Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.
Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.
The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
IDEAL framework and recommendations provide a scientific and integrated evaluation pathway for surgical innovations and other complex therapeutic interventions, and underline that the preliminary studies are needed to prepare for a successful randomized controlled trial. IDEAL framework provides a series of recommendations in terms of nature stages of surgical innovation. We have reported the introduction and reporting guidelines of the IDEAL framework and recommendations in our IDEAL series paper. This paper aimed to provide some empirical evidence, focusing specifically on stages 2a and 2b, to help surgeons and researchers to understand how to imply IDEAL framework and recommendations into their clinical practice.
ObjectiveTo provide recommendations for the management of intensive care unit patients without novel coronavirus disease 2019 (COVID-19).MethodsWe set up a focus group urgently and identified five key clinical issues through discussion. Total 23 databases or websites including PubMed, National Guideline Clearing-House, Chinese Center for Disease Control and Prevention and so on were searched from construction of the library until February 28, 2020. After group discussion and collecting information, we used GRADE system to classify the evidence and give recommendations. Then we apply the recommendations to manage pediatric intensive care unit in the department of critical care medicine in our hospital. ResultsWe searched 13 321 articles and finally identified 21 liteteratures. We discussed twice, and five recommendations were proposed: (1) Patients should wear medical surgical masks; (2) Family members are not allowed to visit the ward and video visitation are used; (3) It doesn’t need to increase the frequency of environmental disinfection; (4) We should provide proper health education about the disease to non-medical staff (workers, cleaners); (5) Medical staff do not need wear protective clothing. We used these recommendations in intensive care unit management for 35 days and there was no novel coronavirus infection in patients, medical staff or non-medical staff. ConclusionThe use of evidence-based medicine for emergency recommendation is helpful for the scientific and efficient management of wards, and is also suitable for the management of general intensive care units in emergent public health events.
In order to monitor the emotional state changes of audience on real-time and to adjust the music playlist, we proposed an algorithm framework of an electroencephalogram (EEG) driven personalized affective music recommendation system based on the portable dry electrode shown in this paper. We also further finished a preliminary implementation on the Android platform. We used a two-dimensional emotional model of arousal and valence as the reference, and mapped the EEG data and the corresponding seed songs to the emotional coordinate quadrant in order to establish the matching relationship. Then, Mel frequency cepstrum coefficients were applied to evaluate the similarity between the seed songs and the songs in music library. In the end, during the music playing state, we used the EEG data to identify the audience’s emotional state, and played and adjusted the corresponding song playlist based on the established matching relationship.
The prevention and control of COVID-19 has entered a critical moment. “Disease control of 2019 novel coronavirus infection in hospital: West China urgent recommendation” based on the best available evidence and expert experience, provided emergency recommendations for key clinical issues in hospital prevention and control during the COVID-19 epidemic. This recommendation with strong reference value and timeliness is worth learning for hospital managers, sensory control personnel and medical staff at all levels. All medical institutions should establish an emergency response mechanism to accelerate the formation of medical teams and strengthen the protection of medical staff and hospital infection control. We should enhance the implementation of policy and reinforce risk assessment. It is essential to strengthen the implementation of various prevention and control measures as well as risk assessment so as to eventually win the battle of coronavirus infection as soon as possible.
Mitral valve replacement is one of the most common heart valve surgeries in China. In recent years, with the increase in degenerative valve diseases, older patients, and the progress of anti-calcification technology of biological valves, the proportion of mitral valve biological valve replacement has been increasing year by year. After the damage of traditional mitral valve biological valves, re-operation of valve replacement with thoracotomy is required. However, the adhesion between the heart and sternum, as well as the damage caused by cardiopulmonary bypass and cardiac arrest, can cause significant trauma to elderly patients and those with multiple organ dysfunction, leading to increased mortality and complication rates. In recent years, interventional valve surgery, especially transcatheter valve-in-valve surgery, has developed rapidly. This procedure can correct the damaged mitral valve function without stopping the heart, but there are still many differences between its technical process and conventional aortic valve replacement surgery. Therefore, organizing and writing multicenter expert recommendations on the technical process of transcatheter valve-in-valve surgery for damaged mitral valve biological valves is of great significance for the training and promotion of this technology.
To introduce the definition, applicable scenarios, methodology and examples of mixed methods systematic reviews, aiming to promote the application of mixed methods in China and to help clinical decision-makers to select appropriate qualitative results from systematic reviews to guide clinical practice.
In the process of formation of recommendations of clinical practice guidelines, experts have many difficult problems of lack of transparency and high subjectivity in making final decisions, such as incomplete comprehensive consideration of dimensions and great heterogeneity in the evaluation of importance between dimensions, etc. As a decision-making tool, multi-criterion decision analysis improves the decision-making level of recommendation by adding the combination of qualitative and quantitative methods. By analyzing the challenges facing the formation of recommendations, this paper introduces the decision assistance of multi-criterion decision, and analyzes and summarizes the advantages and methods of the application of multi-criterion decision, so as to provide reference and guidance for guide makers to solve the difficulties in the formation of recommendations.