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Dr Andrew Entwistle, a PPI contributor and carer for his twin brother, recently got in touch with us to give us his thoughts on PPI and CLAHRC Oxford.
A randomised controlled trial of blood pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: A feasibility trial.
OBJECTIVE: To assess the feasibility of a blood pressure self-monitoring intervention for managing pregnancy hypertension. STUDY DESIGN: OPTIMUM-BP was an unmasked randomised controlled trial comparing a self-monitoring of blood pressure (SMBP) intervention versus usual care for the management of pregnancy hypertension. Women with chronic (CH) or gestational hypertension (GH) from 4 UK centres were randomised (2:1) intervention to control. Self-monitoring involved daily home blood pressure (BP) measurements, with recording via study diary or telemonitoring. Clinicians were invited to use the home readings in clinical and antihypertensive titration decisions. MAIN OUTCOMES: The primary outcomes were recruitment, retention, adherence and persistence with the intervention. RESULTS: Women from four UK centres were randomised: 158/222 (71%) of those approached agreed, comprising: 86 women with chronic hypertension (55 SMBP, 31 control) and 72 with gestational hypertension (49 SMBP, 23 control) of whom outcome data were available from 154 (97%) and were included in the analysis. The median (IQR) number of days with home BP readings per week were 5.5 (3.1-6.5) for those with chronic hypertension and 6.1 (4.5-6.7) with gestational hypertension. Participants persisted with the intervention for 80% or more of their time from enrolment until delivery in 86% (43/50) and 76% (38/49) of those with chronic and gestational hypertension respectively. Recorded clinic and study BPs were similar for both groups. CONCLUSIONS: This is the first randomised investigation of BP self-monitoring for the management of pregnancy hypertension and indicates that a large RCT would be feasible.
Publisher Correction: The metabolite BH4 controls T cell proliferation in autoimmunity and cancer (Nature, (2018), 563, 7732, (564-568), 10.1038/s41586-018-0701-2)
© 2019, The Author(s), under exclusive licence to Springer Nature Limited. In this Letter, owing to an error in the production process, author Martin Aichinger was inadvertently associated with affiliation 14 (Karolinska Institute, Department of Medicine Solna, Center for Molecular Medicine, Karolinska University Hospital Solna, Stockholm, Sweden) instead of affiliation 13 (Research Institute of Molecular Pathology, Vienna Biocenter, Campus-Vienna-Biocenter 1, Vienna, Austria). In addition, the chemical structure of QM385 in Fig. 3a was incorrect. Figure 1 of this Amendment shows the incorrect and corrected structures, for transparency. These errors have been corrected online.
Development of a risk score for early saphenous vein graft failure: An individual patient data meta-analysis.
OBJECTIVES: Early saphenous vein graft (SVG) occlusion is typically attributed to technical factors. We aimed at exploring clinical, anatomical, and operative factors associated with the risk of early SVG occlusion (within 12 months postsurgery). METHODS: Published literature in MEDLINE was searched for studies reporting the incidence of early SVG occlusion. Individual patient data (IPD) on early SVG occlusion were used from the SAFINOUS-CABG Consortium. A derivation (n = 1492 patients) and validation (n = 372 patients) cohort were used for model training (with 10-fold cross-validation) and external validation respectively. RESULTS: In aggregate data meta-analysis (48 studies, 41,530 SVGs) the pooled estimate for early SVG occlusion was 11%. The developed IPD model for early SVG occlusion, which included clinical, anatomical, and operative characteristics (age, sex, dyslipidemia, diabetes mellitus, smoking, serum creatinine, endoscopic vein harvesting, use of complex grafts, grafted target vessel, and number of SVGs), had good performance in the derivation (c-index = 0.744; 95% confidence interval [CI], 0.701-0.774) and validation cohort (c-index = 0.734; 95% CI, 0.659-0.809). Based on this model. we constructed a simplified 12-variable risk score system (SAFINOUS score) with good performance for early SVG occlusion (c-index = 0.700, 95% CI, 0.684-0.716). CONCLUSIONS: From a large international IPD collaboration, we developed a novel risk score to assess the individualized risk for early SVG occlusion. The SAFINOUS risk score could be used to identify patients that are more likely to benefit from aggressive treatment strategies.
A key role for the novel coronary artery disease gene JCAD in atherosclerosis via shear stress mechanotransduction.
