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Whiting P.,University of Bristol | Whiting P.,National Health Research Institute | Whiting P.,Kleijnen Systematic Reviews Ltd | Savovic J.,University of Bristol | And 11 more authors.
Journal of Clinical Epidemiology | Year: 2016

Objective To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies). Study Design and Setting We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting. Results ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews ("reviews of reviews"), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions. Conclusions ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews. © 2016 The Authors. Published by Elsevier Inc.


Morrison A.P.,University of Manchester | Morrison A.P.,Greater Manchester West Mental Health NHS Foundation Trust | Turkington D.,Northumbria University | Turkington D.,Tyne and Wear NHS Mental Health Foundation Trust | And 28 more authors.
The Lancet | Year: 2014

Background Antipsychotic drugs are usually the first line of treatment for schizophrenia; however, many patients refuse or discontinue their pharmacological treatment. We aimed to establish whether cognitive therapy was effective in reducing psychiatric symptoms in people with schizophrenia spectrum disorders who had chosen not to take antipsychotic drugs. Methods We did a single-blind randomised controlled trial at two UK centres between Feb 15, 2010, and May 30, 2013. Participants aged 16-65 years with schizophrenia spectrum disorders, who had chosen not to take antipsychotic drugs for psychosis, were randomly assigned (1:1), by a computerised system with permuted block sizes of four or six, to receive cognitive therapy plus treatment as usual, or treatment as usual alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. Our primary outcome was total score on the positive and negative syndrome scale (PANSS), which we assessed at baseline, and at months 3, 6, 9, 12, 15, and 18. Analysis was by intention to treat, with an ANCOVA model adjusted for site, age, sex, and baseline symptoms. This study is registered as an International Standard Randomised Controlled Trial, number 29607432. Findings 74 individuals were randomly assigned to receive either cognitive therapy plus treatment as usual (n=37), or treatment as usual alone (n=37). Mean PANSS total scores were consistently lower in the cognitive therapy group than in the treatment as usual group, with an estimated between-group effect size of -6·52 (95% CI -10·79 to -2·25; p=0·003). We recorded eight serious adverse events: two in patients in the cognitive therapy group (one attempted overdose and one patient presenting risk to others, both after therapy), and six in those in the treatment as usual group (two deaths, both of which were deemed unrelated to trial participation or mental health; three compulsory admissions to hospital for treatment under the mental health act; and one attempted overdose). Interpretation Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs. Evidence-based treatments should be available to these individuals. A larger, definitive trial is needed. Copyright © Chatterjee et al.


Kontopantelis E.,University of Manchester | Kontopantelis E.,Institute of Population Health | Springate D.A.,Institute of Population Health | Springate D.A.,University of Manchester | And 4 more authors.
BMJ (Online) | Year: 2015

Objectives: To quantify the relationship between a national primary care pay-for-performance programme, the UK's Quality and Outcomes Framework (QOF), and all-cause and cause-specific premature mortality linked closely with conditions included in the framework. Design: Longitudinal spatial study, at the level of the "lower layer super output area" (LSOA). Setting: 32482 LSOAs (neighbourhoods of 1500 people on average), covering the whole population of England (approximately 53.5 million), from 2007 to 2012. Participants: 8647 English general practices participating in the QOF for at least one year of the study period, including over 99% of patients registered with primary care. Intervention: National pay-for-performance programme incentivising performance on over 100 quality-of-care indicators. Main outcome measures: All-cause and cause-specific mortality rates for six chronic conditions: diabetes, heart failure, hypertension, ischaemic heart disease, stroke, and chronic kidney disease. We used multiple linear regressions to investigate the relationship between spatially estimated recorded quality of care and mortality. Results: All-cause and cause-specific mortality rates declined over the study period. Higher mortality was associated with greater area deprivation, urban location, and higher proportion of a non-white population. In general, there was no significant relationship between practice performance on quality indicators included in the QOF and all-cause or cause-specific mortality rates in the practice locality. Conclusions: Higher reported achievement of activities incentivised under a major, nationwide pay-for-performance programme did not seem to result in reduced incidence of premature death in the population.


