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1. Interpretation of Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research (the PRO Ethics Guidelines)
ZHOU Hui, LIN Ying, ZHOU Guojin, TANG Kejing, YUAN Gang, YAO Mi
Chinese General Practice    2023, 26 (04): 395-400.   DOI: 10.12114/j.issn.1007-9572.2022.0598
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Patient-reported outcome (PRO) can provide evidence for medical decision making, health care policy development, and also serve as symptom parameters for condition monitoring to provide timely care targeting personal needs. With the widespread applications of PRO in clinical research, related ethical issues have received deeply attention. Published in 2022, the Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research (the PRO Ethics Guidelines) , is an important consensus-based reference developed for addressing ethical considerations of PRO in clinical research. Addressing ethical issues in PRO can improve the quality of PRO data while minimizing the risk, burden, and harm to participants and protecting the rights of participants and researchers. We interpreted the guideline, aiming to provide a guide for colleagues addressing ethical issues of PRO, and to increase their attention to these issues.

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2. Patient-reported Outcome: Recent Advances in Applications and Research at Home and Abroad
SHI Zhao, DOU Lei, LI Shunping
Chinese General Practice    2023, 26 (04): 401-408.   DOI: 10.12114/j.issn.1007-9572.2022.0805
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Patient-reported outcome (PRO) refers to any information about the patient's own health condition, functional status, and feelings about treatment that directly comes from the patient without interpretation by physicians, nurses or anyone else. Measuring outcomes from the patient perspective is conducive to improving the quality of medical services and treatment satisfaction. We summarized recent applications of PRO in many fields, such as drug review and approval, drug and medical equipment supervision, quality evaluation of medical services, health technology assessment, and comprehensive clinical evaluation of drugs, and reviewed the latest advances in research on PRO, such as the development of PRO instruments, the construction of a health state utility value set, the health measurement in children and adolescents, and the quality evaluation of PRO instruments. Then we put forward recommendations to further promote the studies and use of PRO in China: strengthening the development of PRO instruments applicable to China, valuing the use of PRO in clinical practice, enhancing the interdisciplinary research on PRO, broadening the profile of research on PRO, and intensifying relevant research.

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3. Application of Minimal Clinically Important Difference in Outcome Assessment Tools for Bronchiectasis Treatment
Jiarui GUAN, Jiaming REN, Yang XIE, Peng ZHANG
Chinese General Practice    2022, 25 (30): 3739-3746.   DOI: 10.12114/j.issn.1007-9572.2022.0290
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Increased bronchiectasis (BE) prevalence has imposed heavy economic burden on patients and their families, greatly affecting the quality of life of patients. With increased use of patient reported outcome (PRO) in bronchiectasis treatment assessment, researchers not only focus on statistical pre-and post-treatment differences (P<0.05) , but also pay attention to minimal clinically important difference (MCID) . Currently, there is still a lack of relevant data about MCID in BE-PRO assessment tools. We reviewed the latest research on the use of MCID in BE-PRO assessment tools, aiming at providing a quantitative basis for outcome assessment in BE treatment.

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4. Association of Baseline Geriatric Nutritional Risk Index and Clinical Outcome of Endovascular Therapy in Patients with Diabetic Foot and Lower Extremity Arterial Disease
WU Wenxia, CHEN Guishan, LIU Xingzhou, YOU Lili, LIU Dan, YAN Li
Chinese General Practice    2022, 25 (36): 4496-4501.   DOI: 10.12114/j.issn.1007-9572.2022.0470
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Background

Patients with diabetic foot undergoing endovascular therapy for lower extremity arterial disease exhibit poor outcomes and a high mortality rate. It is unclear whether malnutrition assessed by geriatric nutritional risk index (GNRI) is associated with clinical outcomes in these patients.

Objective

To investigate the association of baseline malnutrition assessed by GNRI and clinical outcomes of endovascular therapy for lower extremity arterial disease in patients with diabetic foot.