INTRODUCTION: Genome Wide Association studies have consistently identified an association between coronary artery disease (CAD) and a locus on chromosome 10 containing a single gene, JCAD (formerly KIAA1462). However, little is known about the mechanism by which JCAD could influence the development of atherosclerosis. METHODS AND RESULTS: Vascular function was quantified in subjects with CAD by flow mediated dilatation [FMD] and vasorelaxation responses in isolated blood vessel segments. The JCAD risk allele identified by GWAS was associated with reduced FMD and reduced endothelial-dependent relaxations. To study the impact of loss of Jcad on atherosclerosis, Jcad-/- mice were crossed to an ApoE-/- background and fed a high fat diet from 6 to16 weeks of age. Loss of Jcad did not affect blood pressure or heart rate. However, Jcad-/-ApoE-/- mice developed significantly less atherosclerosis in the aortic root and the inner curvature of the aortic arch. En-face analysis revealed a striking reduction in pro-inflammatory adhesion molecules at sites of disturbed flow on the endothelial cell layer of Jcad-/- mice. Loss of Jcad lead to a reduced recovery perfusion in response to hind limb ischemia, a model of altered in vivo flow. Knock down of JCAD using siRNA in primary human aortic endothelial cells significantly reduced the response to acute onset of flow, as evidenced by reduced phosphorylation of NF-КB, eNOS and Akt. CONCLUSION: The novel CAD gene JCAD promotes atherosclerotic plaque formation via a role in the endothelial cell shear stress mechanotransduction pathway. TRANSLATIONAL PERSPECTIVE: We reveal that JCAD is a novel coronary artery disease susceptibility gene which determines atherosclerosis progression via a role in the endothelial cell shear stress mechanotransduction pathway. Identifying this new role for JCAD in atherosclerotic plaque progression highlights the importance of new coronary artery disease genes that mediate blood flow mechanotransduction in the pathogenesis of coronary artery disease. These genes are potential novel targets for treatments to reduce atherosclerotic plaque formation, independent of established risk factors and biological mechanisms.
The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial.
BACKGROUND: High salt intake is a risk factor for hypertension and cardiovascular disease. Reducing salt intake has been shown to reduce blood pressure. Despite population-level interventions, including product reformulation and public awareness campaigns, adult salt consumption in the UK still exceeds recommendations; this is primarily due to salt consumed in processed and pre-packaged foods. Moderate or high-intensity dietary advice to encourage individuals to reduce their salt intake has been shown to be effective at reducing blood pressure, but evidence of the effectiveness of interventions that are suitable for delivery at scale in routine primary care is scarce. This feasibility trial investigates a complex behavioural change intervention to reduce dietary salt intake and blood pressure by encouraging individuals to purchase lower-salt foods when grocery shopping. METHODS: This randomised controlled trial will test the feasibility of a novel intervention to reduce salt intake, and the trial procedures to assess its effectiveness. We will recruit participants through UK general practices and randomise 40 participants with high blood pressure, in a 2:1 allocation to receive either the Salt Swap intervention or a control information leaflet. The primary outcomes relate to the criteria for progression to a large-scale trial. These include follow-up rates at 6 weeks, fidelity of intervention delivery and use of the intervention mobile app. Secondary outcomes include the effect of the intervention on the salt content of purchased foods (grams per 100 g), urinary sodium excretion assessed through 24-hour urine samples and blood pressure. Trial process measures will be collected and qualitative assessment will provide insights into participant engagement with the intervention content and perceived barriers to and facilitators of salt reduction dietary behavioural change. DISCUSSION: If the outcomes indicate the trial is feasible and there is evidence that behavioural change may result in salt reduction, we will proceed to a definitive trial to test the effectiveness of the intervention to lower blood pressure. If successful, this intervention approach could be applied not only to people with high blood pressure, but also to the wider population with normal blood pressure in whom dietary salt intake exceeds recommendations. TRIAL REGISTRATION: ISRCTN, 20910962 . Registered on 5 April 2017.
