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Abstract
Objectives To develop a generalised tool to evaluate the success of implementation of clinical practice guidelines (CPGs).
Design and setting Systematic review, group brainstorming discussion and modified Delphi method.
Participants A steering group (3 members) was assembled responsible for the guidance and ensuring stakeholder’s involvement. A tool development group (24 members) of leading experts provided expertise in refining the frame and items during the development and participated in the Delphi process. And a secretary group (7 members) was responsible for the organization and coordination, systematic reviewing, drafting of the preliminary list of items, documenting and revising the tool according to the suggestions of the development group.
Interventions Four process stages were employed. First, the project was launched with core groups formed for the development. Second, based on the Reach Effectiveness Adoption Implementation Maintenance framework, a systematic review of existing methods for evaluating the success of CPGs implementation and a brainstorming discussion were conducted to form a preliminary list. Third, a modified Delphi method was organised, integrating a multidisciplinary face-to-face consultation meeting with two rounds of online Delphi consultations. Fourth, the tool was revised and finalised incorporating all expert suggestions.
Results Development teams comprising multidisciplinary experts were formed. In the systematic review, 7 biomedical literature databases were searched, and 208 pieces of literature were included. After three rounds of brainstorming discussions on items identified in the literature, a 23-item preliminary list was produced. In the modified Delphi method, 14 experts made 23 main suggestions in the face-to-face meeting on the list. 13 experts participated in the first round of Delphi consultation, reached agreement on 20 items, removed 4 items and added 1 new item. 11 experts attended the second-round consultation and had an agreement to include 20 items after revision.
Conclusions The Guideline Implementation Success Assessment Tool (A-GIST) was systematically developed as a comprehensive tool to assess the success of CPGs implementation. It comprises 5 dimensions, Reach, Adoption, Implementation, Effectiveness and Maintenance, encompassing 20 items that integrate perspectives from both clinicians and patients. A-GIST is designed to facilitate evaluating, benchmarking and cross-comparison of implementation success between guidelines, facilities and regions. Additionally, it provides evidence-based insights to inform the development of targeted strategies for optimising guideline implementation practices.
- Clinical Decision-Making
- Evidence-Based Practice
- Health Care Quality, Access, and Evaluation
Data availability statement
Data sharing not applicable as no datasets generated and/or analysed for this study.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
Adherence to high-quality guidelines could improve patient outcomes, reduce medical expenditure and promote rational allocation and use of limited medical resources.
Assessing the success of guideline implementation is vital for healthcare quality improvement.
However, there is still a lack of generalised and comprehensive tool for evaluating the success of guideline implementation.
WHAT THIS STUDY ADDS
To address the gap, a generalised Guideline Implementation Success Assessment Tool (A-GIST) was developed based on Reach Effectiveness Adoption Implementation Maintenance framework, with 5 dimensions (Reach, Adoption, Implementation, Effectiveness, Maintenance) and 20 items, involving both clinicians’ and patients’ perspectives.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
A-GIST enables evaluation, benchmarking and comparison of the success of guideline implementation across guidelines, health facilities and geographical regions, thereby informing design of targeted strategies to enhance clinical practice guidelines implementation for healthcare quality improvement.
