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RCT protocol

Chris Moore, Jenna Bulger, Matt Morgan, Timothy Driscoll, Alison Porter, Saiful Islam, Mike Smyth, Gavin Perkins, Bernadette Sewell, Timothy Rainer, Prabath Nanayakkara, Chukwudi Okolie, Susan Allen, Greg Fegan, Jan Davies, Theresa Foster, Nick Francis, Fang Gao Smith, Gemma Ellis, Tracy Shanahan, Robin Howe, Helen Snooks
Background: Sepsis is a common condition which kills between 36,000 and 64,000 people every year in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve the health and well-being of people with sepsis. Paramedics frequently come into contact with patients with sepsis and are well placed to provide early diagnosis and treatment.We aim to determine the feasibility of undertaking a fully powered randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics obtaining blood cultures from and administering IV antibiotics to patients with sepsis, so we can make a decision about whether to proceed to a fully powered randomised controlled trial, which will answer questions regarding safety and effectiveness for patients and benefit to the National Health Service (NHS)...
2018: Pilot and Feasibility Studies
Fengwen Yang, Jiahan Zou, Xuemei Li, Long Ge, Jinhui Tian, Myeong Soo Lee, Junhua Zhang
BACKGROUND: Chinese herbal injections (CHIs) have been commonly used in the treatment of unstable angina pectoris (UAP) in China. However, there is no consensus or evidence on how to select CHIs for patients with UAP. The choice often depends on the personal experience or preference of clinician. This study aims to compare the effect of different CHIs for UAP using Bayesian network meta-analysis (NMA). METHODS: A systematic search will be conducted in PubMed, the Cochrane Central Register of Controlled Trials, Embase, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, and Wanfang Data from inception to February 2018...
March 2018: Medicine (Baltimore)
Tara McCrimmon, Susan Witte, Gaukhar Mergenova, Assel Terlikbayeva, Sholpan Primbetova, Azamat Kuskulov, Scarlett L Bellamy, Nabila El-Bassel
BACKGROUND: Among women at high risk for HIV and other sexually transmitted diseases (STIs), gender and economic issues limit the impact of behavioral prevention strategies. Women in Kazakhstan with dual risks of sex trading and drug use face elevated risk for HIV and STIs and may benefit from an economic empowerment intervention which combines HIV-risk reduction (HIVRR) education with financial skills-building and asset-building to promote reduced reliance on sex trading for income. METHODS/DESIGN: The study employs a two-arm, cluster-randomized controlled trial (c-RCT) design...
March 20, 2018: Trials
Holly J Silvers-Granelli, Mario Bizzini, Amelia Arundale, Bert R Mandelbaum, Lynn Snyder-Mackler
PURPOSE: The 11+ injury prevention program has been shown to decrease injury rate. However, few studies have investigated compliance and if it is correlated to time loss. The purpose of this study was to (1) analyze how differences in compliance may impact injury rate and (2) if compliance may impact time loss due to injury. METHODS: This study was a Level 1 prospective cluster randomized controlled trial conducted in NCAA men's football (soccer) teams that examined the efficacy of the 11+ injury prevention program...
March 19, 2018: Knee Surgery, Sports Traumatology, Arthroscopy: Official Journal of the ESSKA
Tamara J Somers, Sarah A Kelleher, Caroline S Dorfman, Rebecca A Shelby, Hannah M Fisher, Krista Rowe Nichols, Keith M Sullivan, Nelson J Chao, Gregory P Samsa, Amy P Abernethy, Francis J Keefe
BACKGROUND: Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT). OBJECTIVE: This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. METHODS: Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7)...
March 19, 2018: JMIR MHealth and UHealth
Sarang Kim, Mitchell McMaster, Susan Torres, Kay L Cox, Nicola Lautenschlager, George W Rebok, Dimity Pond, Catherine D'Este, Ian McRae, Nicolas Cherbuin, Kaarin J Anstey
INTRODUCTION: It has been estimated that a 10%-25% reduction in seven key risk factors could potentially prevent 1.1-3.0 million Alzheimer's disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia...
March 17, 2018: BMJ Open
Ditte Beck Jepsen, Jesper Ryg, Niklas Rye Jørgensen, Stinus Hansen, Tahir Masud
BACKGROUND: PaVOS is a randomized controlled trial (RCT) which aims to address the use of whole-body vibration exercise (WBV) in combination with parathyroid hormone 1-34 fragment teriparatide (PTH 1-34) treatment in patients with osteoporosis. PTH 1-34 is an effective but expensive anabolic treatment for osteoporosis. WBV has been found to stimulate muscle and bone growth. Animal studies have shown a beneficial effect on bone when combining PTH 1-34 with mechanical loading. A combined treatment with PTH 1-34 and WBV may potentially have beneficial effects on bone and muscles, and reduce fracture risk...
