25 results on '"Seuc AH"'
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
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Vogel, JP, Chawanpaiboon, S, Watananirun, K, Lumbiganon, P, Petzold, M, Moller, A-B, Thinkhamrop, J, Laopaiboon, M, Seuc, AH, Hogan, D, Tuncalp, O, Allanson, E, Betran, AP, Bonet, M, Oladapo, OT, Gulmezoglu, AM, Vogel, JP, Chawanpaiboon, S, Watananirun, K, Lumbiganon, P, Petzold, M, Moller, A-B, Thinkhamrop, J, Laopaiboon, M, Seuc, AH, Hogan, D, Tuncalp, O, Allanson, E, Betran, AP, Bonet, M, Oladapo, OT, and Gulmezoglu, AM
- 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.
- Published
- 2016
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, GJ, Singata, M, Lawrie, T, Vogel, JP, Landoulsi, S, Seuc, AH, Guelmezoglu, AM, Hofmeyr, GJ, Singata, M, Lawrie, T, Vogel, JP, Landoulsi, S, Seuc, AH, and Guelmezoglu, AM
- 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 i
- Published
- 2015
4. A trial of contraceptive methods in women with systemic lupus erythematosus.
- Author
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Sánchez-Guerrero J, Uribe AG, Jiménez-Santana L, Mestanza-Peralta M, Lara-Reyes P, Seuc AH, and Cravioto MC
- Published
- 2005
5. Mortality attributable to diabetes in Cuba: Estimates for 2019.
- Author
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Seuc AH, Mirabal-Sosa M, Garcia-Serrano Y, Alfonso-Sague K, and Fernandez-Gonzalez L
- Abstract
Objective: To estimate the national and provincial number of excess deaths due to diabetes across Cuba in 2019., Study Design: Cross-sectional design with secondary data., Methods: We used DISMODII, a computerized generic disease model, to assess disease burden by modelling the relationships between incidence, prevalence, and disease-specific mortality. Baseline input data included population structure, total mortality, and age- and sex-specific estimates for diabetes prevalence from the Cuban National Health Survey 2019, and available published estimates of the relative risk of death for people with diabetes compared to people without diabetes. The results were internally validated with DISMODII output for duration of diabetes (years)., Results: In 2019, we estimated an excess of mortality attributable to diabetes of 7.5 times the diabetes mortality reported by the National Death Registry, which is equivalent to 16.4 % of all deaths in Cuba. The percentages of all-cause mortality among provinces varied between 10.7 % in Villa Clara and 24.5 % in Ciego de Avila., Conclusions: These are the first estimates of mortality attributable to diabetes in Cuba and its provinces. Diabetes is likely to be a much more prominent leading cause of death than the 9th ranking reported by the Cuban National Death Registry 2019. Disease models similar to DISMODII are important tools to validate the epidemiologic indicators used in the burden of disease calculations., Competing Interests: The authors have no competing interests to declare., (© 2024 The Authors.)
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- 2024
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6. Viral shedding of SARS-CoV-2 in body fluids associated with sexual activity: a systematic review and meta-analysis.
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Calvet GA, Kara E, Gonsalves L, Seuc AH, de Oliveira RVC, Thwin SS, Gomez Ponce de León R, Gámez MC, Peña GM, Pendás BVR, Alzugaray MG, Carballo GO, Cala DC, Guimarães PMQ, Bonet M, Taylor M, Thorson A, Kim C, Ali M, and Broutet N
- Abstract
Objective: To identify and summarise the evidence on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA detection and persistence in body fluids associated with sexual activity (saliva, semen, vaginal secretion, urine and faeces/rectal secretion)., Eligibility: All studies that reported detection of SARS-CoV-2 in saliva, semen, vaginal secretion, urine and faeces/rectal swabs., Information Sources: The WHO COVID-19 database from inception to 20 April 2022., Risk of Bias Assessment: The National Institutes of Health tools., Synthesis of Results: The proportion of patients with positive results for SARS-CoV-2 and the proportion of patients with a viral duration/persistence of at least 14 days in each fluid was calculated using fixed or random effects models., Included Studies: A total of 182 studies with 10 023 participants., Results: The combined proportion of individuals with detection of SARS-CoV-2 was 82.6% (95% CI: 68.8% to 91.0%) in saliva, 1.6% (95% CI: 0.9% to 2.6%) in semen, 2.7% (95% CI: 1.8% to 4.0%) in vaginal secretion, 3.8% (95% CI: 1.9% to 7.6%) in urine and 31.8% (95% CI: 26.4% to 37.7%) in faeces/rectal swabs. The maximum viral persistence for faeces/rectal secretions was 210 days, followed by semen 121 days, saliva 112 days, urine 77 days and vaginal secretions 13 days. Culturable SARS-CoV-2 was positive for saliva and faeces., Limitations: Scarcity of longitudinal studies with follow-up until negative results., Interpretation: SARS-CoV-2 RNA was detected in all fluids associated with sexual activity but was rare in semen and vaginal secretions. Ongoing droplet precautions and awareness of the potential risk of contact with faecal matter/rectal mucosa are needed., Prospero Registration Number: CRD42020204741., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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7. Health systems analysis and evaluation of the barriers to availability, utilisation and readiness of sexual and reproductive health services in COVID-19-affected areas: a WHO mixed-methods study protocol.