Background
Clinical practice guidelines (CPGs) are statements that include recommendations intended to optimise patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.1 CPGs serve to support professionals and patients in making clinical decisions about appropriate healthcare intervention in particular contexts. Furthermore, the implementation of CPGs has demonstrated significant value in promoting standardisation of clinical practice, improving quality of healthcare and optimal use of limited healthcare resources.2–4 However, the implementation of CPGs in daily healthcare practice has been suboptimal. Despite the rapid increase in the number of CPGs published each year, many of them were reported to be poorly implemented with low adherence.5–7 A bundle of studies have revealed that a considerable fraction of patients fail to receive healthcare aligned with guidelines’ recommendations.8 Insufficient time of healthcare professionals, doubts about the validity and applicability of guidelines, lack of resources and training opportunities were the most commonly reported barriers to the implementation of guidelines.9–11
In recent decades, with the rise of evidence-based medicine and implementation science, the success of guideline implementation has been of great concern to improve clinical practice and quality of healthcare.12 13 Numerous studies have been undertaken concerning the barriers and facilitators during implementation, the selection of implementation strategies and the effectiveness or cost-effectiveness of selected implementation strategies.14 15 Meanwhile, tools and frameworks were developed for clinicians and methodology experts to evaluate the implementability of CPGs. For example, GuideLine Implementability Assessment (GLIA) was developed to help guideline developers to standardise their writing and design the implementation strategies, and to help users to select guidelines and analyse the potential barriers to implement guideline recommendations.16 Gagliardi et al designed a conceptual framework for guideline implementation, which included adaptation, usability, validity, applicability, communicability and accommodation, defining features that facilitate CPGs use.17 Besides, empirical studies were also conducted to evaluate the outcomes of guideline implementation, providing insights into the real-world impacts of CPGs on patient care and healthcare systems.3 18–22
However, there is an absence of a generalised, multifaceted tool to evaluate the success of CPGs implementation, making it difficult to compare the success of implementation between guidelines and cross-comparison between institutions and regions.23 Previous studies often used disease-specific indices to evaluate individual CPG, making it difficult to conduct evaluation, monitoring, benchmarking and cross-comparison between guidelines, institutions, geographical regions or countries, and formulation of targeted strategies to improve the implementation of guidelines.24 Moreover, as regard to dimensions of evaluation, most studies focused on health professionals’ attitude, knowledge or adherence to the CPGs, while other aspects of successful implementation, such as adoption, maintenance and their impacts, especially on patient-reported outcomes, have largely been overlooked.25 26
Therefore, this study was conducted to develop a generalised, comprehensive, multiperspective tool for appraising the success of CPGs implementation, to make it comparable between different guidelines, health facilities and geographical regions. It also has potential applications in identifying gaps in guideline implementation and informing the design of targeted strategies, thus supporting both evaluation and appropriate intervention.
Methods
For the development of the tool, we followed the methods for scale development, which contained four stages: project launch, systematic review and brainstorming discussion, modified Delphi method and the development of the final tool (figure 1).27 28
Flow diagram of the four stages in A-GIST development. A-GIST, Guideline Implementation Success Assessment Tool; CPG, clinical practice guideline; RE-AIM, Reach Effectiveness Adoption Implementation Maintenance framework.
Theoretical framework
We used the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to offer a structured approach to evaluate the success of CPGs implementation. The RE-AIM framework was proposed by Glasgow et al.29 It contains five dimensions including Reach, Effectiveness, Adoption, Implementation and Maintenance, covering the whole span of guideline (intervention) implementation from its initiation to process and outcomes.24 It was chosen because it is well structured with comprehensive assessment domains, making it one of the most commonly used frameworks in healthcare interventions and implementation science, providing a valuable guide for practitioners in planning, implementing and evaluating the impacts of health interventions, enhancing the translation of evidence into practice.30–32 In this research, the five evaluation dimensions of the RE-AIM framework and their definitions guided the overall design of the dimensions and items.
Definitions of core conceptions
The definition of success of CPGs implementation was adopted from the RE-AIM framework,29 referring to the whole process of CPGs implementation through specific channels to Reach the healthcare institutions, professionals and patients, be Adopted, then be Implemented in accordance with the recommendations, producing certain clinical effects on patients (Effectiveness) and be Maintained for a sufficient period of time (table 1).
Definitions of dimensions of the success of CPGs implementation in this research
Step 1: project launch
The development groups were formed at project launch. A steering group was first assembled constituted by three experts from the Medical Management Service Guidance Center, National Health Commission of the People’s Republic of China and West China Second University Hospital, Sichuan University, responsible for the overarching guidance and ensuring stakeholder involvement. Under the guidance of the steering group, a tool development group was formed which consisted of 24 leading experts from China from relevant disciplines, including clinical medicine, evidence-based medicine, evidence-based pharmacy, evidence-based nursing, epidemiology and statistics, to provide expertise in refining the frame and items of the tool during the tool’s development. Besides, a secretary group of seven researchers from West China Second University Hospital, Sichuan University was formed, responsible for the organisation and coordination, systematic reviewing, drafting of the preliminary list of items, documenting the development process and revising the tool according to the suggestions of the tool development group. See online supplemental 1 for a detailed list of the Guideline Implementation Success Assessment Tool (A-GIST) development groups.
