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The stepped wedge cluster randomised trial (SW-CRT) is increasingly being used to evaluate policy or service delivery interventions. However, there is a dearth of trials literature addressing analytical approa...
Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. Howev...
Radiation therapy (RT) of bone metastases provides an important treatment approach in palliative care treatment concepts. As a consequence of treatment, the extent of radiation-induced toxicity is a crucial fe...
Sedentary behaviour (e.g. television viewing, sitting time) tracks over time and is associated with adverse health and developmental outcomes across the lifespan. Young children (5 years or younger) spend up t...
The original article was published in Trials 2016 17:181
The original article was published in Trials 2016 17:568
Promoting Recruitment using Information Management Efficiently (PRIME) is a stepped wedge, cluster randomised trial-within-a-trial of a complex intervention to help sites in the United Kingdom to attain their ...
NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centr...
Research into methods to boost recruitment has been identified as the highest priority for randomised controlled trial (RCT) methodological research in the United Kingdom. Slow recruitment delays the delivery ...
The Correction to this article has been published in Trials 2019 20:438
The Erratum to this article has been published in Trials 2017 18:146
Health care workers (HCW) are at high risk for developing occupational hand dermatitis (HD) due to frequent exposure to ‘wet work’. Amongst HCWs, nurses are at highest risk, with an estimated point prevalence ...
The Update to this article has been published in Trials 2018 19:421
Proximal humeral fractures are common in older patients. The majority are minimally displaced and are associated with good outcomes after nonoperative treatment. Poorer outcomes are associated with displaced, ...
Anterior shoulder dislocation is a common injury and may have considerable impact on shoulder-related quality of life (QoL). If not warranted for initial stabilising surgery, patients are mostly left with litt...
American Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents hav...
Gait and mobility impairments affect the quality of life (QoL) of patients with progressive multiple sclerosis (MS). Robot-assisted gait training (RAGT) is an effective rehabilitative treatment but evidence of...
Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. The current evidence to guide clinica...
Clinical trial registries are being increasingly acknowledged worldwide. We searched for possibly trustworthy online registries that are not already included in the International Clinical Trials Registry Platf...
Liver failure patients have traditionally been empirically transfused prior to invasive procedures. Blood transfusion is associated with immunologic and nonimmunologic reactions, increased risk of adverse outc...
Upper limb paresis is one of the most frequent and persistent impairments following stroke. Only 12–34% of stroke patients achieve full recovery of upper limb functioning, which seems to be required to habitua...
When designing studies that have a binary outcome as the primary endpoint, the hypothesized proportion of patients in each population experiencing the endpoint of interest (i.e., π 1,π ...
Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in...
Depression following acute coronary syndrome (ACS) constitutes a serious and debilitating problem. Approximately one in five patients will develop significant depression following ACS and less severe depressiv...
Long-acting bronchodilator monotherapy (long-acting β2-agonist [LABA] or long-acting muscarinic antagonist [LAMA]) is extensively used for treatment of patients with chronic obstructive pulmonary disease (COPD) w...
Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requ...
White matter hyperintensities (WMHs) are commonly seen on in brain imaging and are associated with stroke and cognitive decline. Therefore, they may provide a relevant intermediate outcome in clinical trials. ...
Enhanced recovery after surgery (ERAS) programs are aimed at minimizing postoperative stress and accelerating postoperative recovery by implementing multiple perioperative principles. “Early mobilization” is o...
Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping tec...
Bullying is a major problem worldwide and Chile is no exception. Bullying is defined as a systematic aggressive behavior against a victim who cannot defend him or herself. Victims suffer social isolation and p...
The original article was published in Trials 2016 17:442
Fractures of the extremities are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury. Patients typically require up to 7 days of inpatient bed rest and elevation t...
Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone ...
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 ha...
People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest i...
Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme ...
Linezolid, an oxazolidinone, substantially improves treatment outcomes of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. We started a trial to test whether the use of linezolid i...
The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activit...
HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in h...
Early hospital readmission of patients after discharge is a public health problem. One major cause of hospital readmission is dysfunctions in integrated pathways between community and hospital care that can ca...
Identifying characteristics associated with transcranial magnetic stimulation (TMS) benefit would offer insight as to why some individuals experience tinnitus relief following TMS treatment, whereas others do ...
It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social ch...
Clinical trial success depends on appropriate management, but practical guidance to trial organisation and planning is lacking. The Incident Command System (ICS) is the ‘gold standard’ management system develo...
The ending of a clinical trial may be challenging, particularly if staff are required to withdraw the investigated treatment(s); however, this aspect of trial work is surprisingly under-researched. To address ...
The original article was published in Trials 2016 17:507
People with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits. Rather than being merely a consequence of symptom-related physical impairments...
Intramuscular injections of botulinum toxin A (BoNT-A) have been a cornerstone in the treatment of spasticity for the last 20 years. In Norway, the treatment is now offered to two out of three children with sp...
Liver resection is the only potentially curative treatment for colorectal liver metastases (LM). It is considered a safe procedure, but is often associated with blood loss during liver transection. Blood trans...
Chest tube insertion is a standard intervention for management of various injuries of the thorax. Quick and accurate execution facilitates efficient therapy without further complications. Here, we propose a ne...
Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevente...
This letter describes the substantial activity on the Core Outcome Measure in Effectiveness Trials (COMET) website in 2015, updating our earlier progress reports for the period from the launch of the COMET web...
The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not...
The Erratum to this article has been published in Trials 2017 18:113
Randomized controlled trials (RCTs) form the foundational background of modern medical practice. They are considered the highest quality of evidence, and their results help inform decisions concerning drug dev...
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