To systematically analyzed the reporting status of core elements in publicly available clinical practice guideline(hereafter referred to as "guideline") protocols published domestically and internationally over the past decade, identified existing problems, and provided evidence to inform the standardized writing and publication of future guideline protocols.

This study explores methodological issues in the design， evaluation， and reporting of randomized controlled trials （RCTs） under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design， the screening of research participants， the standardization of syndrome differentiation， the balance between intervention individualization and standardization， the integration of multi-dimensional outcome measures， and the limitations of existing evaluation and reporting tools when applied to this type of research， along with corresponding recommendations and future perspectives. Regarding research design， it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs， in order to innovate the design format of RCTs. Meanwhile， criteria for participant screening， TCM syndrome differentiation， and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization， and a multidimensional assessment system encompassing TCM syndromes， disease-specific outcomes， and patient-reported outcomes should be established. For risk of bias assessment and research reporting， it is recommended，to develop specialized assessment and reporting tools based on existing instruments， in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design， risk-of-bias assessment， and reporting quality assessment of RCTs based on the "syndrome dominating disease" model， with a particular focus on methodological optimization， data integration， and enhancement of research quality.

This study explores methodological issues in the design， evaluation， and reporting of randomized controlled trials （RCTs） under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design， the screening of research participants， the standardization of syndrome differentiation， the balance between intervention individualization and standardization， the integration of multi-dimensional outcome measures， and the limitations of existing evaluation and reporting tools when applied to this type of research， along with corresponding recommendations and future perspectives. Regarding research design， it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs， in order to innovate the design format of RCTs. Meanwhile， criteria for participant screening， TCM syndrome differentiation， and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization， and a multidimensional assessment system encompassing TCM syndromes， disease-specific outcomes， and patient-reported outcomes should be established. For risk of bias assessment and research reporting， it is recommended，to develop specialized assessment and reporting tools based on existing instruments， in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design， risk-of-bias assessment， and reporting quality assessment of RCTs based on the "syndrome dominating disease" model， with a particular focus on methodological optimization， data integration， and enhancement of research quality.

Lacticaseibacillus rhamnosus GG is one of the most studied probiotic strains，characterized by high acid resistance，high bile salt resistance，and strong adhesion.The main functions of Lacticaseibacillus rhamnosus GG include enhancing intestinal barrier function，inhibiting pathogen adhesion，regulating the body's immune system，which make it effective in treating and preventing gastrointestinal diseases in children and adults.This article reviewes the application research progress of Lacticaseibacillus rhamnosus GG in the treatment of common pediatric digestive system diseases such as necrotizing enterocolitis，infantile colic，non-alcoholic fatty liver disease，inflammatory bowel disease，antibiotic associated diarrhea，irritable bowel syndrome，and acute gastroenteritis in children.

Objective:To investigate the association of serum γ-glutamyltransferase (GGT) with stroke severity and outcome in patients with acute ischemic stroke (AIS).Methods:Patients with AIS admitted to the Department of Neurology, Hefei Second People's Hospital (Guangde Road Branch) from January 2023 to December 2023 were included retrospectively. According to the baseline National Institutes of Health Stroke Scale score, the patients were divided into mild stroke group (≤8) and moderate to severe stroke group (>8); According to the modified Rankin Scale score at 3 months after onset, the patients were divided into a good outcome group (0-2) and a poor outcome group (>2). Multivariate logistic regression analysis was used to determine the independent influencing factors of stroke severity and outcome, and the receiver operating characteristic (ROC) curve was used to evaluate the predictive value of serum GGT for poor outcome. Results:A total of 136 patients with AIS were included, with 42 patients (30.88%) in the mild stroke group and 94 (69.12%) in the moderate to severe stroke group; 80 patients (58.82%) in the good outcome group and 56 (41.18%) in the poor outcome group. Multivariate logistic regression analysis showed that higher serum GGT was an independent related factor for moderate to severe stroke (odds ratio [ OR] 1.075, 95% confidence interval [ CI] 1.017-1.135; P<0.05) and poor outcome ( OR 1.131, 95% CI 1.069-1.197; P<0.05). The ROC curve analysis showed that the area under the curve for predicting poor outcome by serum GGT was 0.820 (95% CI 0.747-0.892). Conclusion:Serum GGT is significantly correlated with the severity of stroke in patients with AIS, and has certain predictive value for poor short-term outcome.

