Abstract:
BACKGROUND:Current management for men with lower urinary tract symptoms (LUTS) is a pathway that results in prostate surgery in a significant proportion. While helpful in relieving benign prostatic obstruction (BPO), surgery may be ineffective for men suffering from difficulties not relating to BPO. The UPSTREAM trial started recruitment in October 2014 with the aim of establishing whether a care pathway including urodynamics (a diagnostic tool for BPO and thus an indication of whether surgery is needed) is no worse for men, in terms of symptomatic outcome, than one without (routine care). METHODS/DESIGN:This analysis plan outlines the main outcomes of the study and specific design choices, such as non-inferiority margins. The trial is currently recruiting in 26 hospitals across the UK, randomising men to either urodynamics or routine care, with recruitment set to end on the 31 December 2016. All outcomes will be measured 18 months after randomisation to allow sufficient time for surgical procedures and recovery. The primary outcome is based on a non-inferiority design with a margin of 1 point on the International Prostate Symptom Score (IPSS) scale. The key secondary outcome for this trial is surgery rate per arm, which is estimated to be at least 18% lower in the urodynamics arm. Surgery rates, adverse events, flow rate, urinary symptoms and sexual symptoms are secondary outcomes to be assessed for superiority. This is an update to the UPSTREAM protocol, which has already been published in this journal. DISCUSSION:This a priori statistical analysis plan aims to reduce reporting bias by allowing access to the trial's objectives and plans in advance of recruitment end. The results of the trial are expected to be published soon after the trial end date of 30 September 2018. TRIAL REGISTRATION:ISRCTN registry, ISRCTN56164274 . Registered on 8 April 2014.
journal_name
Trialsjournal_title
Trialsauthors
Young GJ,Lewis AL,Lane JA,Winton HL,Drake MJ,Blair PSdoi
10.1186/s13063-017-2206-ysubject
Has Abstractpub_date
2017-10-03 00:00:00pages
455issue
1issn
1745-6215pii
10.1186/s13063-017-2206-yjournal_volume
18pub_type
杂志文章,多中心研究,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:Nitrogen containing bisphosphonates such as zoledronic acid (ZA) are known to contain certain anti-cancer properties. These have been investigated in the past in various cancers such as breast, prostate and colon. ZA in particular has shown promising results in pre-clinical studies. We propose a multicentre ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2851-9
更新日期:2018-08-29 00:00:00
abstract:BACKGROUND:Multi-centre randomised controlled trials (RCTs) in surgery are challenging. It is particularly difficult to establish standards of surgery and ensure that interventions are delivered as intended. This study developed and tested methods for identifying the key components of surgical interventions and standar...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-1127-x
更新日期:2015-12-28 00:00:00
abstract:BACKGROUND:Low back pain is a common, disabling musculoskeletal disorder in both developing and developed countries. Although often recommended, the potential efficacy of massage therapy in general, and Chinese massage (tuina) in particular, for relief of chronic low back pain (CLBP) has not been fully established due ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-418
更新日期:2014-10-29 00:00:00
abstract:OBJECTIVES:The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who have early stage disease, compared to current standard of care. This study will also provide an important opportunity to investigate the safety and tolerability of favipiravir, the...
journal_title:Trials
pub_type: 信件,多中心研究,随机对照试验
doi:10.1186/s13063-020-04891-1
更新日期:2020-11-19 00:00:00
abstract:BACKGROUND:Untreated advanced hepatocellular carcinoma (HCC) is linked to poor prognosis. While sorafenib is the current recommended treatment for advanced HCC, radioembolisation (RE; also called selective internal radiation therapy or SIRT) with yttrium-90 microspheres has shown efficacy in cohort studies. However, th...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-474
更新日期:2014-12-03 00:00:00
abstract:BACKGROUND:Sharing interim results by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an issue that can affect trial integrity. It is unclear what should be shared. This study assesses the views of professionals to understand what interim information should be shared at interim, with whom and why. MET...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2655-y
更新日期:2018-05-21 00:00:00
abstract:BACKGROUND:Patients' treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients' treatment preferences and identified key strategies to improve informed decision-making and trial recruitment. METHODS:Audio-recordings o...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-15-323
更新日期:2014-08-13 00:00:00
abstract::After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled. ...