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Kouanda S, Nahyuha Chomi E, Kim C, Jen S, Bahamondes L, Cecatti JG, Lumbiganon P, Emefa M, Brizuela V, Kuganantham H, Seuc AH, and Ali M
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- Cross-Sectional Studies, Female, Humans, Pandemics, Pregnancy, Systems Analysis, World Health Organization, COVID-19, Reproductive Health Services
- Abstract
Introduction: COVID-19 has led to an unprecedented increase in demand on health systems to care for people infected, necessitating the allocation of significant resources, especially medical resources, towards the response. This, compounded by the restrictions on movement instituted may have led to disruptions in the provision of essential services, including sexual and reproductive health (SRH) services. This study aims to assess the availability of contraception, comprehensive abortion care, sexually transmitted infection prevention and treatment and sexual and gender-based violence care and support services in local health facilities during COVID-19 pandemic. This is a standardised generic protocol designed for use across different global settings., Methods and Analysis: This study adopts both quantitative and qualitative methods to assess health facilities' SRH service availability and readiness, and clients' and providers' perceptions of the availability and readiness of these services in COVID-19-affected areas. The study has two levels: (1) perceptions of clients (and the partners) and healthcare providers, using qualitative methods, and (2) assessment of infrastructure availability and readiness to provide SRH services through reviews, facility service statistics for clients and a qualitative survey for healthcare provider perspectives. The health system assessment will use a cross-sectional panel survey design with two data collection points to capture changes in SRH services availability as a result of the COVID-19 epidemic. Data will be collected using focus group discussions, in-depth interviews and a health facility assessment survey., Ethics and Dissemination: Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (protocol ID CERC.0103). Each study site is required to obtain the necessary ethical and regulatory approvals that are required in each specific country., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2022
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8. Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial.
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Hofmeyr GJ, Betrán AP, Singata-Madliki M, Cormick G, Munjanja SP, Fawcus S, Mose S, Hall D, Ciganda A, Seuc AH, Lawrie TA, Bergel E, Roberts JM, von Dadelszen P, and Belizán JM
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- Adult, Argentina, Developing Countries, Double-Blind Method, Female, Gestational Age, Global Health, Humans, Pregnancy, Risk Factors, South Africa, Young Adult, Zimbabwe, Calcium administration & dosage, Dietary Supplements, Pre-Eclampsia prevention & control, Prenatal Care methods
- Abstract
Background: Reducing deaths from hypertensive disorders of pregnancy is a global priority. Low dietary calcium might account for the high prevalence of pre-eclampsia and eclampsia in low-income countries. Calcium supplementation in the second half of pregnancy is known to reduce the serious consequences of pre-eclampsia; however, the effect of calcium supplementation during placentation is not known. We aimed to test the hypothesis that calcium supplementation before and in early pregnancy (up to 20 weeks' gestation) prevents the development of pre-eclampsia METHODS: We did a multicountry, parallel arm, double-blind, randomised, placebo-controlled trial in South Africa, Zimbabwe, and Argentina. Participants with previous pre-eclampsia and eclampsia received 500 mg calcium or placebo daily from enrolment prepregnancy until 20 weeks' gestation. Participants were parous women whose most recent pregnancy had been complicated by pre-eclampsia or eclampsia and who were intending to become pregnant. All participants received unblinded calcium 1·5 g daily after 20 weeks' gestation. The allocation sequence (1:1 ratio) used computer-generated random numbers in balanced blocks of variable size. The primary outcome was pre-eclampsia, defined as gestational hypertension and proteinuria. The trial is registered with the Pan-African Clinical Trials Registry, number PACTR201105000267371. The trial closed on Oct 31, 2017., Findings: Between July 12, 2011, and Sept 8, 2016, we randomly allocated 1355 women to receive calcium or placebo; 331 of 678 participants in the calcium group versus 320 of 677 in the placebo group became pregnant, and 298 of 678 versus 283 of 677 had pregnancies beyond 20 weeks' gestation. Pre-eclampsia occurred in 69 (23%) of 296 participants in the calcium group versus 82 (29%) of 283 participants in the placebo group with pregnancies beyond 20 weeks' gestation (risk ratio [RR] 0·80, 95% CI 0·61-1·06; p=0·121). For participants with compliance of more than 80% from the last visit before pregnancy to 20 weeks' gestation, the pre-eclampsia risk was 30 (21%) of 144 versus 47 (32%) of 149 (RR 0·66, CI 0·44-0·98; p=0·037). There were no serious adverse effects of calcium reported., Interpretation: Calcium supplementation that commenced before pregnancy until 20 weeks' gestation, compared with placebo, did not show a significant reduction in recurrent pre-eclampsia. As the trial was powered to detect a large effect size, we cannot rule out a small to moderate effect of this intervention., Funding: The University of British Columbia, a grantee of the Bill & Melinda Gates Foundation; UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO; the Argentina Fund for Horizontal Cooperation of the Argentinean Ministry of Foreign Affairs; and the Centre for Intervention Science in Maternal and Child Health., (© 2019 This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.)
