Objective To systematically review the requirements of patient participation in clinical practice guidelines (CPGs) in Chinese and foreign guideline development manuals. Methods Thirty-six authoritative society websites and guideline databases and 5 commonly used databases were searched online. Relevant information on patients’ participation in the guideline manuals was collected, summarized, and analyzed. Results A total of 37 manuals (33 foreign and 4 Chinese) were included. The requirements for the number of patients, the right to speak, status equality, and the right to vote in the guideline development manual accounted for 35.1%, 13.5%, 8.1%, and 5.4%, respectively. The requirements for participants’ mode of participation were not mentioned in the guideline development manuals from 2000 to 2010. There were 6 (16.2%) in 2011–2015 and 12 (32.4%) in 2016–2022. The comprehensive guidelines for multiple disease types accounted for 35.7%, 28.6%, and 57.1%, respectively, in terms of requirements for participants’ knowledge or experience, management of specialized personnel, and training support. The specific guidelines for a certain type of disease or drug accounted for 21.7%, 4.3%, and 17.4%, respectively; fifteen (40.5%) guideline development manuals mentioned the specific collection forms of patients’ values and preferences in guideline development. Conclusion Given changes to medical models and the emphasis on patients’ rights and interests, an increasing number of manuals have proposed requirements that consider the expression of patients’ values and preferences in manual development, and the dimensions of manual development are constantly enriched. However, manuals outlining the requirements of patient participation are still not comprehensive and can continue to improve.
Psoriatic arthritis (PsA) is a disease with heterogeneous manifestations in patients who have manifest or latent psoriasis. It comprises both musculoskeletal and non-musculoskeletal manifestations. Active chronic PsA is often accompanied by cardiovascular, psychological and metabolic complications. Although the quantity of disease-modifying antirheumatic drugs (DMARDs) indicated for PsA has increased, clinicians still require some guidance in decision-making. Based on the latest evidence-based research results, the European League Against Rheumatism (EULAR) in 2019 developed the recommendations for the pharmacological management of PsA updated in 2015 with new recommendations. This paper interprets the update contents of the guideline to provide references for the clinical treatment of PsA.
ObjectiveTo evaluate the reliability and validity of Guideline Implementation Success Assessment Tool (A-GIST). MethodsWith the guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the target guideline, health care providers and patients from different hospitals across the country were investigated by questionnaire using A-GIST. Spearman-Brown coefficient and Cronbach's α coefficient were used to evaluate the split-half reliability and internal consistency reliability, while the structural validity, convergent validity and discriminant validity were investigated by confirmatory factor analysis based on structural equation. ResultsThe internal consistency reliability and split half reliability coefficients of the whole tool and each dimension ranged from 0.650 to 0.986. The scale-level content validity index (S-CVI/Ave) of content validity was 0.846. Confirmatory factor analysis showed that, the χ2/df of two sections of the tool were 8.695 and 6.123, respectively. The root mean square residual (RMR), the standard root mean square residual (SRMR) and the root mean square error of approximation (RMSEA) were under or almost under the threshold. Besides, the goodness-of-fit index (GFI) of them were 0.901 and 0.822, the adjusted goodness-of-fit index (AGFI) were 0.836 and 0.787, and the parsimonious normed fit index (PNFI) were 0.545 and 0.788, respectively. ConclusionGuideline Implementation Success Assessment Tool (A-GIST) was proved to be valid and reliable, and it shows that it is necessary to optimize the items under the dimensions of maintenance and evaluation of diagnosis and treatment effect in the future.
Chronic kidney disease (CKD) and hypertension are very common chronic diseases. Active and standardized treatment of hypertension in patients with CKD can not only delay the progress of renal disease, but also reduce the risk of cardiovascular events. In recent years, although the guidelines for hypertension have put forward detailed suggestions for the management of hypertension in CKD patients, there are differences in the recommendation of blood pressure target value for CKD patients. Combined with the latest guidelines, this review interprets the blood pressure measurement methods, diagnostic criteria, antihypertensive targets and drug therapy in patients with CKD.
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.
ObjectiveTo evaluate the implementability of traditional Chinese medicine (TCM) guidelines in the field of paediatrics. MethodsWe searched the paediatrics-related TCM guidelines published in CNKI, WanFang Data, VIP, SinoMed and PubMed databases, and related websites from inception to November 1, 2023. The implementability of the included guidelines was evaluated using the clinical practice guideline implementability assessment tool. ResultsA total of 47 guidelines were included, covering 37 paediatric diseases and recommending 27 TCM therapies, including TCM decoction, Chinese patent medicines, acupuncture, paediatric massage, and acupoints. The results of the guideline implementability evaluation showed that 5 guidelines (10.6%) were of high grade, 12 guidelines (25.5%) were of medium grade, and 30 guidelines (63.8%) were of low grade. With the exception of accessibility (multi-channel access methods) and communicability, which was of high quality, there is room for improvement in all areas, particularly in the areas of applicability and ease of recognition. ConclusionThe overall quality of implementability of the included paediatric TCM guidelines was low, and it is recommended that in the process of developing paediatric TCM guidelines in the future, we focus on improving the quality of implementability of the guidelines themselves from the source, so as to promote the implementation and application of the guidelines.
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.
Surgical management of osteoarthritis of the knee: evidence based guideline contains 38 recommendations pertaining to the preoperative, perioperative, and postoperative care of patients with knee osteoarthritis (KOA) who are considering surgical treatment. Compared with the domestic consensus on diagnosis and treatment for KOA, this clinical practice guideline (CPG) prepared by the American Academy of Orthopedic Surgeons (AAOS) has some advantages in terms of methodology selection and recommendation. Therefore, it is necessary for us to interpret this CPG to speed up the understanding and dissemination of the CPG. The ultimate aims are to: ① strengthen the standardization and understanding of surgical treatment of KOA; ② enhance the understanding of clinicians for this CPG in treating KOA; ③ speed up the development of guideline development methodologies in China; ④ provide methodological guidance for the development of CPG based on the current situation in China.
ObjectiveTo systematically review the clinical applicability of the global guidelines evaluation index system, and to provide some foundation for the evidence-based establishment of the clinical applicability evaluation index system in China. MethodsThe PubMed, Embase, Cochrane Library, CNKI, WanFang and VIP databases were electronically searched to collect literature on the clinical applicability evaluation index system of guidelines from inception to November 2022. Two reviewers independently screened literature, extracted data and then organized the data to form the evaluation items pool through qualitative systematic review and thematic synthesis. ResultsA total of 82 articles were finally included, and 141 clinical applicability evaluation indicators were obtained, including 5 third-level topics, 14 analytical topics and 141 descriptive topics. The third-level topics were availability, readability, feasibility, acceptability and overall evaluation. Influencing factors in the feasibility field were summarized as medical staff factors, patient/patient family factors, environmental factors and guideline factors. ConclusionThis study systematically sort out the applicability evaluation items of the guidelines, which provide an evidence-based reference for the construction of relevant evaluation index systems in China.