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CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : Recommendations, explanation and elaboration.
Li, Jiang; Hu, Jia-Yuan; Zhai, Jing-Bo; Niu, Jun-Qiang; Kwong, Joey S W; Ge, Long; Li, Bo; Wang, Qi; Wang, Xiao-Qin; Wei, Dang; Tian, Jin-Hui; Ma, Bin; Yang, Ke-Hu; Dai, Min; Tian, Gui-Hua; Shang, Hong-Cai.
Afiliación
  • Li J; National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Hu JY; Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
  • Zhai JB; Tianjin University of Traditional Chinese Medicine, Tianjin, China.
  • Niu JQ; First Hospital of Lanzhou University, Lanzhou, China.
  • Kwong JSW; Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.
  • Ge L; Department of Medicine, McMaster University, Hamilton, Canada.
  • Li B; Beijing Institute of Traditional Chinese Medicine, Beijing, China.
  • Wang Q; Department of Medicine, McMaster University, Hamilton, Canada.
  • Wang XQ; Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
  • Wei D; Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden.
  • Tian JH; Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
  • Ma B; Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
  • Yang KH; Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
  • Dai M; National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Tian GH; Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China. Electronic address: rosetgh@163.com.
  • Shang HC; Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China; College of Integrated Traditional Chinese and Western Medicine, Hunan University of Chinese Medicine. Electronic address: shanghongcai@foxmail.com.
Complement Ther Med ; 46: 180-188, 2019 Oct.
Article en En | MEDLINE | ID: mdl-31519276
BACKGROUND: N-of-1 trial is a desired and appropriate approach to assessing the efficacy and safety of traditional Chinese medicine (TCM) interventions. There have been an increasing number of N-of-1 trials for TCM published. However, a lack of preferred reporting guidance led in the general poor reporting quality of these trials. Due to the unique characteristics of TCM, the working group developed this CONSORT Extension for reporting N-of-1 Trials for Traditional Chinese Medicine (CENT for TCM) to assist TCM researchers in reporting N-of-1 trials for TCM. METHODS: We registered CENT for TCM at the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network (available at equator-network.org). The development was a comprehensive process through collection of the initial reporting items, two-round scientific Delphi consensus survey with 17 panelists, revision and formation of the final reporting checklist. RESULTS: The checklist includes 25 items within six domains, eight items in which were extended and elaborated on the items of the CENT 2015 checklist. Explanation of the items were listed adequately considering the nature of TCM, introducing the concept of TCM syndrome differentiation and TCM interventions. CONCLUSIONS: CENT for TCM can be used to assess the completeness of the reporting of N-of-1 trials for TCM. The working group expect that CENT for TCM could be a practical tool to enhance the comprehensiveness and transparency of the design, implementation and reporting of N-of-1 trials for TCM.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Informe de Investigación / Medicina Tradicional China Tipo de estudio: Diagnostic_studies / Guideline Límite: Humans Idioma: En Revista: Complement Ther Med Asunto de la revista: TERAPIAS COMPLEMENTARES Año: 2019 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Informe de Investigación / Medicina Tradicional China Tipo de estudio: Diagnostic_studies / Guideline Límite: Humans Idioma: En Revista: Complement Ther Med Asunto de la revista: TERAPIAS COMPLEMENTARES Año: 2019 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido