Clinical practice guidelines have become increasingly widely used to guide quality improvement of clinical practice. Qualitative research may be a useful way to improve the quality and implementation of guidelines. The methodology for qualitative evidence used in guidelines development is worthy of further research. Sixty-four guidelines were identified. The overall quality of the guidelines was high (almost over 60%). Domain 1 (Scope and Purpose) was ranked the highest with a median score of 83% (IQ 78–83). Domain 2 (Stakeholder involvement) and Domain 5 (Applicability) were ranked the lowest with median scores of 67% (IQ 67–78) and 67% (IQ 63–73) respectively. 20% guidelines used qualitative research to identify clinical questions. 86% guidelines used qualitative evidence to support recommendations (mainly based on primary studies, a few on qualitative evidence synthesis). 19% guidelines applied qualitative evidence when considering facilitators and barriers to recommendations’ implementation. 52% guideline developers evaluated the quality of the primary qualitative research study using the CASP tool or NICE checklist for qualitative studies. No guidelines evaluated the quality of qualitative evidence synthesis to formulate recommendations. 17% guidelines presented the level of qualitative research using the grade criteria of evidence and recommendation in different forms such as I, III, IV, very low. 28% guidelines described the grades of the recommendations supported by qualitative and quantitative evidence. No guidelines described the grade of recommendations only supported by qualitative evidence.
The translation and implementation of clinical practice guidelines (CPGs) for Traditional Chinese Medicine (TCM) and Integrated Traditional Chinese and Western medicine is crucial to the adoption of medical science and technology, but the low operability and slow update of integrated traditional Chinese and Western Medicine guidelines, and the lack of integration between guidelines and clinical practice, result in the guidelines not having the desired clinical effects in practice. The application of Artificial Intelligence (AI) to the field of CPGs development aims to shorten the development time, optimize and accelerate the whole process of CPG’s development. This article summarized the current research and application status of AI in development and implementation CPGs for TCM and Integrated Traditional Chinese and Western medicine and proposed the method of Combining real world data and AI technology to enrich for TCM and Integrated Traditional Chinese and Western medicine.
3. The Methodology of Key Steps in Implementation for Clinical Practice Guideline (in Chinese)
Since the new definition of clinical practice guidelines (CPGs) was published by the American Medical Research Institute in 2011, it is a critical period for CPGs to be high quality and high standardization in recent years. Domestic scholars have published a series of articles on the methodology for developing CPGs, and gradually pay attention to its implementation. This study focuses on the current situation on implementation of CPGs, discuss key steps in the process of the guidelines’ implementation in order to provide some suggestions for practitioners of clinical medical quality improvement.
4. Methodology for clinical practice guidelines--Application of EtD frameworks in the process of evidence recommendation forming (in Chinese)
This article is the fifth article on the GRADE system. The previous articles introduced the GRADE classification method and its application in the GRADEpro GDT from four aspects: basic concept, interventional systematic evaluation, observational systematic evaluation and diagnostic systematic evaluation. This article mainly introduced the basic content of the EtD framework, and simply demonstration how to make final decision through GRADEpro GDT.
5. Methodology for clinical practice guidelines--Application of GRADEpro GDT in Evidence Grading of Systematic Reviews of Interventional trial (in Chinese)
Guideline Development Tool (GDT) is an online tool based on GRADE Profiler (GRADEpro) software extension launched by the GRADE working group in 2013. GRADEpro GDT supports the creation of concise summaries (evidence profiles and summary of findings tables) for systematic reviews, facilitates the development of clinical practice guidelines, and advises on public health policies and decisions. This paper uses the GRADEpro GTD tool to classify the evidence of systematic review of interventional trials and briefly introduces the five degradation factors (risk of bias, inconsistency, imprecision, indirectness, publication bias) encountered in the evidence classification.
6. Methodology for clinical practice guidelines--GRADE method theory (in Chinese)
Scientific evidence grading and recommendation intensity are of great significance for the development and implementation of the guidelines. Evidence is the core of evidence-based medicine, and the GRADE evidence quality grading and recommendation intensity system is a milestone in the history of evidence development. This article introduces GRADE from the development of the GRADE method, the basic concepts and principles, the scope of application and the theoretical aspects of the tools.
7. Methodology for clinical practice guidelines: Application of GRADE in observational system evaluation (in Chinese)
This article focuses on the use of three escalation factors in the observational system evaluation in the evidence quality grading process and presents the results in the GRADEpro GDT online tool through an example and explains the problems that may be encountered in the results entry.
8. Methodology for clinical practice guidelines: application of GRADE in systematic review of diagnostic tests (in Chinese)
The systematic review of diagnostic tests includes the systematic review based on diagnostic intervention studies and the systematic review based on diagnostic accuracy tests. This paper will describe how to use GRADE to classify the evidence bodies of diagnostic tests, how to effectively use GRADEpro GDT tools to present GRADE grading results, and further interpret the GRADE grading results.
9. Methodological series for clinical practice guidelines: Patient Values and Preferences (in Chinese)
Patient's values and preferences is one of the key elements of evidence-based practice and development of clinical practice guideline. This paper introduces the application status and methods of patient's values and preferences in guidelines development based on a number of guidelines manuals and related literatures. We hope this article to call on guidelines developers pay attention to the role of patient's values and preferences in the process of guidelines formulation, and also to provide relevant methodological references for guidelines developers.
10. Methodology for clinical practice guidelines--economic evaluation evidence (in Chinese)
Clinical practice guidelines are decision-making tools that narrow the gap between current best evidence and clinical practice. Health economics analysis allows for the rational allocation and effective use of limited health resources by comparing health inputs with health outcomes, which is one of the factors, considered in the development of clinical practice guidelines. With the sudden increase in medical costs, the issue of considering the cost of medical resources in the development of guidelines has received increasing attention. This study will provide a brief overview of the principles and methods for incorporating economic evidence into the development of guidelines for reference in our clinical practice guidelines.
11. Methodology for clinical practice guidelines-consensus methods for building recommendations (in Chinese)
It is an essential part to form recommendation through expert consensus during the development of clinical practice guidelines. This article, by referring to some relevant guideline handbooks, introduced in detail the definition, characteristics, advantages and disadvantages, as well as the general process of some major methods to reach a consensus, including the Informal Consensus, the Delphi Method, the Nominal Group Technique, the Consensus Development Conference, the Modified Delphi Methods, the GRADE Grid. Particularly, this article also explained the modified Delphi Methods raised by ASCO (American Society of Clinical Oncology) thoroughly and systematically. It is expected to provide a reference for guideline developer on how to reach consensus when making the recommendation.
12. Methodology for clinical practice guidelines--Evidence Searching and Evaluation (in Chinese)
The systematic identification of evidence is an essential step in developing guidelines. A comprehensive, objective, and repeatable literature search is the most time-consuming, challenging, and important task in the developing guidelines. Sensitive search strategies and multiple search resources are key to reduce bias. It is a process that often include constructing key questions, determining search resources, and assessing methodological quality. According to the different problems that need to be solved, searching different types of research and evaluating related documents are the basis for formulating systematic reviews and eventually forming recommendations.
13. Methodology for clinical practice guidelines--evidence to recommendation (in Chinese)
Much more than evidence must be considered when crafting practice recommendations. The evidence-based conclusion and our confidence in the ability of the evidence to support practice recommendations form the foundation. The side effects, risks, cost effectiveness, resource implications, values and preferences and health service delivery issues have been considered in formulating the recommendations. At present, there is no perfect and uniform method to guide the formulation of recommendations. Developers of evidence-based clinical practice guidelines can learn from their experience, combine with their own characteristics of guidelines such as specific target population and specific clinical situations, establish a rational method of recommendations formation.
14. Methodology for clinical practice guidelines-standardized report of guidelines (in Chinese)
The standardized report of clinical practice guidelines can not only improve the reporting quality of the guidelines, but also effectively promote the dissemination and implementation of the guidelines. This article systematically expounded the necessity of standardized reporting of guidelines, introduced its reporting requirements in detail on the basis of each guide manual, and comprehensively introduced the more internationally recognized reporting specifications (COGS standard, RIGHT statement), in order to provide references for the standardization of reporting guidelines for guideline developers.
15. Methodology for clinical practice guidelines--implementation tools of guidelines (in Chinese)
This study aimed to determine the tool or theory for guideline implementation. We searched Pubmed, Web of science, CNKI, etc supplemented papers published by Shiffman RN and Gagliardi AR. Three tools identified. The GuideLine Implementability Appraisal (GLIA) is intended to provide information about a guideline’s implementability to (1) A guideline authoring group, which may decide to modify content to improve implementability; (2) Those individuals who choose guidelines for application within a health care delivery system, in which case, GLIA can be used to anticipate potential problems in implementation. The implementability framework included 22 elements organized in the domains of adaptability, usability, validity, applicability, communicability, accommodation, implementation, and evaluation. Developers or users can apply the Guideline implementation planning checklist to prepare for and/or undertake guideline implementation. Guideline implementation is complex, and basing on guideline implementation theory or tool is necessary. Guideline implementation would benefit from including knowledge translation experts.
16. Methodology for clinical practice guidelines--implementation and transformation of guidelines (in Chinese)
The vitality of CPGs lies in their implementation. Researchers have shown that the uptake of CPGs is inconsistent, and there is concern that guidelines have not always delivered the predicted improvements in clinical care. Guideline developers and users have expressed the need for guidance by which to choose, tailor and operationalize implementation strategies. We reviewed information from guideline development manuals, research of guideline implementation theory and practice.
17. Methodology for clinical practice guidelines--external review of guidelines prior to publication (in Chinese)
External review before publication is an important process in the formulation of guidelines and plays an important role in ensuring the rigor of formulation of guidelines. The main purpose of external review is to evaluate the accuracy, feasibility, clarity and applicability of the recommendation. Based on the existing guidelines handbooks, this article systematically expounds the necessity of external review before the publication of the guide, and introduces the methodology of external review in detail, including its concept, object, process and other information, hoping to provide reference for guideline developer.