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- 2019
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9. Cuban Application of Two Methods for Analyzing Multiple Causes of Death.
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Seuc AH, Fernández L, Mirabal-Sosa M, and González CA
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- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Child, Child, Preschool, Comorbidity, Cuba epidemiology, Databases as Topic, Death Certificates, Epidemiologic Methods, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Mortality, Sex Factors, Young Adult, Cause of Death
- Abstract
INTRODUCTION Mortality analysis based on a single cause of death is not, in most cases, fully informative. There are several more illuminating procedures using a multiple cause of death approach; these are little known and rarely used in Cuba. The simplest of these methods, while methodologically limited, consists of summing all deaths from a specific cause mentioned on death certificates, regardless of whether the cause is listed as underlying or contributing. OBJECTIVE Using Cuban data, critically assess and implement two of the most recognized approaches to analyzing multiple causes of death. METHODS Multiple causes of death in Cuba were assessed for the years 2005, 2010 and 2015, employing death records from the National Medical Records and Health Statistics Bureau of Cuba's Ministry of Public Health. With the example of diabetes mellitus as underlying cause, we explored connections between underlying and associated (antecedent and contributing) causes on death certificates using two approaches from the international literature: the simple method and the cause-of-death association indicator. RESULTS The study identified main trends in multiple causes of death identified in 2005, 2010 and 2015, overall and by age group and sex. We observed a trend to increasing mean number of causes of death per death certificate between 2005 and 2015. The number of causes reported showed no substantial differences by age group or sex. Diseases of the arteries, arterioles and capillaries were by far the most frequently associated with diabetes mellitus as underlying cause. CONCLUSIONS The multiple causes of death approach affords more nuanced understanding of patterns of disease, comorbidity and death in the Cuban population. The indicators used fulfill different roles: the simple method brings to light the full range of ways in which a given cause contributes to mortality, and the cause-of-death association indicator enables exploration of links between different causes of death, not possible with the simple method. KEYWORDS Mortality, multifactorial causality, causes of death, diabetes mellitus, Cuba.
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- 2018
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10. Are women with history of pre-eclampsia starting a new pregnancy in good nutritional status in South Africa and Zimbabwe?