Objective:Surgical site infection (SSI) is a common health care-related infection after gastrointestinal surgery. Once SSI occurs after surgery, it can significantly prolong the postoperative hospital stay, increase the cost burden of patients and society, and even endanger the life safety of patients. The purpose of this study was to investigate the clinical phenotypes of gastrointestinal surgery, identify the clinical characteristics of SSI, and provide reference for the prevention of SSI after gastrointestinal surgery.Methods:This is a multicenter prospective cohort study that collected clinical data from all adult patients undergoing gastrointestinal surgery from March 2021 to February 2022 at 42 hospitals in China, including baseline and perioperative characteristics. Based on the variables associated with SSI, latent class analysis (LCA) was used to explore the population characteristics of SSI.Results:In total, 16 087 patients were included in the study, of whom 345 (2.1%) developed SSI. LCA analysis revealed that patients undergoing gastrointestinal surgery were classified into four clinical phenotypes, including α (3851), β (1538), γ (6387), and δ (4311). Type α had minimal abnormality on related system functions (ASA score > 2: 4.5% [173/3851]), and mainly underwent appendix surgery (98.9% [3808/3851]). The postoperative SSI incidence of type α was 0.4% (16/3,851), which belonged to the group of SSI low risk. The abnormality of system functions of type β (ASA score > 2: 17.4% [268/1538]) was worse than that of type α. Type β mainly underwent stomach surgery (72.4% [1113/1538]), and its incidence of postoperative SSI was 1.2% (18/1538), belonging to the group of SSI medium risk. The ASA score of type γ (ASA score > 2: 18.0% [1148/6387]) was comparable to that of type β. Type γ mainly received colorectal surgery (colon surgery: 40.1% [2562/6387]; rectal surgery: 33.6%[2143/6387]), and its incidence of postoperative SSI was 1.7% (106/6387), belonging to the group of SSI medium risk. Type δ (ASA score > 2: 23.5%[1015/4311]) was the most serious type with the highest proportion of open surgery. Type δ mainly underwent small intestine (54.0%[2327/4311]) and stomach surgery (32.3% [1392/4311]) and had the highest incidence of SSI (4.8% [205/4311]) and the highest mortality rate (0.6% [24/4311]), belonging to the group of SSI high risk. Compared with type α and β, the median length of hospital stay (α, β, γ, and δ: 5.0 days, 9.6 days, 13.0 days, and 16.0 days, P<0.001) and postoperative hospital stay (α, β, γ, and δ: 4.0days, 6.0days, 8.3 days, and 10.0 days, P<0.001) of type γ and δ were significantly increased, and the median medical costs (α, β, γ, and δ: 14 178.7 yuan, 39 514.2 yuan, 62 893.0 yuan and 57 266.6 yuan, P<0.001) were also significantly increased. Conclusion:LCA analysis elucidated four clinical phenotypes of patients undergoing gastrointestinal surgery. Type α had a low risk of SSI. Type β and γ had a medium risk of SSI, and type δ had a high risk of SSI.

Objective:Surgical site infection (SSI) is a common health care-related infection after gastrointestinal surgery. Once SSI occurs after surgery, it can significantly prolong the postoperative hospital stay, increase the cost burden of patients and society, and even endanger the life safety of patients. The purpose of this study was to investigate the clinical phenotypes of gastrointestinal surgery, identify the clinical characteristics of SSI, and provide reference for the prevention of SSI after gastrointestinal surgery.Methods:This is a multicenter prospective cohort study that collected clinical data from all adult patients undergoing gastrointestinal surgery from March 2021 to February 2022 at 42 hospitals in China, including baseline and perioperative characteristics. Based on the variables associated with SSI, latent class analysis (LCA) was used to explore the population characteristics of SSI.Results:In total, 16 087 patients were included in the study, of whom 345 (2.1%) developed SSI. LCA analysis revealed that patients undergoing gastrointestinal surgery were classified into four clinical phenotypes, including α (3851), β (1538), γ (6387), and δ (4311). Type α had minimal abnormality on related system functions (ASA score > 2: 4.5% [173/3851]), and mainly underwent appendix surgery (98.9% [3808/3851]). The postoperative SSI incidence of type α was 0.4% (16/3,851), which belonged to the group of SSI low risk. The abnormality of system functions of type β (ASA score > 2: 17.4% [268/1538]) was worse than that of type α. Type β mainly underwent stomach surgery (72.4% [1113/1538]), and its incidence of postoperative SSI was 1.2% (18/1538), belonging to the group of SSI medium risk. The ASA score of type γ (ASA score > 2: 18.0% [1148/6387]) was comparable to that of type β. Type γ mainly received colorectal surgery (colon surgery: 40.1% [2562/6387]; rectal surgery: 33.6%[2143/6387]), and its incidence of postoperative SSI was 1.7% (106/6387), belonging to the group of SSI medium risk. Type δ (ASA score > 2: 23.5%[1015/4311]) was the most serious type with the highest proportion of open surgery. Type δ mainly underwent small intestine (54.0%[2327/4311]) and stomach surgery (32.3% [1392/4311]) and had the highest incidence of SSI (4.8% [205/4311]) and the highest mortality rate (0.6% [24/4311]), belonging to the group of SSI high risk. Compared with type α and β, the median length of hospital stay (α, β, γ, and δ: 5.0 days, 9.6 days, 13.0 days, and 16.0 days, P<0.001) and postoperative hospital stay (α, β, γ, and δ: 4.0days, 6.0days, 8.3 days, and 10.0 days, P<0.001) of type γ and δ were significantly increased, and the median medical costs (α, β, γ, and δ: 14 178.7 yuan, 39 514.2 yuan, 62 893.0 yuan and 57 266.6 yuan, P<0.001) were also significantly increased. Conclusion:LCA analysis elucidated four clinical phenotypes of patients undergoing gastrointestinal surgery. Type α had a low risk of SSI. Type β and γ had a medium risk of SSI, and type δ had a high risk of SSI.

