1.External Quality Assessment of Clozapine for Therapeutic Drug Monitoring in Guangdong Province
Yongshuang GAO ; Jiaxuan ZHANG ; Xiaojia NI ; Wei GUO
China Pharmacist 2016;19(9):1791-1793
Objective:To implement the external quality assessment ( EQA) of clozapine for therapeutic drug monitoring ( TDM) among psychiatric hospitals in Guangdong. Methods:The parameters of HPLC used by the hospitals were understood through question-naires. The EQA of clozapine for TDM was implemented by distributing the quality control serum. Results:The qualified rate of cloza-pine in the quality control serum at low, medium and high concentrations for TDM was 66. 67%, 66. 67% and 83. 33%, respectively. Conclusion:It is necessary to implement EQA of clozapine for TDM in Guangdong.
2.Systematic review of relevant guidelines for the prevention and treatment of stroke in Chinese neurovascular surgery
Hao LIN ; Qingbin ZHU ; Xiaojia NI ; Wenjing LIAO ; Xufei LUO ; Hanzi QIAO ; Yaolong CHEN ; Yefeng CAI
Chinese Journal of Cerebrovascular Diseases 2018;15(4):169-176
Objective To evaluate the evidence and recommendations of the relevant clinical practice guidelines for the prevention and treatment of stroke published in the last five years. Methods The stroke and guideline-related key words and free words domestic computer retrieval platforms(China biomedical literature database,CNKI,and Yimaitong etc.),as well as foreign platforms(PubMed,NGC,GIN,etc.) were retrieved.The retrieval time limit ranged from January 2012 to May 2017.Appraisal of Guidelines for Research and Evaluation Ⅱ(AGREE Ⅱ)was used to assess the quality of the guidelines. Results A total of 9 490 documents were retrieved preliminarily and finally 16 articles were included. The average scoring rates of the 16 guidelines in the 6 fields of AGREE Ⅱ,including the scope and purpose,participants,rigor of the formulation,clarity of expression,applicability,and independence of the editors were 66.3%, 27.4%,23.0%,53.9%,18.8%,and 0%,respectively.The different guidelines all recommend that internal endarterectomy or carotid balloon dilatation and carotid artery stenting are used to extracranial carotid stenosis,while the treatment of vertebral artery stenting is recommended for extracranial vertebral artery stenosis.However,the intravascular interventional therapy is not recommended for intracranial arterial stenosis.The perioperative period of ischemic stroke intravascular intervention need to pay attention to the application of anti-platelet aggregation,anticoagulation,blood pressure,blood glucose,blood lipid management,and postoperative monitoring. For postoperative stent restenosis,especially after vertebral artery stenting,the guidelines recommend using drug-eluting stents,however,the dosage of heparin in intraoperative anticoagulation is still controversial.The intracranial aneurysm guidelines are more recommended for interventional therapy.The cerebral hemorrhage in different regions is recommended for different surgical procedures. Conclusions The guidelines in this field can reflect the key problems in clinical practice and keep up with the international concept.However,the quality of the methodology of the guidelines development needs to be improved. Some of them need to be updated and the recommendations should refer more evidence of the Chinese population.
3.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
4.Methodology for Developing Patient Guideline(1):The Concept of Patient Guideline
Lijiao YAN ; Ning LIANG ; Ziyu TIAN ; Nannan SHI ; Sihong YANG ; Yufang HAO ; Wei CHEN ; Xiaojia NI ; Yingfeng ZHOU ; Ruixiang WANG ; Zeyu YU ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(20):2086-2091
Since the concept of patient versions of guidelines (PVGs) was introduced into China, several PVGs have been published in China, but we found that there is a big difference between the concept of PVG at home and abroad, and the reason for this difference has not been reasonably explained, which has led to ambiguity and even misapplication of the PVG concept by guideline developers. By analyzing the background and purpose of PVGs, and the understanding of the PVG concept by domestic scholars, we proposed the term patient guidelines (PGs). This refers to guidelines developed under the principles of evidence-based medicine, centered on health issues that concern patients, and based on the best available evidence, intended for patient use. Except for the general attribute of providing information or education, which is typical of common health education materials, PGs also provide recommendations and assist in decision-making, so PGs include both the patient versions of guidelines (PVG) as defined by the Guidelines International Network (GIN) and "patient-directed guidelines", i.e. clinical practice guidelines resulting from the adaptation or reformulation of recommendations through clinical practice guidelines.
5.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.