BACKGROUND: The standard way most people are advised to stop smoking is by quitting abruptly on a designated quit day. However, many people who smoke have tried to quit many times and may like to try an alternative method. Reducing smoking behaviour before quitting could be an alternative approach to cessation. However, before this method can be recommended it is important to ensure that abrupt quitting is not more effective than reducing to quit, and to determine whether there are ways to optimise reduction methods to increase the chances of cessation. OBJECTIVES: To assess the effect of reduction-to-quit interventions on long-term smoking cessation. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialised Register, MEDLINE, Embase and PsycINFO for studies, using the terms: cold turkey, schedul*, cut* down, cut-down, gradual*, abrupt*, fading, reduc*, taper*, controlled smoking and smoking reduction. We also searched trial registries to identify unpublished studies. Date of the most recent search: 29 October 2018. SELECTION CRITERIA: Randomised controlled trials in which people who smoked were advised to reduce their smoking consumption before quitting smoking altogether in at least one trial arm. This advice could be delivered using self-help materials or behavioural support, and provided alongside smoking cessation pharmacotherapies or not. We excluded trials that did not assess cessation as an outcome, with follow-up of less than six months, where participants spontaneously reduced without being advised to do so, where the goal of reduction was not to quit altogether, or where participants were advised to switch to cigarettes with lower nicotine levels without reducing the amount of cigarettes smoked or the length of time spent smoking. We also excluded trials carried out in pregnant women. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. Smoking cessation was measured after at least six months, using the most rigorous definition available, on an intention-to-treat basis. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for smoking cessation for each study, where possible. We grouped eligible studies according to the type of comparison (no smoking cessation treatment, abrupt quitting interventions, and other reduction-to-quit interventions) and carried out meta-analyses where appropriate, using a Mantel-Haenszel random-effects model. We also extracted data on quit attempts, pre-quit smoking reduction, adverse events (AEs), serious adverse events (SAEs) and nicotine withdrawal symptoms, and meta-analysed these where sufficient data were available. MAIN RESULTS: We identified 51 trials with 22,509 participants. Most recruited adults from the community using media or local advertising. People enrolled in the studies typically smoked an average of 23 cigarettes a day. We judged 18 of the studies to be at high risk of bias, but restricting the analysis only to the five studies at low or to the 28 studies at unclear risk of bias did not significantly alter results.We identified very low-certainty evidence, limited by risk of bias, inconsistency and imprecision, comparing the effect of reduction-to-quit interventions with no treatment on cessation rates (RR 1.74, 95% CI 0.90 to 3.38; I2 = 45%; 6 studies, 1599 participants). However, when comparing reduction-to-quit interventions with abrupt quitting (standard care) we found evidence that neither approach resulted in superior quit rates (RR 1. 01, 95% CI 0.87 to 1.17; I2 = 29%; 22 studies, 9219 participants). We judged this estimate to be of moderate certainty, due to imprecision. Subgroup analysis provided some evidence (P = 0.01, I2 = 77%) that reduction-to-quit interventions may result in more favourable quit rates than abrupt quitting if varenicline is used as a reduction aid. Our analysis comparing reduction using pharmacotherapy with reduction alone found low-certainty evidence, limited by inconsistency and imprecision, that reduction aided by pharmacotherapy resulted in higher quit rates (RR 1. 68, 95% CI 1.09 to 2.58; I2 = 78%; 11 studies, 8636 participants). However, a significant subgroup analysis (P < 0.001, I2 = 80% for subgroup differences) suggests that this may only be true when fast-acting NRT or varenicline are used (both moderate-certainty evidence) and not when nicotine patch, combination NRT or bupropion are used as an aid (all low- or very low-quality evidence). More evidence is likely to change the interpretation of the latter effects.Although there was some evidence from within-study comparisons that behavioural support for reduction to quit resulted in higher quit rates than self-help resources alone, the relative efficacy of various other characteristics of reduction-to-quit interventions investigated through within- and between-study comparisons did not provide any evidence that they enhanced the success of reduction-to-quit interventions. Pre-quit AEs, SAEs and nicotine withdrawal symptoms were measured variably and infrequently across studies. There was some evidence that AEs occurred more frequently in studies that compared reduction using pharmacotherapy versus no pharmacotherapy; however, the AEs reported were mild and usual symptoms associated with NRT use. There was no clear evidence that the number of people reporting SAEs, or changes in withdrawal symptoms, differed between trial arms. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that neither reduction-to-quit nor abrupt quitting interventions result in superior long-term quit rates when compared with one another. Evidence comparing the efficacy of reduction-to-quit interventions with no treatment was inconclusive and of low certainty. There is also low-certainty evidence to suggest that reduction-to-quit interventions may be more effective when pharmacotherapy is used as an aid, particularly fast-acting NRT or varenicline (moderate-certainty evidence). Evidence for any adverse effects of reduction-to-quit interventions was sparse, but available data suggested no excess of pre-quit SAEs or withdrawal symptoms. We downgraded the evidence across comparisons due to risk of bias, inconsistency and imprecision. Future research should aim to match any additional components of multicomponent reduction-to-quit interventions across study arms, so that the effect of reduction can be isolated. In particular, well-conducted, adequately-powered studies should focus on investigating the most effective features of reduction-to-quit interventions to maximise cessation rates.
