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.
ObjectiveTo investigate the recommendations on imaging diagnosis in Chinese clinical practice guidelines (CPGs). MethodsWe electronically searched WanFang Data, VIP, CNKI and CBM databases from inception to December 31, 2014. Two reviewers independently screened literature and extracted data. The method of bibliometrics was used to analyze the data (including basic characteristics, strength of recommendation, quality of evidence, etc.). ResultsA total of 341 CPGs formulating the recommendations on diagnosis were included. 48.7% (166/341) guidelines developed the recommendations on imaging diagnosis (a total of 534). 25.7% (137/534) recommendations were with the symbols of quality of evidence and strength of recommendation, and 18.9% (101/534) with special words such as recommend, suggest. 22.3% (119/534) recommendations reported the strength of recommendation. Of which, 38.7% (46/119) were strong and 16.0% (19/119) were weak. However, 23.9% (11/46) strong recommendations were based on low quality of evidence. And 42.1% (8/19) weak recommendations were based on high quality of evidence. ConclusionAmong Chinese CPGs formulating the recommendations on diagnosis, the number of CPGs with recommendations on imaging is about 50%. And the quantity increases by years. The proportions of recommendations on imaging which report the strength of recommendation and/or quality of evidence are low. Meanwhile, the rating systems are uniform. Then the developers do not report the explanation for the strong recommendations based on low quality of evidence or the weak recommendations based on high quality of evidence in guideline.
The formulation process of recommendations in evidence-based clinical practice guidelines was often complex and cumbersome. This paper described the evolution of levels of evidence and strength of recommendations in medical research and analyzed existing problems when making recommendations. We also summarized and introduced the method of formulating the final recommendation. At present, there isn’t a perfect and uniform method to guide the formulation of recommendations. But some organizations provided different content frameworks or auxiliary tools to guide formulation of recommendations. Developers of evidence-based clinical practice guidelines can learn from their experiences, combine with their own characteristics of guidelines such as specific target population and specific clinical situations, establish a rational method of recommendations formation.
Based on the charming quality theories and characteristics of hospital outpatient services in China, this paper defined and analyzed the quality of hospital services, and then made several corresponding recommendations for improving charming quality of outpatient services. The aim is to explore an effective way to tap the potential needs of the patients and to retain some loyal patients, under the impact of the hospital competitiveness.
With the development of evidence-based medicine, an increasing amount of clinical care experts are paying attention to recommendations in the guidelines and the application of guidelines in clinical nursing practice. The demand for clinical practice guidelines is becoming increasingly important. Based on characteristics of nursing, this paper focuses on primary steps in the formulation of nursing-clinical practice guideline, such as clinical problems, outcomes, nursing evidence retrieval and selection, evidence and recommendations classification, methods from evidence to recommendations, patients' preference and value, and provides suggestions for development of nursing-clinical practice guidelines.
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.
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.
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, the recommendations of the clinical practice guidelines related to acupuncture in China and abroad are opaque to the source of the acupuncture prescription, there is a lack of comprehensive evaluation of the rationality of the acupuncture prescription, and the standards for the selection of the acupuncture prescription are opaque and nonstandard, and the writing and reporting details are insufficient, thus affecting the clinical applicability of the guidelines. To a certain extent, the utilization rate of the recommendations of the guidelines is low. This paper discusses the origin, rationality comprehensive evaluation, priority selection, writing and reporting of acupuncture prescriptions, and puts forward detailed methodological suggestions, to provide guidance makers of methodological optimization thoughts and suggestions for the evaluation, selection and writing of acupuncture prescriptions in the recommendations.