Methods

Ninety-five patients who were admitted in Department of Endocrinology, Sun Yat-sen Memorial Hospital due to diabetic foot and lower extremity arterial disease were included from January 2011 to December 2016. All of them received endovascular therapy and followed up for two years. Baseline GNRI was assessed, and divided into three levels: normal nutrition (43 cases) , mild malnutrition (31 cases) and moderate to severe malnutrition (21 cases) . Clinical characteristics were collected, including sex, age, diabetes duration, smoking, body mass index, prevalence of cardiovascular and cerebrovascular diseases, diabetic foot classification, systolic and diastolic blood pressure, and blood test results containing white blood cell count, platelet count, lymphocyte count, neutrophil count, neutrophil-to-lymphocyte ratio, hemoglobin, fasting blood glucose, glycosylated hemoglobin, total cholesterol, triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol, albumin, creatinine, and estimated glomerular filtration rate. The primary endpoint was all-cause mortality, and the secondary endpoint was major lower extremity amputation. The Kaplan-Meier curve was used for survival analysis. Univariate and multivariate Cox proportional hazards regression analysis were analyzed to evaluate the risk factors of all-cause mortality.

Results

Fifty-two cases (54.7%) were assessed with malnutrition (GNRI≤98) . Normal nutrition, mild malnutrition, and moderate to severe malnutrition patients had significant differences in average body mass index, leukocyte count, neutrophil count, neutrophil-to-lymphocyte ratio, hemoglobin, triglyceride and albumin (P<0.05) . During the follow-up, 16 patients died, 10 of whom were due to cardiovascular or cerebrovascular diseases; five patients underwent major lower extremity amputation. The two-year survival rate was 92.1%, 75.6% and 50.1% in normal nutrition, mild malnutrition, and moderate to severe malnutrition patients, respectively, showing statistically significant difference (Log-rank test: χ2=10.812, P=0.004) . GNRI≤98〔HR=3.937, 95%CI (1.070, 13.942) , P=0.037〕 was an independent risk factor for all-cause mortality.

Conclusion

The two-year survival rate of patients in normal nutrition group (GNRI>98) was higher than that in malnutrition group (GNRI≤98) . Baseline GNRI-assessed malnutrition may be an independent risk factor for all-cause mortality in diabetic foot patients with lower extremity arterial disease treated by endovascular therapy, so assessing and improving the nutritional status may better improve the clinical outcome of these patients.

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5. A Review of Studies on Patient-reported Outcomes and Disease-specific Health-related Quality of Life Instruments for Irritable Bowel Syndrome
WU Xiaoyu, WAN Chonghua, CHEN Ying, RUAN Yanqin, WENG Yijie, XU Xiaojiang
Chinese General Practice    2023, 26 (18): 2268-2276.   DOI: 10.12114/j.issn.1007-9572.2022.0787
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Scale assessment for irritable bowel syndrome (IBS) has been widely implemented in clinical practice, how to choose an appropriate assessment tool is very important. In view of this, we used literature research methodology to search patient-reported outcomes and disease-specific health-related quality of life instruments for IBS, summarized their main contents and psychometric properties, then put forward recommendations on the selection of the instruments. A total of 37 commonly used instruments for IBS were retrieved, which have proven to have good reliability, validity and responsiveness, and can be better applied in clinical practice. We suggest medical professionals and researchers choose an assessment instrument for IBS according to the purpose and content of their research.

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6.

Research Status and Thinking of Minimal Clinically Important Difference in Patient-reported Outcome Assessment Tool for Allergic Rhinitis

ZHANG Peng, REN Jiaming, GUAN Jiarui, XIE Yang
Chinese General Practice    2022, 25 (11): 1314-1319.   DOI: 10.12114/j.issn.1007-9572.2021.01.502
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As the patient-reported outcome (PRO) assessment tool has been increasingly used in the clinical efficacy evaluation of patients with allergic rhinitis (AR) , the judgment and interpretation of changes in measurement results of assessment tools have become increasingly important. For the judgment of clinical research results, not only the statistical differences, but also the minimum clinically important difference (MCID) must be paid attention to. This paper systematically sorts out the MCID of the AR-PRO assessment tool, in order to provide a reference for AR-related clinical diagnosis and treatment decision-making and the objectification of the PRO assessment tool.

