A systematic literature search and a comparative study were conducted to investigate the evolution of the levels of evidence and strength of recommendations in medical research. Fifty systems were included from 1979 to 2007, and 11 of these, which came from five states or international organizations, were selected and divided into three stages according to their characteristics, sphere of influence and application fields. Ideas about levels of evidence and strength of recommendations are becoming mature in medical research. The challenge for the future is how to introduce evidence-based principles and develop the corresponding levels of evidence and strength of recommendations in the fields of management, education, basic medical sciences, economics, sociology and legal research.
ObjectiveChinese practice guideline for therapeutic drug monitoring of vancomycin is the first therapeutic drug monitoring guideline in the framework of GRADE in China. The guideline panels met a recommendation consensus in December 21th, 2014 and finalized 14 recommendations. The aim of the current study was to assess the property of recommendations and revise them. MethodsWe commissioned an external review of recommendations by questionnaire. Physicians, clinical pharmacists and nurses above or equal to intermediate certificate were investigated for appreciations, clarity and feasibility of 14 recommendations as well as other suggestions about guideline. The guideline panels discussed the results and revised recommendations based on the result of external review. ResultsA total of 40 physicians, clinical pharmacist and nurses from 11 departments of 4 hospitals participated in the external review. The overall appreciation degree of recommendations was 70%, the overall clarity degree of recommendations was 88%, and the overall feasibility degree of recommendations was 70%. Among them, appreciation degree of 4 recommendations and feasibility degree of 5 recommendations were fewer than 50%. 165 subjective suggestions were received. After review of the results, the guideline panels reserved 6 recommendations while revised 8 (Deleted 4, combined 2 and improved 2). ConclusionOur external review is an exploration and attempt in the region of development of Chinese evidence-based practice guideline. More interest-related individuals are involved in the development of guideline. Clarity and feasibility of recommendations are ensured.
Research of generating real-world evidence using real world data has attracted considerable attention globally. Outcome research of treatment based on existing health and medical data or registries has become one of the most important topics. However, there exists certain confusions in this line of research on how to design and implement appropriate statistical analysis. Therefore, in the fourth chapter of the series technical guidance to develop real world evidence by China REal world data and studies Alliance (ChinaREAL), we aim to provide an guidance on statistical analysis in the study to assess therapeutic outcomes based on existing health and medical data or registries.In this chapter, we first emphasize the significance of pre-specified statistical analysis plan, recommending key components of the statistical analysis plan. We then summarize the issue of sample size calculation in this content and clarify the interpretation of statistical p-value. Secondly, we recommend procedures to be considered to tackle the issue related to the selection bias, information bias and most importantly, confounding bias. We discuss the multivariable regression analysis as well as the popular causal inference models. We also suggest that careful consideration should be made to deal with missing data in real-world databases. Finally, we list core content of the statistical report.
Acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) is one of the most common emergencies of the digestive system. With the continuous development of digestive endoscopy technology and widespread use of proton pump inhibitors, the morbidity and mortality of ANVUGIB have declined, but there are still numerous difficulties to be solved in clinical treatment. The International Consensus Group in 2019 updated the international consensus guideline in 2003 and 2010 with new clinical recommendations on fluid resuscitation, risk assessment, pre-endoscopic treatment, endoscopic treatment, drug therapy, and secondary prevention, etc. This paper interprets the update to provide references for the clinical treatment of ANVUGIB.
The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) published the first clinical practice guideline for sudden sensorineural hearing loss in 2012 and updated it in 2019. The guideline, which includes 13 expert consensus recommendations and treatment protocols, advocates medication (glucocorticoids are the sole optional medicine) and hyperbaric oxygen therapy. In order to provide references for the formulation of the guidelines for sudden sensorineural hearing loss that are more suitable for our national conditions, this article interprets the treatment regimens of the guideline.
Currently, there is a lack of clarity and standardization regarding the implementation details of interventions in traditional Chinese medicine clinical practice guidelines (CPGs). This in methodological guidance for standardizing the implementation prescription adversely impacts the quality of implementation and hinders the clinical application rate of recommendations. Through in-depth analysis of implementation prescription of evidence-based CPGs in traditional Chinese medicine, we identified the challenges associated with standardization. In response, we propose enhancing the technical specifications of implementation prescriptions, advocating for improved formulation processes, diverse reporting approaches, and standardizedological guidelines. These recommendations aim to serve as a methodological reference and guidance for clinical practice guideline developers.