGRY in the 15 of 19 main outcome measures of PGSAS-45. Moreover, multiple regression analysis indicated that the type of gastrectomy, TGRY, most strongly and broadly impaired the postoperative QOL among six explanatory variables. CONCLUSION The results of the present study suggested that TGRY had a certain detrimental impact on the postoperative QOL, and the loss of reservoir capacity could be a major cause.

关键词： Postgastrectomy syndrome Quality of life Gastric cancer Gastrectomy patient-reported outcome

Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study

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World Journal of Gastroenterology 2022年第34期28卷 5058-5075页

作者： Talat Bessissow Geoffrey C Nguyen Osman Tarabain Laurent Peyrin-Biroulet Nathalie Foucault Kevin McHugh Joannie Ruel Department of Medicine McGill University Health CenterMontreal H3G 1A4QuebecCanada Mount Sinai Hospital Inflammatory Bowel Disease Centre Toronto M5T 3L9OntarioCanada Dr.O.Tarabain Clinic Windsor N8W 1E6OntarioCanada Department of Gastroenterology University of LorraineCHRUNancyNancy F-54000France AbbVie Corporation Saint-Laurent H4S 1Z1QuebecCanada Department of Medicine Sherbrooke University Hospital CenterSherbrooke J1H 5N4QuebecCanada

BACKGROUND A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis(UC)patients treated in a real-world *** use of patient-reported outcomes(PROs)has been discussed as a primary endpoint in the context of the FDA PRO Guidance,for labelling ***,the efficacy and safety of adalimumab have been demonstrated in pivotal trials;however,data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients,such as symptoms,health-related quality of life(HRQoL),and *** To assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe *** UCanADA was a single arm,prospective,1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed—with psychologic distress/depression symptoms as the primary endpoint—by patients with moderate-to-severe *** were performed during patients’routine care visit schedule,which was at the initiation of adalimumab(baseline),after induction(approximately 8 wk),and 52 wk after *** optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this *** safety events and per-protocol adverse events were *** From 23 Canadian centres,100 patients were enrolled and 48 completed the *** with the patient Health Questionnaire–9 items at week 52,61.5%(40/65)[95%confidence interval(CI):49.7%-73.4%]of the patients improved in psychologic distress/depression symptoms,which was slightly higher in completers[65.9%(29/44);95%CI:51.9%-79.9%].At week 52,clinical response and clinical remission were achieved respectively by 65.7%(44/73)and 47.8%(32/73)of the *** odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinic

关键词： Disease burden patient-reported outcome Depressive symptoms Ulcerative colitis Adalimumab Real-world data

Literature review and analysis of the application of health outcome assessment instruments in Chinese medicine

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Journal of Integrative Medicine 2013年第3期11卷 157-167页

作者： Feng-bin Liu Zheng-kun Hou Yun-ying Yang Pei-WU Li Qian-wen Li Nelson Xie Jing-wei Li Xiang-jing Zeng Department of Spleen-Stomach Diseases the First Affiliated HospitalGuangzhou University of Chinese Medicine The School of Medical and Molecular Biosciences University of Technology SydneyUltimoNew South Wales2007 Australia Jiangmen Wuyi Traditional Chinese Medicine Hospital

OBJECTIVE： To evaluate the application of health assessment instruments in Chinese medicine. METHODS： According to a pre-defined search strategy, a comprehensive literature search for all articles published in China National Knowledge Infrastructure databases was conducted. The resulting articles that met the defined inclusion and exclusion criteria were used for analysis. RESULTS： A total of 97 instruments for health outcome assessment in Chinese medicine have been used in fundamental and theoretical research, and 14 of these were also used in 29 clinical trials that were randomized controlled trials, or descriptive or cross-sectional studies. In 2 152 Chinese medicine-based studies that used instruments in their methodology, more than 150 questionnaires were identified. Among the identified questionnaires, 51 were used in more than 10 articles （0.5%）. Most of these instruments were developed in Western countries and few studies （4%） used the instrument as the primary evidence for their conclusions. CONCLUSION： Usage of instruments for health outcome assessment in Chinese medicine is increasing rapidly; however, current limitations include selection rationale, result interpretation and standardization, which must be addressed accordingly.