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7. The Application and Consideration of Patient-reported Outcomes 
LONG Lizhi,YUAN Ling
Chinese General Practice    2020, 23 (32): 4120-4127.   DOI: 10.12114/j.issn.1007-9572.2020.00.015
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The research and development of patient-reported outcomes (PROs) in China are slow,which needs to be vigorously carried out and promoted to improve the quality of medical services and improve people's health and well-being.This is a review of the research progress of PROs at home and abroad,with a view to providing references for related clinical research and health management.Based on PROs at home and abroad in recent years the literature analysis and summary,this paper introduced the concept,classification and content,the selection of scale,the making and implementation of Patient-reported outcomes,as well as its general situation of the main application.We also proposed the problem of PROs development in our country and put forward related suggestions.
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8. Selection Path of Patient-Reported Outcome Measures:a Case Study of Selecting an Activities of Daily Living Scale for Chinese Patients with Low Back Pain 
CHEN Qianji, CHEN Hong, ZHANG Ying, WAN Ying, ZHOU Yanji, AN Yi, SUN Yanan, YU Changhe
Chinese General Practice    2021, 24 (36): 4648-4652.   DOI: 10.12114/j.issn.1007-9572.2021.02.068
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Patient-reported outcome measures(PROMs)are tools for evaluating and quantifying patient-reported outcomes,and qualified measurement properties is a basic prerequisite for their application. There have been a large number of PROMs,whose measurement properties have not been evaluated standardly and comprehensively,so how to select an appropriate PROM has become one problem that needs to be solved urgently in clinical research. COnsensus-based Standards for the selection of health Measurement INstruments(COSMIN)are designed to help researchers and medical workers choose the most appropriate outcome measurement. Referring to the COSMIN,we attempted to explore the selection path of PROMs for Chinese patients via showcasing the process of selecting an activities of daily living scale for Chinese low back pain patients. We found that the path for selecting an PROM includes five main steps:(1)acomprehensive retrieval to determine the presence of targeted PROMs;(2)development of new PROMs or cross-cultural adaption of foreign PROMs;(3)research on measurement properties;(4)systematic review of the properties;(5)optimization of current PROMs. In particular,system review of the propertiesis emphasized as the critical step. Meanwhile,the selection of PROMs is not overnight,but a circular and forward process.
Low back pain;Patient reported outcome measures;COnsensus-based Standards for the selection of health Measurement Instruments;Patient-Reported Outcome Measures;Systematic reviews
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9. Development and Item Selection of the Inflammatory Bowel Disease Patient-reported Outcomes Scale Based on Theories of Traditional Chinese Medicine
Jianfeng LUO, Jiangtao HOU, Zhengkun HOU, Bin PENG, Huibiao LI, Shiying LIU, Zhenfan HE, Jiamin ZHONG, Shijing ZHANG, Fengbin LIU, Xinlin CHEN
Chinese General Practice    2022, 25 (29): 3672-3677.   DOI: 10.12114/j.issn.1007-9572.2022.0038
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Background

The prevalence of inflammatory bowel disease (IBD) increases annually in China. The integrated traditional Chinese and western medicine is helpful to alleviate and control symptoms of IBD. Quality of life (QoL) is an important index to evaluate the clinical efficacy of IBD. However, there are few studies about IBD patient-reported outcomes (PROs) based on TCM theories.

Objective

To determine the framework and items, and then use them to develop the IBD PROs scale using TCM theories.

