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Daragh McGee, Fabiana Lorencatto, Karen Matvienko-Sikar, Elaine Toomey
BACKGROUND: Intervention fidelity is the degree to which interventions have been implemented as intended by their developers. Assessing fidelity is crucial for accurate interpretation of intervention effectiveness, but fidelity is often poorly addressed within trials of complex healthcare interventions. The reasons for this are unclear, and information on the use of methods to enhance and assess fidelity in trials of complex interventions remains insufficient. This study aimed to explore the knowledge, practice and attitudes towards intervention fidelity amongst researchers, triallists and healthcare professionals involved with the design and conduct of trials of complex healthcare interventions...
September 19, 2018: Trials
Robert Fahed, Stefanos Finitsis, Naim Khoury, Yan Deschaintre, Nicole Daneault, Laura Gioia, Gregory Jacquin, Céline Odier, Alexande Y Poppe, Alain Weill, Daniel Roy, Tim E Darsaut, Thanh N Nguyen, Jean Raymond
BACKGROUND: The Endovascular Acute Stroke Intervention (EASI) trial was conceived as a pragmatic care trial, designed to integrate trial methods with clinical practice. Reporting the EASI experience was met with objections and criticisms during peer review concerning both scientific and ethical issues. Our goal is to discuss these criticisms in order to promote the pragmatic approach of care trials in outcome-based medical care. METHODS: The comments and criticisms of 11 reviewers from 5 journals were collected and analyzed...
September 19, 2018: Trials
Aviv Ladanie, Benjamin Speich, Florian Naudet, Arnav Agarwal, Tiago V Pereira, Francesco Sclafani, Juan Martin-Liberal, Thomas Schmid, Hannah Ewald, John P A Ioannidis, Heiner C Bucher, Benjamin Kasenda, Lars G Hemkens
BACKGROUND: The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database providing the relevant information required to systematically analyze and assess this early evidence in meta-epidemiological research. METHODS: We designed a modular and flexible database of systematically collected data...
September 19, 2018: Trials
Ladislav Timulak, Daragh Keogh, Craig Chigwedere, Charlotte Wilson, Fiona Ward, David Hevey, Patrick Griffin, Louise Jacobs, Brenda Irwin
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 presenting in the non-clinical range after a course of treatment. Furthermore, not all clients prefer CBT as a psychological therapy. Recently, emotion-focused therapy (EFT) was developed for GAD and was tested in an open trial with promising results...
September 19, 2018: Trials
Marcelo Teixeira Holanda, Mauro Felippe Felix Mediano, Alejandro Marcel Hasslocher-Moreno, Sérgio Salles Xavier, Roberto Magalhães Saraiva, Andrea Silvestre Sousa, Erica Rodrigues Maciel, Fernanda Martins Carneiro, Paula Simplicio da Silva, Luiz Henrique Conde Sangenis, Henrique Horta Veloso, Claudia Santos de Aguiar Cardoso, Maria da Gloria Bonecini-Almeida, Andreia Lamoglia Souza, Eric Henrique Roma, Marcos José Azevedo, Fernanda Sant'Ana Pereira-Silva, Luis Otavio Pimentel, Marcelo Oliveira Mendes, Luciana Ribeiro Garzoni, Beatriz M S Gonzaga, Anna Cristina Calçada Carvalho, Pedro Emmanuel Alvarenga Americano Brasil, Gilberto Marcelo Sperandio da Silva, Tania Cremonini Araújo-Jorge
Several studies evaluating clinical forms of chronic Chagas disease show that about one-third of patients present cardiac involvement. Heart failure, sudden death and cardioembolic stroke are the main mechanisms of death in Chagas heart disease. The impact of specific etiologic treatment on the prognosis of patients with chronic Chagas heart disease is very limited regardless of the presence or absence of heart failure. Patients with symptomatic Chagas heart disease present serum selenium (Se) levels lower than patients without Chagas heart disease...
September 19, 2018: Trials
Adwoa Parker, Peter Knapp, Shaun Treweek, Vichithranie Madhurasinghe, Roberta Littleford, Stephanie Gallant, Frank Sullivan, Stuart Schembri, Jo Rick, Jonathan Graffy, David J Collier, Sandra Eldridge, Anne Kennedy, Peter Bower
BACKGROUND: Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment...