18. Methodology for clinical practice guidelines--summary of global handbooks on clinical practice guideline development and implementation (in Chinese)
To deeply analyze and review the global handbooks on clinical practice guideline, and summarize the methodological key points in guideline development and spreading so as to provide methodology evidences and references for guideline developers in China. The websites of all major guideline databases, famous academic societies or institutions were retrieved and 4 journal databases were retrieved additionally. The information about origination, published year, version, purpose, types and definition of obtained guidelines, and process of guideline development were analyzed. There were totally 36 handbooks of guidelines development included, among them 2 from China, and 8 issued by national health ministry or national-level research or evaluation center. Evidence-based clinical practice guideline is a tendency of guideline development. Some handbooks were rich in content, and supplied plentiful form tools with higher operability. The development processes of guidelines described in different handbooks are similar, but they have their own features and advantages.
19. Methodology for clinical practice guidelines--declaration and management of conflict of interest (in Chinese)
Conflict of interest can directly affect the independence of clinical practice guidelines, and it is an
important factor in quality control of clinical practice guidelines. The conflict of interest mainly includes two types: financial and non-financial, In the process of developing guideline, any interest relationship that affects individual objectivity and independence must be declared, and the developing guideline is restricted or prohibited according to the severity of the conflict of interest.
20. Methodology for clinical practice guidelines: level of evidence and strength of recommendations (in Chinese)
Scientific level of evidence and strength of recommendation standards are of great significance for the development and implementation of the guidelines. Level of evidence and strength of recommendation standards have gone through a process of continuous exploration and development over the past three decades. There is no uniform standard of level of evidence and strength of recommendations in the world at present, the standards recommended by the various guideline development agencies around the world are also different. A systematic literature was conducted to review the evolution of the level of evidence and strength of recommendations. Through reviewing more than 30 guideline development manuals around the world, we summarize the classification, specific connotation and update status of their level of evidence and strength of recommendations. Thus providing a methodology reference for guideline developers.
21. Methodology for clinical practice guidelines: registration of guidelines and design and writing of guideline proposal (in Chinese)
The proposal of clinical practice guidelines is necessary to be developed, complied and implemented for ensuring carrying out successfully the projects in guidelines. The content of the proposal commonly includes objectives, meaning, users, target audience, members of guideline formulating group and methodology for guideline development. Guideline registration is an effective strategy for normalizing guideline development, increasing transparency, avoiding duplication and improving credibility, and it can also promote the dissemination and implementation of guidelines.
22. Methodology for clinical practice guidelines--identifying and forming the scope, topic and clinical question (in Chinese)
Only when the scope is well defined will it be possible to develop guideline meeting the clinical requirement, assess the workload and timescale of the guideline development process. Scope and topic involve considering in detail the areas of clinical practice that will be addressed by the guideline. There are some key principals: inviting the coordinators of all interest groups or stakeholders to propose and discuss new guideline topics; giving priority on topics with high costs, major patient impact; high practice variation. The questions listed in the scope or topic need to be translated into review questions for developing review questions and planning the evidence review. Clinical questions should be more clear and focused. A helpful framework to format key questions systematically is the PICO framework.
23. Methodology for clinical practice guidelines--members, groups or committee of guideline development (in Chinese)
Guideline development groups should include individuals from a range of relevant stakeholder groups to minimize bias. Multidisciplinary participation helps identify and evaluate all relevant evidence, builds support among the intended guideline users, and increases the chances of addressing practical problems related to implementation. The methodologist should be fluent with guideline methodology, understand the process of systematic review, and have direct experience with prior guidelines developed by the organization. Lay members usually have direct experience of the condition, services or topic being covered by the guideline--as a patient, service user, carer or family member, so views and perspectives of lay members should be incorporated in the guideline development.
24. The methodology of recommendations in evidence-based clinical practice guideline (in Chinese)
The formulation process of recommendations in evidence-based clinical practice guidelines was often complex and cumbersome. This paper described the evolution of levels of evidence and strength of recommendations in medical research and analyzed existing problems when making recommendations. We also summarized and introduced the method of formulating the final recommendation. At present, there isn’t a perfect and uniform method to guide the formulation of recommendations. But some organizations provided different content frameworks or auxiliary tools to guide formulation of recommendations. Developers of evidence-based clinical practice guidelines can learn from their experiences, combine with their own characteristics of guidelines such as specific target population and specific clinical situations, establish a rational method of recommendations formation.
25. Application of evidence of diagnostic test in clinical nursing practice guideline (in Chinese)
Nursing assessment is the basis of nursing diagnosis, and is essential part in the process of nursing practice. It often uses assessment tools to collect disease data. The accuracy and clinical value of assessment tools has attracted more and more attention of clinical nursing specialists. With clinical nursing practice guidelines development upsurge, making recommendations related to diagnostic assessment tools has become significant content for guideline development group to consider. This article discussed and summarized the necessity of the application of diagnostic test in nursing assessment and questions on application of diagnostic systematic review in clinical nursing practice guidelines for the sake of making suggestions for nursing researchers.