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Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient nu...
This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surg...
Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1–2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significan...
The original article was published in Trials 2016 17:152
In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs co...
The evidence for systemic treatments for severe childhood eczema is limited and largely based on extrapolation of data from adult studies. Current therapies are often immunosuppressant and may be associated wi...
The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women.
Laparoscopic training has become an important part of surgical education. Laparoscopic Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed. Surgeons must be well trained prior to o...
Some realists have criticised randomised controlled trials for their inability to explain the causal relations that they identify; to take into account the influence of the social context of the interventions ...
PRESSURE 2 is a randomised evaluation of the clinical and cost effectiveness of two types of pressure relieving mattress for the prevention of pressure ulcers. The primary endpoint is the time to development o...
Improved maternal nutrition and glycaemic control before and during pregnancy are thought to benefit the health of the mother, with consequent benefits for infant body composition and later obesity risk. Mater...
China has the largest burden of primary angle-closure glaucoma (PACG) worldwide. The mechanism of the angle closure is complex and includes pupillary block and non-pupillary block. Currently, opinion is that l...
Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystallo...
Neovascular glaucoma (NVG) is rare, comprising only 3.9% of all glaucoma cases. The most common cause of NVG is ischaemic central retinal vein occlusion (iCRVO). NVG frequently results in blindness and painful...
Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medic...
Major depressive disorder is a leading cause of disease burden worldwide, indicating the importance of effective therapies. Outcome studies have shown overall efficacy of different types of psychotherapy acros...
Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to...
Resistant hypertension is defined as an uncontrolled blood pressure despite treatment at best-tolerated doses with at least three antihypertensive agents including a diuretic. It is an emerging public health p...
Retrospective analysis of Center effect of the multi-center trial conducted to compare Immucothel (KLH Immunotherapy drug product) with Mytomycin-C (MM) concluded that efficacy evaluation of the drug product m...
Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measur...
Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions...
Sharing interim data, results or result extrapolations is an important issue that can affect trial integrity. The different ways in which Data Safety Monitoring Boards (DSMBs) share interim results with non-DS...
Stepped wedge cluster randomised trials frequently involve a relatively small number of clusters. The most common frameworks used to analyse data from these types of trials are generalised estimating equations...
Children in low and middle-income countries (LMICs) are at risk for problems in their cognitive, social and behavioural development. Factors such as a lack of cognitive stimulation, harsh parenting practices, ...
In a non-inferiority (NI) trial, analysis based on the intention-to-treat (ITT) principle is anti-conservative, so current guidelines recommend analysing on a per-protocol (PP) population in addition. However,...
Post-polio syndrome (PPS) is a condition that affects polio survivors years after recovery from an initial acute infection by the Poliomyelitis virus. Most often, patients who suffered from polio start to expe...
Our prospective pilot study of acupuncture affecting insulin sensitivity on polycystic ovary syndrome (PCOS) combined with insulin resistance (IR) showed that acupuncture had a significant effect on improving ...
Self-myofascial release (SMR) aims to mimic the effects of manual therapy and tackle dysfunctions of the skeletal muscle and connective tissue. It has been shown to induce improvements in flexibility, but the ...
Last this year in this journal, Barbour and colleagues reported a study of “marketing trials” in leading medical journals (Trials 2016;17:31). In this commentary I discuss their research, describe new analyses of...
The original article was published in Trials 2017 18:52
Rituximab is effective as therapy for induction of remission in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, the effect of rituximab is not sustained, and subsequent relaps...
Patients with germline mutations in a tumour suppressor gene called CYLD develop multiple, disfiguring, hair follicle tumours on the head and neck. The prognosis is poor, with up to one in four mutation carriers ...
Acupressure therapy may be potentially beneficial in improving postoperative symptoms like postoperative nausea and vomiting (PONV), pain and sleep disorder and improving postoperative quality of recovery. The...
The current methodology for sample size calculations for stepped-wedge cluster randomised trials (SW-CRTs) is based on the assumption of equal cluster sizes. However, as is often the case in cluster randomised...
Salivary gland hypofunction and xerostomia are major complications following radiotherapy for head and neck cancer and may lead to debilitating oral disorders and impaired quality of life. Currently, only symp...
There is no consensus on the preferred method for defining the non-inferiority margin in non-inferiority trials, and previous studies showed that the rationale for its choice is often not reported. This study ...
There is increasing evidence that low levels of physical activity and diets low in fruit and vegetables and high in meat and dairy products are risk factors for prostate cancer disease progression. The Prostat...
Peripheral arterial disease (PAD) has a population prevalence of 4.6% with intermittent claudication (IC) presenting as one of the earliest and most common symptoms. PAD has detrimental effects on patients’ wa...
Exergaming is a novel approach to increase motivation for regular physical activity (PA) among sedentary individuals such as patients with type 2 diabetes mellitus (T2DM). Because existing exergames do not off...
Manual acupuncture (MA) manipulations are one of the key factors influencing acupuncture effects in traditional Chinese medicine theory. Different MA manipulations contain different stimulating parameters, thu...
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...
Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce p...
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
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