Supplemental material
Step 2: systematic review and brainstorming discussion
A systematic review was conducted previously to inform the preliminary items to evaluate the success of CPGs implementation. Seven electronic literature databases were systematically searched, including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), China Science and Technology Journal Database (VIP) and Wanfang Database, from their inceptions to June 2022. Methodological or empirical studies on the evaluation of the success of CPGs implementation were included. Theories, tools, dimensions and items for evaluation of the success of guideline implementation were summarised. Identified items were reorganised and refined based on the five dimensions of the RE-AIM framework, to inform the preliminary list of items of the tool.29 The detailed methods and findings of the systematic review have been published earlier.23
In addition, the secretary group, consisting of seven researchers with diverse expertise, held three rounds of brainstorming discussion based on the results of the systematic review and the RE-AIM framework.33 34 Among the group, four of the members (LZeng, KZ, HL and LH) held doctoral degrees and had over 20 years of experience in evidence-based medicine or pharmacy research and clinical practice, one member (QY) had 5 years of experience in evidence-based pharmacy research, and two were master’s students (NY and SH) with 2 years of evidence-based research experience. During the sessions, each member freely contributed ideas and suggestions for evaluation items, drawing from relevant literature as well as their clinical and research experience. The process involved independent idea generation, followed by face-to-face discussions where all contributions were reviewed. The significance, feasibility and acceptability of each suggestion were critically assessed, and consensus was reached through deliberation. These discussions culminated in the development of the preliminary list of evaluation dimensions and items after three iterative rounds.
Step 3: modified Delphi method
As an iterative and multistage method to solicit information and synthesise opinions, a modified Delphi method was conducted to reach the consensus, combining one round of face-to-face consultation meeting with two rounds of Delphi consultations.
Face-to-face consultation meeting
A face-to-face expert consultation meeting with 14 experts from the tool development group was conducted to freely discuss the proposed preliminary list of dimensions and items of the tool, definitions of terminologies, phrases and the scoring criteria. All experts were selected from leading universities and tertiary teaching hospitals across China, all of which had more than 10 years of experience in development and implementation of CPGs and a minimum of 20 years of clinical practice experience. Suggestions and comments from the experts were collected through the meeting, and the proposed preliminary list of dimensions and items of the tool were revised accordingly, forming the drafted tool.
Delphi consultations
Two rounds of Delphi consultations were conducted using an online or offline questionnaire.35–37 Experts of the tool development group were invited to evaluate the dimensions and items in the drafted tool using a 5-point Likert scale as regards five aspects:38 39
Importance: How significant is this item?
Familiarity (Cs): How well acquainted are you with this item?
Judgement basis (Ca): How do you determine the ‘importance’ of this item based on theoretical analysis, practical experience, peer information or personal intuition?
Dimension relevance: How closely do you believe this item aligns with the content depicted in the dimension?
Comprehensibility: How clear and easy to understand do you find the expression of this item?
In each round, two researchers of the secretary group collected and collated experts’ comments and suggestions on the dimensions and items and revised the tool accordingly.
Statistical analysis
Statistical analyses were performed using Microsoft Excel 2016 and IBM SPSS Statistics V.23. Expert authority coefficient, concentration of opinions, coordination of opinions, reliability and content validity were calculated using data from the consultations. The definitions of and methods to calculate these indicators are described below.38–40
Authority coefficient reflected the expertise and authority of the experts, which was the arithmetic average of the Cs and Ca.
Concentration of opinions was measured by the average of the importance scores and their coefficient of variation (CV), serving as a basis of consideration for revising or deleting indicators.
Coordination of opinions was measured by two metrics, CV and Kendall’s coefficient of concordance (W). The CV represents the degree of coordination of experts on each item and the W represents the consistency of all item.
Reliability was assessed using Cronbach’s α coefficient.
Content validity was analysed using the content validity index (CVI), including item-level CVI (I-CVI) and scale-level CVI (S-CVI), where I-CVI was corrected for random consistency, and the adjusted kappa value (denoted as K*) was calculated.
Step 4: development of the tool
After the two rounds of Delphi consultations, the secretary group discussed and finalise the drafted A-GIST, including dimensions, items and expressions, incorporating all the feedback collected. On completion of the development, the translation process began with a researcher (NY), a native Chinese speaker familiar with English, who conducted an initial translation of the tool. This was followed by a detailed translation and revision of the entire tool by a second researcher (KZ), a native Chinese speaker with 4 years of international research experience and proficiency in both written and spoken English. Then, in order to ensure the clarity, neutrality and cultural appropriateness in the translation, an experienced senior guideline researcher (LZeng) with 6 years of international research experience proofread the translated version in detail to preserve the original meaning, ensuring that the translation was both accurate and free from any biases. Any issues regarding the expression or cultural nuances were further discussed with the tool development team, and necessary adjustments were made to maintain consistency with the original version.
