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.
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.
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 protocol of rational use of oral H1 receptor antagonists in children: a clinical practice guideline primarily introduces key methods, processes and precautions of the guideline to standardize and guarantee the formulation of this evidence-based guideline. Referring to the World Health Organization Guidelines Development Manual, the guideline will be conducted according to the following steps, which involves the establishment of project group; registration (IPGRP-2020CN110); declaration of interest and funding support; identification of the clinical issues and outcomes; evidence retrieval, assessment, synthesis and utilization; investigation of patients’ preferences and values; development, external review and revision of recommendations; guideline release, dissemination and update.
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.
High quality clinical trial depends on the preliminary research design and optimizing, the quality control in the medium term, the source data verification and statistics in later stages. Steering committee (SC) can meet above requirements. According to the characteristics of the research project, we invited international experts whose professional background are obstetrics and gynecology, statistics and methodology to set up SC. SC will hold regular conference, the content of the conference included project progress and quality control, research assistant training and assessment, conducting knowledge lectures and so on. The establishment of SC ensured the protocol maneuverability, answered PCOS related problems from different professional perspectives, and solved the problems such as how to improve the scientific research output. At the same time, it provides a platform of scientific research practice and self-improvement. It has profound influence on standardizing the management of the clinical trial, strengthening the consciousness of team work, promoting multi-disciplinary team cooperation, expanding scientific research thinking and cultivating clinical research talent.
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.
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.
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.
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.