Burnier D.,Institute of Population Health | Dubois L.,Institute of Population Health | Dubois L.,University of Ottawa | Girard M.,Institute of Population Health
Journal of Nutrition Education and Behavior | Year: 2011

Objective: To examine how arguments at mealtimes relate to children's daily energy intake. Design: A cross-sectional study using data obtained through the Québec Longitudinal Study of Child Development 1998-2010 (QLSCD), a representative sample of children born in 1998, in the province of Québec, Canada. Setting: Face-to-face interviews, questionnaires, and 24-hour dietary recall interviews addressed to children's parents. Participants: One thousand five hundred forty-nine 4-year-old children who participated in a nutrition substudy. Main Outcome Measure: Children's energy intakes were measured through a 24-hour dietary recall interview administered to parents by trained nutritionists, in the children's homes. Analysis: The main associations were examined through chi-square tests of independence and through multivariate logistic regression analyses. Results: The adjusted odds for consuming a high daily energy intake was 2.5 (95% confidence interval: 1.3-4.9) in children who were never exposed to arguments (between parents and children) at mealtimes, in comparison to children who were often or always exposed to arguments. Conclusions and Implications: Mealtimes that are free of arguments, specifically between parents and children, appear to associate with high daily energy intakes in children, even after controlling for other factors, including a child's level of physical activity, eating in front of the television, mother's educational level, and number of overweight parents, among others. © 2011 Society for Nutrition Education and Behavior.


El-Gohary M.,University of Southampton | Hay A.D.,University of Bristol | Coventry P.,Institute of Population Health | Coventry P.,University of Manchester | And 3 more authors.
Family Practice | Year: 2013

Background: Cough associated with acute respiratory tract infection (RTI) is one of the most common problems managed in primary care. Despite minimal evidence for the use of antibiotics, they continue to be prescribed at great cost and are a significant cause of emerging bacterial resistance. Objectives: To carry out a systematic review of randomized controlled trials to evaluate the effect of corticosteroid therapy in otherwise-healthy adults with acute RTI. Methods: Seven electronic databases and five ongoing trial registers were searched. Studies were eligible if they compared the use of any corticosteroid treatment against a control group in adults with an acute (<3 weeks) or subacute (<8 weeks) cough associated with an RTI but no asthma. Primary outcomes were differences in mean cough and other symptom scores. Secondary outcomes included adverse effects, subsequent diagnosis of asthma and patient satisfaction. Results: Four trials (335 participants) investigating the effects of inhaled corticosteroids were identified. None investigated the use of oral corticosteroids. Results were mixed, with two reporting equivalence and two reporting benefits for mean cough score (P = 0.012) and cough frequency (P = 0.047). One reported additional benefits in non-smokers. Adverse events were rare and there were no data on patient satisfaction or the subsequent diagnosis of asthma. Most trials were of unclear risk of bias. Study outcomes were too heterogeneous to meta-analyse. Conclusions: There is insufficient evidence to recommend the routine use of inhaled corticosteroids for acute RTI in adults. However, some trials have shown benefits, suggesting the need for further high-quality, adequately powered trials. © The Author 2013.


Zhang W.-J.,Institute of Population Health | Zhang W.-J.,University of Manchester | Cristinacce P.L.H.,Institute of Population Health | Cristinacce P.L.H.,University of Manchester | And 11 more authors.
Radiology | Year: 2015

