Effectiveness-implementation hybrid designs can test the effectiveness of interventions and the outcomes of implementation strategies concurrently and accelerate the transformation of research results into routine practice. This paper introduced three types of effectiveness-implementation hybrid designs and corresponding reporting guidelines, including standards for reporting implementation studies, cluster randomized design and CONSORT 2010, stepped-wedge cluster randomized design and extended version CONSORT 2018, qualitative research and COREQ reporting guideline, and provide references for domestic researchers to produce research reports on effectiveness-implementation hybrid design.
Evidence-based evidence translated into health care services requires three conversion processes, preclinical research-clinical research-implementation research, which might take a very long time. In order to speed up the process of research results translated into daily medical practice and health policy, an effectiveness-implementation hybrid design combining the effectiveness research of clinical and implementation research was emerging. This paper introduced the concept, classification and application of effectiveness-implementation hybrid design, to provide references for researchers in this area.
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.
The consolidated framework for implementation research (CFIR) extracted, analyzed and integrated many published theories, frameworks and models of implementation research, and provided a comprehensive and practical theoretical framework for researchers to explore the influencing factors in the implementation of evidence. This paper introduces the origin, core content and application examples of CFIR in evidence-based nursing practice, in order to provide reference for researchers to use CFIR to carry out implementation research.
The consolidated framework for implementation research (CFIR) is one of the most commonly used theoretical frameworks for implementation science. The updated CFIR was optimized based on the original version. The background, process and contents of the updated CFIR were introduced, and the domains and constructs of the updated CFIR were interpreted in this article. We analyzed the similarities and differences of the updated CFIR compared with the original CFIR, in order to provide methodological references for Chinese researchers to explore the determinants of implementation.
The RE-AIM framework is the most commonly used framework for implementation research outcome evaluation, with the original paper cited 2 800 times. However, in the specific operationalization process of the framework, there are often situations of misuse or overuse of various dimensions and indicators. This article provides a detailed introduction to the main content, application scenarios, and characteristics of the RE-AIM framework. Taking the implementation research of Evidence-based Practice Guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Stroke as an example, it introduces how to use the silent & anonymous feedback technology, which combines the improved Delphi method and nominal group technique, to construct an implementation outcome indicator evaluation system to achieve the operability of the RE-AIM framework. This will provide a reference for other researchers to use implementation science theories, models, and frameworks to develop implementation plans or evaluate implementation outcomes.
ObjectiveTo summarize the evaluation tools for the implementation effect of clinical practice guidelines (CPGs), to inform and support the evidence-based development of a general tool for the evaluation of implementation effect of CPGs. MethodsSeven biomedical literature databases, including PubMed, Embase and CNKI, and two academic websites, were searched from establishment to June 2022. Theoretical and empirical research on the evaluation tools of the implementation effect of CPGs were included. Two researchers independently screened literature and extracted data according to the inclusion and exclusion criteria. Based on the Implementation Science RE-AIM theoretical framework, an evaluation framework and a list of alternative items of the implementation effect of the CPGs were initially drawn up by thematic synthesis methods. ResultsA total of 208 articles were included, and 8 mature evaluation tools related to the implementation effect of guidelines were selected. Current research on the evaluation of the implementation effect of CPGs mainly focused on single diseases, with concern of the cognition, attitude and compliance of users to CPGs, and the process of the implementation of CPGs and factors affecting the implementation effect of CPGs. There were limitations such as a lack of evaluation on the terminal effect of the implementation of CPGs, the rare use of mature theoretical frameworks, the use of single evaluation perspectives, and inclusion of limited evaluation dimensions. The initial proposed evaluation framework contains a list of alternative items with 6 primary indicators, 12 secondary indicators and 41 tertiary indicators. ConclusionCurrently, there is a lack of a comprehensive, multi-perspective, mature theory based, general tool for the evaluation of implementation effect of CPGs. The framework and the list of alternative items for the evaluation of implementation effect of CPGs based on the implementation science RE-AIM theory can inform and support the development of a tool for the evaluation of implementation effect of CPGs.
With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.
Objective To review main obstacles to health care professionals' adherence to clinical practice guidelines (CPGs) by employing the scoping review method and a determinants framework, and to explore the effect of implementation strategies in intervention researches on guideline adherence. Methods The articles published from January 1, 2011 to June 10, 2023 were retrieved from the PubMed, CINAHL, MEDLINE, Embase, Scopus, Cochrane Library, SinoMed, CNKI, WanFang Data and VIP databases. The original literature on the CPGs implementation obstacles and strategies was included, and the primary and secondary screening of the literature were completed by four researchers according to the inclusion and exclusion criteria. The basic characteristics of the literature, the factors affecting the implementation of the CPGs, and the strategies used were extracted. The results were analyzed and summarized using qualitative and quantitative methods. Results A total of 61 articles were included in the scoping review. The factors affecting the implementation of CPGs could be divided into five categories: guidelines themselves, external factors, internal factors, individual factors, and implementation process. The most common implementation obstacles were insufficient knowledge or skills of professionals regarding guidelines (n=21, 34.4%), insufficient necessity of using guidelines according to doctors (n=17, 27.9%), and unreasonable factors within hospital (n=16, 26.2%). The factors that promoted the implementation of CPGs included guidelines based on high-quality evidence (n=5, 8.2%), good department or hospital culture (n=4, 6.6%), convenient accessibility of guideline knowledge and information (n=4, 6.6%), and doctors’ excellent professional ability (n=4, 6.6%). The overall effectiveness of the guideline implementation strategy was 50%. Clinical decision support system (CDSS) could improve the adherence of CPGs. Guideline education or training was one of the most commonly used methods, but the effect of improving guideline compliance was unstable. Conclusion The primary challenges in implementing guidelines include inadequate professional capacity and demand, suboptimal hospital infrastructure and limited resources. However, the obstacles are not absolute. It is recommended to use implementation strategies to improve the absorption and implementation of guidelines, among which CDSS is an effective measure for promoting guideline adherence.
N-of-1 trial design offers a methodologically sound approach to determining optimum treatment for an individual patient and solves some limitations of randomized controlled trials. This design could offer an efficient method of reaching a personal treatment regime tailored to suit individual needs and preferences. The paper introduces practical application, objects and the implementation process of N-of-1 trial, to explore its design points and implementation.