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RCT protocol

Sonia Johnson, Luke Sheridan Rains, Steven Marwaha, John Strang, Thomas Craig, Tim Weaver, Paul McCrone, Michael King, David Fowler, Stephen Pilling, Louise Marston, Rumana Z Omar, Meghan Craig, Mark Hinton
BACKGROUND: Around 35-45 % of people in contact with services for a first episode of psychosis are using cannabis. Cannabis use is associated with delays in remission, poorer clinical outcomes, significant increases in the risk of relapse, and lower engagement in work or education. While there is a clear need for effective interventions, so far only very limited benefits have been achieved from psychological interventions. Contingency management (CM) is a behavioural intervention in which specified desired behavioural change is reinforced through financial rewards...
October 22, 2016: Trials
Amirabbas Azizi, Robab Aboutorabi, Zahra Mazloum-Khorasani, Monavar Afzal-Aghaea, Hamed Tabesh, Mahmood Tara
BACKGROUND: There are 4 main types of chronic or noncommunicable diseases. Of these, diabetes is one of the major therapeutic concerns globally. Moreover, Iran is among the countries with the highest incidence of diabetic patients. Furthermore, library-based studies by researchers have shown that thus far no study has been carried out to evaluate the relationship between Web-based diabetic personal health records (DPHR) and self-care indicators in Iran. OBJECTIVE: The objective of this study is to examine the effect of Web-based DPHR on self-care status of diabetic patients in an intervention group as compared with a control group...
October 21, 2016: JMIR Medical Informatics
Hanna F Skjåkødegård, Yngvild S Danielsen, Mette Morken, Sara-Rebekka F Linde, Rachel P Kolko, Katherine N Balantekin, Denise E Wilfley, Pétur B Júlíusson
BACKGROUND: The purpose of the FABO-study is to evaluate the effect of family-based behavioral social facilitation treatment (FBSFT), designed to target children's family and social support networks to enhance weight loss outcomes, compared to the standard treatment (treatment as usual, TAU) given to children and adolescents with obesity in a routine clinical practice. METHODS: Randomized controlled trial (RCT), in which families (n = 120) are recruited from the children and adolescents (ages 6-18 years) referred to the Obesity Outpatient Clinic (OOC), Haukeland University Hospital, Norway...
October 21, 2016: BMC Public Health
S Scambler, M Delgado, K Asimakopoulou
Objective This paper presents the results of a systematic review, designed to explore how patient-centred care (PCC) is defined in the dental literature.Method An electronic search of MEDLINE (1946-2012), Embase (1980-2012) PsycINFO (1806-2012), the Cochrane Library and non-peer reviewed literature was conducted using a standardised search protocol. Definitions of patient centred care were identified and scored on two criteria to evaluate quality of definition and quality/type of evidence.Results Of the 28 papers included in the review the majority provided definitions of PCC synonymous with good quality general care (holistic, humanitarian)...
October 21, 2016: British Dental Journal
Massimo Del Fabbro, Stefano Corbella, Patrick Sequeira-Byron, Igor Tsesis, Eyal Rosen, Alessandra Lolato, Silvio Taschieri
BACKGROUND: When primary root canal therapy fails, periapical lesions can be retreated with or without surgery. Root canal retreatment is a non-surgical procedure that involves removal of root canal filling materials from the tooth, followed by cleaning, shaping and obturating of the canals. Root-end resection is a surgical procedure that involves exposure of the periapical lesion through an osteotomy, surgical removal of the lesion, removal of part of the root-end tip, disinfection and, commonly, retrograde sealing or filling of the apical portion of the remaining root canal...
October 19, 2016: Cochrane Database of Systematic Reviews
Shashank S Sinha, Devraj Sukul, John J Lazarus, Vivek Polavarapu, Paul S Chan, Robert W Neumar, Brahmajee K Nallamothu
BACKGROUND: Cardiac arrest is a major public health concern worldwide. The extent and types of randomized controlled trials (RCT)-our most reliable source of clinical evidence-conducted in these high-risk patients over recent years are largely unknown. METHODS AND RESULTS: We performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on the acute treatment of nontraumatic cardiac arrest in adults...
