Publications by authors named "Nicole Minckas"

18 Publications

  • Page 1 of 1

Direct maternal morbidity and the risk of pregnancy-related deaths, stillbirths, and neonatal deaths in South Asia and sub-Saharan Africa: A population-based prospective cohort study in 8 countries.

PLoS Med 2021 Jun 28;18(6):e1003644. Epub 2021 Jun 28.

London School of Hygiene & Tropical Medicine, London, United Kingdom.

Background: Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa.

Methods And Findings: This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman's self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes.

Conclusions: Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths.

Trial Registration: The study is not a clinical trial.
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http://dx.doi.org/10.1371/journal.pmed.1003644DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8277068PMC
June 2021

'My story is like a magic wand': a qualitative study of personal storytelling and activism to stop violence against women in Turkey.

Glob Health Action 2021 01;14(1):1927331

Institute for Global Health, University College London, UK.

: Telling personal stories of violence has been central to recent advocacy efforts to prevent violence against women around the world. In this paper, we explore the use of personal storytelling as a form of activism to prevent femicide in Turkey. This study is part of a broader storytelling initiative called SHAER (Storytelling for Health: Acknowledgement, Expression and Recovery) to alleviate the psychological and emotional suffering of women who have experienced gender-based violence in high-prevalence settings.: We conceptually explore personal stories of violence as a form of both distributed agency and activism. This conceptual framework is used to answer the following research question in the Turkish context: How do women use their personal stories of interpersonal violence for their own benefit (support) and that of others (activism)?: Our study is based on 20 in-depth semi-structured interviews with women who have experienced violence and were purposefully recruited by the 'We Will End Femicide' Platform in Istanbul. Interviews were conducted between March and August 2019. We used inductive and deductive thematic analysis to identify instances of personal storytelling at three levels: intrapersonal, relational and collective.: Our results show how the use of personal storytelling can provide a means of healing from experiences of violence. However, this process is not linear and is often influenced by the surrounding context including: the listener of the story, their reaction, and what social networks the woman has to support her. In supportive social contexts, personal storytelling can be an effective support for activism against violence: personal stories can provide opportunities for individuals to shape broader discourses about violence against women and the right of women to share their stories.: Telling one's personal story of violence can both support women's agency and contribute to the collective struggle against violence against women more broadly.
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http://dx.doi.org/10.1080/16549716.2021.1927331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8231392PMC
January 2021

Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight.

N Engl J Med 2021 05;384(21):2028-2038

The affiliations of the members of the writing committee are as follows: the Department of Maternal, Newborn, Child, and Adolescent Health, and Ageing, World Health Organization, Geneva (S.P.N.R., S.Y., N.M., H.V.J., H.T., R.B.); Vardhman Mahavir Medical College and Safdarjung Hospital (S.A., P.M., N.C., J.S., P.A., K.N., I.S., K.C.A., H.C.) and the All India Institute of Medical Sciences (M.J.S.), New Delhi, and Translational Health Science and Technology Institute, Faridabad (N.W.) - all in India; Muhimbili University of Health and Allied Sciences (H.N., E.A., A.M.) and Muhimbili National Hospital (M.N., R.M.) - both in Dar es Salaam, Tanzania; the University of Malawi, College of Medicine, Blantyre, Malawi (K.K., L.G., A.T.M., V.S., Q.D.); Obafemi Awolowo University, Ile-Ife, Nigeria (C.H.A., O.K., B.P.K., E.A.A.); Kwame Nkrumah University of Science and Technology (S.N., R.L.-R., D.A., G.P.-R.) and Komfo Anokye Teaching Hospital (A.B.-Y., N.W.-B., I.N.), Kumasi, and the School of Public Health, University of Ghana, Accra (A.A.M.) - all in Ghana; Karolinska University Hospital (A.L.) and Karolinska Institute (N.B., A.L., B.W.), Stockholm; the Institute for Safety Governance and Criminology, University of Cape Town, Cape Town, South Africa (B.M.); and Stavanger University Hospital, Stavanger, Norway (S.R.).