Results
Preliminary list
The systematic literature search yielded 4993 citations. After study selection according to the inclusion and exclusion criteria, 208 eligible studies were included. The characteristics of the studies, theories, frameworks, dimensions and items to evaluate the success of CPGs implementation were extracted, summarised and reorganised based on the RE-AIM framework.23 During this process, items reflecting both clinicians’ and patients’ perspectives were included. The dimensions and items identified in the systematic review were combined with results from brainstorming discussions, drawing up a preliminary tool consisting of 5 dimensions and 23 items to evaluate the success of guideline implementation (see details in online supplemental 2).
Supplemental material
Face-to-face consultation meeting
The face-to-face consultation meeting convened a total of 14 experts, with 10 attending in person and 4 participating via online video conferencing. The meeting lasted for over 2 hours with thorough discussions. 23 main suggestions were made by experts on the dimensions and items of the preliminary list, such as: (a) adding detailed definitions of the evaluation dimensions and reconsidering the wording of the items, adding explanatory words as appropriate; (b) merging items with similar content and revising the wording of the items to enhance their differentiation; (c) adding items of attitude to guidelines; (d) rearranging items and response options to improve logical flow and (e) adjusting the questions for patients to make it easier to understand and simplify the content. All comments and suggestions were incorporated into the revision of the list. See online supplemental 3–1 for the summary of the suggestions and responses.
Supplemental material
Delphi consultations
Participants’ characteristics of Delphi consultations
The characteristics of the Delphi participants are summarised in table 2. In the first round, 13 experts answered the consultation. Among them, six experts completed the paper-based questionnaire and seven experts completed the Delphi questionnaire online. In the second round, 11 experts participated to reassess and critique the revised dimensions and items, with all feedback being submitted through the online questionnaire. Each expert who participated in the Delphi process had more than 10 years of experience in clinical guideline development and a minimum of 20 years of clinical practice experience.
Descriptive characteristics of the Delphi panels
First round of Delphi
The authority coefficients (Cr 0.888–0.915) and concentration of expert opinions were high. A high level of the coordination of opinions and reliability (Cronbach’s α=0.928) was achieved. Content validity was achieved for 73.9% of items (I-CVI values ≥0.78 and K* ≥0.74) and that at the scale level was 0.838 (S-CVI/Ave). Agreement (score average ≥4 and CV <0.3) was reached for the inclusion of 16/23 (70%) of the items. 7/23 (30%) items were proposed for modification. Indicators and their thresholds for Delphi consultation are listed in table 3.
Indicators for evaluation of the results of Delphi consultation
Incorporating insights garnered from the face-to-face consultation meeting and the first round of Delphi consultation, revisions have been made to the dimensions and items of the tool. Specifically, four items were deleted (including the extent to use the guideline when encountering a patient applicable; the extent of adherence to the guideline in clinical practice; overall effectiveness of the guideline and the degree of maintenance), while one new item was added (the extent of clinician’s acceptance of the investigated guideline). 10 items were modified to improve their clarity and readability.
Second round of Delphi
In the second round of Delphi, the authority coefficients (Cr 0.911–0.941) and concentration of opinions also met the standards. There was high reliability (Cronbach’s α of 0.895), and the scale-level content validity was 0.846 (S-CVI/Ave). Agreement (score average ≥4 and CV<0.3) was reached for the inclusion of 14/20 (70%) of the items, while suggestions for proposed for modification were made on 6/20 (30%) items. No item was added or deleted after this round, as agreement was not reached for inclusion or exclusion of any item. The wording of five items was revised, and core concepts of two items were supplemented. See online supplemental 3 for details on the Delphi consultations.
Guideline Implementation Success Assessment Tool
When the first three steps were completed, the secretary group reviewed the dimensions and items. Subsequently, refinements were made to the interface design, and a comprehensive user manual was compiled.
