Inherited retinal diseases (IRDs) are a group of severe retinal degenerative diseases leading to permanent visual impairment. IRDs are the major cause of irreversible blindness in children and working age groups. Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs, while, there are still risks in clinical research and application. How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment. However, there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy. Therefore, in order to standardize the perioperative management, the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience, so as to provide clinicians with reference and application in clinical research and practice.
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.
Objective To improve care and outcomes for all migraine suffers, the USHC created these evidence-based guidelines for migraine headache. Methods Firstly, 5 relative Technical reviews were done according to the Methods used in the AHCPR Technical Reviews. Secondly, based on the results of the 5 technical reviews, the 4 treatment guidelines were developed in direction of the USHC’S Methods used in developing clinical guidelines. Results Evidence supporting the acute treatment and preventive treatment were exclusively Class 1 studies, evidence supporting the diagnostic testing were either Class 2 or Class 3 studies , only very few expert judgment was given on some compelling issues without evidence. The recommendations they supporting were high-qualified, middle-qualified, and poor-qualified respectively. Conclusion This Evidence-Based Guidelines is one of the first and most extensive cooperative projects available for creating guidelines. The guideline was developed with systematical and scientific methods and stroven to base all of its recommendations on evidence.
Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2022 edition) has been published this year. The 2022 edition has been updated in the aspects of lung cancer screening, pathology, standards of thoracic surgery, treatment of metastatic lung cancer. In this study, we tried to introduce those updated aspects in the guideline of 2022 edition.
ObjectivesTo evaluate the reporting status of conflict of interest and economic evidence in Chinese clinical practice guidelines published in 2017 and to provide implications for the guideline development in China.MethodsCNKI, WanFang Data and Google Scholar were electronically searched to collect clinical practice guidelines published in 2017 from January 1st to December 31st, 2017. Two authors independently screened literature, extracted information of interest, such as conflict of interest disclosure and economic evidences, then, the analysis was performed by using the Microsoft Excel 20013 software.ResultsA total of 53 guidelines were included; in which, 14 (26.42%) disclosed conflict of interest, 10 (18.87%) stated sources of funding, and 6 (11.32%) mentioned economics evidence.ConclusionIn China, inadequate attention is addressed to the conflict of interest disclosure and economics evidence during the development of clinical practice guidelines. We propose the inclusion of conflict of interest and economics evidence disclosure in clinical practice guidelines, which will improve their objectivity, independence, and transparency.
A lot of evidence-based medical evidence has shown that laparoscopic Roux-en-Y gastric bypass (LRYGB) is a durable and effective method for obesity and diabetes, and can significantly improve a series of obesity-related metabolic complications. This guideline provides a detailed description of the main operating steps and technical points of the symmetric three-port LRYGB, including posture layout, trocar position selection, liver suspension, gauze exposure, production of small gastric sacs, gastrojejunal anastomosis and production of biliary pancreatic branches, entero-enteric side to side anastomosis, closure of gastrointestinal anastomosis and mesenteric hiatus, greater omentum coverage, and closure of incisions. The purpose is to standardize the operating process of the symmetrical three hole method of LRYGB, providing standardized surgical operation references for clinical doctors in the field of obesity metabolic surgery.
ObjectivesTo systematically review the necessary factors of questionnaires design on patients' values and preferences in order to provide information on the most appropriate questionnaires when developing clinical practice guidelines.MethodsA systematic literature search of PubMed, EMbase, The Cochrane Library, CBM, CNKI and WanFang Data databases was performed to identify studies on questionnaires evaluating patient values and preferences. The authors included the articles that used fully structured questionnaires or scales with standardized questions and answer options. We assessed the questionnaires' construction with psychometric methodology and summarized the necessary factors on patients' preferences and values into the domains and items.ResultsTwenty articles were eventually included. Five out of 20 studies (25%, 5/20) described the process of item generation while merely one questionnaire (5%, 1/20) mentioned pilot testing. Regarding validity, there were 6 questionnaires (30%, 6/20) that assessed validity. For acceptability, the time taken to complete the questionnaires range from 10 to 30 minutes and only 6 studies reported response rates. The results showed that the factors affecting the design of questionnaires on patients' values and preference were related to the effectiveness, safety, prognostic factors and others. The main factors were the effects, side effects and risk of complications, risk of relapse and the cost of treatments.ConclusionsOnly a few studies have developed questionnaires with rigorous psychometric methods to measure patients' preference and values. There is still no valid or reliable questionnaires for patients' preference and values when developing clinical practice guidelines. Further study should be conducted to develop standardized instruments to measure patients' preference and values. It is suggested that the factors this study provides can be used in formulating questionnaires on patients' preference and values.