Background: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain.

Methods: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life.

Results: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care.

Conclusions: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).
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http://dx.doi.org/10.1056/NEJMoa2026486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108485PMC
May 2021

Disrespect and abuse as a predictor of postnatal care utilisation and maternal-newborn well-being: a mixed-methods systematic review.

BMJ Glob Health 2021 04;6(4)

Institute for Global Health, University College London, London, UK.

Introduction: Globally, a substantial number of women experience abusive and disrespectful care from health providers during childbirth. As evidence mounts on the nature and frequency of disrespect and abuse (D&A), little is known about the consequences of a negative experience of care on health and well-being of women and newborns. This review summarises available evidence on the associations of D&A of mother and newborns during childbirth and the immediate postnatal period (understood as the first 24 hours from birth) with maternal and neonatal postnatal care (PNC) utilisation, newborn feeding practices, newborn weight gain and maternal mental health.

Methods: We conducted a systematic review of all published qualitative, quantitative and mixed-methods studies on D&A and its postnatal consequences across all countries. Pubmed, Embase, Web of Science, LILACS and Scopus were searched using predetermined search terms. Quantitative and qualitative data were analysed and presented separately. Thematic analysis was used to synthesise the qualitative evidence.

Results: A total of 4 quantitative, 1 mixed-methods and 16 qualitative studies were included. Quantitative studies suggested associations between several domains of D&A and use of PNC as well as maternal mental health. Different definitions of exposure meant formal meta-analysis was not possible. Three main themes emerged from the qualitative findings associated with PNC utilisation: (1) women's direct experiences; (2) women's expectations and (3) women's agency.

Conclusion: This review is the first to examine the postnatal effect of D&A of women and newborns during childbirth. We highlight gaps in research that could help improve health outcomes and protect women and newborns during childbirth. Understanding the health and access consequences of a negative birth experience can help progress the respectful care agenda.
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http://dx.doi.org/10.1136/bmjgh-2020-004698DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061800PMC
April 2021

Preterm care during the COVID-19 pandemic: A comparative risk analysis of neonatal deaths averted by kangaroo mother care versus mortality due to SARS-CoV-2 infection.

EClinicalMedicine 2021 Mar 15;33:100733. Epub 2021 Feb 15.

Maternal, Adolescent, Reproductive and Child Health Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London WC1E 7HT, United Kingdom.

Background: COVID-19 is disrupting health services for mothers and newborns, particularly in low- and middle-income countries (LMIC). Preterm newborns are particularly vulnerable. We undertook analyses of the benefits of kangaroo mother care (KMC) on survival among neonates weighing ≤2000 g compared with the risk of SARS-CoV-2 acquired from infected mothers/caregivers.

Methods: We modelled two scenarios over 12 months. Scenario 1 compared the survival benefits of KMC with universal coverage (99%) and mortality risk due to COVID-19. Scenario 2 estimated incremental deaths from reduced coverage and complete disruption of KMC. Projections were based on the most recent data for 127 LMICs (~90% of global births), with results aggregated into five regions.

Findings: Our worst-case scenario (100% transmission) could result in 1,950 neonatal deaths from COVID-19. Conversely, 125,680 neonatal lives could be saved with universal KMC coverage. Hence, the benefit of KMC is 65-fold higher than the mortality risk of COVID-19. If recent evidence of 10% transmission was applied, the ratio would be 630-fold. We estimated a 50% reduction in KMC coverage could result in 12,570 incremental deaths and full disruption could result in 25,140 incremental deaths, representing a 2·3-4·6% increase in neonatal mortality across the 127 countries.

Interpretation: The survival benefit of KMC far outweighs the small risk of death due to COVID-19. Preterm newborns are at risk, especially in LMICs where the consequences of disruptions are substantial. Policymakers and healthcare professionals need to protect services and ensure clearer messaging to keep mothers and newborns together, even if the mother is SARS-CoV-2-positive.