October 18, 2016: Circulation. Cardiovascular Quality and Outcomes
Leila Rooshenas, Daisy Elliott, Julia Wade, Marcus Jepson, Sangeetha Paramasivan, Sean Strong, Caroline Wilson, David Beard, Jane M Blazeby, Alison Birtle, Alison Halliday, Chris A Rogers, Rob Stein, Jenny L Donovan
BACKGROUND: Randomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians' difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians' reported intentions compared with their actual practices...
October 2016: PLoS Medicine
James K Hamill, Jamie-Lee Rahiri, Gamage Gunaratna, Andrew G Hill
BACKGROUND: No enhanced recovery after surgery protocol has been published for laparoscopic appendectomy. This was a review of evidence-based interventions that could optimize recovery after appendectomy. METHODS: Interventions for the review Clinical pathway, fast-track or enhanced recovery protocols; needlescopic approach; single incision laparoscopic (SIL) approach; natural orifice transluminal endoscopic surgery (NOTES); regional nerve blocks; intraperitoneal local anaesthetic (IPLA); drains...
October 17, 2016: Surgical Endoscopy
Saghar Salehpour, Marzieh Zamaniyan, Nasrin Saharkhiz, Shahrzad Zadeh Modares, Sedighe Hosieni, Samira Seif, Narges Malih, Parinaz Rezapoor, Mohammad-Reza Sohrabi
BACKGROUND: Recurrent implantation failure is one of the most issues in IVF cycles. Some researchers found that beneficial effects of endometrial Scratching in women with recurrent implantation failure, while some authors demonstrated contrary results. OBJECTIVE: The present study aimed to investigate the effect of intrauterine. Saline infusion as a form of endometrial injury, during fresh in vitro fertilization-embryo transfer cycle, among patients with recurrent implantation failure...
September 2016: International Journal of Reproductive Biomedicine (Yazd, Iran)
Lianne M Tomfohr-Madsen, Tavis S Campbell, Gerald F Giesbrecht, Nicole L Letourneau, Linda E Carlson, Joshua W Madsen, Sona Dimidjian
BACKGROUND: Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy...
October 13, 2016: Trials
Karen L Barker, David Beard, Andrew Price, Francine Toye, Martin Underwood, Avril Drummond, Gary Collins, Susan Dutton, Helen Campbell, Nicola Kenealy, Jon Room, Sarah E Lamb
BACKGROUND: The number of knee arthroplasties performed each year is steadily increasing. Although the outcome is generally favourable, up to 15 % fail to achieve a satisfactory clinical outcome which may indicate that the existing model of rehabilitation after surgery may not be the most efficacious. Given the increasing number of knee arthroplasties, the relative limited physiotherapy resources available and the increasing age and frailty of patients receiving arthroplasty surgery, it is important that we concentrate our rehabilitation resources on those patients who most need help to achieve a good outcome...
October 13, 2016: Trials
Anne Tsampalieros, Greg A Knoll, Amber O Molnar, Nicholas Fergusson, Dean A Fergusson
BACKGROUND: A number of corticosteroid minimization and avoidance protocols for post-solid organ transplant have been developed. The study objective was to examine the effect of corticosteroid withdrawal/avoidance on growth and safety parameters in pediatric solid organ transplant recipients. METHODS: A systematic review using Medline and Embase was performed. All randomized controlled trials (RCT) and observational studies comparing corticosteroid withdrawal/avoidance to controls receiving corticosteroids in pediatric transplant recipients which reported growth as change in height or final height were included...
July 12, 2016: Transplantation
Astrid Baljé, Anja Greeven, Anne van Giezen, Kees Korrelboom, Arnoud Arntz, Philip Spinhoven
BACKGROUND: Social anxiety disorder (SAD) with comorbid avoidant personality disorder (APD) has a high prevalence and is associated with serious psychosocial problems and high societal costs. When patients suffer from both SAD and APD, the Dutch multidisciplinary guidelines for personality disorders advise offering prolonged cognitive behavioral therapy (CBT). Recently there is increasing evidence for the effectiveness of schema therapy (ST) for personality disorders such as borderline personality disorder and cluster C personality disorders...
October 8, 2016: Trials
Elena Longhi, Lynne Murray, Rachael Hunter, David Wellsted, Samantha Taylor-Colls, Kathryn MacKenzie, Gwynne Rayns, Richard Cotmore, Peter Fonagy, Richard M Pasco Fearon
BACKGROUND: Young mothers living in low-income urban settings often are exposed to significant and chronic environmental difficulties including poverty, social isolation and poor education and typically also have to cope with personal histories of abuse and depression. Minding the Baby® (MTB) is an interdisciplinary home-visiting programme developed to support first-time young mothers, which integrates primary care and mental health approaches into a single intensive intervention from the last trimester of pregnancy until the child's second birthday...