March 16, 2018: Trials
Sarah K Schäfer, Frank R Ihmig, Karen A Lara H, Frank Neurohr, Stephan Kiefer, Marlene Staginnus, Johanna Lass-Hennemann, Tanja Michael
BACKGROUND: Specific phobias are among the most common anxiety disorders. Exposure therapy is the treatment of choice for specific phobias. However, not all patients respond equally well to it. Hence, current research focuses on therapeutic add-ons to increase and consolidate the effects of exposure therapy. One potential therapeutic add-on is biofeedback to increase heart rate variability (HRV). A recent meta-analysis shows beneficial effects of HRV biofeedback interventions on stress and anxiety symptoms...
March 16, 2018: Trials
Igor Filipčić, Ivona Šimunović Filipčić, Tomislav Gajšak, Željko Milovac, Strahimir Sučić, Ena Ivezić, Sandra Zečević Penić, Ivana Orgulan, Damir Šebo, Vjekoslav Jeleč, Žarko Bajić
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique with few side effects that has been reported to be effective in the treatment of major depressive disorder (MDD). At present, no randomized controlled trials (RCT) have compared the efficacy and safety of rTMS delivered by the figure-8-coil and the H1-coil. We describe an industry-independent, randomized, controlled, single-blinded, single-center study protocol assessing the differences in efficacy and safety of rTMS for patients diagnosed with MDD with the H1-coil and figure-8-coil as an add-on to stable pharmacotherapy or pharmacotherapy alone...
March 2018: Psychiatria Danubina
Tanya Moutray, Jennifer R Evans, Noemi Lois, David J Armstrong, Tunde Peto, Augusto Azuara-Blanco
BACKGROUND: Diabetic retinopathy (DR) is a chronic progressive disease of the retinal microvasculature associated with prolonged hyperglycaemia. Proliferative DR (PDR) is a sight-threatening complication of DR and is characterised by the development of abnormal new vessels in the retina, optic nerve head or anterior segment of the eye. Argon laser photocoagulation has been the gold standard for the treatment of PDR for many years, using regimens evaluated by the Early Treatment of Diabetic Retinopathy Study (ETDRS)...
March 15, 2018: Cochrane Database of Systematic Reviews
Jun Ma, Bin Chen, Dong Li, Yue Zhang, Zhaoxia Ying
Port-wine stain (PWS) birthmark is a congenital microvascular malformation of the skin. A 1064-nm Nd:YAG laser can achieve a deeper treatment, but the weak absorption by blood limits its clinical application. Multiple laser pulses (MLPs) are a potential solution to enhance the curative effect of a Nd:YAG laser. To reduce the pulse number (pn ) required for the thermal destruction of the blood vessel, the effect of glucose in conjunction with MLP was investigated. In vivo experiments were performed on a dorsal skin chamber model...
March 14, 2018: Lasers in Medical Science
Guowei Li, Meha Bhatt, Mei Wang, Lawrence Mbuagbaw, Zainab Samaan, Lehana Thabane
Evidence from a well-designed randomized controlled trial (RCT) is generally considered to be the gold standard that can inform clinical practice and guide decision-making. However, several deficiencies in the reporting of RCTs have frequently been identified, including incomplete, selective, and biased or inconsistent reporting. Such suboptimal reporting may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct...
March 13, 2018: Proceedings of the National Academy of Sciences of the United States of America
Tinne Smets, Bregje B D Onwuteaka-Philipsen, Rose Miranda, Lara Pivodic, Marc Tanghe, Hein van Hout, Roeline H R W Pasman, Mariska Oosterveld-Vlug, Ruth Piers, Nele Van Den Noortgate, Anne B Wichmann, Yvonne Engels, Myrra Vernooij-Dassen, Jo Hockley, Katherine Froggatt, Sheila Payne, Katarzyna Szczerbińska, Marika Kylänen, Suvi Leppäaho, Ilona Barańska, Giovanni Gambassi, Sophie Pautex, Catherine Bassal, Luc Deliens, Lieve Van den Block
BACKGROUND: Several studies have highlighted the need for improvement in palliative care delivered to older people long-term care facilities. However, the available evidence on how to improve palliative care in these settings is weak, especially in Europe. We describe the protocol of the PACE trial aimed to 1) evaluate the effectiveness and cost-effectiveness of the 'PACE Steps to Success' palliative care intervention for older people in long-term care facilities, and 2) assess the implementation process and identify facilitators and barriers for implementation in different countries...
