Developing a core outcome set on traditional Chinese medicine (COS-TCM) for chronic heart failure (CHF): a study protocol

Zhang, Mingyan; Chua, Hui Zi; Zhang, Junhua; Niu, Bohan; Wang, Zheng; Li, Kai; Zhang, Boli

doi:10.1136/bmjopen-2020-047148

“…Chronic heart failure (CHF) refers to chronic primary cardiomyopathy and ventricular overload due to long-term pressure or volume, which weakens myocardial contractility and cannot maintain cardiac output [ 1 ]. It is appropriate in left heart failure, right heart failure, and total heart failure.…”

Section: Introductionmentioning

confidence: 99%

Effect of ICD/CRT-D Implantation on Adverse Events and Readmission Rate in Patients with Chronic Heart Failure (CHF)

Liu

¹

,

Xing

²

2022

Computational and Mathematical Methods in Medicine

View full text Add to dashboard Cite

Objective. To explore the effect of implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) implantation on adverse events and the readmission rate in patients with chronic heart failure (CHF). Methods. Sixty patients with CHF treated in our hospital from April 2019 to July 2021 were enrolled. The patients were randomly assigned into the control group and study group. The control group received routine intervention, and the study group received remote management with ICD/CRT-D implantation. Results. First of all, we compared the general data of the two groups. There was no significant difference in LVEF, NYHA grade, concomitant disease, and history of arrhythmia ( P > 0.05 ). Secondly, we compared the end-point events. In the study group, 5 cases of heart failure were readmitted, 0 cases died, and 4 cases were admitted to hospital with arrhythmia and ICD events, with a total incidence of 30.0%, while in the control group, 12 cases were rehospitalized with heart failure, 3 cases died, 25 cases were admitted with arrhythmia and ICD events, and the total incidence rate was 56.67% ( P < 0.05 ). In terms of the readmission rate of patients with heart failure in grade NYHAII and grade III, among the patients with grade NYHAII, the number of patients with heart failure less than once in the study group was higher compared to that in the control group and the number of patients with heart failure ≥ once in the study group was lower compared to that in the control group ( P < 0.05 ). Among the patients with grade NYHAIII, the number of patients with heart failure less than once in the study group was higher compared to that in the control group and the number of patients with heart failure ≥ once in the study group was lower compared to that in the control group. There exhibited no significant difference in the data ( P > 0.05 ). Considering the occurrence of VT and VF events, the study team reported that 14 patients recorded a total of 276 ventricular arrhythmias: 261 ventricular tachycardia and 15 ventricular fibrillations. Among them, 24 VT (9.2%) and 4 VF (26.7%) were determined to be misrecognition of the equipment. A total of 178 ventricular arrhythmias were recorded in 13 patients in the control group, including 152 ventricular tachycardia and 26 ventricular fibrillations. Among them, 10 VT (6.6%) and 8 VF (30.8%) were determined as misrecognition of the device. In regard to the treatment results of the two groups, after admission to the hospital for radio frequency, ablation, and adjustment of drug treatment to reprogram control, the patients did not reappear to have CRT-D misidentification and misdischarged. Finally, we compared the diagnosis time of VT/VE events. The time from VT/VE events to diagnosis in 14 patients in the study group was 2.55 ± 1.41 days, and that in 13 patients in the control group was 37.32 ± 15.31 days. The discovery of ICD events in the study group was significantly earlier compared to that in the routine follow-up group ( P < 0.05 ). This gives doctors enough time to assess the patient’s condition and determine a further diagnosis and treatment plan. Conclusion. Using ICD/CRT-D implantation to remotely monitor patients with CHF, through remote monitoring of the 24-hour average heart rate and the heart rate at rest and patient activity and other parameters and early intervention, the readmission rate caused by the deterioration of heart failure can be reduced. Compared with routine follow-up, remote monitoring significantly reduced the diagnosis time of VT/VE events.

