For the purposes of promoting the effect of secondary prevention of myocardial infarction, and improving the compliance with myocardial infarction (MI) secondary prevention, a guideline for strengthening patients self-management on non-pharmacological secondary prevention was produced by an multidiscipline team leaded by Chinese Association of Integrative Medicine clinical cardiovascular branch, Lanzhou University Evidence-Based Medicine Center, Peking University School of Nursing, Tianjin University of Traditional Chinese Medicine and Beijing University of Chinese Medicine. This is the first version of patient guideline in China. This paper introduces the main methods, processes and characteristics of the patient guideline development. It will provide reference to future researchers to the development of the patient guideline.
Objective To calculate the typical time taken to complete protocols and reviews, to track how often reviews are updated and compare with Collaboration policies, to feed back any gaps in documentation of dates to individual Cochrane Collaborative Review Groups, and to suggest changes to presentation of reviews and to editorial processes.Methods Data were extracted either from The Cochrane Library or a specially constructed database to calculate the age of reviews and protocols, and the frequency of updating of reviews. Issue 1, 2003, with 1 596 reviews and 1 200 protocols, was used as the index issue.Results Median number of issues between a protocol and its completed review being published on The Cochrane Library is 5 (1.25 years). 65% of protocols have appeared on The Cochrane Library for no longer than two years, but the number of protocols more than two years old is probably increasing. One-third of reviews have been substantively updated, but generally only once and often within several months of the first publication of the review. The number of out-of-date reviews is probably increasing. Conclusions While the stage between publishing a protocol and the completed review is usually completed in no longer than two years, the number of out-of-date reviews and protocols requires continuing attention. How up-to-date a review is depends on when the evidence base was last searched and when additional relevant evidence has been integrated into the review. This needs to be reflected in the information provided to readers of Cochrane Reviews and some alternative ways of presenting the components of this information are given. More accurate and complete reporting will also allow the Collaboration to track progress against policy.
Objective To compare the advantages between SmartCare weaning and protocoldirected weaning in COPD patients regarding five aspects including comfort degree of COPD patients in weaning stage, workload of medical staff, weaning success rate, weaning time, and complications associated with mechanical ventilation. Methods COPD patients who’s planning to receive ventilation weaning were randomly divided into a SmartCare weaning group ( SC group) and a protocol-directed weaning group ( SBT group) . The comfort degree of patients and workload of medical staff were assessed by the visual analogue scale ( VAS) as the weaning plan started. 0 was for the most discomfort and maximal workload, and 10 was for the most comfort and minimal workload. Data fromthe following aspects had been recorded: times of blood gas analysis, weaning success rate, weaning time, self-extubation rate, the rate of re-intubation within 48 hours, and ventilator-associated pneumonia ( VAP) incidences. Results 40 patients were selected and divided into the SC group ( n =19) and the SBT group ( n =21) . There was no significant difference in the enrolled age and APACHEⅡ between two groups. The VAS scores was higher in the SC group than that in the SBT group in the first three days ( Plt;0.01) . The weaning time was shorter in the SBT group than that in the SBT group [ ( 4.7 ±2.7) days vs. ( 5.5 ±3.2) days] , without significant difference between two groups ( P gt;0.05) . There were no differences in times of blood gas analysis, weaning success rate, weaning time, self-extubation rate, the rate of re-intubation within 48 hours, and ventilator-associated pneumonia ( VAP) incidences between two groups ( P gt; 0.05) .Conclusion As compared with protocol-directed weaning, SmartCare weaning can increase comfort degree of patients and reduce the workload of medical staff with similar weaning success rate, weaning time, and complications associated with mechanical ventilation.
To assess the efficacy and safety of thrombolytic therapy. Electronic search was applied to the Cochrane Airways Group register (MEDLINE, EMBASE, CINAHL standardized searches) with the date up to 2003 April. Hand searched respiratory journals and meeting abstracts. All randomized controlled trials comparing thrombolytic therapy with heparin alone or surgical intervention (eg. embolectomy) met the inclusion criteria. Two reviewers independently selected trials, assessed trial quality and extracted the data.
