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Husereau D.,Institute of Health Economics | Husereau D.,University of Ottawa | Husereau D.,University of Medical Sciences and Technology | Drummond M.,University of York | And 10 more authors.
Value in Health | Year: 2013

Background: Economic evaluations of health interventions pose a particular challenge for reporting because substantial information must be conveyed to allow scrutiny of study findings. Despite a growth in published reports, existing reporting guidelines are not widely adopted. There is also a need to consolidate and update existing guidelines and promote their use in a user-friendly manner. A checklist is one way to help authors, editors, and peer reviewers use guidelines to improve reporting. Objective: The task force's overall goal was to provide recommendations to optimize the reporting of health economic evaluations. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines into one current, useful reporting guidance. The CHEERS Elaboration and Explanation Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force facilitates the use of the CHEERS statement by providing examples and explanations for each recommendation. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. Methods: The need for new reporting guidance was identified by a survey of medical editors. Previously published checklists or guidance documents related to reporting economic evaluations were identified from a systematic review and subsequent survey of task force members. A list of possible items from these efforts was created. A two-round, modified Delphi Panel with representatives from academia, clinical practice, industry, and government, as well as the editorial community, was used to identify a minimum set of items important for reporting from the larger list. Results: Out of 44 candidate items, 24 items and accompanying recommendations were developed, with some specific recommendations for single study-based and model-based economic evaluations. The final recommendations are subdivided into six main categories: 1) title and abstract, 2) introduction, 3) methods, 4) results, 5) discussion, and 6) other. The recommendations are contained in the CHEERS statement, a user-friendly 24-item checklist. The task force report provides explanation and elaboration, as well as an example for each recommendation. The ISPOR CHEERS statement is available online via Value in Health or the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices - CHEERS Task Force webpage (http://www.ispor.org/ TaskForces/EconomicPubGuidelines.asp). Conclusions: We hope that the ISPOR CHEERS statement and the accompanying task force report guidance will lead to more consistent and transparent reporting, and ultimately, better health decisions. To facilitate wider dissemination and uptake of this guidance, we are copublishing the CHEERS statement across 10 health economics and medical journals. We encourage other journals and groups to consider endorsing the CHEERS statement. The author team plans to review the checklist for an update in 5 years. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Scarella A.,University of Valparaíso | Chamy V.,University of Valparaíso | Belizan J.M.,Institute for Clinical Effectiveness and Health Policy IECS
European Journal of Obstetrics Gynecology and Reproductive Biology | Year: 2011

Objective: The aim of this study is to implement the Ten Group Classification System (TGCS) and evaluate whether the introduction of the medical audit cycle reduces the cesarean section (CS) rate without increasing maternal-fetal risk. Study design: A prospective cohort study was performed including all women who gave birth during 21 months. The study was subdivided into three consecutive periods: (1) implementation of the TGCS identifying the major CS rate contributor groups (three months), (2) audit and report changes in the CS rates to the medical and midwifery staff according to the TGCS (6 months) and (3) discontinue interventions but continue auditing the CS rates (6 months). Results: The first period CS rate of 36.8% was reduced to 26.5% after the introduction of interventions in the second period (RR 0.71 IC 0.63-0.81). After the intervention was stopped, the CS rate increased again to 31.8% (RR 1.19 IC 1.09-1.32). This is a decrease of 5.08% from the basal period (RR 0.86 IC 0.76-0.97). The asphyxia rate remained unchanged for the periods studied. Conclusion: Auditing through the TGCS and feedback is an effective, safe, and easy-to-implement strategy to reduce the CS rate. Its diffusion would allow reduction of the CS rates in countries as ours, and by means of the TGCS, figures can be compared within individual entities and others. © 2010 Elsevier Ireland Ltd.

Hofmeyr G.J.,University of Witwatersrand | Belizan J.M.,Institute for Clinical Effectiveness and Health Policy IECS | Von Dadelszen P.,University of British Columbia
BJOG: An International Journal of Obstetrics and Gynaecology | Year: 2014

