TrialsThe impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial
Surgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fra...Trials 2019 20:570Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?
Patient-reported outcome measures (PROMs) are now frequently used in randomised controlled trials (RCTs) as primary endpoints. RCTs are longitudinal, and many have a baseline (PRE) assessment of the outcome an...Trials 2019 20:566The Correction to this article has been published in Trials 2019 20:611Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle
There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fract...Trials 2019 20:565Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham-controlled trial
Polycystic ovary syndrome (PCOS) is one of the most common endocrine diseases for women. Acupuncture is widely used for the infertile female because of it is non-invasive and has fewer side effects, but the po...Trials 2019 20:564The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial
The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac ...Trials 2019 20:563Impact of deep water running in interval training (DWR-IT) on body composition, functional capacity, and quality of life in overweight adults: study protocol for a randomized controlled trial
Interval training in deep water running (DWR-IT) is a training method to improve cardiovascular fitness, functional health, and quality of life and to help control body weight. Its main advantages are the redu...Trials 2019 20:562Leucine-enriched essential amino acid supplementation in mechanically ventilated trauma patients: a feasibility study
Critically ill patients lose up to 2% of muscle mass per day. We assessed the feasibility of administering a leucine-enriched essential amino acid (L-EAA) supplement to mechanically ventilated trauma patients ...Trials 2019 20:561Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial
Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single as...Trials 2019 20:560Virtual training leads to real acute physical, cognitive, and neural benefits on healthy adults: study protocol for a randomized controlled trial
Keeping a certain level of physical activity has beneficial effects on the body itself but also, surprisingly, on cognition: specifically, physical high-intensity intermittent aerobic exercise (HIE) can show i...Trials 2019 20:559Is dangling of the lower leg after a free flap reconstruction necessary? Study protocol for a large multicenter randomized controlled study
Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperat...Trials 2019 20:558Correction to: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial
Following publication of the original article [1], it has been brought to our attention that an error was slipped into the article’s title.Trials 2019 20:557The original article was published in Trials 2019 20:499An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units
Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units...Trials 2019 20:556N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial
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 effec...Trials 2019 20:555Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial
Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral netwo...Trials 2019 20:554Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events
Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent informati...Trials 2019 20:553Interval-cohort designs and bias in the estimation of per-protocol effects: a simulation study
Randomized trials are considered the gold standard for making inferences about the causal effects of treatments. However, when protocol deviations occur, the baseline randomization of the trial is no longer su...Trials 2019 20:552Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial
Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer’s disease, which is the world’s most common form of dementia. It is important to identify early and easily available ...Trials 2019 20:551Smoking cessation Through Optimisation of clinical care in Pregnancy: the STOP randomised controlled trial
Cigarette smoking negatively impacts on maternal and fetal health. Smoking cessation is one of the few interventions capable of improving pregnancy outcomes. Despite the risks, the most effective antenatal mod...Trials 2019 20:550Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study – the Integrated Diabetes Education, Awareness and Lifestyle modification in Singapore (IDEALS) Program
There is a global pandemic of type 2 diabetes mellitus (T2DM), especially in Asia. Singapore has a prevalence of T2DM at 10.5%, which is higher than the world average of 8.8%. Multiple studies have shown that ...Trials 2019 20:549Using peer education to improve diabetes management and outcomes in a low-income setting: a randomized controlled trial
Diabetes is an important health burden in Indonesia. However, diabetes management and treatment remain poor, with most people with diabetes in Indonesia not achieving the recommended blood glucose levels. Peer...Trials 2019 20:548Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study
Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2...Trials 2019 20:547TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial
Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men p...Trials 2019 20:546Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan
There are significant barriers to providing accessible, quality mental health care for young adolescents affected by adversity. In an attempt to overcome this, the World Health Organization (WHO) has developed...Trials 2019 20:545The Correction to this article has been published in Trials 2019 20:617Therapy of nodal Follicular Lymphoma (WHO grade 1/2) in clinical stage I/II using response adapted Involved Site Radiotherapy in combination with Obinutuzumab (Gazyvaro) - GAZAI Trial (GAZyvaro and response adapted Involved-site Radiotherapy): a study protocol for a single-arm, non-randomized, open, national, multi-center phase II trial
Large field irradiation had been standard for early-stage follicular lymphoma (FL) for a long time. Although involved field radiotherapy (IF-RT) was recently favored because of the toxicity of large field irra...Trials 2019 20:544Supporting elderly people with cognitive impairment during and after hospital stays with intersectoral care management: study protocol for a randomized controlled trial
The sectorization of health-care systems leads to inefficient treatment, especially for elderly people with cognitive impairment. The transition from hospital care to primary care is insufficiently coordinated...Trials 2019 20:543The effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in overweight or obese nursing women: a study protocol for a randomized placebo-controlled clinical trial
The optimal vitamin D intake for nursing mothers with overweight or obesity has not been defined. Vitamin D concentrations are associated with body composition indices, particularly body fat mass. Few studies ...Trials 2019 20:542Interventions to promote healthy environments in family child care homes in Oklahoma—Happy Healthy Homes: study protocol for a randomized controlled trial