Evaluation of New Technology-Based Tools for Dietary Intake Assessment-An ILSI Europe Dietary Intake and Exposure Task Force Evaluation.
BACKGROUND: New technology-based dietary assessment tools, including Web-based programs, mobile applications, and wearable devices, may improve accuracy and reduce costs of dietary data collection and processing. The International Life Sciences Institute (ILSI) Europe Dietary Intake and Exposure Task Force launched this project to evaluate new tools in order to recommend general quality standards for future applications. METHODS: A comprehensive literature search identified technology-based dietary assessment tools, including those published in English from 01/2011 to 09/2017, and providing details on tool features, functions and uses. Each of the 43 tools identified (33 for research and 10 designed for consumer use) was rated on 25 attributes. RESULTS: Most of the tools identified (79%) relied on self-reported dietary intakes. Most (91%) used text entry and 33% used digital images to help identify foods. Only 65% had integrated databases for estimating energy or nutrients. Fewer than 50% contained any features of customization and about half generated automatic reports. Most tools reported on usability or reported validity compared with another assessment method (77%). A set of Best Practice Guidelines was developed for reporting dietary assessment tools using new technology. CONCLUSIONS: Dietary assessment methods that utilize technology offer many advantages for research and are often preferable to consumers over more traditional methods. In order to meet general quality standards, new technology tools require detailed publications describing tool development, food identification and quantification, customization, outputs, food composition tables used, and usability/validity testing.
Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial (Preprint)
<sec> <title>BACKGROUND</title> <p>Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits.</p> </sec> <sec> <title>OBJECTIVE</title> <p>We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance.</p> </sec> <sec> <title>METHODS</title> <p>Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study.</p> </sec> <sec> <title>RESULTS</title> <p>A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (–0.16 mmol/L in the intervention and –0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean 2.63 [SD 1.71] readings per day in the intervention and control groups, respectively; P<.001). There was no significant difference in direct health care costs between the two groups, with a mean cost difference of the intervention group compared to control of –£1044 (95% CI –£2186 to £99). There were no unexpected adverse outcomes.</p> </sec> <sec> <title>CONCLUSIONS</title> <p>Remote blood glucocse monitoring in women with GDM is safe. We demonstrated superior data capture using GDm-health. Although glycemic control and maternal and neonatal outcomes were similar, women preferred this model of care. Further studies are required to explore whether digital health solutions can promote desired self-management lifestyle behaviors and dietetic adherence, and influence maternal and neonatal outcomes. Digital blood glucose monitoring may provide a scalable, practical method to address the growing burden of GDM around the world.</p> </sec> <sec> <title>CLINICALTRIAL</title> <p>ClinicalTrials.gov NCT01916694; https://clinicaltrials.gov/ct2/show/NCT01916694 (Archived by WebCite at http://www.webcitation.org/6y3lh2BOQ)</p> </sec>
Experiences of Using Web-Based and Mobile Technologies to Support Self-Management of Type 2 Diabetes: Qualitative Study (Preprint)
<sec> <title>BACKGROUND</title> <p>The prevalence of type 2 diabetes is rising, placing increasing strain on health care services. Web-based and mobile technologies can be an important source of information and support for people with type 2 diabetes and may prove beneficial with respect to reducing complications due to mismanagement. To date, little research has been performed to gain an insight into people’s perspectives of using such technologies in their daily management.</p> </sec> <sec> <title>OBJECTIVE</title> <p>The purpose of this study was to understand the impact of using Web-based and mobile technologies to support the management of type 2 diabetes.</p> </sec> <sec> <title>METHODS</title> <p>In-depth interviews were conducted with 15 people with type 2 diabetes to explore experiences of using Web-based and mobile technologies to manage their diabetes. Transcripts were analyzed using the framework method.</p> </sec> <sec> <title>RESULTS</title> <p>Technology supported the users to maintain individualized and tailored goals when managing their health. A total of 7 themes were identified as important to participants when using technology to support self-management: (1) information, (2) understanding individual health and personal data, (3) reaching and sustaining goals, (4) minimizing disruption to daily life, (5) reassurance, (6) communicating with health care professionals, and (7) coordinated care.</p> </sec> <sec> <title>CONCLUSIONS</title> <p>Patients need to be supported to manage their condition to improve well-being and prevent diabetes-related complications from arising. Technologies enabled the users to get an in-depth sense of how their body reacted to both lifestyle and medication factors—something that was much more difficult with the use of traditional standardized information alone. It is intended that the results of this study will inform a new questionnaire designed to assess self-management in people using Web-based and mobile technology to manage their health.</p> </sec>