Methods

Under the guidance of the TCM theory of "body and mind harmony, and man's adaptation to his total environment" , literature review, core-group discussion and expert consultation were carried out. The conceptual framework and item pool of the draft of an IBD PROs scale were developed, then the corresponding items were determined, forming the draft of the IBD PROs scale. Then the draft scale was pre-tested in IBD patients treated in Department of Spleen and Stomach Diseases, the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January to June 2021. The dispersion tendency, Cronbach's α and correlation analysis were used for further item selection.

Results

The final IBD PROs scale is composed of two domains: body and mind harmony (12 body-related items, and 9 mind-related items) and man's adaptation to his total environment (6 items) .

Conclusion

The IBD PROs scale developed based on theories of TCM could be used to evaluate the QoL of IBD patients. But further clinical research is still needed to verify its reliability and validity.

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10. Effect of Long-term Use of Jiangyabao Series of Chinese Patent Medicines on the Outcome of Hypertension:a Cohort Study 
CUI Weifeng,FAN Xiaohui,WANG Shoufu,FAN Junxing,WU Kewen,DENG Songtao,FAN Junming
Chinese General Practice    2019, 22 (1): 101-105.   DOI: 10.12114/j.issn.1007-9572.2019.01.021
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Background There is a close causal relationship between hypertension and the risk of cardiovascular disease morbidity and mortality. Jiangyabao series of Chinese patent medicines (a sort of hypotensors) have good effects on essential hypertension. Objective To evaluate the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome of patients with hypertension. Methods This study was carried out from 2001 to 2003 based on a cohort design. The 1 364 participants with essential hypertension were recruited from Henan Hypertension Management Center of Integrated Traditional Chinese and Western Medicine. All of them received standardized secondary prevention interventions for hypertension and oral administration of Jiangyabao series of Chinese patent medicines. In accordance with the duration of voluntary administration,they were assigned to short-term medication group (n=236,≤42 months),long-term medication group (n=1 128,>42 months),respectively. Data of age,family history of early onset of hypertension,duration of hypertension,stage of hypertension,use of western antihypertensive drugs,smoking history,drinking history,education level,amount of exercise and sleeping status were collected. All of them were followed up for 42 months,during which the incidence of adverse outcomes (death caused by cardiovascular and cerebrovascular diseases,myocardial infarction,cerebral infarction,cerebral hemorrhage) was recorded. Cox proportional hazards regression analysis was used to analyze the effect of long-term administration of Jiangyabao series of Chinese patent medicines on the outcome. Results The incidence of adverse outcomes in new included participants during the whole study period was 15.90%(217/1 364),and 22.22%(80/360),13.06%(64/490) and 14.20%(73/514) in 2001,2002 and 2003. By the end of the experiment,the incidence of adverse outcomes in the long-term medication group was lower than that in the short-term medication group 〔10.17%(24/236)vs 17.11%(193/1 128),χ2=7.03,P=0.008〕.Analyses with different Cox proportional risk regression models showed that the incidence of adverse outcomes in short-term medication group was higher than that of the long-term medication group (HR>1.00,P<0.05).Conclusion Long-term administration of Jiangyabao series of Chinese patent medicines can significantly reduce the incidence of adverse outcomes in patients with hypertension.
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11. Bibliometric Analysis of Patient-reported Outcomes Using CiteSpaceⅤ 
LI Wenjiao,CHENG Lyu,WANG Han,NING Yun,JIN Changde,LI Yan
Chinese General Practice    2020, 23 (32): 4128-4134.   DOI: 10.12114/j.issn.1007-9572.2020.00.317
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Background The transformation of the traditional medical model to patient-centered medical model indicates that the role of patients are becoming increasingly important in healthcare industry.And patient-reported health information demonstrates distinctive significance in identifying/monitoring symptoms,evaluating treatment effect and sharing decision-making.However,the research on patient-reported outcomes(PROs) is still in its infancy in China,and bibliometric studies based on PROs are still lacking.Objective To evaluate the research results and hotspots about PROs from a global perspective,to provide references for relevant studies in China.Methods Studies about PROs were searched from the database of Web of Science Core Collection from