5 results on '"Seuc, Armando H."'
Search Results
2. Global, regional and national levels and trends of preterm birth rates for 1990 to 2014: protocol for development of World Health Organization estimates.
- Author
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Vogel, Joshua P., Chawanpaiboon, Saifon, Watananirun, Kanokwaroon, Lumbiganon, Pisake, Petzold, Max, Moller, Ann-Beth, Thinkhamrop, Jadsada, Laopaiboon, Malinee, Seuc, Armando H., Hogan, Daniel, Tunçalp, Ozge, Allanson, Emma, Betrán, Ana Pilar, Bonet, Mercedes, Oladapo, Olufemi T., and Gülmezoglu, A. Metin
- Subjects
CINAHL database ,PREMATURE infants ,INFORMATION storage & retrieval systems ,MEDICAL databases ,PSYCHOLOGY information storage & retrieval systems ,STATISTICS ,SURVEYS ,VITAL statistics ,SYSTEMATIC reviews ,EVIDENCE-based medicine ,PROFESSIONAL practice ,DATA analysis ,CONTENT mining - Abstract
Background: The official WHO estimates of preterm birth are an essential global resource for assessing the burden of preterm birth and developing public health programmes and policies. This protocol describes the methods that will be used to identify, critically appraise and analyse all eligible preterm birth data, in order to develop global, regional and national level estimates of levels and trends in preterm birth rates for the period 1990 - 2014. Methods: We will conduct a systematic review of civil registration and vital statistics (CRVS) data on preterm birth for all WHO Member States, via national Ministries of Health and Statistics Offices. For Member States with absent, limited or lower-quality CRVS data, a systematic review of surveys and/or research studies will be conducted. Modelling will be used to develop country, regional and global rates for 2014, with time trends for Member States where sufficient data are available. Member States will be invited to review the methodology and provide additional eligible data via a country consultation before final estimates are developed and disseminated. Discussion: This research will be used to generate estimates on the burden of preterm birth globally for 1990 to 2014. We invite feedback on the methodology described, and call on the public health community to submit pertinent data for consideration. Trial registration: Registered at PROSPERO CRD42015027439 Contact: pretermbirth@who.int [ABSTRACT FROM AUTHOR]
- Published
- 2016
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3. A multicentre randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice to reduce prolonged second stage of labour (the Gentle Assisted Pushing study): study protocol.
- Author
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Hofmeyr, G. Justus, Singata, Mandisa, Lawrie, Theresa, Vogel, Joshua P., Landoulsi, Sihem, Seuc, Armando H., and Gülmezoglu, A. Metin
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CHILDBIRTH ,CONFIDENCE intervals ,DELIVERY (Obstetrics) ,GESTATIONAL age ,LABOR (Obstetrics) ,MATERNAL health services ,RESEARCH methodology ,MEDICAL cooperation ,PRESSURE ,RESEARCH ,STATISTICAL sampling ,STATISTICS ,SUPINE position ,T-test (Statistics) ,TIME ,VAGINA ,PILOT projects ,STATISTICAL power analysis ,DATA analysis ,BODY movement ,RANDOMIZED controlled trials ,NULLIPARAS ,DATA analysis software ,ADVERSE health care events ,UTERINE fundus ,KNEELING - Abstract
Background: Fundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often performed in routine practice, however the benefit and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This trial aims to evaluate the use of GAP in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 min in the second stage of labour. Methods/Design: We will conduct a multicentre, randomized, unblinded, controlled trial with three parallel arms (1:1:1). 1,145 women will be randomized at three hospitals in South Africa. Women will be eligible for inclusion if they are ≥18 years old, nulliparous, gestational age ≥ 35 weeks, have a singleton pregnancy in cephalic presentation and vaginal delivery anticipated. Women with chronic medical conditions or obstetric complications are not eligible. If eligible women are undelivered following 15-30 min in the second stage of labour, they will be randomly assigned to: 1) GAP in the upright posture, 2) upright posture only and 3) routine practice (recumbent/supine posture). The primary outcome is the mean time from randomization to complete delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort. Discussion: This trial will establish whether upright posture and/or a controlled method of applying fundal pressure (GAP) can improve labour outcomes for women and their babies. If fundal pressure is found to have a measurable beneficial effect, this gentle approach can be promoted as a replacement for the uncontrolled methods currently in use. If it is not found to be useful, fundal pressure can be discouraged. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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4. How to assess success of treatment when using multiple doses: the case of misoprostol for medical abortion.
