1.The First Clinical Medical College,Shanxi Medical University,Taiyuan 030001,China;
2.Department of Cardiology,the First Hospital of Shanxi Medical University,Taiyuan 030001,China;
3.Department of Health Statistics,School of Public Health,Shanxi Medical University,Taiyuan 030001,China；
4.Key Laboratory of Major Disease Risk Assessment in Shanxi Province,Taiyuan 030001,China
Abstract：Objective To explore the influencing factors of patient-reported outcome (PRO) with chronic heart failure (CHF),and to provide evidence from PRO for improving the quality of life of patients with chronic heart failure.Methods Totally 366 patients with CHF were assessed with CHF-PRO measure (CHF-PROM) and their CHF electronic case reported form (CHF-eCRF) was recorded.Based on the analysis of univariate and multifactorial factors and the introduction of structural equation model,a causal correlation model for the outcome of PRO treatment was established.Results Multivariate analysis suggested that chronic obstructive pulmonary disease (COPD) and atrial fibrillation were associated with somatic symptoms in patients with heart failure. The independence of patients increased significantly after cardiac surgery.Increased heart rate was a risk factor for anxiety.Central nervous system diseases and coronary heart disease (CHD) were the influencing factors of social support utilization dimension.The PRO structural equation model suggested that patients' physiological symptoms, psychological and therapeutic fields influenced each other.Conclusion The report of clinical outcome in patients with heart failure is a useful supplement to clinical endpoint indicators and provides more comprehensive evidence for clinical diagnosis and treatment and evaluation of curative effect.
张青，田晶，杨弘，任嘉，张岩波，韩清华. 慢性心力衰竭患者报告结局评估与结构方程模型分析[J]. 中国医院统计, 2020, 27(3): 193-197,201.
Zhangqing,Tianjing,Yanghong,Renjia,Zhangyanbo,Hanqinghua. Evaluation of patient-reported outcome and analysis of structural equation model of patients with chronic heart failure. journal1, 2020, 27(3): 193-197,201.
[1]U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FDAC ENTER FOR DRUG EVALUATION AND RESEARCH,U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES FDA CENTERFOR BIOLOGICS EVALUATION AND RESEARCH&U.S.DE-PARTMENT OF HEALTH AND HUMAN SERVICES FDA CENTERFOR DEVICES AND RADIOLOGICAL HEALTH.Guidance for industry:patient-reported outcome measures:use in medical productdevelopment to suppeort labeling elains:draft guidance[J].Healthand Quality of Life Outcomes,2006,4(1):79.
[2]PATRIEK D L.Patient-reported outcomes(PROs),an organizingtool for concepts, measares and application[J].Qol life Newsletter,2003.31：1-5.
[3]LISTED N A.Report.Recommendations for the registration of drugsused in the treatment of rheumatoid arthritis[J].BrJ Rheumatol,1998.16(7)：211-215.
[4]TIAN J.XUE J.HU X,et al. CHF-PROM: Validation of a patient-reported outcome measure for patients with chronic heart failure[J].Health and Quality of Life Outcomes, 2018,16(1):51.
[5]张春森，薛江平，罗艳虹，等.慢性心力衰竭患者报告结局量表的信度、效度和可行性评价[J].中国药物与临床，2014，14(3)：273-276.
[6] 施慎逊，李鸣，张宁，等.抑郁症与焦虑障碍共病临床特征研究[J].上海精神医学,2009,21（4):198-202.
[7]AMERICAN PSYCHIATRIC ASSOCIATION.Diagnostic and statisti-cal manual for mental disonders,Fifth Edition [D]. Washington,DC:American Psychiatrie Association,2013.
[8]AXSON E L,VARUN S,BLOOM C I,et al.Hospitalisation andmotality outcones of patients with comhid COPD and heart failure:a systematic review protocol[J].BMJ Open,2018,8(6):023058.
