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 The number of out-of-date reviews is probably increasing.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between publishing a protocol and the completed review is usually completed in no longer than two years, the number of out-of-date reviews and protocols requires continuing attention.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.
Medication adherence will directly affect the validity of primary endpoint indicator. This article discussed how to improve the medication adherence of clomiphene citrate based on PCOSact. We found that 20 (3+15+2) cases were "protocol violation" and there were cases in which researchers made mistakes while distributing medicine and guiding patients how to take medicine. Focusing on these problems we sumed up experience and emphasized the importance of medication compliance through the following aspects:(1) Improvement of insite supervision and remote monitoring; (2) Standardization training for research assistants; (3) Health education for subjects.
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.
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 promote the clinical diagnosis and treatment of obstructive sleep apnea (OSA) in Chinese children, it is urgent to construct evidence-based guidelines. The protocol and a formal version of the “Chinese guideline for Diagnosis and Treatment of Obstructive Sleep Apnea in Children” will be drawn up by referring to the “World Health Organization Guidelines Development Manual”. This protocol mainly introduces development methodology and process of guideline, including the significance, purpose, target population, users, members of the designated group, collection and determination of clinical problems and outcome indicators, evidence acquisition, evaluation and synthesis, the generation of recommendations and so on.
With the continuous aging of the population in China, the aging of skeletal muscle in the elderly has seriously affected national health and poses a severe challenge to the public health system. Early detection of skeletal muscle aging, and early warning, prevention, and treatment are of great significance for achieving healthy aging. In order to select a series of clinically operable biomarkers for skeletal muscle aging, and to further standardize the early identification and precise diagnosis of skeletal muscle aging, a multidisciplinary team of experts has registered and written this protocol to provide a detailed introduction to the planning process for the development of the consensus.
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.
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.
Rapidly advancing demographic aging in China has led to an increasing prevalence of terminal patients suffering from malignant tumors and chronic diseases, thereby escalating the demand for palliative care services. Palliative care is a multidisciplinary comprehensive management model for patients in the terminal stage and at the end of life. It aims to effectively alleviate the patients' painful symptoms, improve their quality of life, and ensure their comfortable and dignified departure. Symptom control is at the core of palliative care, and rational drug use is the foundation of symptom control. The complexity of physical and psychological factors in terminal patients and the ethical background pose significant challenges to rational drug use. In addition, elderly hospice patients usually suffer from multiple diseases, and their physiological functions decline, resulting in specific pharmacokinetics and reactivity, which undoubtedly increases the complexity of medical decision-making, making doctors often face multiple medication challenges during the treatment process, which in turn poses potential drug treatment risks. Based on current evidence, a multidisciplinary team led by geriatricians registered and drafted the "Protocol for Medication Guideline for Symptom Management in Elderly Hospice Care (2025)". This paper provides a detailed introduction to the planning process for the development of the guidelines.
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.