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.
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.
Ovarian cancer is one of the common malignant tumors of female genital organs. In gynecological tumors, the incidence rate of ovarian cancer ranks the third after cervical cancer and uterine body cancer, but the death rate of ovarian cancer ranks the first, posing a serious threat to women’s life and health. In recent years, the National Comprehensive Cancer Network (NCCN) clinical practice guidelines for ovarian cancer has become an important basis for diagnosis and treatment of ovarian cancer. In this paper, we interpret the latest version (version 4. 2017) of NCCN clinical practice guidelines for ovarian cancer for its better clinical application.
This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations.
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.
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.
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
Spine is a common site of metastasis in patients with malignant tumors, and tumor metastasis to the spine can lead to pain, pathological fractures, and nerve compression. In order to optimize the diagnosis and management of patients with spinal metastases and metastatic spinal cord compression (MSCC), the National Institute for Health and Care Excellence (NICE) in the UK proposed the first diagnostic and treatment guidelines for patients with MSCC (or at risk of MSCC) in 2008. In recent years, with the rapid advancement of spinal surgery and radiotherapy technology, the standardized process of MSCC diagnosis and treatment urgently needs to be updated. In 2023, NICE launched new guidelines for spinal metastases and MSCC. Based on a thorough study of the guidelines, this article discusses and interprets pain management, corticosteroid treatment, application of bisphosphonates and denosumab, tools for assessing spinal stability and prognosis, radiation therapy, surgical timing and approach, etc., providing reference for clinical diagnosis and treatment in China.
Evidence grading and recommendation strength assessment are key steps in the development of evidence-based guidelines, and have made significant progress in recent years. This article systematically reviews the development and evolution of evidence grading and recommendation strength in the past 30 years, and introduces the main representative standards. At the same time, a brief introduction is given to the guidelines and consensus evaluation results published in the field of neurological diseases in China, and future improvements are proposed. This article aims to help readers understand the development patterns of evidence grading and recommendation strength, in order to better understand the guidelines, and to develop more standardized guidelines.
ObjectivesTo evaluate the reporting quality of clinical practice guidelines published in Chinese journals in 2017.MethodsCBM, CNKI and WanFang Data databases were searched for articles published in 2017. Two reviewers independently screened literature, extracted data, and evaluated the reporting quality of clinical practice guidelines using the Reporting Items for Practice Guidelines in Healthcare (RIGHT).ResultsOne hundred and seven clinical practice guidelines were included and a total reporting rate of 34.8%±0.1% in RIGHT. Among the seven domains of RIGHT, field on basic information had the highest reporting rate (56.8%) and fields on review and quality assurance had the lowest reporting rate (9.3%).The average reporting rate of RIGHT items of Chinese Science Citation Database (CSCD) articles was lower than non-CSCD [MD=?0.73, 95%CI (?0.78, ?0.68)] articles. The average reporting rates of RIGHT items differed between Chinese Medical Association (CMA) journal articles and non-CMA journal articles [MD=2.30, 95%CI (2.26, 2.34)]. The average reporting rates of RIGHT items was lower in guidelines established by associations or institutes [MD=?3.78, 95%CI (?3.83, ?3.73)], and was higher reported in Chinese medicine guidelines [MD=21.94, 95%CI (21.91, 21.97)].ConclusionsThe reporting quality of clinical practice guidelines published in journals of mainland China in 2017 is low in general, especially in fields such as review and quality assurance, funding and declaration and management of interests and other information. To improve this phenomena, it is suggested that guideline developers report the guidelines rigorously with international standard.