September 18, 2018: Trials
Rick T van Uum, Roderick P Venekamp, Alies Sjoukes, Alma C van de Pol, G Ardine de Wit, Anne G M Schilder, Roger A M J Damoiseaux
BACKGROUND: Whilst current guidelines highlight the importance of pain management for children with acute otitis media (AOM), there is evidence to suggest that this is not implemented in everyday practice. We have developed a primary care-based multifaceted educational intervention to optimise pain management in children with AOM, and we trial its clinical and cost effectiveness. METHODS: This cluster randomised controlled trial aims to recruit 250 children aged 6 months to 10 years presenting with AOM to general practitioners (GPs) in 30 primary care centres (PCCs) across the Netherlands...
September 17, 2018: Trials
David T Dunn, Andrew J Copas, Peter Brocklehurst
BACKGROUND: The classification of phase 3 trials as superiority or non-inferiority has become routine, and it is widely accepted that there are important differences between the two types of trial in their design, analysis and interpretation. MAIN TEXT: There is a clear rationale for the superiority/non-inferiority framework in the context of regulatory trials. The focus of our article is non-regulatory trials with a public health objective. First, using two examples from infectious disease research, we show that the classification of superiority or non-inferiority trials is not always straightforward...
September 17, 2018: Trials
Tianjing Li, Evan Mayo-Wilson, Nicole Fusco, Hwanhee Hong, Kay Dickersin
Clinical trials and systematic reviews of clinical trials inform healthcare decisions. There is growing concern, however, about results from clinical trials that cannot be reproduced. Reasons for nonreproducibility include that outcomes are defined in multiple ways, results can be obtained using multiple methods of analysis, and trial findings are reported in multiple sources ("multiplicity"). Multiplicity combined with selective reporting can influence dissemination of trial findings and decision-making...
September 17, 2018: Trials
Kathryn Dovel, Frackson Shaba, Mike Nyirenda, O Agatha Offorjebe, Kelvin Balakasi, Khumbo Phiri, Brooke Nichols, Chi-Hong Tseng, Ashley Bardon, Khumbo Ngona, Risa Hoffman
BACKGROUND: Throughout sub-Saharan Africa HIV-testing rates remain low. Barriers to testing, such as inconvenient service hours and long wait times, lack of privacy, and fear of unwanted disclosure, continue to impede service utilization. HIV self-testing (HIVST) is one strategy that addresses these barriers and has been shown to increase use of HIV-testing when distributed through community-based settings. However, the scalability of HIVST is limited because it has yet to be fully integrated into existing health systems and routine care...
September 17, 2018: Trials
Maartje Witlox, Vivivan Kraaij, Nadia Garnefski, Margot W M de Waal, Filip Smit, Erik Hoencamp, Jacobijn Gussekloo, Ernst T Bohlmeijer, Philip Spinhoven
BACKGROUND: Anxiety is among the most prevalent and disabling mental health problems in older adults. Few older adults with mild to moderately severe anxiety symptoms receive adequate interventions, putting them at risk for developing anxiety disorders, depression, and various somatic problems. Effective, low-threshold interventions should be developed. Blended care, in which a web-based intervention is combined with a limited amount of face-to-face contacts with a mental healthcare counselor at the general practice, is a promising option...
September 17, 2018: Trials
Marie Boltz, Ashley Kuzmik, Barbara Resnick, Rebecca Trotta, Jacqueline Mogle, Rhonda BeLue, Douglas Leslie, James E Galvin
BACKGROUND: Hospitalized older persons with Alzheimer's disease and related dementias are at greater risk for functional decline and increased care dependency after discharge due to a combination of intrinsic factors, environmental, policy, and care practices that restrict physical and cognitive activity, lack of family involvement and limited staff knowledge of dementia care. We have developed a theory-based intervention, Family centered Function-focused Care, that incorporates an educational empowerment model for family caregivers (FCGs) provided within a social-ecological framework to promote specialized care to patients with dementia during hospitalization and the 60-day post-acute period...
September 17, 2018: Trials
Jian-Guo Zhou, Nan-Jing Zhou, Qiong Zhang, Yao-Yao Feng, Hang Zhou
BACKGROUND: In China, cervical cancer is the fifth most commonly diagnosed cancer, and the outcomes for patients with advanced or recurrent disease are poor. Apatinib, a small molecule inhibitor of vascular endothelial growth factor receptor (VEGFR-2), is an orally bioavailable agent, which has shown survival benefit in multiple solid tumors. Based on previous research, this phase II clinical trial aims to verify apatinib's efficacy and safety in patients with advanced or recurrent cervical cancer...