inception to August 2019.Bibliometric analysis and CiteSpaceⅤ were used to conduct a visualization analysis of the enrolled studies in terms of changes in annual publication number,major author countries/regions and institutions,publishing journals,keywords and research hotspots.Results A total of 3 288 studies were enrolled.The annual number of these published studies showed a recent increasing trend.The country publishing the most studies was the United States,accounting for 55.20%(1 815/3 288) of the total.The institution with the largest number of papers published was Northwestern University.The publications in which the studies were published numbered 822,among which Quality of Life Research published the most(n=148).The top 6 keywords with highest centrality value were "quality of life" "patient-reported outcomes" "questionnaire" "validation" "impact" "reliability".The major hotspots were PROs,health-related quality of life,measurement of PROs,and clinical application of PROs.Conclusion Developed countries,led by the United States,take the lead in this field,and there are few high-quality studies in this field in China.Therefore,to improve the development of PROs related studies in China,scholars are suggested to put efforts on domestic PROs related development as well as features of traditional Chinese medicine.
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12. Reliability of the Patient Reported Outcomes Scale for Coronary Heart Disease 
ZHANG Chuanmeng,WAN Chonghua,YANG Zheng,HUANG Zhiwen,WU Bin,XU Chuanzhi
Chinese General Practice    2019, 22 (11): 1350-1354.   DOI: 10.12114/j.issn.1007-9572.2018.00.209
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Background Coronary heart disease is difficult to cure,and the course of which is long.Traditional evaluation indexes (such as mortality and cure rate) cannot evaluate the health status and treatment effect on patients.Patient reported outcome is the direct evaluation of patients' own health status without interpretation of medical professionals.The key to the assessment of patient reported outcome is to develop an appropriate measurement scale and evaluate it accordingly.Objective To evaluate the reliability of the Patient Reported Outcome Instruments for Chronic Disease (PROISCD-CHD).Methods To evaluate the reliability of PROISCD-CHD by classical test theory (CTT) and modern test theory (Generalizability Theory,GT),a total of 189 patients with coronary heart disease who were literate and volunteered were investigated at the time of admission and 75 of them were randomly selected for the second survey after one day interval.The correlation coefficients of the first and second measurements were used to evaluate the test-retest reliability while Cronbach's α coefficients were used to evaluate internal consistency.The source of the patient's reported outcome score was explored in G-study and the suggested number of items was given based on their G-coefficient (Ep2) and indexes of dependability (φ) in D-study.Results Coefficients of physiological health,mental health,social health,spirit/belief health,common modules,specific modules and total score of PROISCD-CHD scale were 0.89,0.84,0.75,0.86,0.88,0.89,0.71,respectively (P<0.001),and Cronbach's α coefficients of each item were 0.71,0.75,0.75,0.69,0.88,0.78,0.89,respectively.G-study showed that the biggest source of variation was the interaction between the patients and items,and the smallest was the item.D-study revealed that G-coefficients of all domains were greater than 0.70,except for the domain of spirit/belief health,which had the same result with the reliability analysis of classical test theory.And according to Ep2 andφ,the optimal number of items was also given.Conclusion PROISCD-CHD can be used to assess patient-reported outcome for patients with coronary heart disease with good reliability.
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13. Current Situation of the Revision of Clinical Outcome Assessment Tools and Consideration on the Procedure:with the COPD-PRO as an Example 
WANG Jiajia,XIE Yang,LI Jiansheng
Chinese General Practice    2020, 23 (29): 3644-3648.   DOI: 10.12114/j.issn.1007-9572.2020.00.360
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Efficient assessment tools are needed in assessing clinical outcomes.The development of assessment tools is a cyclical process,and revision is a necessary way to optimize.At present,there is a lack of uniform norms for the revision process of such tools.According to the development standard of international scales,important achievements of domestic research,and the revision of COPD-PRO,this paper proposes a preliminary revision process of clinical outcome assessment tools,with a view to providing guidance for relevant research.
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14. Clinical Outcomes and Related Factors of Coronary Microvascular Obstruction in Patients with Delayed Admission after Acute Myocardial Infarction 