Background Epidemiological data link low dietary calcium with pre-eclampsia. Current recommendations are for 1.5-2 g/day calcium supplementation for low-intake pregnant women, based on randomised controlled trials of ≥1 g/day calcium supplementation from 20 weeks of gestation. This is problematic logistically in low-resource settings; excessive calcium may be harmful; and 20 weeks may be too late to alter outcomes. Objectives To review the impact of lower dose calcium supplementation on pre-eclampsia risk. Search strategy and selection criteria We searched PubMed and the Cochrane Pregnancy and Childbirth Group trials register. Data collection and analysis Two authors extracted data from eligible randomised and quasi-randomised trials of low-dose calcium (LDC, <1 g/day), with or without other supplements. Main results Pre-eclampsia was reduced consistently with LDC with or without co-supplements (nine trials, 2234 women, relative risk [RR] 0.38; 95% confidence interval [95% CI] 0.28-0.52), as well as for subgroups: LDC alone (four trials, 980 women, RR 0.36; 95% CI 0.23-0.57]); LDC plus linoleic acid (two trials, 134 women, RR 0.23; 95% CI 0.09-0.60); LDC plus vitamin D (two trials, 1060 women, RR 0.49; 0.31-0.78) and a trend for LDC plus antioxidants (one trial, 60 women, RR 0.24; 95% CI 0.06-1.01). Overall results were consistent with the single quality trial of LDC alone (171 women, RR 0.30; 95% CI 0.06-1.38). LDC plus antioxidants commencing at 8-12 weeks tended to reduce miscarriage (one trial, 60 women, RR 0.06; 95% CI 0.00-1.04). Conclusions These limited data are consistent with LDC reducing the risk of pre-eclampsia; confirming this in sufficiently powered randomised controlled trials would have implications for current guidelines and their global implementation. ©2014 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

Belizan J.M.,Institute for Clinical Effectiveness and Health Policy IECS | Salaria N.,Biomedical Central Ltd
Reproductive Health | Year: 2015

The editor of Reproductive Health would like to extend a sincere thank you to all our valued reviewers listed below who contributed to the journal in Volume 10 (2013). Without the co-operation and collaboration of peer reviewers, these manuscripts would remain static in a submission system with high quality articles unpublished and inaccessible to the public on a global scale. We are very pleased to have a diverse range of reviewers from high, middle and low income countries, contributing to the dissemination of research findings in an open access journal. Please accept our deepest thanks for your knowledge, time and continuing efforts. © 2014 Belizán and Salaria; licensee BioMed Central Ltd.

Conde-Agudelo A.,U.S. National Institutes of Health | Belizan J.M.,Institute for Clinical Effectiveness and Health Policy IECS | Diaz-Rossello J.,University of Montevideo
Evidence-Based Child Health | Year: 2012

Background Kangaroo mother care (KMC), originally defined as skin-to-skin contact between a mother and her newborn, frequent and exclusive or nearly exclusive breastfeeding, and early discharge from hospital, has been proposed as an alternative to conventional neonatal care for low birthweight (LBW) infants. Objectives To determine whether there is evidence to support the use of KMC in LBW infants as an alternative to conventional neonatal care. Search methods The standard search strategy of the Cochrane Neonatal Group was used. This included searches of MEDLINE, EMBASE, LILACS, POPLINE, CINAHL databases (from inception to January 31, 2011), and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2011). In addition, we searched the web page of the Kangaroo Foundation, conference and symposia proceedings on KMC, and Google scholar. Selection criteria Randomized controlled trials comparing KMC versus conventional neonatal care, or early onset KMC (starting within 24 hours after birth) versus late onset KMC (starting after 24 hours after birth) in LBW infants. Data collection and analysis Data collection and analysis were performed according to the methods of the Cochrane Neonatal Review Group. Main results Sixteen studies, including 2518 infants, fulfilled inclusion criteria. Fourteen studies evaluated KMC in LBWinfants after stabilization, one evaluated KMC in LBW infants before stabilization, and one compared early onset KMC with late onset KMC in relatively stable LBW infants. Eleven studies evaluated intermittent KMC and five evaluated continuous KMC. At discharge or 40-41 weeks' postmenstrual age, KMC was associated with a reduction in the risk of mortality (typical risk ratio (RR) 0.60, 95% confidence interval (CI) 0.39 to 0.93; seven trials, 1614 infants), nosocomial infection/sepsis (typical RR 0.42, 95% CI 0.24 to 0.73), hypothermia (typical RR 0.23, 95% CI 0.10 to 0.55), and length of hospital stay (typical mean difference 2.4 days, 95% CI 0.7 to 4.1). At latest follow up, KMC was associated with a decreased risk of mortality (typical RR 0.68, 95% CI 0.48 to 0.96; nine trials, 1952 infants) and severe infection/sepsis (typical RR 0.57, 95% CI 0.40 to 0.80). Moreover, KMC was found to increase some measures of infant growth, breastfeeding, and mother-infant attachment. Authors' conclusions The evidence from this updated review supports the use of KMC in LBWinfants as an alternative to conventional neonatal care mainly in resource-limited settings. Further information is required concerning effectiveness and safety of early onset continuous KMC in unstabilized LBW infants, long term neurodevelopmental outcomes, and costs of care. © 2011 The Cochrane Collaboration.