March 12, 2018: BMC Palliative Care
Gitendra Uswatte, Edward Taub, Mary H Bowman, Adriana Delgado, Camille Bryson, David M Morris, Staci Mckay, Joydip Barman, Victor W Mark
PURPOSE: To evaluate the efficacy of an expanded form of Constraint-Induced Movement Therapy (eCIMT) that renders CIMT, originally designed for treating mild-to-moderate upper-extremity hemiparesis, suitable for treating severe hemiparesis. METHODS: Twenty-one adults ≥1 year after stroke with severe upper-extremity hemiparesis (with little or no capacity to make movements with the more-affected hand) were randomly assigned to eCIMT (n = 10), a placebo-control procedure (n = 4), or usual care (n = 7)...
2018: Restorative Neurology and Neuroscience
Jonas Verbrugghe, Anouk Agten, Bert O Eijnde, Enzo Olivieri, Xavier Huybrechts, Henk Seelen, Frank Vandenabeele, Annick Timmermans
BACKGROUND: Although low to moderate intensity exercise therapy is a predominant part of rehabilitation in nonspecific chronic low back pain (NSCLBP), effect sizes are small and optimal exercise modalities/intensities are unclear. Conversely, effects of high intensity training have not yet been investigated in this population. OBJECTIVE: The aim of this study is to investigate the feasibility of high intensity training (HIT) and to explore the magnitude of the effects of a HIT program may have on exercise capacity and disease related outcome measures compared to conventional therapy for persons with NSCLBP...
March 2, 2018: Journal of Back and Musculoskeletal Rehabilitation
Lizhou Liu, Simone Petrich, Blair McLaren, Lyndell Kelly, G David Baxter
BACKGROUND: Breast cancer patients experience various side effects during cancer therapy, often resulting in reduced quality of life and poor adherence to treatment. A limited range of proven interventions has been developed to target such side effects. While Tai Chi offers benefits for the health and well-being of breast cancer survivors, the effectiveness of Tai Chi across the treatment continuum has not been evaluated. Improved patient education and support has been suggested as a priority for breast cancer care...
March 2018: Journal of Integrative Medicine
Megan Rose Stafford, Mick Cooper, Michael Barkham, Jeni Beecham, Peter Bower, Karen Cromarty, Andrew J B Fugard, Charlie Jackson, Peter Pearce, Rebekah Ryder, Cathy Street
BACKGROUND: One in ten children in Britain have been identified as experiencing a diagnosable mental health disorder. School-based humanistic counselling (SBHC) may help young people identify, address, and overcome psychological distress. Data from four pilot trials suggest that SBHC may be clinically effective. However, a fully powered randomised controlled trial (RCT) is needed to provide a robust test of its effectiveness, to assess its cost-effectiveness, and to determine the process of change...
March 9, 2018: Trials
T Larsen, H B Urke, I Holsen, C H Anvik, T Olsen, R H Waldahl, K M Antonsen, R Johnson, M Tobro, B Brastad, T B Hansen
BACKGROUND: Drop out from upper secondary school represents a risk for the future health and wellbeing of young people. Strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. This paper is a study protocol of a school based cluster randomized controlled trial (RCT) evaluating two school-based interventions, namely the Dream School Program (DSP) and the Mental Health Support Team (MHST). The interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence...
March 9, 2018: BMC Public Health
Falk Leichsenring, Christiane Steinert
BACKGROUND: In psychotherapy research unified, transdiagnostic and modular treatments have emerged. This is true for both cognitive-behavioral therapy and psychodynamic therapy. Recently, two unified psychodynamic protocols were presented, one for anxiety disorders, another for depressive disorders. Integrating the treatment principles for these two highly prevalent disorder groups into one protocol for "emotional disorders" may be useful for both clinical practice and training in psychotherapy...
November 11, 2017: Journal of Affective Disorders
Stephanie Mazzucca, Rachel G Tabak, Meagan Pilar, Alex T Ramsey, Ana A Baumann, Emily Kryzer, Ericka M Lewis, Margaret Padek, Byron J Powell, Ross C Brownson
Background: The need for optimal study designs in dissemination and implementation (D&I) research is increasingly recognized. Despite the wide range of study designs available for D&I research, we lack understanding of the types of designs and methodologies that are routinely used in the field. This review assesses the designs and methodologies in recently proposed D&I studies and provides resources to guide design decisions. Methods: We reviewed 404 study protocols published in the journal Implementation Science from 2/2006 to 9/2017...
2018: Frontiers in Public Health
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