A brief behavioural intervention to promote regular self-weighing to prevent weight regain after weight loss: a RCT
<jats:sec id="abs1-1"> <jats:title>Background</jats:title> <jats:p>Although behavioural weight loss treatments can be effective, long-term maintenance of this weight loss remains a critical challenge because the vast majority of people will regain their lost weight over time. The period after initial weight loss is the time when people are at the highest risk of weight regain.</jats:p> </jats:sec> <jats:sec id="abs1-2"> <jats:title>Objective</jats:title> <jats:p>The primary aim of this study was to evaluate the effectiveness and cost-effectiveness of a brief behavioural intervention delivered by non-specialist call centre staff to promote regular self-weighing to prevent weight regain after intentional weight loss.</jats:p> </jats:sec> <jats:sec id="abs1-3"> <jats:title>Design</jats:title> <jats:p>Randomised controlled trial.</jats:p> </jats:sec> <jats:sec id="abs1-4"> <jats:title>Setting</jats:title> <jats:p>West Midlands, UK.</jats:p> </jats:sec> <jats:sec id="abs1-5"> <jats:title>Participants</jats:title> <jats:p>Adults were recruited if they had attended a local authority-funded weight management programme and had lost ≥ 5% of their starting weight by the end of their weight loss programme.</jats:p> </jats:sec> <jats:sec id="abs1-6"> <jats:title>Interventions</jats:title> <jats:p>The intervention group received three brief support telephone calls, delivered by non-specialist call centre staff (from a third-sector community organisation), that encouraged setting a weight maintenance target of ≤ 1 kg of weight gain from current weight, which was to be assessed by daily self-weighing and recording weight on a record card, together with regular text messages. Participants were asked to return to their weight loss plan if they gained > 1 kg above their target weight. The usual-care group received a standard weight maintenance leaflet, the infographic EatWell Plate and a list of useful websites pertaining to weight management.</jats:p> </jats:sec> <jats:sec id="abs1-7"> <jats:title>Main outcome measures</jats:title> <jats:p>The primary outcome was the difference between the groups in mean weight change (kg) from baseline to 12 months. The secondary outcomes included the proportion of participants in each group who had regained < 1 kg in weight at the 3- and 12-month follow-up points.</jats:p> </jats:sec> <jats:sec id="abs1-8"> <jats:title>Results</jats:title> <jats:p>A total of 813 potential participants were screened, 583 of whom were eligible and randomised (usual care, <jats:italic>n</jats:italic> = 292; intervention, <jats:italic>n</jats:italic> = 291). A total of 94% and 89% of participants completed follow-up at 3 and 12 months, respectively. At 12 months, the mean unadjusted weight change was +0.39 kg for the intervention group and –0.17 kg for the usual-care group, an adjusted difference of 0.53 kg [95% confidence interval (CI) –0.64 to 1.71 kg]. At 12 months, 134 (45.9%) and 130 (44.7%) participants regained ≤ 1 kg of their baseline weight in the usual-care and intervention groups, respectively (odds ratio 0.96, 95% CI 0.69 to 1.33). As the intervention was ineffective, we did not pursue a cost-effectiveness analysis.</jats:p> </jats:sec> <jats:sec id="abs1-9"> <jats:title>Conclusions</jats:title> <jats:p>Brief behavioural telephone support delivered by non-specialist workers to promote target-setting and daily self-weighing and recording of weight does not prevent weight regain after intentional weight loss. Specifically, as target-setting and daily self-weighing did not increase conscious cognitive restraint, people may need more intensive interventions to promote the use of behavioural techniques that help people maintain lost weight.</jats:p> </jats:sec> <jats:sec id="abs1-10"> <jats:title>Trial registration</jats:title> <jats:p>Current Controlled Trials ISRCTN52341938.</jats:p> </jats:sec> <jats:sec id="abs1-11"> <jats:title>Funding</jats:title> <jats:p>This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in <jats:italic>Public Health Research</jats:italic>; Vol. 7, No. 7. See the NIHR Journals Library website for further project information.</jats:p> </jats:sec>