Since its initial publication in 2013, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines have received widespread international attention. The guidelines aim to enhance the standardization and transparency of clinical trial protocol reporting. With continuous advancements in clinical trial methodologies, the SPIRIT group released an updated version, SPIRIT 2025, in 2025. The SPIRIT 2025 reporting guideline comprises 34 items; compared with the 2013 version, 2 items were added, 5 were revised, 2 were merged, and 3 were deleted. Its core updates are reflected in: the addition of an "open science" section, which emphasizes trial registration, accessibility of the trial protocol and statistical analysis plan, a data sharing statement, and a dissemination policy for research findings; the addition of a "patient and public involvement" item, which requires the protocol to describe the participation of patients or the public in the trial's design, conduct, and reporting phases; structural optimization, which reorganizes the original items into five major sections for clearer logic and strongly recommends the use of a schedule diagram to present the trial timeline. This article provides an illustrative interpretation of the items contained in the SPIRIT 2025 statement using a randomized controlled trial protocol, aiming to offer guidance and convenience for domestic researchers utilizing this tool.
Objectives
To explore potential important factors that impacts the quality of Chinese trials.
Methods
We randomly selected clinical studies registered in the Chinese Clinical Trial Registry during March 15th, 2016 to December 31st, 2016. The randomized controlled trials protocols were retrieved to assess the quality based on the SPIRIT guideline, their data management plan and statement of sharing individual participant data were also investigated.
Results
457 studies were randomly selected from 2 205 studies by a rate of 1∶4. Among them, 393 were randomized controlled trials. Pre-market trials of new medicines conducted by the State Clinical Study Bases had better quality of protocols. In total, 4 protocols were rated as high quality (1.02%) and 21 as higher quality (5.34%). 129 studies in 457 (28.23%) described a correct data management system including a paper case record form and an electronic data capture. 392 studies (85.77%) stated that public sharing IPD will be available.
Conclusions
Poorly developed protocol and lack of professional data management system are common issues in some Chinese clinical studies. We feel confident that most Chinese investigators are good in learning considering that they are willing to share the IPD of their studies. Providing education and technical support focus on three technical aspects are crucial: introducing SPIRIT for developing protocol, providing standardized data management system, and introducing the concept of transparency include sharing IPD which is an essential requirement of clinical study ethics.
In order to develop the clinical practice guideline (CPG) of intra-articular injection for knee osteoarthritis, based on the definition of Institution of Medicine (IOM) about CPG, the WHO handbook, the GRADE instrument, the AGREE Ⅱinstrument, and the Right for Reporting CPG, Chinese Orthopaedic Association,Chinese Journal of Orthopaedics, Arthritis Clinic and Research Center of Peking University People’s Hospital, Chinese GRADE Center established the guideline working groups and develop protocol of the guideline.
ObjectiveTo conduct a Meta-analysis to determine the clinical effect of protocol biopsy (PB)-monitored therapy after renal transplantation.MethodsPubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Standards Database and VIP Database for Chinese Technical Periodicals were searched for trials comparing the efficacy of timely intervention under PB surveillance with the conventional treatment. The quality of included studies was assessed and Meta-analysis was conducted by RevMan 5.3 software.ResultsSix randomized controlled trials met our inclusion criteria, including 698 cases. No significant difference was found between the PB group and the control group in 1-year [relative risk (RR)=0.99, 95% confidence interval (CI) (0.97, 1.01), P=0.39] and 2-year recipient survival rate [RR=1.00, 95%CI (0.97, 1.02), P=0.72]. Graft survival rate after 1 year [RR=1.01, 95%CI (0.99, 1.04), P=0.29] and 2 years [RR=1.02, 95%CI (0.99, 1.06), P=0.19] were also statistically similar. No statistical difference was found in glomerular filtration rate between the two groups [mean difference (MD)=0.45 mL/(min·1.73 m2), 95%CI (–3.77, 4.67) mL/(min·1.73 m2), P=0.83]. Renal function of PB group, monitored by serum creatinine, was superior to the control group [MD=–0.46 mg/dL, 95%CI (–0.63, –0.29) mg/dL, P<0.000 01]. No statistical difference was found in infection between the two groups [RR=1.23, 95%CI (0.69, 2.19), P=0.48].ConclusionsOur study did not suggest PB for every kidney transplantation recipient. However, long-term randomized controlled trials with larger sample size would be necessary to determine whether PB was effective for specific populations.
Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.
The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.