[9]DE MIGUEL-DEZ JAVIER,LOPEZ-DE-ANDR£S ANA,HERNANDEZ.BARRERA VALENTIN,et al Influence of COPD on outcoeres of patientsbospitalized with hert failure:Arulysis of the Spanish National HospitalDischarge atabase(2001-2015)[J].ntemational Journal f Canlidogs,2018:213-269.
[10]ALOSCO M L.SPITZNAGELM B,JOSEPHSON R,et al.COPD isassociated with cognitive dysfunction andpoor physical fitness in heartfailu[J].Heart and Lang The Journal of Acute and Critical Care,2014，44(1):21-26.
[11]STANKOVIC I,NESKOVIC A N,PUTNIKOVIC B,et al.Sinusrhythm versus atrial fibrillation in elderly patients with chronic heartfailure-Insight from the Cardiac Insufficiency Bisoprolol Study in Elderly[J].International journal ofcardiology2012,161(3):160-165.
[12]TESTA M A,ANDERSON R B,NACKLEY J F,et al.Quality of lifeand antihypertensive therapy in men.A comparison of captopril withenalapril.The Qualiy-of-Life Hypertension Study Group[J].N EnglJ Med,1993,328（13):907-913.
[13]SOKORELI1,DE VRIESJJ.PAUWS S C,et al.Depression andanxiety as predictors of mortalityamong heart failue patients,system-atic review and meta-analysis[J].Heart Fail Rer,2016,21(1):49-63.
[14]VONGMANY J,HICKMAN LD, LEWIS J.et al.Anmiety in chronieheart failure and the risk of increased hospitalisations and mortality:Asyste matic review[J].European Jounal of CandiovascularNursing.2016.15(7)：478-485.
[15]NORTHCOTT S,MOSS B,HARRISON K,et al. A systematic review of the impact of sto-ke on social support and social networks,associated factors and pattens of change[J].Clin Rehabil,2016,30（8）：239-245.
[16]陈怡.脑卒中患者社会支持状况的调查[J].实用心脑肺血管病杂志，2008,16(4):305307.
[17]温萌，刘相佟，黄水平.脑卒中患者社会支持状况及其影响因素调查[J].江苏预防医学，2013，24(1)；32-34.
[18]徐冰仙.冠心病患者社会支持及应对方式对患者生存质量的影响［J].中国心血管病研究，2014，12(9)：804-807.
[19]CUNE C M,BJORCK-LINNE A K,ISRAELSSON B Y,et al.Non-compliance and knowledge of prescribed medication in eldedy patientswith heart failure[J].EurJ Heart Fail,1999，1(2):145-149.
[20]HO T H,CAUGHEY G E,SHAKIB S.Guideline compliance inchronic heart failure patients with multiple conorbid diseases,evaluation of an individualised multidiseiplinary melel of care[J].PLaSONE,2014.9(4)：1-7.
[21]BYUN D W,MOON S H,KIM T,et al.Assessment of patient-reported outcomes(PROs):treatment satisfaction,medication adherence,and quality of life(QoL)and the associated factors in postmenopausal osteoporosis (PMO) patients inKorea [J].Journal of Bone&Miner-alMetabolism.2018:563-572.
[22]FREEDLAND K E,HESSELER M J,CARNEY R M,et al.Majordepression and long-term survival of patients with heart failure[].Psychosomatic Medicine,2016.78(8):896-903.
[23]DINESHJB,MAIR FS,ROGER V RONIQUE L,et al.Comorbiddepression and heart failure:a community cohort study[J].PlosOne,2016,11(6):e0158570.
[24]RAMOS,SONIA,PRATAJ,BETTENCOURT P,et al.Depressionpredicts mortality and hespitalizationin heart failure: a six-years follow-up study[J].Journal of Affective Disorlers,2016,201:162.170.
[25]CELANO C M,VILLEGAS A C,ALBANESE A M,et al.Depression and anxiety in heart failure;a review[J].Harvard Review ofP sychiatry,2018,26：175-184.
