HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

<p>Abstract</p> <p>Background</p> <p>Cardiovascular disease (CVD) is the leading cause of death worldwide. Cardiac rehabilitation (CR) is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth) offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial.</p> <p>Methods</p> <p>A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention). The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ), cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio), health related quality of life (SF-36), and cost-effectiveness.</p> <p>Discussion</p> <p>This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed information about physical and psychological well-being, and cost-effectiveness of an automated telecommunication intervention. If effective, this intervention has enormous potential to improve the delivery of CR and could easily be scaled up to be delivered nationally (and internationally) in a very short time, enhancing the translational aspect of this research. It also has potential to extend to comprehensive CR (nutrition advice, smoking cessation, medication adherence).</p> <p>Trial Registration</p> <p><a href="http://www.anzctr.org.au/ACTRN12611000117910.aspx">ACTRN12611000117910</a></p

Evaluation of the appendix during diagnostic laparoscopy, the laparoscopic appendicitis score:a pilot study

<p>Diagnostic laparoscopy is the ultimate diagnostic tool to evaluate the appendix. Still, according to the literature, this strategy results in a negative appendectomy rate of approximately 12-18 % and associated morbidity. Laparoscopic criteria for determining appendicitis are lacking. The goal of this study is to define clear and reliable criteria for appendicitis during diagnostic laparoscopy that eventually may safely reduce the negative appendectomy rate.</p><p>From December 2009 through April 2011, 134 patients were included and analysed in a single-centre prospective pilot study. Intraoperatively, the appendix was evaluated by the surgeon according to nine criteria for appendicitis. The operating surgeon decided whether it should be removed or not. Immediately after the operation the surgeon had to complete a questionnaire on nine criteria for appendicitis. All removed appendices were examined by a pathologist. In case the appendix was not removed, the clinical postoperative course was decisive for the (missed) presence of appendicitis.</p><p>In 109 cases an inflamed appendix was removed; in 25 patients the appendix was normal, 3 of which had been removed. After univariate analysis and clinical judgement six variables were included in the Laparoscopic APPendicitis score (LAPP score). In this study, use of the LAPP score would have led to a positive predictive value of 99 % and a negative predictive value of 100 %.</p><p>This study presents the LAPP score. The LAPP score is an easily applicable score that can be used by surgeons to evaluate the appendix during diagnostic laparoscopy. The score has high positive and negative predictive value. The LAPP score needs to be validated in a multicentre validation study.</p>

Noninvasive measurement of intestinal epithelial damage at time of refeeding can predict clinical outcome after necrotizing enterocolitis.

BACKGROUND: Reintroduction of enteral nutrition in neonates with necrotizing enterocolitis (NEC) should take place when the gut is ready for its normal function. Too early a start of oral feeding might lead to disease relapse, whereas prolonged discontinuation of enteral nutrition is associated with impaired gut function and parenteral nutrition-related complications. This study evaluated whether noninvasive urinary measurement of intestinal fatty acid binding protein (I-FABP) at the time of refeeding can predict clinical outcome in neonates with NEC. METHODS: Urinary I-FABP concentrations were measured in 21 infants with NEC just before reintroducing enteral nutrition. Poor outcome was defined as unsuccessful reintroduction of enteral feeding (EF), (re)operation for NEC, or death related to NEC after reintroduction of EF. RESULTS: Median urinary I-FABP levels in neonates with poor outcome (n = 5) were significantly higher as compared with I-FABP levels in neonates with good outcome (n = 16) (P <0.01). A clinically significant cutoff value of 963 pg/ml was found to discriminate between infants with poor outcome and those with good outcome (sensitivity 80%, specificity 94%). CONCLUSION: Noninvasive urinary I-FABP measurement at time of refeeding differentiates neonates with poor outcome from neonates with good outcome in NEC. Urinary I-FABP measurement may therefore be helpful in the timing of EF in neonates with NEC