WU Duoyi,XU Heping,SUN Juan,LI Quanni
Chinese General Practice    2019, 22 (13): 1592-1597.   DOI: 10.12114/j.issn.1007-9572.2019.00.220
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Background  About 1/3 of patients with ST-segment elevation myocardial infarction(STEMI) have delayed visits.The benefits of late myocardial salvage therapy are affected by the severity of coronary microvascular occlusion(MVO).Objective  To investigate the clinical outcomes,and related factors of MVO in coronary microvascular obstruction in patients with delayed admission after acute myocardial infarction.Methods  From 2014 to 2017,78 STEMI patients with delayed admission(time between symptom onset and hospital arrival is greater than 12 hours) who received emergency percutaneous coronary intervention(PCI) in EICU and CICU,Hainan General Hospital were enrolled.According to the results of coronary angiography,MVO is determined when the thrombolysis in myocardial infarction(TIMI) perfusion grade is less than 2 or the final TIMI grade is 3 and the myocardial blush grade(MBG) is less than 2.Clinical results and echocardiographic follow-up were performed to assess the occurrence of major adverse cardiovascular events(MACE) and left ventricular remodeling.Results  The incidence of MVO in the participants was 50.0%(39/78).Multivariate Logistic regression analysis showed that older age and having left anterior descending branch as the culprit vessel were risk factors for MVO,and pre-infarction angina pectoris was protective factor for MVO(P<0.05).The incidence of MACE and left ventricular remodeling in patients with MVO were higher than those of patients without(P<0.05).Cox proportional hazards regression model showed that MVO and LAD were the predictors of MACE(P<0.05).Conclusion  STEMI patients with delayed admission are relatively susceptible to MVO and related adverse outcome events.Older age and having LAD as the culprit vessel are associated with increased risks while pre-infarction angina pectoris is associated with decreased risk of MVO.Appropriate management and follow-up strategies should be implemented in this group of high-risk patients.
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15. 上消化道出血患者营养状态对临床结局的影响
韩菊平,刘晋
Chinese General Practice    2016, 19 (03): 282-284,291.   DOI: 10.3969/j.issn.1007-9572.2016.03.008
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目的  探讨上消化道出血(UGIB)患者营养状态对其临床结局的影响。方法  选取2009年1月-2011年2月收治于武汉市第五人民医院消化科的UGIB患者413例,根据入院时营养风险评分(NRS2002)将患者分为高营养风险(H-NR,NRS2002≥3分)组和低营养风险(L-NR,NRS2002<3分)组。比较住院期间两组患者临床结局(住院时间、再出血发生率、院内死亡率)。应用受试者工作特征曲线(ROC曲线)评价NRS2002对患者再出血和院内死亡的预测价值。结果  H-NR组患者NRS2002为(4.0±1.0)分,高于L-NR组患者的(1.4±0.5)分(t=29.210,P<0.001)。两组患者的男性比例、治疗方法分布情况比较,差异均无统计学意义(P>0.05);基础疾病分布情况比较,差异有统计学意义(P<0.05);其中H-NR组十二指肠溃疡发生率低于L-NR组,胃溃疡发生率高于L-NR组(P<0.05)。H-NR组患者住院时间为(7.9±3.5)d,长于L-NR组患者的(7.0±2.5)d(t=2.775,P=0.006)。H-NR组患者再出血发生率、院内死亡率均高于L-NR组患者(P<0.05)。NRS2002预测UGIB患者再出血的ROC曲线下面积(AUC)=0.794〔95%CI(0.708,0.890),P<0.001〕,灵敏度和特异度分别为0.778和0.698,NRS2002最佳截断值为3.5分;NRS2002预测UGIB患者院内死亡的AUC=0.827〔 95%CI(0.723,0.932),P<0.001〕,灵敏度和特异度分别为0.765和0.851,NRS2002最佳截断值为4.5分。结论  H-NR与UGIB患者的临床不良结局有关,NRS2002对UGIB患者的临床结局有较好的预测价值,值得临床推广应用。
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16. 基于中医证候要素的消渴目病患者报告结局量表条目池设置及考评
倪琳琳1,徐云生2*
Chinese General Practice    2017, 20 (7): 874-878.   DOI: 10.3969/j.issn.1007-9572.2017.07.022
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目的  制定基于中医证候要素的消渴目病(糖尿病视网膜病变)患者报告结局(PRO)量表,并对其进行初步考评。方法  系统检索2006年1月-2015年12月中国知网和维普网中与消渴目病证候类型有关的文献,整理和归纳其中的消渴目病证型,并将复合证候分解为单一证素;于2015年7-10月在山东省中医院内分泌科病房对糖尿病视网膜病变患者30例、患者家属5例、内分泌科医护人员5例进行半结构化深度访谈。将文献研究结果与访谈结果相结合,设置消渴目病PRO量表初始条目池。采用抽签法,选取2014年3月-2015年11月山东中医药大学第一附属医院内分泌科和眼科、山东中医药大学第二附属医院内分泌科和眼科、济南市中医院内分泌科和眼科收治的糖尿病视网膜病变患者280例,采用初步设置的消渴目病PRO量表条目池对其进行调查,以对量表进行考评。共发放问卷280份,回收有效问卷270份,问卷有效回收率为96.4%。结果  文献检索共纳入合格文献42篇,拆分出证素15种,结合访谈结果,初步设置成的消渴目病PRO量表共31个条目,其中生理维度18个条目(证候效应指标9个、特有症状指标9个),心理维度6个条目,社会维度5个条目,满意度维度2个条目。不同病情分级患者的生理维度证候效应指标、生理维度特有症状指标、心理维度、社会维度得分及总分比较,差异均有统计学意义(P<0.05)。总量表的Cronbach′s α系数为0.944,其中生理维度证候效应指标、生理维度特有症状指标、心理维度、社会维度的Cronbach′s α系数分别为0.909、0.901、0.890、0.857。因子分析共获得5个公因子,累计方差贡献率为66.755%。结论  初步设置的消渴目病PRO量表信效度较好,可以用于中医药治疗消渴目病的疗效评估,建议在临床上推广应用。
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17. 低龄先天性心脏病患儿营养风险与临床结局的关系研究
宋佳音,郑樱,肖本熙,戚本华,张燕军,李远红,王端,李真,马文君
Chinese General Practice    2018, 21 (6): 698-701.   DOI: 10.3969/j.issn.1007-9572.2017.00.270
Abstract366)      PDF(pc) (1148KB)(427)    Save
目的 对低龄先天性心脏病(CHD)患儿术前营养风险进行筛查,探讨中、高度营养风险与低龄CHD患儿临床结局的关系,为临床营养支持提供依据。方法 选择2016年6—12月广东省人民医院收治的1~36个月龄的CHD患儿306例为研究对象,采用营养风险及发育不良筛查工具(STRONGkids)行营养风险筛查并根据筛查结果分为低、中、高度营养风险组。比较中、高度营养风险患儿临床结局指标。结果 306例CHD患儿术前低度营养风险组4例(1.3%)、中度营养风险组134例(43.8%)、高度营养风险组168例(54.9%)。高度营养风险组的总住院费用、住院时间、重症监护(ICU)时间、机械通气时间、术后感染率均高于中度营养风险组(P<0.05),中度营养风险组和高度营养组患儿病死率间差异无统计学意义(P>0.05)。结论 CHD患儿术前多存在中、高度营养风险,高度营养风险CHD患儿的总住院费用、住院时间、ICU时间、机械通气时间、术后感染发生率均较中度营养风险CHD患儿高。