Funding: Eunice Kennedy Shriver National Institute of Child Health & Human Development; Bill & Melinda Gates Foundation; Elma Philanthropies; Wellcome Trust; and Joint Global Health Trials scheme of Department of Health and Social Care, Department for International Development, Medical Research Council, and Wellcome Trust.
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http://dx.doi.org/10.1016/j.eclinm.2021.100733DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955179PMC
March 2021

Small and sick newborn care during the COVID-19 pandemic: global survey and thematic analysis of healthcare providers' voices and experiences.

BMJ Glob Health 2021 03;6(3)

Department of Pediatrics and Child Health, University of Malawi College of Medicine and Queen Elizabeth Central Hospital, Blantyre, Malawi.

Introduction: The COVID-19 pandemic is disrupting health systems globally. Maternity care disruptions have been surveyed, but not those related to vulnerable small newborns. We aimed to survey reported disruptions to small and sick newborn care worldwide and undertake thematic analysis of healthcare providers' experiences and proposed mitigation strategies.

Methods: Using a widely disseminated online survey in three languages, we reached out to neonatal healthcare providers. We collected data on COVID-19 preparedness, effects on health personnel and on newborn care services, including kangaroo mother care (KMC), as well as disruptors and solutions.

Results: We analysed 1120 responses from 62 countries, mainly low and middle-income countries (LMICs). Preparedness for COVID-19 was suboptimal in terms of guidelines and availability of personal protective equipment. One-third reported routine testing of all pregnant women, but 13% had no testing capacity at all. More than 85% of health personnel feared for their own health and 89% had increased stress. Newborn care practices were disrupted both due to reduced care-seeking and a compromised workforce. More than half reported that evidence-based interventions such as KMC were discontinued or discouraged. Separation of the mother-baby dyad was reported for both COVID-positive mothers (50%) and those with unknown status (16%). Follow-up care was disrupted primarily due to families' fear of visiting hospitals (~73%).

Conclusion: Newborn care providers are stressed and there is lack clarity and guidelines regarding care of small newborns during the pandemic. There is an urgent need to protect life-saving interventions, such as KMC, threatened by the pandemic, and to be ready to recover and build back better.
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http://dx.doi.org/10.1136/bmjgh-2020-004347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7959239PMC
March 2021

A public health approach for deciding policy on infant feeding and mother-infant contact in the context of COVID-19.

Lancet Glob Health 2021 04 22;9(4):e552-e557. Epub 2021 Feb 22.

International Center for Equity in Health, Federal University of Pelotas, Pelotas, Brazil.

The COVID-19 pandemic has raised concern about the possibility and effects of mother-infant transmission of SARS-CoV-2 through breastfeeding and close contact. The insufficient available evidence has resulted in differing recommendations by health professional associations and national health authorities. We present an approach for deciding public health policy on infant feeding and mother-infant contact in the context of COVID-19, or for future emerging viruses, that balances the risks that are associated with viral infection against child survival, lifelong health, and development, and also maternal health. Using the Lives Saved Tool, we used available data to show how different public health approaches might affect infant mortality. Based on existing evidence, including population and survival estimates, the number of infant deaths in low-income and middle-income countries due to COVID-19 (2020-21) might range between 1800 and 2800. By contrast, if mothers with confirmed SARS-CoV-2 infection are recommended to separate from their newborn babies and avoid or stop breastfeeding, additional deaths among infants would range between 188 000 and 273 000.
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http://dx.doi.org/10.1016/S2214-109X(20)30538-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906661PMC
April 2021

Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study.

Matern Child Health J 2021 Jan 3;25(1):136-150. Epub 2021 Jan 3.

Mother and Child's Health Research Department, Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.

Introduction: Though interest is growing for trials comparing planned delivery mode (vaginal delivery [VD]; cesarean section [CS]) in low-risk nulliparous women, appropriate study design is unclear. Our objective was to assess feasibility of three designs (preference trial [PCT], randomized controlled trial [RCT], partially randomized patient preference trial [PRPPT]) for a trial comparing planned delivery mode in low-risk women.