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Cormick G, Betrán AP, Harbron J, Dannemann Purnat T, Parker C, Hall D, Seuc AH, Roberts JM, Belizán JM, and Hofmeyr GJ
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- Adult, Body Mass Index, Diet, Dietary Supplements, Female, Folic Acid administration & dosage, Gestational Weight Gain, Humans, Iron administration & dosage, Maternal Health, Pregnancy, Pregnancy, High-Risk, Prevalence, Prospective Studies, Randomized Controlled Trials as Topic, Recommended Dietary Allowances, South Africa epidemiology, Vitamin B Complex administration & dosage, Young Adult, Zimbabwe epidemiology, Micronutrients, Nutritional Status, Obesity epidemiology, Pre-Eclampsia epidemiology
- Abstract
Background: Maternal nutritional status before and during pregnancy is an important contributor to pregnancy outcomes and early child health. The aim of this study was to describe the preconceptional nutritional status and dietary intake during pregnancy in high-risk women from South Africa and Zimbabwe., Methods: This is a prospective observational study, nested to the CAP trial. Anthropometric measurements before and during pregnancy and dietary intake using 24-h recall during pregnancy were assessed. The Intake Distribution Estimation software (PC-SIDE) was used to evaluate nutrient intake adequacy taking the Estimated Average Requirement (EAR) as a cut-off point., Results: Three hundred twelve women who had pre-eclampsia in their last pregnancy and delivered in hospitals from South Africa and Zimbabwe were assessed. 73.7 and 60.2% women in South Africa and Zimbabwe, respectively started their pregnancy with BMI above normal (BMI ≥ 25) whereas the prevalence of underweight was virtually non-existent. The majority of women had inadequate intakes of micronutrients. Considering food and beverage intake only, none of the micronutrients measured achieved the estimated average requirement. Around 60% of pregnant women reported taking folic acid or iron supplements in South Africa, but almost none did so in Zimbabwe., Conclusion: We found a high prevalence of overweight and obesity and high micronutrient intake inadequacy in pregnant women who had the previous pregnancy complicated with pre-eclampsia. The obesity figures and micronutrient inadequacy are issues of concern that need to be addressed. Pregnant women have regular contacts with the health system; these opportunities could be used to improve diet and nutrition., Trial Registration: PACTR201105000267371 . Registered 06 December 2010.
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- 2018
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11. Global, regional and national levels and trends of preterm birth rates for 1990 to 2014: protocol for development of World Health Organization estimates.
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Vogel JP, Chawanpaiboon S, Watananirun K, Lumbiganon P, Petzold M, Moller AB, Thinkhamrop J, Laopaiboon M, Seuc AH, Hogan D, Tunçalp O, Allanson E, Betrán AP, Bonet M, Oladapo OT, and Gülmezoglu AM
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- Birth Rate, Data Interpretation, Statistical, Gestational Age, Humans, Epidemiologic Research Design, Premature Birth epidemiology, World Health Organization
- 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.
- Published
- 2016
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12. 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 GJ, Singata M, Lawrie T, Vogel JP, Landoulsi S, Seuc AH, and Gülmezoglu AM
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- Adolescent, Adult, Clinical Protocols, Data Interpretation, Statistical, Female, Humans, Pilot Projects, Pregnancy, Pressure, Research Design, Young Adult, Delivery, Obstetric methods, Labor Stage, Second physiology, Posture physiology
- 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.
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- 2015
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13. How to assess success of treatment when using multiple doses: the case of misoprostol for medical abortion.
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Seuc AH, Shah IH, Ali M, Diaz-Olavarrieta C, and Temmerman M
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- Abortifacient Agents, Nonsteroidal adverse effects, Abortion, Induced methods, Clinical Trials as Topic methods, Computer Simulation, Data Interpretation, Statistical, Dose-Response Relationship, Drug, Endpoint Determination statistics & numerical data, Female, Humans, Kaplan-Meier Estimate, Life Tables, Misoprostol adverse effects, Numerical Analysis, Computer-Assisted, Pregnancy, Treatment Outcome, Abortifacient Agents, Nonsteroidal administration & dosage, Abortion, Induced statistics & numerical data, Clinical Trials as Topic statistics & numerical data, Misoprostol administration & dosage, Models, Statistical, Research Design statistics & numerical data
- 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.
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- 2015
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14. The effect of calcium supplementation on blood pressure in non-pregnant women with previous pre-eclampsia: An exploratory, randomized placebo controlled study.