The resultant A-GIST comprises five dimensions and twenty items, including Reach (three items), Adoption (four items), Implementation (two items), Effectiveness (five items) and Maintenance (three items). Collectively, they form a holistic approach to evaluating the success of CPGs implementation, along with an analysis of barriers and facilitators to implementation (one item), an overarching evaluation item (one item), as well as suggestions to improve the implementation of the guideline (one item). The dimensions and items of A-GIST are listed in table 4. Please refer to online supplemental 4 for detailed description and given options.
Supplemental material
Dimensions and Items of A-GIST
In order to facilitate the investigation, the A-GIST practical file was designed, including the questionnaire for clinicians and the questionnaire for patients. The questionnaire for clinicians includes two main sections: (a) basic information; (b) evaluation items. For patients, it includes three main sections: (a) basic information; (b) evaluation of patient outcomes and (c) quality of life. The full score of A-GIST was 100, and the scores of each dimension ranged from 0 to 100.
Clinicians and patients applicable in healthcare facilities are the target users of A-GIST. Referring to the requirements of RE-AIM framework for the interventions under evaluation, A-GIST is universally applicable to all CPGs: (1) without restrictions on the diseases or health conditions they pertained to; (2) provided that they have been published for a minimum period of 1 year and (3) represent the most updated version.41
Designed to engage both clinicians and patients, the tool can be used in a survey that entails a concurrent methodology, administering questionnaires to both groups simultaneously. Sample of the participants should be calculated using the sample estimation equation for a cross-sectional study. The consolidated data from these twin perspectives is then amalgamated to derive a final score, indicative of the degree of success of CPGs implementation in real-world settings.
Research to verify the reliability and validity of A-GIST, and an empirical study carried out on a nationwide scale in China have been conducted. Relevant reports have been peer-reviewed for publication.42 Cross-sectional studies to evaluate the success of implementation of three guidelines using A-GIST will be published in the near future to serve as a detailed reference for the usage of the tool, in particular the selection of respondents and the calculation of scores. See online supplemental 4 for a comprehensive overview of A-GIST and its manual.
Compared with other evaluation tools for the implementation issues of guidelines, A-GIST stands out by focusing on the success of implementation in practice rather than the characteristics of the guidelines themselves.23 43 Grounded in the RE-AIM framework, it integrates both clinician and patient perspectives to comprehensively evaluate guideline implementation across 5 dimensions and 20 items (table 5).
Comparison with other guideline implementation evaluation tools for general context
Discussion
Through a four-stage development methodology, a generalised, comprehensive tool A-GIST was developed for evaluating the success of CPGs implementation,25 44 addressing the pressing need for evaluation and improvement of CPGs implementation in routine clinical practice across various levels of healthcare institutions. Assessing the implementation success of CPGs in this context, it could offer valuable insights into the quality and effectiveness of healthcare delivery in medical institutions.
Compared with previous tools, A-GIST incorporated key dimensions essential for a comprehensive assessment of CPGs implementation success, based on the RE-AIM framework, especially the maintenance of implementation, which was often overlooked in previous research. Furthermore, this comprehensive assessment integrates perspectives from both clinicians and patients. The success of CPGs implementation is best evaluated by considering the distinct yet complementary perspectives of these stakeholders, who experience different aspects of guideline adherence and impact. The preliminary list of items was informed by a systematic review of existing measures, to incorporate patient evaluation on guideline implementation outcomes, though patients were not directly involved in the tool development process. This patient-centred approach enhances the holistic understanding of CPGs implementation and reflects the commitment to patient concerns and the principles of patient-centred care.45 In addition, with the help of A-GIST, researchers could identify important practice gaps in the process of guideline implementation, which can help in the design of targeted strategies to promote implementation outcomes.
There are several strengths of A-GIST. First, it is developed based on the RE-AIM framework from implementation science, which captures the full process of guideline implementation. This foundation enables structured, comprehensive evaluations that are both clear and easy to apply. Second, by integrating the perspectives of patients, A-GIST not only considers the viewpoints of healthcare professionals but also delves into understanding the influences and feedback from patients in the context of CPGs implementation. The comprehensive evaluation ensures that our assessment of CPGs implementation extends beyond the medical perspective, overcoming the limitations of possible bias introduced by single-perspective evaluation from clinicians only. Third, the generalisability was a key consideration during the development. On one hand, it is designed to be applicable across CPGs of different medical conditions, allowing for the comparison between CPGs in their implementation effects. On the other hand, it is suitable for comparison across different healthcare institutions, providing insights into the differences in the success of implementation of a CPG among health institutions at the same level or across various levels (primary healthcare, secondary or tertiary hospitals) and geographic regions, helping to identify deficiencies and priorities of intervention.