September 17, 2018: Trials
Lindsay Brammen, Philipp Riss, Julius Lukas, Alois Gessl, Daniela Dunkler, Shuren Li, Asha Leisser, Sandra Rezar-Dreindl, Katharina Eibenberger, Andreas Selberherr, Christian Scheuba, Andrea Papp
BACKGROUND: Graves' disease (GD) is characterized by thyrotoxicosis and goiter and arises through circulating autoantibodies that bind to, and stimulate, the thyroid hormone receptor (TSHR). A temporal relation between the onset of hyperthyroidism and the onset of ophthalmopathy, a common extrathyroidal manifestation, has been demonstrated. Graves' ophthalmopathy (GO) is typically characterized by an inflammation and expansion of the extraocular muscles and an increase in retroorbital fat...
September 15, 2018: Trials
Eun-Young Nam, Ju-Yeon Park, Junyoung Jo, Seung-Hyun Jung, Chi-Yeon Lim, Dong-Il Kim
BACKGROUND: Electroacupuncture has been used for treatment in patients with overactive bladder. This study was conducted to evaluate the efficacy and safety of electroacupuncture for treating overactive bladder of postmenopausal women. METHODS/DESIGN: This is a multicenter, randomized controlled, parallel clinical trial. Two hundred ninety participants with overactive bladder syndrome will be recruited from Dongguk University Bundang Oriental Hospital and Cheonan Korean Medicine Hospital of Daejeon University and randomly allocated into one of two groups in a 1:1 ratio...
September 15, 2018: Trials
Mahalakshmi Ekambareshwar, Seema Mihrshahi, Li Ming Wen, Sarah Taki, Greer Bennett, Louise A Baur, Chris Rissel
BACKGROUND: Recruitment of pregnant women into trials is a challenge exacerbated by a number of factors, including strict eligibility criteria. There has been little in-depth examination of the recruitment process to trials involving pregnant women. This paper presents the findings of a study conducted to identify facilitators and challenges in recruiting pregnant women to the Communicating Healthy Beginnings Advice by Telephone (CHAT) randomised controlled trial, which aims to reduce the prevalence of infant and childhood obesity...
September 15, 2018: Trials
Angelo Antonini, Giovanni Gentile, Manuela Giglio, Andrea Marcante, Heather Gage, Morro M L Touray, Dimitrios I Fotiadis, Dimitris Gatsios, Spyridon Konitsiotis, Lada Timotijevic, Bernadette Egan, Charo Hodgkins, Roberta Biundo, Clelia Pellicano
BACKGROUND: Parkinson's disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable and fluctuating nature of symptoms, often hourly and daily. The PD_Manager mHealth platform aims to provide a continuous feed of data on symptoms to improve clinical understanding of the status of any individual patient and inform care planning. The objectives of this trial are to (1) assess patient (and family carer) perspectives of PD_Manager regarding comfort, acceptability and ease of use; (2) assess clinician views about the utility of the data generated by PD_Manager for clinical decision making and the acceptability of the system in clinical practice...
September 14, 2018: Trials
Wantong Zhang, Baochen Zhu, Weiyi Cao, Rui Li, Shuge Wang, Rui Gao
BACKGROUND: Coronary heart disease (CHD) is a common cardiovascular disease accounting for 10-20% mortality by heart disease worldwide. The gold standard treatment to manage CHD is aspirin, which may prevent myocardial infarction and sudden death; however, long-term use of aspirin may increase its side effects. Currently, more and more clinicians are exploring different approaches to use the right combination of medicine to enhance the efficacy and reduce side effects. Salvianolate can significantly inhibit the aggregation and activation of platelets in patients with CHD; however, its optimum combination with western medicine is not established or supported by clinical trial results...
September 14, 2018: Trials
Xu Zhao, Wei Gao, Feng Liu
BACKGROUND: Implant placement in the posterior maxilla is often complicated by the insufficient bone volume. While transalveolar sinus floor elevation (TSFE) has been proven as a predictable surgical procedure to increase the bone height in the posterior maxilla, questions in regard to the necessity of the bone grafting during the sinus lift and the question of whether TSFE could be performed when the residual bone height is below 5 mm are still debated. Furthermore, high-quality evidence comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited...
September 14, 2018: Trials
Makiko Yamamoto, Akio Kimura, Kento Takii, Naruaki Otake, Wataru Matsuda, Tatsuki Uemura, Takunori Sato, Kentaro Kobayashi, Ryo Sasaki, Akiyoshi Hagiwara, Junko Fujitani
BACKGROUND: Management of trauma involves long-term bed rest even when muscle strength in the lower extremities is preserved. Prolonged bed rest reduces muscle mass and causes muscle atrophy. A recent study reported the efficacy of rehabilitation using electrical muscle stimulation (EMS) for muscle strength maintenance in intensive care unit patients with disturbance of consciousness. However, despite the expected benefits of EMS in maintaining muscle strength, little is known about its efficacy in trauma patients...
September 14, 2018: Trials
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