Purpose: To compare magnetic resonance (MR) quantitative equilibrium signal (qS0) mapping with quantitative computed tomography (CT) in the estimation of emphysema in patients with chronic obstructive pulmonary disease (COPD). Materials and Methods: Written informed consent of the original study permitted future reanalysis of data. This study was a retrospective analysis of data from an institutional review board-approved study. Twenty-four patients with COPD and 12 healthy patients who did not smoke underwent spirometry and two separate 1.5-T MR imaging examinations. All patients with COPD underwent additional chest CT. Lung MR qS 0 maps were generated from MR images obtained with multiple inversion times by fitting the inversion recovery signal equation. Mean, 15th percentile, and standard deviation of whole-lung qS 0 and relative lung area with a qS0 value below 0.20 (RA0.20) were measured and compared between groups with an unpaired t test. Reproducibility between two examinations was tested with intraclass correlation coefficients (ICCs), and their associations with spirometry and CT measurements of 15th percentile attenuation (PA 15) and relative lung area with attenuation below -950 HU (RA-950) were assessed with the Pearson correlation coefficient. Results: Whole-lung mean qS 0 and 15th percentile of qS0 were significantly lower, whereas RA0.20 and standard deviation of qS0 were significantly higher in patients with COPD than in healthy control subjects (P = .014, P = .002, P = .005, and P < .001, respectively). Whole-lung mean qS0, the 15th percentile of qS0, and RA0.20 strongly correlated with RA-950 (r = -0.78, r = -0.81, and r = 0.86, respectively; P < .001) and PA15 (r = 0.78, r = 0.79, and r = 20.71, respectively; P < .001) and moderately correlated with the ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (r = 0.63, r = 0.67, and r = 20.60, respectively; P < .001) and percentage predicted FEV1 (r = 0.54, r = 0.62, and r = -0.56, respectively; P ≤ .001). Good reproducibility of qS0 readouts was found in both groups (ICC range, 0.89-0.98). Conclusion: Lung MR qS0 mapping may be a reliable noncontrast nonradiation alternative to CT in the assessment of emphysema in patients with COPD. © RSNA, 2015.


Labonte R.,Institute of Population Health
Health Promotion International | Year: 2014

Health in All Policies (HiAP) approach is generally perceived as an intersectoral approach to national or sub-national public policy development, such that health outcomes are given full consideration by non-health sectors. Globalization, however, has created numerous 'inherently global health issues' with cross-border causes and consequences, requiring new forms of global governance for health. Although such governance often includes both state and non-state (private, civil society) actors in agenda setting and influence, different actors have differing degrees of power and authority and, ultimately, it is states that ratify intergovernmental covenants or normative declarations that directly or indirectly affect health. This requires public health and health promotion practitioners working within countries to give increased attention to the foreign policies of their national governments. These foreign policies include those governing national security, foreign aid, trade and investment as well as the traditional forms of diplomacy. A new term has been coined to describe how health is coming to be positioned in governments' foreign policies: global health diplomacy. To become adept at this nuanced diplomatic practice requires familiarity with the different policy frames by which health might be inserted into the foreign policy deliberations, and thence intergovernmental/global governance negotiations. This article discusses six such frames (security, trade, development, global public goods, human rights, ethical/moral reasoning) that have been analytically useful in assessing the potential for greater and more health-promoting foreign policy coherence: a 'Health in All (Foreign) Policies' approach. © 2014 The Author.


Hammond E.M.,University of Oxford | Asselin M.-C.,Wolfson Molecular Imaging Center | Forster D.,Wolfson Molecular Imaging Center | O'Connor J.P.B.,Institute of Population Health | And 2 more authors.
Clinical Oncology | Year: 2014

Hypoxia was identified as a microenvironmental component of solid tumours over 60 years ago and was immediately recognised as a potential barrier to therapy through the reliance of radiotherapy on oxygen to elicit maximal cytotoxicity. Over the last two decades both clinical and experimental studies have markedly enhanced our understanding of how hypoxia influences cellular behaviour and therapy response. Furthermore, they have confirmed early assumptions that low oxygenation status in tumours is an exploitable target in cancer therapy. Generally such approaches will be more beneficial to patients with hypoxic tumours, necessitating the use of biomarkers that reflect oxygenation status. Tissue biomarkers have shown utility in many studies. Further significant advances have been made in the non-invasive measurement of tumour hypoxia with positron emission tomography, magnetic resonance imaging and other imaging modalities. Here, we describe the complexities of defining and measuring tumour hypoxia and highlight the therapeutic approaches to combat it. © 2014 The Royal College of Radiologists.