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Hofmeyr GJ, Seuc AH, Betrán AP, Purnat TD, Ciganda A, Munjanja SP, Manyame S, Singata M, Fawcus S, Frank K, Hall DR, Cormick G, Roberts JM, Bergel EF, Drebit SK, Von Dadelszen P, and Belizan JM
- Subjects
- Adult, Argentina, Double-Blind Method, Female, Humans, Pregnancy, Risk Assessment, South Africa, Treatment Outcome, World Health Organization, Zimbabwe, Blood Pressure drug effects, Blood Pressure Determination methods, Bone Density Conservation Agents administration & dosage, Calcium, Dietary administration & dosage, Pre-Eclampsia prevention & control, Pregnancy Complications, Cardiovascular prevention & control
- Abstract
Background: Epidemiological findings suggest that the link between poverty and pre-eclampsia might be dietary calcium deficiency. Calcium supplementation has been associated with a modest reduction in pre-eclampsia, and also in blood pressure (BP)., Methods: This exploratory sub-study of the WHO Calcium and Pre-eclampsia (CAP) trial aims to determine the effect of 500mg/day elemental calcium on the blood pressure of non-pregnant women with previous pre-eclampsia. Non-pregnant women with at least one subsequent follow-up trial visit at approximately 12 or 24weeks after randomization were included., Results: Of 836 women randomized by 9 September 2014, 1st visit data were available in 367 women of whom 217 had previously had severe pre-eclampsia, 2nd visit data were available in 201 women. There was an overall trend to reduced BP in the calcium supplementation group (1-2.5mmHg) although differences were small and not statistically significant. In the subgroup with previous severe pre-eclampsia, the mean diastolic BP change in the calcium group (-2.6mmHg) was statistically larger than in the placebo group (+0.8mmHg), (mean difference -3.4, 95% CI -0.4 to -6.4; p=0.025). The effect of calcium on diastolic BP at 12weeks was greater than in those with non-severe pre-eclampsia (p=0.020, ANOVA analysis)., Conclusions: There is an overall trend to reduced BP but only statistically significant in the diastolic BP of women with previous severe pre-eclampsia. This is consistent with our hypothesis that this group is more sensitive to calcium supplementation, however results need to be interpreted with caution., (Copyright © 2015. Published by Elsevier B.V.)
- Published
- 2015
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15. Age at natural menopause among patients with systemic lupus erythematosus.
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Alpízar-Rodríguez D, Romero-Díaz J, Sánchez-Guerrero J, Seuc AH, and Cravioto Mdel C
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- Adult, Age Distribution, Age Factors, Female, Follow-Up Studies, Humans, Mexico epidemiology, Middle Aged, Risk Factors, Survival Rate trends, Lupus Erythematosus, Systemic epidemiology, Menopause, Risk Assessment methods, Women's Health
- Abstract
Objective: The aim of this study was to estimate the age at natural menopause in women with SLE., Methods: One thousand and thirty-nine consecutive SLE patients <60 years of age were surveyed. Demographic and clinical data were queried by a single investigator. SLE characteristics and co-morbidities were retrieved from their medical records. Natural menopause was defined as amenorrhoea ≥12 months in the absence of previous hysterectomy, CYC exposure and severe chronic kidney disease (SCKD). Pregnant women and those with menses during the 12 months prior to interview were considered premenopausal. Median age at menopause was estimated by both logit and survival analyses. In addition, mean age at menopause was calculated for patients aged ≥40 years. Factors associated with age at natural menopause were assessed by Cox regression analysis., Results: A total of 961 SLE women were analysed. At interview, most patients (81.6%) were premenopausal, 7.9% had natural menopause, 6.3% were postmenopausal previously exposed to CYC, 4.1% had undergone hysterectomy before menopause and 0.1% presented with SCKD and amenorrhoea. The mean age at interview was 35.2 years (s.d. 10.1), the mean age at SLE diagnosis was 26.9 years (s.d. 8.6) and the mean duration of disease was 8.2 years (s.d. 7.1). The mean recalled age at menopause was 46.4 years (s.d. 4.7). Median age at menopause estimated by logit and survival analyses were 50.7 and 50.8 years, respectively. Only the age at SLE diagnosis was associated with age at natural menopause., Conclusion: Median age at natural menopause in women with lupus is 50 years. This is consistent with the age at menopause reported in the general population., (© The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
- Published
- 2014
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16. Side effects unrelated to disease activity and acceptability of highly effective contraceptive methods in women with systemic lupus erythematosus: a randomized, clinical trial.