October 7, 2016: Trials
Wenche Ryberg, Roar Fosse, Per Henrik Zahl, Inge Brorson, Paul Møller, Nils Inge Landrø, David Jobes
BACKGROUND: Collaborative Assessment and Management of Suicidality (CAMS) is a therapeutic framework that appears promising to reduce suicidal ideation and suicidal cognition. CAMS has not previously been evaluated in a standard specialized mental health care setting for patients with suicidal problems in general. In this pragmatic randomized controlled trial (RCT) we will investigate if CAMS is more effective than treatment as usual (TAU) in reducing suicidal thoughts and behaviors. Effects will also be investigated on mental health and symptom relief in general and upon readmissions to inpatient units...
October 3, 2016: Trials
Suzanne L de Kunder, Kim Rijkers, Sander M J van Kuijk, Silvia M A A Evers, Rob A de Bie, Henk van Santbrink
BACKGROUND: With a steep increase in the number of instrumented spinal fusion procedures, there is a need for comparative data to develop evidence based treatment recommendations. Currently, the available data on cost and clinical effectiveness of the two most frequently performed surgeries for lumbar spondylolisthesis, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are not sufficient. Therefore, current guidelines do not advise which is the most appropriate surgical treatment strategy for these patients...
October 6, 2016: BMC Musculoskeletal Disorders
Brooke Ingersoll, Natalie Berger, Danielle Carlsen, Theresa Hamlin
There is a lack of effective social interventions for youths with ASD and co-morbid intellectual disability (ID). A previous single-case design study indicated that reciprocal imitation training (RIT) may improve social interaction and challenging behavior in this population. The current pilot study examined the feasibility of conducting an RCT to investigate the effectiveness of RIT for improving social functioning and challenging behaviors in 20 adolescents with ASD and severe ID in a residential program...
August 11, 2016: Developmental Neurorehabilitation
Laura N Thomas, Tisa F Hill, Alisha Gaines, Jamie S Dollahite
BACKGROUND: This paper presents design and findings from the process evaluation of a randomized controlled trial (RCT) testing the effectiveness of Smarter Lunchrooms Movement (SLM) interventions to encourage consumption of either fruit, vegetables, or unflavored milk in middle school cafeterias (grades 6-8, typically children ages 10-14 years). Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework adapted for environmental interventions, the process evaluation monitored fidelity to SLM protocol, determined barriers and facilitators influencing fidelity, and identified the training and support needs of implementers...
2016: Archives of Public Health, Archives Belges de Santé Publique
Heidi M Crane, Rob J Fredericksen, Anna Church, Anna Harrington, Paul Ciechanowski, Jennifer Magnani, Kari Nasby, Tyler Brown, Shireesha Dhanireddy, Robert D Harrington, William B Lober, Jane Simoni, Stevan A Safren, Todd C Edwards, Donald L Patrick, Michael S Saag, Paul K Crane, Mari M Kitahata
BACKGROUND: Adherence to antiretroviral medications is a key determinant of clinical outcomes. Many adherence intervention trials investigated the effects of time-intensive or costly interventions that are not feasible in most clinical care settings. OBJECTIVE: We set out to evaluate a collaborative care approach as a feasible intervention applicable to patients in clinical care including those with mental illness and/or substance use issues. METHODS: We developed a randomized controlled trial (RCT) investigating an integrated, clinic-based care management approach to improve clinical outcomes that could be integrated into the clinical care setting...
October 5, 2016: JMIR Research Protocols
Shireen Patel, Sam Malins, Boliang Guo, Marilyn James, Joe Kai, Catherine Kaylor-Hughes, Emma Rowley, Jayne Simpson, David Smart, Michelle Stubley, Helen Tyrer, Richard Morriss
BACKGROUND: Health anxiety and medically unexplained symptoms cost the National Health Service (NHS) an estimated £3 billion per year in unnecessary costs with little evidence of patient benefit. Effective treatment is rarely taken up due to issues such as stigma or previous negative experiences with mental health services. An approach to overcome this might be to offer remotely delivered psychological therapy, which can be just as effective as face-to-face therapy and may be more accessible and suitable...
January 2016: BJPsych Open
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