- Author
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Seuc, Armando H., Shah, Iqbal H., Ali, Moazzam, Diaz-Olavarrieta, Claudia, and Temmerman, Marleen
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MISOPROSTOL , *ABORTIFACIENTS , *DRUG dosage , *INFERTILITY treatment , *REPRODUCTIVE technology , *CLINICAL trials , *ABORTION statistics , *ABORTION , *BIOLOGICAL assay , *COMPARATIVE studies , *COMPUTER simulation , *DOSE-effect relationship in pharmacology , *EXPERIMENTAL design , *HIGH performance computing , *LIFE expectancy , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *RESEARCH funding , *STATISTICS , *DATA analysis , *EVALUATION research , *TREATMENT effectiveness , *STATISTICAL models , *KAPLAN-Meier estimator - Abstract
Background: The assessment of treatment success in clinical trials when multiple (repeated) doses (courses) are involved is quite common, for example, in the case of infertility treatment with assisted reproductive technology (ART), and medical abortion using misoprostol alone or in combination with mifepristone. Under these or similar circumstances, most researchers assess success using binomial proportions after a certain number of consecutive doses, and some have used survival analysis. In this paper we discuss the main problems in using binomial proportions to summarize (the overall) efficacy after two or more consecutive doses of the relevant treatment, particularly for the case of misoprostol in medical abortion studies. We later discuss why the survival analysis is best suited under these circumstances, and illustrate this by using simulated data.Methods: The formulas required for the binomial proportion and survival analysis (without and with competing risks) approaches are summarized and analytically compared. Additionally, numerical results are computed and compared between the two approaches, for several theoretical scenarios.Results: The main conceptual limitations of the binomial proportion approach are identified and discussed, caused mainly by the presence of censoring and competing risks, and it is demonstrated how survival analysis can solve these problems. In general, the binomial proportion approach tends to underestimate the "real" success rate, and tends to overestimate the corresponding standard error.Conclusions: Depending on the rates of censored observations or competing events between repeated doses of the treatment, the bias of the binomial proportion approach as compared to the survival analysis approaches varies; however, the use of the binomial approach is unjustified as the survival analysis options are well known and available in multiple statistical packages. Our conclusions also apply to other situations where success is estimated after multiple (repeated) doses (courses) of the treatment. [ABSTRACT FROM AUTHOR]- Published
- 2015
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5. Intermediate outcomes in randomized clinical trials: an introduction.
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Seuc, Armando H., Peregoudov, Alexander, Betran, Ana Pilar, and Gulmezoglu, Ahmet Metin
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DRUG efficacy , *HEALTH outcome assessment , *CLINICAL trials , *PREECLAMPSIA , *PREGNANCY complications , *CALCIUM supplements - Abstract
Background: Intermediate outcomes are common and typically on the causal pathway to the final outcome. Some examples include noncompliance, missing data, and truncation by death like pregnancy (e.g. when the trial intervention is given to non-pregnant women and the final outcome is preeclampsia, defined only on pregnant women). The intention-to-treat approach does not account properly for them, and more appropriate alternative approaches like principal stratification are not yet widely known. The purposes of this study are to inform researchers that the intention-to-treat approach unfortunately does not fit all problems we face in experimental research, to introduce the principal stratification approach for dealing with intermediate outcomes, and to illustrate its application to a trial of long term calcium supplementation in women at high risk of preeclampsia. Methods: Principal stratification and related concepts are introduced. Two ways for estimating causal effects are discussed and their application is illustrated using the calcium trial, where noncompliance and pregnancy are considered as intermediate outcomes, and preeclampsia is the main final outcome. Results: The limitations of traditional approaches and methods for dealing with intermediate outcomes are demonstrated. The steps, assumptions and required calculations involved in the application of the principal stratification approach are discussed in detail in the case of our calcium trial. Conclusions: The intention-to-treat approach is a very sound one but unfortunately it does not fit all problems we find in randomized clinical trials; this is particularly the case for intermediate outcomes, where alternative approaches like principal stratification should be considered. [ABSTRACT FROM AUTHOR]
- Published
- 2013
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