关键词： treatment outcome health-related quality of life patient-reported outcome personal satisfaction questionnaires instrumentation medicine, Chinese traditional outcome assessment (health care)

Literature review and analysis of the development of health outcomes assessment instruments in Chinese medicine

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Journal of Integrative Medicine 2013年第2期11卷 80-89页

作者： Feng-bin Liu Zheng-kun Hou Yun-ying Yang Zheng-zheng Zhang Di Xie Nelson Xie Hong Thach Nguyen Department of Spleen-Stomach Diseases the First Affiliated Hospital Guangzhou University of Chinese Medicine School of Medical and Molecular Biosciences University of Technology Sydney Will of East Medical Ha Noi Viet Nam Ministry of Health of Viet Nam

OBJECTIVE： To evaluate the development of health outcomes assessment instruments in Chinese medicine. METHODS： A comprehensive literature search for all published articles in China National Knowledge Infrastructure Database, Chongqing VIP Database and WANFANG Data was conducted. The studies that met the inclusion and exclusion criteria were used to extract information according to a predesigned assessment instrument. RESULTS： A total of 97 instruments for health outcome assessment in Chinese medicine were identified. Of these questionnaires, 7 were generic, 12 were condition-specific and 78 were disease-specific. All instruments were suitable for adults, children, and both men and women. These instruments aimed to evaluate the health-related quality of life, signs and symptoms as well as patient satisfaction and doctor-reported outcome. However, the descriptions were poorly constructed for some of the most basic parameters, such as the domains and items, administrative mode, response options, memory recall periods, burden evaluation, format, copyright, content validity, and other properties. CONCLUSION： The instrument development for health outcomes assessment in Chinese medicine is increasing rapidly; however, there are many limitations in current methodologies and standards, and further studies are needed.

关键词： health outcomes health-related quality of life patient-reported outcome satisfaction questionnaire Chinese medicine outcome assessment (health care)

Influence of the Different Prosthesis Designs on Subjective Functional Evaluation after TKA: Medium-Term outcome Using the 2011 Knee Society Score

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Open Journal of Orthopedics 2020年第12期10卷 371-383页

作者： Hiroaki Kanazawa Yuichiro Maruyama Department of Orthopaedic Surgery Juntendo University Urayasu Hospital Chiba Japan

Background: patient-reported outcome (PRO) has become the focus of increased attention in the assessment of total knee arthroplasty (TKA). The purpose of this study was to investigate whether different prosthesis desi... 详细信息

Background: Patient-reported outcome (PRO) has become the focus of increased attention in the assessment of total knee arthroplasty (TKA). The purpose of this study was to investigate whether different prosthesis designs affected postoperative patient-reported performance. Materials and Methods: We reviewed 216 patients (234 knees) implanted with the Press-Fit Condylar Sigma prosthesis at our institution between January 2009 and December 2011. This study included 76 knees with fixed-bearing cruciate-retaining (FB-CR), 78 knees with fixed-bearing posterior-stabilized (FB-PS), and 80 knees with mobile-bearing posterior-stabilized (MB-PS) designs. The mean follow-up was 8.0 ± 0.74 years. Preoperative and follow-up ratings according to the 2011 Knee Society Score (2011 KSS), range of motion (ROM), and standing femoro-tibial angle (FTA) were obtained for all patients. Additionally, Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were collected at last follow-up. Results: Three separate subscales of the 2011 KSS of the three cohorts were significantly improved post-operatively compared to the pre-operative values (p 0.05), except for expectation scores. At the time of follow-up, significantly higher the 2011 Knee Society Functional Scores (P = 0.016) were found in the PS group. In particular, there were significant differences in advanced activities of the 2011 KSFS among the three group

关键词： Total Knee Arthroplasty patient-reported outcome 2011 New KSS Prosthesis Design