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Cravioto MD, Jiménez-Santana L, Mayorga J, and Seuc AH
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- Acne Vulgaris chemically induced, Adult, Dysmenorrhea etiology, Female, Follow-Up Studies, Hirsutism chemically induced, Humans, Kaplan-Meier Estimate, Nausea chemically induced, Patient Dropouts, Patient Satisfaction, Severity of Illness Index, Weight Gain drug effects, Young Adult, Contraceptives, Oral, Combined adverse effects, Contraceptives, Oral, Hormonal adverse effects, Intrauterine Devices, Copper adverse effects, Lupus Erythematosus, Systemic physiopathology, Patient Acceptance of Health Care, Precision Medicine, Progestins adverse effects
- Abstract
Objectives: To assess the side effects unrelated to disease activity and the acceptability of combined oral contraceptives (COCs), progestin-only pills (POPs) and copper-releasing intrauterine devices (IUDs) in women with systemic lupus erythematosus (SLE)., Study Design: A randomized clinical trial including 162 women with SLE, assigned to COC (n=54), POP (n=54) or IUD (n=54). Follow-up visits were conducted after 1, 2, 3, 6, 9 and 12 months of treatment to monitor the presence of symptoms, changes in body weight and blood pressure as well as the development of health problems other than those relating to lupus. Reasons for discontinuation and satisfaction with the use of the assigned method were recorded at the end of treatment. Statistical analysis included descriptive statistics, repeated measure analyses and Kaplan-Meier curves., Results: Significantly different discontinuation rates due to any reason [35%, 55%, 29% (p<0.01)] or nonmedical reasons [(11%, 31%, 4% (p<0.05)] were observed among the COC, POP and IUD groups. Nausea was most frequent among COC users, dysmenorrhea among IUD users and acne and hirsutism among POP users. Mean blood pressures remained unchanged. Mild increases in body weight were observed over time in all treatment groups. Most women were satisfied with the use of the assigned contraceptive method., Conclusions: Oral contraceptives and IUD are acceptable birth control methods for patients with lupus, when counseling and specialized health attention are provided; however, the acceptability of POP appears to be inferior. Side effects unrelated to lupus disease activity are not frequent reasons to discontinue the contraceptive methods., Implications: This study delves into an area that has not been explored among patients with lupus. Our findings on the associated side effects and reasons for discontinuing COCs, POPs or copper-bearing IUDs may be useful in improving contraceptive counseling for women with lupus. Furthermore, they also heighten our knowledge on the reasons that may preclude the widespread use of effective contraceptives among lupus patients., (Copyright © 2014. Published by Elsevier Inc.)
- Published
- 2014
- Full Text
- View/download PDF
17. Disability-adjusted life years for breast and reproductive system cancers in Cuban women of child bearing age.
- Author
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Domínguez E, Santana F, and Seuc AH
- Subjects
- Adolescent, Adult, Breast Neoplasms complications, Cuba epidemiology, Epidemiologic Studies, Female, Humans, Infertility, Female etiology, Ovarian Neoplasms complications, Registries, Uterine Neoplasms complications, Young Adult, Breast Neoplasms mortality, Disabled Persons, Ovarian Neoplasms mortality, Quality-Adjusted Life Years, Uterine Neoplasms mortality
- Abstract
INTRODUCTION Disability-adjusted life years is a composite measure that integrates the components of mortality and morbidity. It is a useful indicator of overall disease burden and is particularly useful for evaluating health intervention outcomes. In the cases of breast and reproductive system cancers, these can also negatively affect childbearing opportunities for young women. OBJECTIVE Determine disability-adjusted life years for breast and reproductive system cancers in Cuban women aged 15-44 years during the period 1990-2006. METHODS A national epidemiological study was conducted using Cuba's disease and vital statistics registry data for 1990, 1995, 2000 and 2006. Disability-adjusted life years in women aged 15-44 years were calculated for breast cancer and three female reproductive system cancers (cervical, endometrial and ovarian), by summing years of life lost due to premature mortality and years lived with disability. Years of life lost due to premature mortality were determined based on age-specific estimates of life expectancy. Years lived with disability were calculated as the product of severities (provided by the 1990 Global Burden of Disease study) and incidence and average duration, both obtained via the DISMOD II program. Data entered in the program include national statistics on incidence, prevalence, and mortality. RESULTS Breast cancer and cervical cancer proved to have the highest rates of potential years of life lost due to premature mortality, with the sharpest increases in the period (from 139 to 206.5 and 114.7 to 215.2 per 100,000, respectively). Endometrial and ovarian neoplasms crept up more slowly. An increase in years lived with disability was seen in three of these four types of cancer; only cervical cancer saw a decline (from 12.7 to 9 per 100,000). Breast cancer and cervical cancer presented the highest levels of disability-adjusted life years for all four years studied, rising from 146.9 to 227.8 and 127.4 to 224.2 per 100,000, respectively between 1990 and 2006. CONCLUSIONS An unfavorable trend in disability-adjusted life years was seen for breast and cervical cancer between 1990 and 2006 in Cuban women of childbearing age.
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- 2014
- Full Text
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18. Intermediate outcomes in randomized clinical trials: an introduction.
- Author
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Seuc AH, Peregoudov A, Betran AP, and Gulmezoglu AM
- Subjects
- Calcium administration & dosage, Dietary Supplements, Endpoint Determination, Female, Humans, Intention to Treat Analysis, Medication Adherence, Pre-Eclampsia etiology, Pregnancy, Risk Assessment, Risk Factors, Treatment Outcome, Pre-Eclampsia prevention & control, Randomized Controlled Trials as Topic methods, Research Design
- 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.