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18. 特发性肺纤维化患者报告结局测评工具文献研究
谢洋1,2,赵虎雷2,王佳佳2,王明航1,2
Chinese General Practice    2018, 21 (5): 604-610.   DOI: 10.3969/j.issn.1007-9572.2018.05.022
Abstract350)      PDF(pc) (1898KB)(552)    Save
目的 分析特发性肺纤维化患者报告结局(IPF-PRO)测评工具的研制及应用现状。方法 2017年4—6月,计算机检索PubMed、EMBase、中国知网、中国生物医学文献数据库、万方数据知识服务平台和维普网关于IPF临床疗效测评工具的研制、应用的文献,提取第一作者、题目、发表时间、涉及的测评工具及其领域等信息。结果 本研究共纳入文献65篇,其中英文文献27篇,中文文献38篇;IPF-PRO测评工具研究文献最早见于2000年,而国内最早见于2007年;关于测评工具研制、信度考核、效度考核、适用性评价的文献有20篇,研究各种治疗措施对IPF患者生存质量影响的文献45篇;涉及IPF-PRO测评工具共23个。测评工具的领域主要包括症状、日常活动能力、心理情绪、社会活动、经济状况、疗效满意等内容。中文、英文文献均对圣•乔治呼吸疾病问卷(SGRQ)的使用频次较多。结论 当前临床研究多缺乏基于我国文化背景研制的IPF-PRO测评工具,亟须加强能够反映中医疗效优势的IPF相关特异性测评工具的研制。