Ciapponi A.,Institute for Clinical Effectiveness and Health Policy IECS | Bardach A.,Institute for Clinical Effectiveness and Health Policy IECS | Glujovsky D.,Institute for Clinical Effectiveness and Health Policy IECS | Gibbons L.,Institute for Clinical Effectiveness and Health Policy IECS | Picconi M.A.,National Institute of Infectious Diseases
PLoS ONE | Year: 2011

Background: Cervical cancer is a major public health problem in Latin America and the Caribbean (LA&C), showing some of the highest incidence and mortality rates worldwide. Information on HPV type distribution in high-grade cervical lesions (HSIL) and invasive cervical cancer (ICC) is crucial to predict the future impact of HPV16/18 vaccines and screening programmes, and to establish an appropriate post-vaccinal virologic surveillance. The aim was to assess the prevalence of HPV types in HSIL and ICC in studies in LA&C. Methods and Findings: We performed a systematic review, following the MOOSE guidelines for systematic reviews of observational studies, and the PRISMA statement for reporting systematic reviews and meta-analyses. Inclusion criteria were at least ten cases of HSIL/ICC, and HPV-type elicitation. The search, without language restrictions, was performed in MEDLINE, Cochrane Library, EMBASE, LILACS from inception date to December 2009, proceedings, reference lists and consulting experts. A meta-analysis was performed using arc-sine transformations to stabilize the variance of simple proportions. Seventy-nine studies from 18 countries were identified, including 2446 cases of HSIL and 5540 of ICC. Overall, 46.5% of HSIL cases harbored HPV 16 and 8.9% HPV18; in ICC, 53.2% of cases harbored HPV 16 and13.2% HPV 18. The next five most common types, in decreasing frequency, were HPV 31, 58, 33, 45, and 52. Study's limitations comprise the cross-sectional design of most included studies and their inherent risk of bias, the lack of representativeness, and variations in the HPV type-specific sensitivity of different PCR protocols. Conclusions: This study is the broadest summary of HPV type distribution in HSIL and ICC in LA&C to date. These data are essential for local decision makers regarding HPV screening and vaccination policies. Continued HPV surveillance would be useful, to assess the potential for changing type-specific HPV prevalence in the post-vaccination era in Latin America. © 2011 Ciapponi et al.

Kinney M.V.,Saving Newborn Lives Save the Children | Lawn J.E.,Saving Newborn Lives Save the Children | Howson C.P.,March of Dimes Foundation | Belizan J.,Institute for Clinical Effectiveness and Health Policy IECS
Reproductive Health | Year: 2012

Each year, more than 1 in 10 of the world's babies are born preterm, resulting in 15 million babies born too soon. World Prematurity Day, November 17, is a global effort to raise awareness about prematurity. This past year, there has been increased awareness of the problem, through new data and evidence, global partnership and country champions. Actions to improve care would save hundreds of thousands of babies born too soon from death and disability. Accelerated prevention requires urgent research breakthroughs. © 2012 Kinney et al.; licensee BioMed Central Ltd.

Khan K.,BJOG An International Journal of Obstetrics and Gynaecology | Belizan J.M.,Institute for Clinical Effectiveness and Health Policy IECS
Reproductive Health | Year: 2014

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a core outcomes set - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women's health have come together to support The CROWN (CoRe Outcomes in WomeN's health) Initiative. © 2014 Khan and Belizan; licensee BioMed Central Ltd.

Cormick G.,Institute for Clinical Effectiveness and Health Policy IECS | Ciapponi A.,Institute for Clinical Effectiveness and Health Policy IECS | Cafferata M.L.,Institute for Clinical Effectiveness and Health Policy IECS | Belizan J.M.,Institute for Clinical Effectiveness and Health Policy IECS
The Cochrane database of systematic reviews | Year: 2015

