The Study On The Process And Methods Of Development Of Clinical Pathway

Background From 2009,in order to strength the normalization and standardization of the clinical diagnostic and treating practice in Chinese hospitals,the National Health and Family Planning Commission have commissioned the Chinese Medical Association developing 1010 clinical pathways.However,the current handbooks or guidelines for development of clinical pathway in the world do not clearly report the process and methods of developing the handbooks and the key steps and important methods of developing the clinical pathway.In addition,there is a lack of systematic and comprehensive guideline for development of clinical pathway in China.Thus,these clinical pathways were developed without guiding by the scientific,transparent and rigor development handbook.Objective 1)To conduct a systematic review of the current guidelines for development of clinical pathway and the relevant methodological researches.2)To develop a process and comprehensive checklist for developing clinical pathway.3)Based on the process and comprehensive checklist we developed,to develop a clinical pathway of inguinal hernia.Methods We used two methods to develop the checklist,including: 1)systematic reviews of the current handbooks for development of clinical pathway and the relevant methodological studies,2)a face-to-face consensus conference for the initiative version of the process and comprehensive checklist developed from the results of the former systematic reviews.Results(1)21 handbooks for development of clinical pathway were included,of which 1)one(4.8%)reported the process of development of the handbook,2)14(66.7%)reported establishing the relevant working groups(mean of working groups was two,ranging from one to five),3)11(52.4%)reported selecting the topics or prioritizing the diseases,4)one(4.8%)reported the process and methods of collecting the specific clinical problems,5)six(28.6%)reported the evidence sources of clinical pathway which the styles included clinical pathway,clinical guideline,systematic review and randomized controlled trial,6)three(14.3%)reported rating the quality of evidence in clinical pathway,7)four(19.0%)reported the methods of consensus process,8)eight(38.1%)reported peer review,9)nine(42.9%)reported conducting a pilot trial before the informal implementation,10)eight(38.1%)reported the updating of clinical pathway.(2)30 methodological researches were included,of which 1)13(43.3%)focused on the methods of development of the certain diseases,2)nine(30%)focused on the methods of implementation of the clinical pathway of the certain diseases,3)four(13.3%)focused on the general methods of development of clinical pathway,4)three(10%)focused on the methods of consensus process,5)three(10%)focused on the evaluation of the evidence,6)three(10%)focused on the general methods of implementation,7)three(10%)focused on the reporting of clinical pathway.(3)Through the face-to-face consensus conference,we developed a process and comprehensive checklist for development of clinical pathway which the process included seven phases(18 steps)and the checklist included eight domains(43 items).Conclusion 1)The concept and methods of Evidence-Based Medicine have been introduced to the development of clinical pathway in some handbooks.However,most handbooks do not report the process of the development of them and the key steps and important methods of development of clinical pathway which lacks of operation and influences the practical value of the handbooks.2)The consent of the process and comprehensive checklist in this project are systematic and comprehensive,which include all the key steps and important methods,namely,priority of disease,organization and planning,collecting and detailing the specific clinical problem,collecting and evaluating the evidence,development and consensus of the options of clinical practice,reporting and peer-review,pilot trial of clinical pathway,implementation,monitoring and updating.