Methods: A cross-sectional survey of low-risk, nulliparous pregnant women (N = 416) and healthcare providers (N = 168) providing prenatal care and/or labor/delivery services was conducted in Argentina (2 public, 2 private hospitals). Proportion of pregnant women and providers willing to participate in each design and reasons for not participating were determined.

Results: Few women (< 15%) or professionals (33.3%) would participate in an RCT, though more would participate in PCTs (88% women; 65.9% professionals) or PRPPTs (44.4% public, 63.4% private sector women; 44.0% professionals). However, most women would choose vaginal delivery in the PCT and PRPPT (> 85%). Believing randomization unacceptable (RCT, PRPPT) and desiring choice of delivery mode (RCT) were women's reasons for not participating. For providers, commonly cited reasons for not participating included unacceptability of performing CS without medical indication, difficulty obtaining informed consent, discomfort enrolling patients (all designs), and violating women's right to choose (RCT).

Conclusions For Practice: Important limitations were found for each trial design evaluated. The necessity of stronger evidence regarding delivery mode in low-risk women suggests consideration of additional designs, such as a rigorously designed cohort study or an RCT within an obstetric population with equivocal CS indications.
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http://dx.doi.org/10.1007/s10995-020-03073-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7922524PMC
January 2021

Contribution of calcium in drinking water from a South American country to dietary calcium intake.

BMC Res Notes 2020 Oct 2;13(1):465. Epub 2020 Oct 2.

Bone Biology Laboratory, School of Medicine, Rosario National University, 2000, Rosario, Santa Fe, Argentina.

Objective: To describe the calcium concentration of tap and bottled waters from Argentina and to estimate the contribution of drinking water to calcium recommendations.

Results: Calcium concentrations provided by water authorities ranged from 6 to 105 mg/L. The mean calcium level of samples analysed at the Laboratorio de Ingeniería Sanitaria, National University of La Plata was 15.8 (SD ± 13.2) mg/L and at the Bone Biology Laboratory of the National University of Rosario was 13.1 (± 10.0) mg/L. Calcium values of samples from supply systems and private wells was similar. Most bottled waters had calcium levels well below 50 mg/L. The intake of one litre of drinking water from Argentina could represent in average between 1.2 and 8.0% of the calcium daily values for an adult.
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http://dx.doi.org/10.1186/s13104-020-05308-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532645PMC
October 2020

The role of participation and community mobilisation in preventing violence against women and girls: a programme review and critique.

Glob Health Action 2020 12;13(1):1775061

Institute for Global Health, University College London , London, UK.

Background: Violence against women and girls (VAWG) is a public health problem and one of the most prevalent human rights violations in the world. Recently practitioners and researchers have taken an interest in community participation as a strategy for preventing VAWG. Despite the recent enthusiasm however, there has been little articulation of how participation in VAWG prevention programmes mobilises communities to challenge social norms and prevent VAWG.

Objectives: In an attempt to help address this gap, this article seeks to answer two research questions: (1) How does participation theoretically mobilise communities to prevent VAWG, and (2) how do nominally programmes make use of these theoretical concepts in their (explicit or implicit) theories of change?

Methods: To answer the first question, we draw on two well-recognised theories of participation and community mobilisation - Rifkin and Pridmore's continuum of participation and Freire's steps towards achieving critical consciousness - to clarify theoretical assumptions about how participation can mobilise community to reduce VAWG. To answer our second research question, we present the results from a review of primary prevention programmes that seek to reduce VAWG through community participation. Our analysis examines the explicit and implicit theories of change for these prevention programmes against the assumptions outlined from the theoretical literature.

Results: Our results help to better articulate realistic goals for community mobilisation and outline a theoretical basis for how participation as part of programming can effectively mobilise communities to reduce violence.