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- 2013
- Full Text
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19. Efficacy of estrogen plus progestin on menopausal symptoms in women with systemic lupus erythematosus: a randomized, double-blind, controlled trial.
- Author
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Cravioto MD, Durand-Carbajal M, Jiménez-Santana L, Lara-Reyes P, Seuc AH, and Sánchez-Guerrero J
- Subjects
- Adult, Aged, Analysis of Variance, Chi-Square Distribution, Double-Blind Method, Estrogens, Conjugated (USP) adverse effects, Factor Analysis, Statistical, Female, Humans, Kaplan-Meier Estimate, Medroxyprogesterone Acetate adverse effects, Mexico, Middle Aged, Patient Selection, Principal Component Analysis, Progestins adverse effects, Risk Assessment, Surveys and Questionnaires, Time Factors, Treatment Outcome, Vasomotor System physiopathology, Estrogen Replacement Therapy adverse effects, Estrogens, Conjugated (USP) administration & dosage, Lupus Erythematosus, Systemic complications, Medroxyprogesterone Acetate administration & dosage, Menopause drug effects, Progestins administration & dosage, Vasomotor System drug effects
- Abstract
Objective: To define the effects of continuous sequential estrogen plus progestin therapy on menopausal symptoms in women with systemic lupus erythematosus (SLE)., Methods: We performed a randomized, double-blind, 24-month clinical trial involving 106 women with SLE who were in the menopausal transition or early or late postmenopause. Patients received continuous sequential estrogen plus progestin (n = 52) or placebo (n = 54). Menopausal symptoms were assessed using the Greene Climacteric Scale at 0, 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 months. A new factor analysis of the scale reduced 21 items to 5 factors. The primary outcome was improvement of menopausal symptoms throughout the followup period. Results were analyzed by the intent-to-treat principle., Results: At baseline, demographic and disease characteristics were similar in both groups. Fifteen of 21 menopausal symptoms had a prevalence of ≥50%, with a similar distribution between groups. Vasomotor factor scores decreased over time in both groups (P = 0.002), but in the estrogen plus progestin group the reduction was more pronounced than in the placebo group (1.5-2.0 versus 0.35-0.8 points on a scale of 0-6; P = 0.03). Maximum effects were observed among the most symptomatic women. Psychological, subjective-somatic, and organic-somatic factors scores also improved along time (P < 0.001), but the treatment and placebo arms improved to a similar degree. Thromboses occurred in 3 patients receiving estrogen plus progestin and in 1 patient receiving placebo., Conclusion: Menopausal symptoms are highly prevalent in peri- and postmenopausal lupus patients. Estrogen plus progestin improved vasomotor symptoms at a clinically significant level, but not other menopausal symptoms. Given the thrombotic risks of menopausal hormone therapy, this should be used only in women with significant vasomotor symptoms., (Copyright © 2011 by the American College of Rheumatology.)
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- 2011
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20. Evolution of disease mortality burden in Cuba: 1990-2005.
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Seuc AH and Domínguez E
- Subjects
- Aged, Aged, 80 and over, Cluster Analysis, Cuba epidemiology, Female, Humans, Male, Middle Aged, Cause of Death trends, Life Expectancy trends
- Abstract
The objective of this study was to estimate the evolution of the burden of disease in Cuba for 20 major causes at five year intervals from 1990 to 2005, in terms of mortality and years of life lost due to premature death (YLL), using national mortality registries. Six summary measures were computed for each of the 20 major causes of death which characterized the evolution of the disease burden over the period studied. The 20 causes were then grouped according to their behaviour in these summary measures; hierarchical cluster analysis was used to support this grouping process. We compute YLL results with and without age-weighting and time discounting (3%). The 20 major causes were grouped into 12 subgroups, each with a particular pattern. The burden of disease in Cuba during the period 1990-2005 has a peculiar pattern that does not reproduce the one characteristic of other low- and middle-income countries. The approach used in this study supports a better description of mortality and YLL trends for major causes, for identifying possible explanations, and for supporting public health policy making. It seems convenient to reproduce this analysis using shorter time intervals, e.g. annually.
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- 2010
- Full Text
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21. [The burden of disease from cancer in Cuba, 1990-2002].
