Abstract:
BACKGROUND:In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). METHODS:A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. RESULTS AND DISCUSSION:The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. CONCLUSIONS:Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.
journal_name
Trialsjournal_title
Trialsauthors
Zhao L,Liang FR,Li Y,Zhang FW,Zheng H,Wu Xdoi
10.1186/1745-6215-10-123subject
Has Abstractpub_date
2009-12-27 00:00:00pages
123issn
1745-6215pii
1745-6215-10-123journal_volume
10pub_type
杂志文章相关文献
Trials文献大全abstract:BACKGROUND:Dietary interventions have limited success in promoting sustainable weight loss; new treatments allowing better compliance with hypocaloric diets should be developed. The aim of this trial is to describe the effects of a protocol combining repetitive active transcranial direct current stimulation (tDCS) with...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2776-3
更新日期:2018-07-16 00:00:00
abstract:BACKGROUND:Announcements of interim analyses of a clinical trial convey information about the results beyond the trial's Data Safety Monitoring Board (DSMB). The amount of information conveyed may be minimal, but the fact that none of the trial's stopping boundaries has been crossed implies that the experimental therap...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-15-73
更新日期:2014-03-07 00:00:00
abstract:BACKGROUND:The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-sc...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0996-3
更新日期:2015-10-15 00:00:00
abstract:BACKGROUND:Randomised clinical trials are the 'gold standard' for evaluating the effectiveness of healthcare interventions. However, successful recruitment of participants remains a key challenge for many trialists. In this paper, we present a conceptual framework for creating a digital, population-based database for t...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-016-1381-6
更新日期:2016-05-26 00:00:00
abstract:BACKGROUND:Quadriplegia is a severe, catastrophic injury that predominantly affects people early in life, resulting in lifelong physical disability. Obstructive sleep apnoea is a direct consequence of quadriplegia and is associated with neurocognitive deficits, sleepiness and reduced quality of life. The usual treatmen...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-181
更新日期:2013-06-19 00:00:00
abstract:BACKGROUND:Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-14-219
更新日期:2013-07-17 00:00:00
abstract:BACKGROUND:Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65 years and above. More effective ways to manage dementia symptoms are needed because current treatment options (antidepressants and antipsychotics) can...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4085-x
更新日期:2020-02-14 00:00:00
abstract:BACKGROUND:Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular fe...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-260
更新日期:2011-12-14 00:00:00
abstract:BACKGROUND:The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilat...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-285
更新日期:2014-07-15 00:00:00
abstract::The period toward the end of patients' participation in late stage blinded clinical trials is highly resource intensive for the sponsor. Consider first a Phase 3 trial. If the trial is a success, the sponsor has to implement the next steps, which might be filing for approval of the drug with the US Food and Drug Admin...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-016-1465-3
更新日期:2016-07-20 00:00:00
abstract:BACKGROUND:A variety of videolaryngoscopes with angulated blade have been recently introduced into clinical practice. They provide an indirect view of the glottic structures in normal and challenging clinical settings. Despite the very good visualization of the laryngeal structures by these devices, the insertion and a...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-298
更新日期:2013-09-16 00:00:00
abstract:BACKGROUND:Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this s...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0673-6
更新日期:2015-04-10 00:00:00
abstract:BACKGROUND:Asylum seekers and refugees are at great risk for developing mental disorders. Afghan refugees are a particularly vulnerable group with a low average education and mental health literacy level. Traumatic experiences and hardship before and during migration are predictive of mental health problems. However, p...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-019-3839-9
更新日期:2020-01-09 00:00:00
abstract:BACKGROUND:This descriptive study aimed to investigate adolescents' motivations for participating in a randomised controlled trial (RCT), to explore the understanding that the young people had regarding a number of aspects of the trial design, to examine whether or not they found participation in the trial to be accept...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1474-2
更新日期:2016-07-28 00:00:00
abstract::Tuberculosis (TB) remains a major killer amongst the infectious diseases. Current treatment involves a four-drug regimen for at least 6 months. New drugs and regimens are required to shorten treatment duration, reduce toxicity and combat drug resistance, but the optimal methodology to define the critical path for nove...
journal_title:Trials
pub_type: 杂志文章,meta分析,评审
doi:10.1186/s13063-015-1050-1
更新日期:2015-11-14 00:00:00
abstract:BACKGROUND:Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However,...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-199
更新日期:2012-10-26 00:00:00
abstract:BACKGROUND:Diabetic foot ulcers (DFUs) represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all admi...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-8
更新日期:2013-01-09 00:00:00
abstract:BACKGROUND:Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4094-9
更新日期:2020-03-04 00:00:00
abstract:BACKGROUND:Generalised anxiety disorder (GAD) is a chronic and debilitating condition characterised by high co-morbidity. Alongside pharmacological treatment, cognitive behavioural therapy (CBT) is an established psychological therapy for GAD. Its effectiveness is limited, however, with only an estimated 50% of clients...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2892-0
更新日期:2018-09-19 00:00:00
abstract:BACKGROUND:Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota-gut-brain axis. However, the exact mechani...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-4040-x
更新日期:2020-02-11 00:00:00
abstract:BACKGROUND:Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04396-x
更新日期:2020-06-08 00:00:00
abstract:BACKGROUND:Neck pain caused by cervical spondylosis (CS) has become one of the most common health problems around the world. Electroacupuncture (EA) has been employed to relieve CS neck pain, but there is limited clinical evidence for its effectiveness. METHODS/DESIGN:This study consists of a randomized controlled tri...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-360
更新日期:2013-10-29 00:00:00
abstract:BACKGROUND:Maori, the indigenous people of New Zealand, who present to hospital after intentionally harming themselves, do so at a higher rate than non-Maori. There have been no previous treatment trials in Maori who self harm and previous reviews of interventions in other populations have been inconclusive as existing...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-117
更新日期:2011-05-11 00:00:00
abstract:BACKGROUND:Intrathecally administered morphine is effective as part of a postoperative analgesia regimen following major hepatopancreaticobiliary surgery. However, the potential for postoperative respiratory depression at the doses required for effective analgesia currently limits its clinical use. The use of a low-dos...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2370-0
更新日期:2017-12-29 00:00:00
abstract:BACKGROUND:Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the effica...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3770-0
更新日期:2019-12-16 00:00:00
abstract:BACKGROUND:The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. METHO...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2534-6
更新日期:2018-03-15 00:00:00
abstract:BACKGROUND:Approximately 40% of the newly diagnosed patients with advanced ovarian cancer are aged 70 years or older. Standard treatment for advanced disease consists of cytoreductive surgery and combination chemotherapy. In older patients, standard treatment is often withheld or prematurely stopped due to suspected fr...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4157-y
更新日期:2020-02-22 00:00:00
abstract:BACKGROUND:The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporti...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2335-3
更新日期:2017-12-22 00:00:00
abstract::Data sharing from clinical trials is one way of promoting fair and transparent conduct of clinical trials. It would maximise the use of data and permit the exploration of additional hypotheses. On the other hand, the quality of secondary analyses cannot always be ascertained, and it may be unfair to investigators who ...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-017-1816-8
更新日期:2017-02-14 00:00:00
abstract:BACKGROUND:The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi (a specific and compound sensation during the acupuncture), which is necessary to achieve the best therapeutic effect. However, the notion that de qi must be achieved for maximu...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-301
更新日期:2014-07-24 00:00:00