Despite the strengths, there are still some limitations. First, given the diverse medical conditions targeted by different CPGs and different fields (such as prevention, diagnosis or treatment), it was challenging to include objective clinical outcome measurements applicable to all scenarios. In order to adapt the tool to more situations, A-GIST focuses on general indicators of the implementation, prioritising flexibility over specificity. Future development of the tool series may address this limitation by integrating disease-specific core clinical indicator sets, thereby enhancing the tool’s objectivity and relevance for specific disease fields.
Second, while patient perspectives were considered during the tool development, the lack of patient involvement in the development process is a limitation. Future work could be strengthened by involving patient representatives in the international adoption or refinement of the A-GIST, thereby advancing the tool’s inclusiveness and comprehensiveness.
Finally, the development process of the tool was conducted in Chinese. The Chinese version of the tool was finalised and then translated into English by the research team. Though we have involved leading experts with strong backgrounds in evidence-based medicine, nursing and pharmacy, the reliance on a single linguistic and cultural context may have introduced biases, limiting its applicability to other language and culture settings. Differences in healthcare systems, culture and values could influence how the tool’s indicators are interpreted. To address these limitations, future studies should be conducted for language and cultural adaptations, involving international experts in the validating and revision of the tool, and conducting pilot testing in diverse healthcare contexts. Such efforts will be vital to ensure that the A-GIST is both linguistically accurate and culturally relevant across various global contexts.
In summary, A-GIST represents an important advancement as a new generalised tool for evaluating the success of CPGs implementation. Future work will focus on enhancing the tool’s adaptability for international use by inviting global experts to its revision and validating it in diverse cultural and healthcare contexts. Additionally, efforts to integrate disease-specific indicators and to invite patient participation in the revision of the tool will further enhance its utility and inclusivity. Besides, research on A-GIST’s impact on CPGs adherence and healthcare quality improvements postimplementation will be crucial for ensuring its relevance, providing empirical evidence of its effectiveness as a feedback intervention beyond evaluation use.
Conclusions
A generalised A-GIST, based on RE-AIM framework, has been developed to assess the success of CPGs implementation. A-GIST provided comprehensive assessment of the whole process of guideline implementation including Reach, Adoption, Implementation, Effectiveness and Maintenance. With its robust theoretical ground, universal applicability, and multiperspective approach, A-GIST provides a useful tool for guideline developers, researchers and practitioners to compare the success of implementation across CPGs, healthcare facilities and geographical regions, providing insights into the weaknesses in the implementation process and facilitating design of improvement strategies.
Data availability statement
Data sharing not applicable as no datasets generated and/or analysed for this study.
Ethics statements
Patient consent for publication
Acknowledgments
We sincerely thank all the experts of the A-GIST Development Group for their valuable contributions throughout the development of the A-GIST (the full list is provided in Supplement 1). We also sincerely appreciate the staff of the Medical Management Service Guidance Center of National Health Commission of P.R.China for their support and efforts in facilitating the progress of this project.
References
Footnotes
KZ and NY are joint first authors.
KZ and NY contributed equally.
Contributors KZ, NY and SH were responsible for the searching of the systematic review, data extraction and analysis, drafting the preliminary list, assisting in organising the expert consultation meetings, and designing the Delphi consultation forms. They also collected expert opinions and conducted statistical analysis to revising the tool. KZ and NY were the primary contributors to manuscript writing. LZeng and HL helped to review the manuscript and improve the writing. LZeng, LH, HL and QY made significant contribution to the brainstorming method to determine the preliminary list, and adjusting the tool for applicability and readability. XG, JR and MZ assisted in the literature search and selection in systematic review. QW and LZhang oversaw the overall project progress and quality, organised face-to-face expert consultation meetings and coordinated with experts to complete the Delphi consultation. As guarantors of this work, QW and LZhang accept full responsibility for the study, had access to all data, and controlled the decision to publish.
Funding The whole development work received funding support from National Health Commission Project of China No. (2022)047.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.