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Alonso ED, Jo AH, and Galán Y
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Cuba epidemiology, Female, Humans, Infant, Male, Middle Aged, Time Factors, Young Adult, Cost of Illness, Neoplasms mortality
- Abstract
Objective: To describe the burden of disease, using morbidity and mortality in Cuba from 1990-2002, by cancer type and location., Methods: A descriptive study of the disease burden in the years 1990, 1995, 2000, and 2002, by Cuba's most frequently associated cancer types and locations. Official Cuban sources were used to calculate years of potential life lost (YPLL) due to mortality (based on life expectancy) and morbidity (based on the incidence, average duration, and severity of the disease), as well as years of potential life lost per death (YPLL/D) and the disability-adjusted life years (DALY), for each cancer type and location, by sex and age group., Results: The locations with higher YPLL were also those with the greatest total burden: lung, breast, prostate, colon and rectum, and cervix, and showed an upward trend for all cancer types and locations, except leukemia. The morbidity-related YPLL were concentrated in: breast, lung, prostate, colon and rectum, and cervix. In men, the highest mortality-related YPLL values were in the oral cavity and oropharynx, esophagus, stomach, lung, bladder, melanoma, lymphoma, and leukemia; women were more affected by cancer of the colon and rectum. The highest YPLL/D values were observed for cervix, breast, ovaries, leukemia, and lymphoma. The cancer types and locations with more DALYs were: lung, breast, prostate, colon and rectum, cervix, and endometrium., Conclusions: The burden of disease from cancer increased in Cuba from 1990-2002, mostly due to a rise in the mortality burden.
- Published
- 2009
22. Short-term prediction of major lower-limb amputation based on clinical indicators on admission: a single institutional experience in a developing country.
- Author
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Seuc AH, López M, Rodríguez L, and Montequín JF
- Subjects
- Developing Countries, Humans, Longitudinal Studies, Models, Statistical, Patient Admission, Prognosis, Retrospective Studies, Severity of Illness Index, Time Factors, Amputation, Surgical statistics & numerical data, Leg blood supply, Leg surgery, Peripheral Vascular Diseases diagnosis, Peripheral Vascular Diseases surgery
- Abstract
Aim: The aim of this study was to analyze the possibility of predicting short-term major lower-limb amputation (SMLA) in patients with vascular diagnoses, based only on clinical variables measured on admission., Methods: A longitudinal, retrospective cohort study of patients with peripheral vascular diagnoses admitted at our Institute was carried out. A stratified sample of 463 patients admitted during 1997, 2000 and 2003, was studied. Logistic regression was used to identify significant predictors of amputation; twelve clinical variables measured on admission were considered as potential predictors., Results: Of the 463 patients, 93 (20%) were amputated. Significant predictors of amputation identified by the logistic regression analysis were ''type of lesion'' (none; neuro-infectious; ischemic; mixture), ''initial diagnosis'' (phlebolymphopathies, acute arterial insufficiency, chronic arterial insufficiency, diabetic foot, others), ''plantar region lesion'' (no; yes), ''diabetes'' (no; yes), ''number of toes affected'' (none; 1-2; 3 or more), and ''area of leg affected'' (none; lower third; + lower third). More than 80% of patients were correctly classified with the final model: sensitivity was 42% and specificity 96%., Conclusions: It seems that SMLA in patients with vascular diagnoses can be predicted reasonably well using as predictors only clinical variables measured on admission. This is a potentially useful result for Angiology Services located in developing/poor communities. The amputation probability for each patient obtained from the logistic regression model can be used in several ways: 1) the medical care of patients can be customized so that the amputation rate of the whole Service can be reduced, and 2) the amputation probability of the statistical model can be used as an estimation of the severity of the disease in each patient, which in turn can be used to standardize the amputation rates computed on different years; this would allow a better assessment of the Institutional performance over time.
- Published
- 2009
23. Relation between the prevalence of a characteristic and the size of the sample needed to estimate it.
- Author
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Seuc AH
- Subjects
- Humans, Predictive Value of Tests, Reproducibility of Results, Epidemiologic Studies, Prevalence, Sample Size
- Published
- 1998
- Full Text
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24. [Defense of the nil hypothesis: a comment on statistical significance and acceptance of the nil hypothesis].
- Author
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Seuc AH
- Subjects
- Statistics as Topic methods
- Published
- 1996
25. Cochran Q test with Turbo BASIC.
- Author
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Seuc AH
- Subjects
- Programming Languages, Software Design, Mathematical Computing, Observer Variation, Software
- Abstract
A microcomputer program written in Turbo BASIC for the sequential application of the Cochran Q test is given. A clinical application where the test is used in order to explore the structure of the agreement between observers is also presented. A program listing is available on request.
- Published
- 1995
- Full Text
- View/download PDF
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