show abstract

“…Any disagreements will be resolved through discussion after a thorough reading of the paper or by consulting with the third researcher. An extraction table will be designed by the working group to collect relevant information on the study design, setting, demographics of participants, types of intervention, and outcomes [ 21 ]. Data extracted on the outcomes reported will include the name, definition, measurement time points, and measurement instruments or methods.…”

Section: Methodsmentioning

confidence: 99%

Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys

Zhang¹,

Chen

²

,

Niu

³

et al. 2022

Trials

View full text Add to dashboard Cite

Background Neurogenic bladder (NGB) is a chronic and disabling condition with a high prevalence rate, which can cause economic burden on patients and their families and reduce the quality of life of patients. Researchers have carried out a large number of clinical trials on the effectiveness and safety of different interventions for the treatment of NGB. The published clinical trials of NGB generally suffered from inconsistent and irregular reporting of outcome indicators. To facilitate future research studies of NGB, a core outcome set (COS) is required, which helps translate the results into high-quality evidence. Methods and analysis This mixed-method project has four phases instrument: in phase 1, a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of clinical trials of interventions for NGB; in phase 2, a qualitative component using interviews to obtain the views of NGB patients, families, and their caregivers; in phase 3, Delphi survey among stakeholders to prioritize the core outcomes; and in phase 4, a face-to-face consensus meeting to discuss and agree on the final NBG COS. Conclusions We will develop a COS that should be reported in future clinical trials of NGB. Trial registration Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1985. Registered on 02 January 2022. INPLASY INPLASY202210007

show abstract

“…Following the experience of semistructured interviews in prior COS research,34 35 simple samplings will be used to recruit at least 40 patients. We will consider each patient’s gender, age and treatment history.…”

Section: Stage 1: Identification Of Preliminary Outcomesmentioning

confidence: 99%

Development of a core outcome set on Traditional Chinese Medicine andWestern Medicinefor rheumatic heart disease: a study protocol

Sheng

¹

,

Chen²,

Ji³

et al. 2022

View full text Add to dashboard Cite

IntroductionGlobally, rheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents. Clinical trials on RHD treatment with Traditional Chinese Medicine (TCM) or integrated medicine are gradually increasing in China. However, because the outcomes of clinical trials are subject to heterogeneity and selective reporting, similar studies cannot be merged and compared, complicating assessing the effectiveness and safety of TCM, and diminishing the value of clinical trials. Therefore, there is an urgent need to design a TCM or integrated medicine core outcome set (COS) for RHD.Methods and analysisThe development of this study will take place in four stages under the direction of a multidisciplinary advisory board. (1) Establishing a comprehensive outcomes checklist through a systematic review of previously published research, retrieval of clinical trial registration centres, patient’s semistructured interviews, and clinician’s questionnaire surveys; (2) Screen stakeholder groups from various fields to participate in the Delphi survey; (3) Two e-Delphi surveys will be conducted to determine the outcomes of various concerned stakeholder groups; (4) Hold a face-to-face consensus meeting to develop the COS-TCM-RHD.Ethics and disseminationThe ethical approval for this study has been obtained from the Tianjin University of Traditional Chinese Medicine Ethics Committee (TJUTCM-EC20210008). The findings will be disseminated in peer-reviewed journals and meetings.Trial registration numberThis study has been registered at the Core Outcome Measures in Effectiveness Trials (COMET) database (Registration #1743).

show abstract

Developing a core outcome set on traditional Chinese medicine (COS-TCM) for chronic heart failure (CHF): a study protocol

Cited by 11 publications

References 26 publications

Effect of ICD/CRT-D Implantation on Adverse Events and Readmission Rate in Patients with Chronic Heart Failure (CHF)

Effect of ICD/CRT-D Implantation on Adverse Events and Readmission Rate in Patients with Chronic Heart Failure (CHF)

Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys

Development of a core outcome set on Traditional Chinese Medicine andWestern Medicinefor rheumatic heart disease: a study protocol

Contact Info

Product

Resources

About