ObjectivesTo summarize and compare the operative mechanisms of the most representative comprehensive clinical practice guideline (CPG) databases worldwide, so as to provide references for establishing and managing Chinese CPG database.MethodsCPG databases were collected worldwide by discussing with experts in the guideline and database fields. Studies on guideline databases were searched in PubMed and CNKI to further collect CPG databases mentioned in these studies. Representative comprehensive guideline databases were finally selected by consulting relevant guideline experts. The institutions’ names of establishing and managing CPG databases, funding sources, human resources, aims, quality control measures (including CPG inclusion and updating criteria) were extracted and summarized. Databases were divided into government-led, society-led, and enterprise-led models. A descriptive analysis was conducted.ResultsThere were four government-led databases, four society-led databases and merely one enterprise-led database. The institutions of establishing CPG databases were same as the institutions of managing databases in the seven databases. All CPG databases had set up offices, seven of which were located in the capital. Most databases’ funds came from the government. Four databases implemented board management. According to the division of functions, members involved in establishing and managing CPG databases mainly included leaders, expert teams, managerial personnel, secretaries, web developers, and patient representatives. Criteria for inclusion of CPG were relevant to the purpose of establishing databases. Most databases required guidelines that had be updated within three to five years.ConclusionsThis study provides comprehensive information on operative mechanism of different CPG databases which can assist guideline database builders to optimize their operative mechanism.
ObjectiveTo adapt existing clinical practice guidelines to the management of medication adherence to highly active antiretroviral therapy (HAART) in China, so as to provide evidence to support the development of practice guidelines that meet China's actual conditions. MethodsAccording to ADAPTE methodology and status of HAART in China, we searched, appraised, selected and adapted current clinical practice guidelines on the management of medication adherence to HAART. ResultsA total of 10 guidelines were included, and the final clinical practice guidelines for the management of medication adherence to HAART involved 3 aspects, including influential factors, assessment methods, and interventions. High quality evidence resources had been formed, and the quality of final clinical practice guidelines was higher. ConclusionIt is feasible to develop clinical practice guidelines according to the ADAPTE method, and reliable evidence support has been provided for the development of clinical practice guidelines based on guideline adaption.
ObjectiveTo evaluate the quality of guidelines for the management of delirium in adult patients in the last ten years, so as to provide references for updating, selection, implementation guidelines and delirium management optimization.MethodsWe searched guidelines from databases including PubMed, EMbase, WanFang Data and CNKI, and websites of guidelines from January 1st 2010 to September 1st 2019. Guidelines were comprehensively screened, evaluated based on AGREE Ⅱ and data was independently extracted by two researchers.ResultsGuidelines of NICE, RNAO and SIGN had higher scores, while CSCCM’s and IPS’s gained lower. Among domains of AGREE Ⅱ, Domain I (scope and purpose) and IV (clarity of presentation) scored the highest, with a minimum of Domain Ⅱ (stakeholder involvement) and V (applicability). Delirium management focused on screening, prediction, prevention and treatment both pharmacologically and non-pharmacologically, and information support.ConclusionsFuture development of delirium guidelines should follow the methodology of guideline development, update or adjustment, and dedicate to every domain, especially domain of application. Medical staffs can establish our own domestic guidelines based on high quality guidelines, to promote knowledge translation and delirium management.