journal_title:Trials
pub_type: 杂志文章,已发布勘误
doi:10.1186/s13063-020-4107-8
更新日期:2020-02-12 00:00:00
abstract:BACKGROUND:Older adults living in nursing homes spend the majority of their time inactive. The associated levels of chronic disease place an increasing burden on healthcare systems. Physical activity (PA) interventions delivered through exercise classes may be resource-intensive and require specialist staff. The aim of...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2848-4
更新日期:2018-08-29 00:00:00
abstract:BACKGROUND:Burst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed t...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1706-5
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND:Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effective treatments. Predicated on promising preclinical and pilot clinical data, this paper presents a ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3628-5
更新日期:2019-09-10 00:00:00
abstract:OBJECTIVES:Primary Objective: To determine the feasibility of delivering a protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention, within 12-weeks of hospital discharge, for adult survivors of Covid-19 related critical illness. Secondary objectives: To investigate whether remote...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-020-04805-1
更新日期:2020-11-17 00:00:00
abstract:BACKGROUND:Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mo...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1305-5
更新日期:2016-04-02 00:00:00
abstract:BACKGROUND:During leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss, tinnitus and hyperacusis. Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temp...
journal_title:Trials
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1186/1745-6215-15-110
更新日期:2014-04-05 00:00:00
abstract:BACKGROUND:This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such pr...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-100
更新日期:2010-10-21 00:00:00
abstract:BACKGROUND:The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1443-9
更新日期:2016-07-26 00:00:00
abstract::In October 2015 we published the paper 'Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis'. Chatterjee and Pradhan have submitted a letter to the editor asking critical questions regarding the methods we used. We offer th...
journal_title:Trials
pub_type: 评论,信件
doi:10.1186/s13063-017-1981-9
更新日期:2017-05-26 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:Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperativ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-288
更新日期:2013-09-09 00:00:00
abstract:BACKGROUND:In the paediatric population, pain and distress associated with burn injuries during wound care procedures remain a constant challenge. Although silver dressings are the gold standard for burn care in Australasia, very few high-level trials have been conducted that compare silver dressings to determine which...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-403
更新日期:2013-11-25 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:Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0875-y
更新日期:2015-08-11 00:00:00
abstract:BACKGROUND:This is a phase II randomised, double-blind, sham-controlled trial to evaluate the effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine amongst migraine subjects. METHODS:Subjects age 18 to 60 years will undergo a baseline evaluation to...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04832-y
更新日期:2020-11-11 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: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:Chronic subdural hematoma (cSDH) is one of the most common conditions encountered in neurosurgical practice. Recurrence, observed in 5-30% of patients, is a major clinical problem. The temperature of the irrigation fluid used during evacuation of the hematoma might theoretically influence recurrence rates si...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-017-2194-y
更新日期:2017-10-11 00:00:00
abstract:BACKGROUND:Youth depression is highly prevalent and is related to impairments in academic, social and behavioural functioning. Evidence-based treatments are available, but many young people do not respond or sufficiently recover with first-line options, and a significant proportion experience relapse. Consequently, the...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-019-4036-6
更新日期:2020-01-14 00:00:00
abstract:BACKGROUND:Prospective meta-analysis (PMA) is a collaborative research design in which individual sites perform randomized controlled trials (RCTs) and pool the data for meta-analysis. Members of the PMA collaboration agree upon specific research interventions and outcome measures, ideally before initiation but at leas...
journal_title:Trials
pub_type: 杂志文章,meta分析,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-104
更新日期:2011-04-29 00:00:00
abstract:BACKGROUND:Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, redu...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04552-3
更新日期:2020-07-06 00:00:00
abstract::After publication of our article [1] we have been notified on a mistake in the sample size. ...
journal_title:Trials
pub_type: 已发布勘误
doi:10.1186/s13063-020-04268-4
更新日期:2020-03-30 00:00:00