Hemorrhoids, as one of the highest clinical incidence of anorectal diseases, has been widely paid attention to by the medical community. In recent years, with the increase of urban population, people's work pressure and accelerated pace of life, the incidence of hemorrhoids is getting higher and higher. The clinical symptoms such as pain and bleeding seriously affect the quality of life of patients, so the research on the pathogenesis and treatment of hemorrhoids has never stopped. There are various treatment methods for hemorrhoids, including oral administration of traditional Chinese medicine decoction, fumigation of traditional Chinese medicine, Chinese patent medicine, acupuncture, plaster to anus, suppository to anus, internal hemorrhoidal ligation, external hemorrhoidal ligation, automatic hemorrhoidal ligation, hemorrhoidal mucosa resection and so on. Traditional Chinese medicine plays an important role in the treatment of hemorrhoids. Core Outcome Set (COS) refers to the minimum set of outcomes that should be reported in clinical research of a specific disease or health field. The purpose of this study is to develop a core outcome set (COS) for future research on the treatment of hemorrhoids by traditional Chinese medicine, in order to solve the pain of patients and improve the quality of life, and to provide reference and ideas for the majority of researchers in the later period. We will search six databases and two registries to screen and extract indicators of postoperative care outcomes for patients with hemorrhoids reported in randomized controlled trials, meta-analyses, and systematic reviews. Semi-structured interviews were also conducted with doctors, nurses and patients to gather their opinions on important outcomes. Finally, a relatively complete list of results was generated and two rounds of international Delphi surveys were conducted for each result. A consensus was reached through the expert consensus meeting to form a set of COS for the effect of traditional Chinese medicine on hemorrhoids.
ContributorsLi Yanming, School of Nursing, Gansu University of Traditional Chinese Medicine, Center for Evidence-Based Medicine, Lanzhou University; (principal investigator)
Ma Xiaoting, School of Nursing, Gansu University of Traditional Chinese Medicine; (principal investigator)
Hu Zhiruo, School of Nursing, Gansu University of Traditional Chinese Medicine, Center for Evidence-Based Medicine, Lanzhou University;
Xiaoyun Zhao, School of Nursing, Gansu University of Traditional Chinese Medicine, Center for Evidence-Based Medicine, Lanzhou University;
Zhang Mingyue, School of Basic Medicine, Center for Evidence-Based Medicine, Lanzhou University;
Caihua Xu, School of Basic Medicine, Center for Evidence-Based Medicine, Lanzhou University;
Li Yiyi, School of Nursing, Gansu University of Traditional Chinese Medicine, Center for Evidence-Based Medicine, Lanzhou University;
Tengfei Li, School of Nursing, Gansu University of Traditional Chinese Medicine, Center for Evidence-Based Medicine, Lanzhou University;
Zhou Yongjia, School of Nursing, Gansu University of Traditional Chinese Medicine, Center for Evidence-Based Medicine, Lanzhou University;
Zhang Jun, School of Basic Medicine, Center for Evidence-Based Medicine, Lanzhou University; (principal investigator)
Jinhui Tian, Center for Evidence-Based Medicine, Lanzhou University, School of Basic Medicine.(principal investigator, )
Disease Category: Gastroenterology
Disease Name: hemorrhoids
Age Range: 18 - 70
Sex: Either
Nature of Intervention: Drug, Traditional Chinese Medicine
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Delphi process
- Literature review
- Semi structured discussion
- Survey
- Systematic review
Our team consists of anorectal specialists, anorectal clinicians, anorectal specialist nurses, hemorrhoid patients and methodologists. We will search six databases and two registries to screen and extract outcome indicators of traditional Chinese medicine treatment and care of hemorrhoids reported in randomized controlled trials, meta-analyses, and systematic reviews. Semi-structured interviews were also conducted with doctors, nurses and patients to gather their opinions on important outcomes. Finally, a relatively complete list of outcome indicators was compiled and two rounds of international Delphi surveys were conducted for each outcome indicator. A consensus was reached through the expert consensus meeting, the main outcome indicators were reached, and finally a set of COS for treating and nursing hemorrhoids with traditional Chinese medicine was formed.