Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
ObjectivesTo assess the methodological quality of clinical practice guidelines of cervical cancer in China published from 2014 to 2018.MethodsCNKI, WanFang Data, CBM, VIP, Medlive.cn, the National Guideline Clearinghouse, PubMed, The Cochrane Library and EMbase were searched for cervical cancer clinical practice guidelines published in China from January 1st, 2014 to December 31st, 2018. Four reviewers searched and selected the literature independently according to the inclusion and exclusion criteria and assessed the methodological quality of the included guidelines by using AGREE Ⅱ.ResultsA total of 9 guidelines were included. The average score for each area was: scope and purpose 75.47%, stakeholders’ involvement 35.09%, the rigor of development 43.70%, clarity of presentation 87.74%, applicability 80.76%, and editorial independence 0%.ConclusionsThe quality of cervical cancer clinical practice guidelines in China requires further improvement.
Clinical practice guidelines are decision-making tools for bridging the gap between current best evidence and clinical practice. Studies have shown poor clinical applicability of existing guidelines, which may not be solved by improving the quality of guidelines alone. National medical management service guidance center is developing clinical practice guidelines of clinical evaluation system of construction projects, based on evidence-based method formulated by the target users of clinical guidelines evaluators’ applicability evaluation system of clinical practice guidelines. It aims to identify guidelines with high clinical applicability and provide the evaluation results of clinical applicability to developers and revisers of clinical guidelines, and then optimize the development and update, eventually improving the clinical applicability of guides and promote Chinese clinical guidelines in clinical application.
Massive cerebral infarction with malignant brain edema has poor prognosis with very high mortality, despite aggressive medical treatment. Surgical decompression is recommended by Chinese and international clinical guidelines for patients with massive cerebral infarction, however, there is no standardized diagnosis and treatment protocol in clinical practice. Following the principle of evidence-based medicine and based on the diagnosis and treatment norms of the participating hospitals of Severe Ischaemic Stroke Collaboration in recent years, we recommend this consensus statement of the standardized surgical decompression for malignant brain edema in massive cerebral infarction.
Objectives To assess the quality of clinical practice guidelines for primary hepatic carcinoma published in 2016 and 2017 in China. Methods CNKI, WanFang Data, CBM and VIP databases were searched for clinical practice guidelines for primary hepatic carcinoma in China. The search date was from Jan. 1st, 2016 to Jan. 1st, 2018. Four researchers independently selected literatures and extracted data according to the inclusion and exclusion criteria. The Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) was utilized to assess the methodological quality of the guidelines. Results A total of 7 guidelines were included. The average scores of six domains for these guidelines were: 65.1% for scope and purpose, 39.4% for stakeholders’ involvement, 64.3% for rigor of development, 55.6% for clarity of presentation, 61.8% for applicability and 6.1% for editorial independence. Conclusions The quality of clinical practice guidelines for primary hepatic carcinoma in China is relative high, of which the recommendations are of great value in clinical practice, yet still required to be improved in some ways.
In 2014, The International Diabetes Federation (IDF), American Diabetes Association (ADA), International Society for Paediatric and Adolescent Diabetes (ISPAD), and Chinese Diabetes Society (CDS) published several guidelines and consensuses in the clinical diagnosis, treatment and comprehensive management of diabetes mellitus. In addition, guidelines and consensuses published by the American Stroke Association (ASA), American National Lipid Association (ANLA), Chinese Society for Metabolic & Bariatric Surgery (CSMB) and European Association for the Study of Obesity (EASO) also included some contents related to the management and control of diabetes mellitus. In order to further strengthen the clinical management and treatment of diabetes mellitus, this paper reviewed the important advantages of clinical practice guidelines and consensuses published in 2014 in the field of diabetes mellitus.
Objective To evaluate quality and current status of traditional Chinese medicine (TCM) guidelines and consensus, and to promote the improvements in the quality of guidelines and consensus. Methods A systematic collection of TCM guidelines and consensus published in medical journals in 2022 was conducted. We used scientific, transparent, and applicable ranking tools (STAR) for evaluation, analyzed the scoring rates (%), and assessed the quality level and influencing factors of guidelines and consensus through methods such as comparison and stratification. Results A total of 130 TCM guidelines and consensus were included. Guideline areas with higher scores included recommendations (65.3%), evidence (55.9%), and guideline development groups (54.2%). In the case of consensus, higher scores were observed in recommendations (38.7%), guideline development groups (37.0%), and funding (30.0%). The total score rate of TCM guidelines exceeded that of national guidelines, while the consensus rate was lower. Stratified analysis revealed statistical differences in guideline score rates among journals and issuing institutions, as well as significant differences in consensus score rates among journals, formulation institutions, subjects, and funding categories. Conclusion The quantity and quality of TCM guidelines and consensus are on a positive trajectory, with higher quality levels in guidelines than in consensus. The overall quality of TCM guidelines surpasses that of national guidelines, particularly emphasizing the scientificity of guideline formulation. However, the overall quality of consensus remains lower than that of the national consensus. Factors such as journals, formulation institutions, subjects, and funding categories are identified as potential influences on the quality of TCM guidelines and consensus.
Nausea and vomiting are common side effects of anti cancer drug therapy, and significantly impact patient quality of life and treatment efficacy. Timely and effective prevention and management of these symptoms are crucial. In consideration of the healthcare situation in Sichuan province and relevant research findings, we have updated the "Expert consensus on the prevention and treatment of anti cancer drug induced nausea and vomiting of Sichuan province (2024)". This consensus aims to provide clinicians with professional advice and guidance tailored to the conditions in Sichuan province.
Infiltrative optic neuropathy (ION) is characterized by the infiltration of tumor cells or inflammatory cells in the optic nerve and its sheath. ION is rare in clinic practice, and ION caused by direct infiltration or metastasis of malignant tumors is easily misdiagnosed as optic perineuritis or optic neuritis, which means delayed proper treatment and makes patients risking possible side effects of steroid therapy. Currently, ophthalmologists are lack of sufficient knowledge about ION, which contributes to the high rate of misdiagnosis and missed diagnosis of ION in clinical practice. The diagnosis and treatment of ION have not yet formed systematic standardized guidelines. Therefore, Neuro-ophthalmology Group of Ophthalmology Branch of Chinese Medical Association organized experts to propose consenus of opinions on definition, diagnosis and treatment of ION, which helps to guide clinical diagnosis and treatment of ION, as well as basic researches about ION.
Laparoscopy has become a commonly used approach to diagnosis and treatment of acute abdomen, and it has good diagnostic value and therapeutic effect in selective cases. It should be practiced by experienced surgeons in laparoscopic surgery and emergency abdominal surgery. Hemodynamic instability, severe abdominal distension, fecal peritonitis, and tumor perforation are contraindications to laparoscopy. In recent years, more and more acute abdominal diseases can be successfully treated by laparoscopy. Randomized controlled trials have proved the laparoscopic treatment in acute appendicitis, acute cholecystitis, peptic ulcer perforation, acute gynecological diseases was comparable to open surgery, and had advantages of fewer complications and faster postoperative recovery. The utilization of laparoscopy in other diseases such as blunt and penetrating abdominal trauma, small intestinal obstruction, and diverticulitis with perforation remains controversial, and needs more randomized controlled trials to investigate the feasibility of laparoscopic surgery.