Laliberte M.-C.,University of Montréal | Laliberte M.-C.,Cite Of La Sante Hospital | Perreault S.,University of Montréal | Jouini G.,University of Montréal | And 4 more authors.
Osteoporosis International | Year: 2011

This study aims to evaluate the effectiveness of primary care interventions to improve the detection and treatment of osteoporosis. Eight electronic databases and six gray literature sources were searched. Randomized controlled trials, controlled clinical trials, quasi-randomized trials, controlled before-after studies, and interrupted time series written in English or French from 1985 to 2009 were considered. Eligible studies had to include patients at risk (women ≥ 65 years, men ≥ 70 years, and men/women ≥ 50 years with at least one major risk factor for osteoporosis) or at high risk (men/women using oral glucocorticoids or with previous fragility fractures) for osteoporosis and fractures. Outcomes included bone mineral density (BMD) testing, osteoporosis treatment initiation, and fractures. Data were pooled using a random effects model when applicable. Thirteen studies were included. The majority were multifaceted and involved patient educational material, physician notification, and/or physician education. Absolute differences in the incidence of BMD testing ranged from 22% to 51% for high-risk patients only and from 4% to 18% for both at-risk and high-risk patients. Absolute differences in the incidence of osteoporosis treatment initiation ranged from 18% to 29% for high-risk patients only and from 2% to 4% for at-risk and high-risk patients. Pooling the results of six trials showed an increased incidence of osteoporosis treatment initiation (risk difference (RD) = 20%; 95% CI: 7-33%) and of BMD testing and/or osteoporosis treatment initiation (RD = 40%; 95% CI: 32-48%) for high-risk patients following intervention. Multifaceted interventions targeting high-risk patients and their primary care providers may improve the management of osteoporosis, but improvements are often clinically modest. © 2011 International Osteoporosis Foundation and National Osteoporosis Foundation.


Shea B.,University of Ottawa | Swinden M.V.,University of Ottawa | Ghogomu E.T.,University of Ottawa | Ortiz Z.,National Academy of Medicine | And 6 more authors.
Journal of Rheumatology | Year: 2014

Objective. To perform a systematic review of the benefits and harms of folic acid and folinic acid in reducing the mucosal, gastrointestinal, hepatic, and hematologic side effects of methotrexate (MTX); and to assess whether folic or folinic acid supplementation has any effect on MTX benefit. Methods. We searched the Cochrane Library, MEDLINE, EMBASE, and US National Institutes of Health clinical trials registry from inception to March 2012. We selected all double-blind, randomized, placebo-controlled clinical trials in which adult patients with rheumatoid arthritis (RA) were treated with MTX (dose ≤ 25 mg/week) concurrently with folate supplementation. We included only trials using low-dose folic or folinic acid (a starting dose of ≤ 7 mg weekly) because the high dose is no longer recommended or used. Data were extracted from the trials, and the trials were independently assessed for risk of bias using a predetermined set of criteria. Results. Six trials with 624 patients were eligible for inclusion. Most studies had low or unclear risk of bias for key domains. The quality of the evidence was rated as "moderate" for each outcome as assessed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group, with the exception of hematologic side effects, which were rated as "low." There was no significant heterogeneity between trials, including where folic acid and folinic acid studies were pooled. For patients supplemented with any form of exogenous folate (either folic or folinic acid) while receiving MTX therapy for RA, a 26% relative (9% absolute) risk reduction was seen for the incidence of gastrointestinal side effects such as nausea, vomiting, or abdominal pain (RR 0.74, 95% CI 0.59 to 0.92; p = 0.008). Folic and folinic acid also appear to be protective against abnormal serum transaminase elevation caused by MTX, with a 76.9% relative (16% absolute) risk reduction (RR 0.23, 95% CI 0.15 to 0.34; p < 0.00001), as well as reducing patient withdrawal from MTX for any reason [60.8% relative (15.2% absolute) risk reduction, RR 0.39, 95% CI 0.28 to 0.53; p < 0.00001]. Conclusion. The results support a protective effect of supplementation with either folic or folinic acid for patients with RA during treatment with MTX. There was a clinically important significant reduction shown in the incidence of GI side effects and hepatic dysfunction (as measured by elevated serum transaminase levels), as well as a clinically important significant reduction in discontinuation of MTX treatment for any reason.

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