  Objective  To analyze the current status of the development of adaptation guidelines in China, as well as their methodological quality and the reporting quality, in order to provide reference for the development of adaptation guidelines.  Methods  We searched and collected adaptation guidelines led by Chinese researchers or institutions from 2015 to 2023 from four electronic databases, China National Knowledge Infrastructure, WanFang Data Knowledge Service Platform, SinoMed and PubMed, extracted the basic information of the adapted guidelines, and assessed their methodological quality and reporting quality using the Appraisal of Guidelines for REsearch and Evaluation (AGREE) Ⅱ and RIGHT-Ad@pt tools.  Results  A total of 14 adaptation guidelines were included, mainly focusing on nursing (42.9%, 6/14), with the most frequently used adaptation method of ADAPTE (71.4%, 10/14), and with reference to pre-existing guidelines mainly from the United States, the United Kingdom, and international organizations. Assessment by the AGREE Ⅱ tool showed that the average methodological quality score of the adapted guidelines was 36.6%. The scores were relatively high in the domains of clarity of expression and rigor of formulation (44.4% and 54.9%), and lowest in the domain of applicability (15.3%). The results of the RIGHT-Ad@pt tool showed that the reporting quality of the adaptation guidelines was relatively good, with the highest reporting rate of 91.2% and the lowest of 35.3%, and the reporting rates of seven articles were higher than 70%.  Conclusions  Adaptation guidelines in China are still in their infancy, with a relatively small number and mainly focusing on the nursing field. The most commonly used adaptation method is the ADAPTE method. The methodological quality and reporting quality of adaptation guidelines need to be further improved, and more research should be conducted on the specific conditions and timing of adaptation guidelines development.

With the development of the Scientific, Transparent and Applicable Rankings tool for clinical practice guidelines(STAR), the publication of evaluation and ranking for scientificity, transparency and applicability of Chinese guidelines and consensus published in the medical journals in 2021and 2022, as well as the publication of the STAR evaluation and ranking for some specialities, the STAR evaluation and ranking has received widespread attention in the medical community. In order to further enhance its scientificity and transparency, Methodology and Technology Specialization Committee of the STAR Working Group presents this article to introduce sample identification and speciality assignment in the evaluation and ranking process.

National health standards involve all kinds of technical requirements formulated and numbered in accordance with the procedures and formats stipulated in the standardisation system for the implementation of national health and hygiene laws, regulations and policies, and the protection of human health. The establishment of health standards in China should align with our legal framework, including laws, regulations, departmental rules, and health and hygiene policies. During the development of these standards, a comprehensive approach is advocated, encompassing in-depth investigations, rigorous demonstrations, and extensive stakeholder engagement. However, the process of standard formulation may suffer from insufficient research evidence. The evidence-based concept emphasizes the significance of evidence. Therefore, integrating evidence-based concept into the process of developing health standards can enhance the quality and scientific basis of these standards. This article systematically elucidates the current status and development process of health standards in China, explores the necessity and feasibility of incorporating evidence-based concept into the development of these standards, analyzes the challenges and opportunities, and presents reflections and suggestions.