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19. 基于健康调查量表的脑卒中患者报告结局与临床客观指标的相关性研究
许清安1,常履华2,万崇华1,孙凤琴2,许传志3,刘洲4
Chinese General Practice    2018, 21 (6): 643-647.   DOI: 10.3969/j.issn.1007-9572.2017.00.193
Abstract337)      PDF(pc) (1131KB)(615)    Save
目的 探讨脑卒中患者报告结局(PRO)与临床客观指标的相关性。方法 选取2010年5月—2011年3月在昆明医科大学第一附属医院神经内科确诊住院的100例脑卒中患者,采用健康调查量表(SF-36)对其进行调查并计分,临床客观指标采集于患者住院病历,包括入院第2天清蛋白、球蛋白、尿素、空腹血糖、血钾、血小板计数、活化部分凝血活酶时间及患者文化程度。采用简单相关和典型相关分析对PRO和临床客观指标进行分析并探讨其相关性。结果 简单相关分析结果显示,球蛋白与肌体疼痛(BP)、生命力(VT)呈负相关(P<0.05),尿素与躯体功能(PF)呈负相关(P<0.05),空腹血糖与一般健康状况(GH)呈负相关(P<0.05),血钾与PF呈负相关(P<0.05),血小板计数与PF呈负相关(P<0.05),文化程度与PF、BP、VT、情感角色(RE)呈正相关(P<0.05)。典型相关分析显示,典型变量(μ1,ν1)、(μ2,ν2)存在相关性(r=0.536 0、0.325 6,P<0.05)。球蛋白与μ1的典型变量系数为-0.832 2,活化部分凝血活酶时间与μ1的典型变量系数为0.358 5;血小板计数与μ2的典型变量系数为0.581 6,文化程度与μ2的典型变量系数为0.672 0;VT与ν1的典型变量系数为1.061 7,心理健康(MH)与ν1的典型变量系数为-0.761 8;PF与ν2的典型变量系数为-0.950 1,GH与ν2的典型变量系数为0.443 8。球蛋白与μ1呈高度负相关(r=-0.835 0,P<0.05),PF与ν2呈高度负相关(r=-0.738 6,P<0.05),VT与ν1呈高度正相关(r=0.727 2,P<0.05)。结论 PRO与临床客观指标之间存在相关性,关注相关指标并提出相应对策对改善脑卒中患者PRO有一定的价值。

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