Conclusion: We argue that, in order to be both effective and sustainable, the role of external agents in introducing programmes needs to be secondary to the ownership and empowerment of communities in designing and delivering their own strategies for VAWG prevention.
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http://dx.doi.org/10.1080/16549716.2020.1775061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7480621PMC
December 2020

Correction to: Feminisation of the health workforce and wage conditions of health professions: an exploratory analysis.

Hum Resour Health 2019 Nov 15;17(1):84. Epub 2019 Nov 15.

Centre for Gender and Global Health, Institute for Global Health, University College London, 3rd floor, Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.

The original article [1] contained an error in the presentation of all figures and tables; each figure and table is now set out and designated appropriately in the original article.
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http://dx.doi.org/10.1186/s12960-019-0425-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6857298PMC
November 2019

Feminisation of the health workforce and wage conditions of health professions: an exploratory analysis.

Hum Resour Health 2019 10 17;17(1):72. Epub 2019 Oct 17.

Centre for Gender and Global Health, Institute for Global Health, University College London, 3rd floor, Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.

Background: The feminisation of the global health workforce presents a unique challenge for human resource policy and health sector reform which requires an explicit gender focus. Relatively little is known about changes in the gender composition of the health workforce and its impact on drivers of global health workforce dynamics such as wage conditions. In this article, we use a gender analysis to explore if the feminisation of the global health workforce leads to a deterioration of wage conditions in health.

Methods: We performed an exploratory, time series analysis of gender disaggregated WageIndicator data. We explored global gender trends, wage gaps and wage conditions over time in selected health occupations. We analysed a sample of 25 countries over 9 years between 2006 and 2014, containing data from 970,894 individuals, with 79,633 participants working in health occupations (48,282 of which reported wage data). We reported by year, country income level and health occupation grouping.

Results: The health workforce is feminising, particularly in lower- and upper-middle-income countries. This was associated with a wage gap for women of 26 to 36% less than men, which increased over time. In lower- and upper-middle-income countries, an increasing proportion of women in the health workforce was associated with an increasing gender wage gap and decreasing wage conditions. The gender wage gap was pronounced in both clinical and allied health professions and over lower-middle-, upper-middle- and high-income countries, although the largest gender wage gaps were seen in allied healthcare occupations in lower-middle-income countries.

Conclusion: These results, if a true reflection of the global health workforce, have significant implications for health policy and planning and highlight tensions between current, purely economic, framing of health workforce dynamics and the need for more extensive gender analysis. They also highlight the value of a more nuanced approach to health workforce planning that is gender sensitive, specific to countries' levels of development, and considers specific health occupations.
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http://dx.doi.org/10.1186/s12960-019-0406-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6796343PMC
October 2019

Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions.

Trials 2019 Jun 6;20(1):329. Epub 2019 Jun 6.

Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.

Background: Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Although there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions.

Methods: We used a stepped approach to develop a practical framework for researchers. This consisted of (1) a systematic review of the innovative qualitative methods mentioned in the health literature, (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries, and (3) a framework development and group consensus-building process.

Results: The findings are presented in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories, and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and short message service, community mapping, spiral walks, pair interviews and visual participatory analysis.

Conclusions: The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention or process (or both) of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.
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http://dx.doi.org/10.1186/s13063-019-3439-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6555705PMC
June 2019

An approach to identify a minimum and rational proportion of caesarean sections in resource-poor settings: a global network study.

Lancet Glob Health 2018 08;6(8):e894-e901

Department of Obstetrics and Gynecology, Columbia University, New York City, NY, USA.

Background: Caesarean section prevalence is increasing in Asia and Latin America while remaining low in most African regions. Caesarean section delivery is effective for saving maternal and infant lives when they are provided for medically-indicated reasons. On the basis of ecological studies, caesarean delivery prevalence between 9% and 19% has been associated with better maternal and perinatal outcomes, such as reduced maternal land fetal mortality. However, the specific prevalence of obstetric and medical complications that require caesarean section have not been established, especially in low-income and middle-income countries (LMICs). We sought to provide information to inform the approach to the provision of caesarean section in low-resource settings.