BACKGROUND: Hypertension is a major public health problem that increases the risk of cardiovascular and kidney diseases. Several studies have shown an inverse association between calcium intake and blood pressure. As small reductions in blood pressure have been shown to produce rapid reductions in vascular disease risk even in individuals with normal blood pressure ranges, this review intends to evaluate the effect of calcium supplementation in normotensive individuals as a preventive health measure.OBJECTIVES: To assess the efficacy and safety of calcium supplementation versus placebo or control for reducing blood pressure in normotensive people.SEARCH METHODS: We searched the Cochrane Hypertension Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, EMBASE and ClinicalTrials.gov for randomised controlled trials up to October 2014. The WHO International Clinical Trials Registry Platform (ICTRP) is searched for inclusion in the Group's Specialised Register. We also reviewed reference lists from retrieved studies and contacted authors of relevant papers. We applied no language restrictions.SELECTION CRITERIA: We selected trials that randomised normotensive people to dietary calcium interventions such as supplementation or food fortification versus placebo or control. We excluded quasi-random designs. The primary outcomes were hypertension (defined as blood pressure ≥ 140/90 mmHg) and blood pressure measures.DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, abstracted the data and assessed the risks of bias.MAIN RESULTS: We included 16 trials with 3048 participants. None of the studies reported hypertension as a dichotomous outcome. The effect on systolic and diastolic blood pressure was mean difference (MD) -1.43 mmHg (95% confidence interval (CI) -2.15 to -0.72) and -0.98 mmHg (95%CI -1.46 to -0.50) respectively. The effect on systolic and diastolic blood pressure for those younger than 35 years (7 trials with 399 participants) was -2.11 mmHg (95%CI -3.58 to -0.64) / -2.61 mmHg (95% CI -3.74, -1.49). The effect on systolic and diastolic blood pressure for those 35 years or more (9 trials with 2649 participants) was -0.96 mmHg (95%CI -1.83 to -0.09) / -0.59 mmHg (95%CI -1.13 to -0.06). The effect on systolic and diastolic blood pressure for women (6 trials with 1823 participants) was -1.45 mmHg (95% CI -2.78 to -0.12) / -0.92 mmHg (95% CI -1.71 to -0.14). The effect on systolic and diastolic blood pressure for men (5 trials with 617 participants) was -2.07 (95%CI -3.56 to -0.59] / -1.91 (95%CI -2.80 to -1.02).The quality of evidence for each of these outcomes was high. The effect is consistent in both genders regardless of baseline calcium intake.The effect on systolic blood pressure was 0.08 mmHg (95% CI -2.16 to 2.32) with doses less than 1000 mg, -1.14 mmHg (95% CI -2.01 to -0.27) with 1000 - 1500 mg, and -2.79 mmHg (95% CI -4.71 to -0.86) with more than 1500 mg. The effect on diastolic blood pressure was -0.54 mmHg (95% CI -2.23 to 1.15), -0.71 mmHg (95% CI -1.37 to -0.06) and -1.43 mmHg (95% CI -2.22 to -0.64) respectively. The quality of evidence for each of these outcomes was high.None of the studies reported adverse events.AUTHORS' CONCLUSIONS: An increase in calcium intake slightly reduces both systolic and diastolic blood pressure in normotensive people, particularly in young people, suggesting a role in the prevention of hypertension. These results should be interpreted with caution, since the proposed biological mechanism explaining the relationship between calcium and blood pressure has not been fully confirmed. The effect across multiple prespecified subgroups and a possible dose response effect reinforce this conclusion. Even small reductions in blood pressure could have important health implications for reducing vascular disease.There is a great need for adequately-powered clinical trials randomising young people. Subgroup analysis should involve basal calcium intake, age, sex, basal blood pressure, and body mass index. We also require assessment of side effects, optimal doses and the best strategy to improve calcium intake.

Rubinstein A.,Institute for Clinical Effectiveness and Health Policy IECS | Gutierrez L.,Institute for Clinical Effectiveness and Health Policy IECS | Beratarrechea A.,Institute for Clinical Effectiveness and Health Policy IECS | Irazola V.E.,Institute for Clinical Effectiveness and Health Policy IECS
PLoS ONE | Year: 2014

Introduction: According to the Argentine National Risk Factor Survey (ANRFS), between 2005 and 2009, self-reported Diabetes increased in Argentina from 8.4% to 9.6%, accompanied by a raise in the prevalence of obesity and low physical activity. In the same period, it also increased blood sugar checks from 69.3% to 75.7%. Since surveillance data in Argentina rely on self-reports, the estimated prevalence of diabetes may be affected by an increase in the proportion of subjects with access to preventive services. We evaluated the independent effect of a recent blood sugar check, on the increase in self-reported diagnoses of diabetes between 2005 and 2009. Materials and Methods: A secondary analysis of data from the 2005 and 2009 ANRFS was performed. Diabetes was defined as having been diagnosed Diabetes or high blood sugar by a health professional, obesity was calculated as BMI≥30 kg/m 2, based on self-reported height and weight and physical activity was measured using the International Physical Activity Questionnaire. We used logistic regression models to explore the relationship between prevalence of self-reported diabetes and recent blood sugar check as the main predictor. Results: The prevalence of diabetes rose from 8.4% to 9.6%; obesity from 14.5% to 18% and low physical activity from 46.2% to 55%, between 2005 and 2009. Among those who recently checked their blood sugar no differences were found in the prevalence of diabetes: 13% in 2005 vs. 13.2% in 2009. Findings of the multivariable analysis showed that obesity and low physical activity were significantly associated with self reported diabetes in the adjusted model (OR = 1.80 for obesity, and OR = 1.12 for low physical activity but the strongest predictor was recent blood sugar check (OR = 4.75). Discussion: An increased prevalence of self-reported diabetes between 2005 and 2009 might indicate an improvement in the access to preventive services rather than a positive increase in the prevalence of diabetes. © 2014 Rubinstein et al.

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