High-quality randomized controlled trials are the best source of evidence to explain the relationship between health interventions and outcomes. However, in cases where they are insufficient, indirect, or inappropriate, researchers may need to include non-randomized studies of interventions to strengthen the evidence body and improve the certainty (quality) of evidence. The latest research from the GRADE working group provides a way for researchers to integrate randomized and non-randomized evidence. The present paper introduced the relevant methods to provide guidance for systematic reviewers, health technology assessors, and guideline developers.
With the rapid development of medicine and the emergence of new evidence, the formulation of living guidelines is significant in guiding clinical practice and providing timely and effective references for clinical workers. This article summarizes the status of living guidelines, and puts forward thoughts and suggestions on the challenges and opportunities of the development of living guidelines, in order to promote the development of living guidelines and provide a reference for guideline developers and users.
Previous methods of grading evidence for systematic reviews of diagnostic test accuracy have generally focused on assessing the certainty (quality) of evidence at the level of diagnostic indicators. When the question is not limited to follow the diagnostic test accuracy results themselves, the grading results may be inaccurate due to the lack of consideration of the downstream effects of the test accuracy in specific settings. To address these challenges, the GRADE working group conducted a series of studies focused on updating methods to explore or simulate important downstream effects of diagnostic test accuracy outcomes within a contextual framework. This paper aimed to introduce advances in the contextual framework of the GRADE approach to rate the certainty of evidence from systematic reviews of single diagnostic test accuracy.
ObjectiveTo develop a survey questionnaire on preferences and values regarding perineal injury prevention measures during pregnancy and conduct reliability and validity tests. MethodsCombining literature reviews, qualitative interviews, and expert consultations, we summarized key elements of perineal injury prevention during pregnancy and synthesized the best evidence. Through multiple discussions within the core working group, a survey questionnaire on preferences and values regarding perineal injury prevention measures during pregnancy was formulated. Using convenience sampling, pregnant women were recruited, and a pre-survey was conducted using the questionnaire. Pre-survey results were analyzed using item analysis and reliability and validity testing methods to validate and refine the questionnaire. ResultsThe questionnaire was compiled based on the theory of evidence-based decision-making. The initial version of the questionnaire was developed by combining systematic evaluation, network meta-analysis, and semi-structured interviews. The questionnaire was modified and improved through expert consultation, group discussion, and pre-investigation, which ensured that the questionnaire had good reliability, validity, and practicability. The Cronbach's α coefficient was 0.87, the split-half reliability was 0.71, and the content validity index was 0.97 of the survey questionnaire. ConclusionThe present version of the perineal injury preventive measures preference and values questionnaire has good reliability, validity, and practicability. It can serve as a valuable tool for investigating preferences and values related to perineal injury prevention during pregnancy.
By comparing the diagnostic accuracy of two or more tests in the same study, the one with the higher diagnostic accuracy can be screened. Therefore, it is extremely important to conduct the comparative diagnostic test accuracy study. This paper introduced the concept of the comparative diagnostic test accuracy study, compared it with single diagnostic test accuracy study, and described its role, study design, statistical analysis, current status, and challenges.
Network meta-analysis (NMA) is a method that can compare and rank the effects of different interventions, which plays an important role in evidence translation and evidence-based decision-making. In 2014, the GRADE working group first introduced the GRADE method for NMA evidence certainty grading. Since then, its method system has been gradually supplemented and improved. In recent years, the GRADE working group has further improved the methods for evaluating intransitivity and imprecision in NMA, and has made recommendations for the presentation and interpretation of NMA results, forming a complete methodological chain of NMA evidence certainty grading and result interpretation consisting of 6 steps. Our team updated the method system of GRADE applied in NMA with specific cases to provide references for relevant researchers.
Rapid, living evidence-based points, as a new model promoting the rapid translation of evidence, aim to integrate the current best evidence, clinical status, public/patient preferences and values, and provide concise and practical guidance rapidly to important questions concerned in clinical medicine and public health. This paper introduces the methodological framework for the development of "Rapid, Living Evidence-Based Points" from 4 aspects: initiation and planning, evidence search and review, development, update, publication and dissemination of evidence-based points, in order to provide a reference for domestic scholars in developing rapid, living evidence-based points.
ObjectiveIn order to summarize the best evidence, evaluate the efficacy and safety of interventions for the treatment of COVID-19, and provide practical guidance for medical workers, public health workers, and COVID-19 patients, we formulated the evidence-based practice points. MethodsWe followed the "Evidence-based practice points: methods and processes of development", with comprehensively considering the pros and cons of evidence, quality of evidence, public and patient preferences and values, cost of interventions, acceptability, and feasibility based on systematic reviews. Practice points Finally, 12 practice points were formed for non-severe, severe and critical COVID-19 patients. Non-severe: ① Consider Hanshiyi formula or Gegenqinlian pills for patients with nausea, vomiting and diarrhea; ② Consider Huashibaidu granules (decoration), Jinyinhua oral liquid, Jinhuaqinggan granules, Xuanfeibaidu granules (decoration), Lianhuaqingwen capsules (granules), or Reyanning mixture for patients with sore throat, fever, muscle aches or cough; ③ Consider Qingfeipaidu granules (decoration) for patients with nasal congestion, runny nose, cough, low-grade fever, aversion to wind and cold, and fatigue; ④ Consider Toujiequwen granules for patients with fever, chills, itchy throat, cough, dry mouth and throat, and constipation; ⑤ Consider Reduning injection or Xiyanping injection for patients with high fever, mild aversion to wind and cold, headache and body pain, cough, and yellow phlegm; ⑥ Consider molnupiravir, nirmatrelvir–ritonavir (Paxlovid), remdesivir or VV116 for patients within 5 to 7 days of the onset of symptoms and at high risk for progressing to severe disease. Severe: ① Consider Shenhuang granules or Xuebijing injection for patients with high fever, irritability, and thirst; ② Consider remdesivir used as soon as possible for patients with severe symptoms. Critical severe: Consider corticosteroids, IL-6 receptor inhibitors, and baricitinib for patients 7 days after the onset of symptoms.