Methods: We did a literature review to establish the prevalence of obstetric and medical conditions for six potentially life-saving indications for which caesarean section could reduce mortality in LMICs. We then analysed a large, prospective population-based dataset from six LMICs (Argentina, Guatemala, Kenya, India, Pakistan, and Zambia) to determine the prevalence of caesarean section by indication for each site. We considered that an acceptable number of events would be between the 25th and 75th percentile of those found in the literature.

Findings: Between Jan 1, 2010, and Dec 31, 2013, we enrolled a total of 271 855 deliveries in six LMICs (seven research sites). Caesarean section prevalence ranged from 35% (3467 of 9813 deliveries in Argentina) to 1% (303 of 16 764 deliveries in Zambia). Argentina's and Guatemala's sites all met the minimum 25th percentile for five of six indications, whereas sites in Zambia and Kenya did not reach the minimum prevalence for caesarean section for any of the indications. Across all sites, a minimum overall caesarean section of 9% was needed to meet the prevalence of the six indications in the population studied.

Interpretation: In the site with high caesarean section prevalence, more than half of the procedures were not done for life-saving conditions, whereas the sites with low proportions of caesarean section (below 9%) had an insufficient number of caesarean procedures to cover those life-threatening causes. Attempts to establish a minimum caesarean prevalence should go together with focusing on the life-threatening causes for the mother and child. Simple methods should be developed to allow timely detection of life-threatening conditions, to explore actions that can remedy those conditions, and the timely transfer of women with those conditions to health centres that could provide adequate care for those conditions.

Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development.
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http://dx.doi.org/10.1016/S2214-109X(18)30241-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6357956PMC
August 2018

Inflammatory Bowel Disease in Latin America: A Systematic Review.

Value Health Reg Issues 2018 Dec 22;17:126-134. Epub 2018 Jun 22.

London School of Hygiene and Tropical Medicine, London, UK; Argentine Cochrane Center, Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.

Background: Inflammatory bowel disease (IBD) is the name given to two inflammatory diseases of the colon and/or small intestine: Crohn disease (CD) and ulcerative colitis (UC). There is no information summarizing the complete body of evidence about IBD in developing regions, including Latin America.

Objectives: To estimate the burden of IBD in Latin America.

Methods: We conducted a systematic review searching published and unpublished studies on major international and regional databases from January 2000 to September 2015. Outcomes considered were incidence, prevalence, mortality, hospitalization attributable, treatment patterns, comparative effectiveness, patient-reported outcomes, and adherence to treatment. Pairs of reviewers independently selected, extracted, and assessed the risk of bias of the studies. Discrepancies were solved by consensus.

Results: We retrieved 3445 references, finally including 25 studies. Only 19% of the observational studies had a low risk of bias for participant selection and 60% were based on registries. The incidence ranged from 0.74 to 6.76/100,000 person-years for UC and from 0.24 to 3.5/100,000 person-years for CD. The prevalence rate ranged from 0.99 to 44.3/100,000 inhabitants for UC and 0.24 to 16.7/100,000 inhabitants for CD. Mortality rates ranged from 0.60 to 1.02 for UC and from 0.23 to 0.40 for CD. Patient-reported outcomes showed a decrease in quality of life associated with depression and anxiety and correlated with the time of diagnosis. The most frequently used medication in the studies was mesalazine.

Conclusions: The burden of IBD in Latin America seems to be important, but there is a considerable gap of high-quality evidence in the region.
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http://dx.doi.org/10.1016/j.vhri.2018.03.010DOI Listing
December 2018

How Should Trainees Respond in Situations of Obstetric Violence?

AMA J Ethics 2018 Mar 1;20(1):238-246. Epub 2018 Mar 1.

A researcher at the Institute for Global Health, University College London (UCL) in England, and served as a teaching assistant for research methods and public policy courses at the University La Matanza in Buenos Aires, Argentina, and for global health research methods and evidence courses at UCL.