Early childhood is a critical period of development. Caregivers, including providers of early care and education (ECE), have a substantial influence on the health of young children. Family child care homes (FC...Trials 2019 20:541A double-blinded, randomized placebo-controlled trial on the effect of traditional Chinese medicine formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters
In Hong Kong, one of six couples is affected by subfertility problems. Male infertility contributes to half of the infertility cases. In male infertility, there is no effective treatment for patients with idio...Trials 2019 20:540Comparing the effect of STan (cardiotocographic electronic fetal monitoring (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with CTG alone on emergency caesarean section rates: study protocol for the STan Australian Randomised controlled Trial (START)
Cardiotocography is almost ubiquitous in its use in intrapartum care. Although it has been demonstrated that there is some benefit from continuous intrapartum fetal monitoring using cardiotocography, there is ...Trials 2019 20:539Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. Currently, the treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes...Trials 2019 20:538Si-ni-tang (a Chinese herbal formula) for improving immunofunction in sepsis: study protocol for a pilot randomized controlled trial
Immunologic derangement may be the critical pathophysiologic mechanism in sepsis, and immunotherapy might be a potential new treatment. Si-ni-tang (SNT), an ancient Chinese herbal formula documented in Shanghan L...Trials 2019 20:537Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: protocol for a cluster randomized controlled trial in Georgia
Tuberculosis is one of the greatest global health concerns and disease management is challenging particularly in low- and middle-income countries. Despite improvements in addressing this epidemic in Georgia, t...Trials 2019 20:536An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India
Clinical Trials Registry - India (CTRI) was established in July 2007 and today hosts thousands of trials, a significant fraction of them registered in the last couple of years. We wished to undertake an up-to-...Trials 2019 20:535MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation
Accidental Accidental awareness during general anesthesia (AAGA) occurs in 1–2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Howev...Trials 2019 20:534Effects of C8 nerve root block during interscalene brachial plexus block on anesthesia of the posterior shoulder in patients undergoing arthroscopic shoulder surgery: study protocol for a prospective randomized parallel-group controlled trial
A classical approach to produce interscalene brachial plexus block (ISBPB) consistently spares the posterior aspect of the shoulder and ulnar sides of the elbow, forearm, and hand, which are innervated by the ...Trials 2019 20:533Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early...Trials 2019 20:532The Correction to this article has been published in Trials 2019 20:606Treatment of carpal tunnel syndrome with wrist splinting: study protocol for a randomized placebo-controlled trial
Carpal tunnel syndrome (CTS) is a common cause of pain, weakness, sensory loss, and activity limitations. Currently, the most common initial treatment is use of a rigid splint immobilizing the wrist, usually d...Trials 2019 20:531Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial
Guidelines in pediatric restorative dentistry recommend the use of preformed pediatric stainless steel crowns (SSCs) in cases of severe tooth decay of at least two surfaces. This clinically effective and safe ...Trials 2019 20:530Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial
Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with increased morbidity, mortality, healthcare costs and decreased quality of life. African Americans in the USA ...Trials 2019 20:529Regional lymphadenectomy vs. extended lymphadenectomy for hilar cholangiocarcinoma (Relay-HC trial): study protocol for a prospective, multicenter, randomized controlled trial
The prognostic benefits and safety of extended lymphadenectomy for hilar cholangiocarcinoma remain uncertain. The available evidence is still insufficient concerning its retrospective aspect. The aim of this s...Trials 2019 20:528Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival
While the clinical trials and statistical methodology literature on sample size re-estimation (SSRE) is robust, evaluation of SSRE procedures following the completion of a clinical trial has been sparsely repo...Trials 2019 20:527Skeletal muscle hypertrophy and attenuation of cardio-metabolic risk factors (SHARC) using functional electrical stimulation-lower extremity cycling in persons with spinal cord injury: study protocol for a randomized clinical trial
Persons with spinal cord injury (SCI) are at heightened risks of developing unfavorable cardiometabolic consequences due to physical inactivity. Functional electrical stimulation (FES) and surface neuromuscula...Trials 2019 20:526Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial
Unanticipated responses by research participants can influence randomised controlled trials (RCTs) in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an em...Trials 2019 20:525Investigating causal mechanisms in randomised controlled trials
In some randomised trials, the primary interest is in the mechanisms by which an intervention exerts its effects on health outcomes. That is, clinicians and policy-makers may be interested in how the intervent...Trials 2019 20:524Efficacy of DiaLife, an education program for relatives of adult patients with diabetes – study protocol of a cluster randomized controlled trial
The global prevalence of diabetes mellitus (DM) has been increasing over recent decades. In Germany, the prevalence for DM type 1 and type 2 in adults is estimated at about 7.7%. Hence, diabetes has to be clas...Trials 2019 20:523VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access cont...Trials 2019 20:522Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation
Early detection of diabetic foot ulcerations (DFUs) can avoid or delay any progression into more severe stages, which may require limb amputation or lead to infectious sequelae and death. However, frequent cli...Trials 2019 20:521The efficacy and safety of Shenzhu Guanxin Recipe Granules for the treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial
Coronary artery disease (CAD) is one of the most common types of the cardiovascular disease. Previous pilot trials have suggested that Traditional Chinese Medicine (TCM) has brought clinical benefits for patie...Trials 2019 20:520Effectiveness of Yi-Zhi-An-Shen granules on cognition and sleep quality in older adults with amnestic mild cognitive impairment: protocol for a randomized, double-blind, placebo-controlled trial
Amnestic mild cognitive impairment (aMCI) is a syndrome characterized by significant forgetfulness that does not meet the criteria of dementia. Individuals with aMCI are at greater risk of progressing to demen...Trials 2019 20:518Correction to: Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial
Following publication of the original article [1], the authors notified us of a few requested editions that were not implemented adequately during proofing. The publisher apologizes for the inconvenience cause...Trials 2019 20:516The original article was published in Trials 2019 20:431
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