Argentina passed a law for humanized birth in 2004 and another law against obstetric violence in 2009, both of which stipulate the rights of women to achieve respectful maternity care. Clinicians and women might still be unaware of these laws, however. In this article, we discuss the case of a fourth-year medical student who, while visiting Argentina from the United States for his obstetric rotation, witnesses an act of obstetric violence. We show that the student's situation can be understood as one of moral distress and argue that, in this specific instance, it would be appropriate for the student to intervene by providing supportive care to the patient. However, we suggest that medical schools have an obligation to better prepare students for rotations conducted abroad.
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http://dx.doi.org/10.1001/journalofethics.2018.20.3.ecas2-1803DOI Listing
March 2018

Comparison of self-reported and directly measured weight and height among women of reproductive age: a systematic review and meta-analysis.

Acta Obstet Gynecol Scand 2018 Apr;97(4):429-439

Department of Mother and Child Health Research, Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Buenos Aires, Argentina.

Introduction: The use of self-report as a strategy for collecting data on women's weight and height is widespread in both clinical practice and epidemiological studies. This study aimed to compare self-reported and directly measured weight and height among women of reproductive age.

Material And Methods: In July 2015 we searched MEDLINE, EMBASE, COCHRANE, CINHAL, LILACS and gray literature. We included women of reproductive age (12-49 years old) independently of their weight or height at the time of the study. Women with any condition that implies regular tracking of their weight (for example, eating disorder) were excluded. Two reviewers independently selected, extracted and assessed the risk of bias of the studies. We used REVMAN 5.3 to perform the meta-analysis. Heterogeneity was assessed using the I statistic.

Results: Following eligibility assessment, 21 studies of 18 749 women met the inclusion criteria. The results of the meta-analysis showed an underestimation of weight by -0.94 kg (95% CI -1.17 to -0.71 kg; p < 0.0001; I  = 0%) in the overall sample and an overestimation of height by 0.36 cm (95% CI 0.20-0.51; p < 0.0001; I  = 35%) based on self-reported vs. directly measured values.

Conclusion: This review shows that self-reported weight and height of women of reproductive age differs slightly from direct measures. We consider that the magnitude at which self-reported data over- or underestimates the real value, is negligible regarding clinical and research use.
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http://dx.doi.org/10.1111/aogs.13326DOI Listing
April 2018

[Spatial analysis of childhood obesity and overweight in Peru, 2014].

Rev Peru Med Exp Salud Publica 2016 Jul-Sep;33(3):489-497

Johns Hopkins Bloomberg School of Public Health. Baltimore, USA.

Objectives.: To estimate regional prevalence and identify the spatial patterns of the degree of overweight and obesity by districts in under five years children in Peru during 2014.

Materials And Methods.: Analysis of the information reported by the Information System Nutritional Status (SIEN) of the number of cases of overweight and obesity in children under five years recorded during 2014. Regional prevalence for overweight and obesity, and their respective confidence intervals to 95% were calculated. Moran index was used to determine patterns of grouping districts with high prevalence of overweight and/or obesity.

Results.: Data from 1834 districts and 2,318,980 children under five years were analyzed. 158,738 cases (6.84%; CI 95%: 6.81 to 6.87) were overweight, while 56,125 (2.42%; CI 95%: 2.40 to 2.44) obesity. The highest prevalence of overweight were identified in the regions of Tacna (13.9%), Moquegua (11.8%), Callao (10.4%), Lima (10.2%) and Ica (9.3%), and in the same regions for obesity with 5.3%; 4.3%; 4.0%; 4.0% and 3.8% respectively. The spatial analysis found grouping districts of high prevalence in 10% of all districts for both overweight and obesity, identifying 199 districts for overweight (126 urban and 73 rural), and 184 for obesity (136 urban and 48 rural).

Conclusions.: The highest prevalence of overweight and obesity were identified in the Peruvian coast regions. Moreover, these regions are predominantly exhibited a spatial clustering of districts with high prevalence of overweight and obesity.
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http://dx.doi.org/10.17843/rpmesp.2016.333.2298DOI Listing
March 2018
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