124 results on '"Katherine Semrau"'
Search Results
2. Effectiveness of community outreach HIV prevention programs in Vietnam: a mixed methods evaluation
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Lora L. Sabin, Katherine Semrau, Mary DeSilva, Loan T T Le, Jennifer J. Beard, Davidson H. Hamer, Jordan Tuchman, Theodore M. Hammett, Nafisa Halim, Manisha Reuben, Aldina Mesic, and Taryn Vian
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Mixed methods design ,HIV prevention ,Vietnam ,Community outreach ,Risk reduction behavior ,Injection drug users ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background In 2014, Vietnam was the first Southeast Asian country to commit to achieving the World Health Organization’s 90–90-90 global HIV targets (90% know their HIV status, 90% on sustained treatment, and 90% virally suppressed) by 2020. This pledge represented further confirmation of Vietnam’s efforts to respond to the HIV epidemic, one feature of which has been close collaboration with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Starting in 2004, PEPFAR supported community outreach programs targeting high-risk populations (people who inject drugs, men who have sex with men, and sex workers). To provide early evidence on program impact, in 2007–2008 we conducted a nationwide evaluation of PEPFAR-supported outreach programs in Vietnam. The evaluation focused on assessing program effect on HIV knowledge, high-risk behaviors, and HIV testing among high-risk populations—results relevant to Vietnam’s push to meet global HIV goals. Methods We used a mixed-methods cross-sectional evaluation design. Data collection encompassed a quantitative survey of 2199 individuals, supplemented by 125 in-depth interviews. Participants were members of high-risk populations who reported recent contact with an outreach worker (intervention group) or no recent contact (comparison group). We assessed differences in HIV knowledge, risky behaviors, and HIV testing between groups, and between high-risk populations. Results Intervention participants knew significantly more about transmission, prevention, and treatment than comparison participants. We found low levels of injection drug-use-related risk behaviors and little evidence of program impact on such behaviors. In contrast, a significantly smaller proportion of intervention than comparison participants reported risky sexual behaviors generally and within each high-risk population. Intervention participants were also more likely to have undergone HIV testing (76.1% vs. 47.0%, p
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- 2019
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3. Measurement and accountability for maternal, newborn and child health: fit for 2030?
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Catherine Kyobutungi, Allisyn Moran, Tanya Marchant, Katherine Semrau, Luis Huicho, Lars Åke Persson, Lynn Freedman, Melissa Burgess, Claire-Helene Mershon, Kate Somers, Cheikh Faye, Hadiza Galadanci, John Grove, Rima Jolivet, Allen Kabagenyi, Ali Karim, Nosa Orobaton, Ahmed Ehsanur Rahman, William Sambisa, Abiy Seifu Estfanos, Ash Shah, Savitha Subramanian, and William Weiss
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Medicine (General) ,R5-920 ,Infectious and parasitic diseases ,RC109-216 - Published
- 2020
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4. What is meant by validity in maternal and newborn health measurement? A conceptual framework for understanding indicator validation.
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Lenka Benova, Ann-Beth Moller, Kathleen Hill, Lara M E Vaz, Alison Morgan, Claudia Hanson, Katherine Semrau, Shams Al Arifeen, and Allisyn C Moran
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Medicine ,Science - Abstract
BACKGROUND:Rigorous monitoring supports progress in achieving maternal and newborn mortality and morbidity reductions. Recent work to strengthen measurement for maternal and newborn health highlights the existence of a large number of indicators being used for this purpose. The definitions and data sources used to produce indicator estimates vary and challenges exist with completeness, accuracy, transparency, and timeliness of data. The objective of this study is to create a conceptual overview of how indicator validity is defined and understood by those who develop and use maternal and newborn health indicators. METHODS:A conceptual framework of validity was developed using mixed methods. We were guided by principles for conceptual frameworks and by a review of the literature and key maternal and newborn health indicator guidance documents. We also conducted qualitative semi-structured interviews with 32 key informants chosen through purposive sampling. RESULTS:We categorised indicator validity into three main types: criterion, convergent, and construct. Criterion or diagnostic validity, comparing a measure with a gold standard, has predominantly been used to assess indicators of care coverage and content. Studies assessing convergent validity quantify the extent to which two or more indicator measurement approaches, none of which is a gold-standard, relate. Key informants considered construct validity, or the accuracy of the operationalisation of a concept or phenomenon, a critical part of the overall assessment of indicator validity. CONCLUSION:Given concerns about the large number of maternal and newborn health indicators currently in use, a more consistent understanding of validity can help guide prioritization of key indicators and inform development of new indicators. All three types of validity are relevant for evaluating the performance of maternal and newborn health indicators. We highlight the need to establish a common language and understanding of indicator validity among the various global and local stakeholders working within maternal and newborn health.
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- 2020
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5. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India
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Jonathon D. Gass, Anamika Misra, Mahendra Nath Singh Yadav, Fatima Sana, Chetna Singh, Anup Mankar, Brandon J. Neal, Jennifer Fisher-Bowman, Jenny Maisonneuve, Megan Marx Delaney, Krishan Kumar, Vinay Pratap Singh, Narender Sharma, Atul Gawande, Katherine Semrau, and Lisa R. Hirschhorn
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Data Quality Assurance (DQA) ,Safe Childbirth Checklist (SCC) ,Maternal morbidity ,Maternal and perinatal mortality ,Data feedback ,Supportive supervision ,Medicine (General) ,R5-920 - Abstract
Abstract Background There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. Methods We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. Results The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout consecutive audits. The DQMIS was successful, despite an increase from 20 to 130 data collectors. Conclusions In the absence of widely disseminated data quality methods and standards for large RCT interventions in limited-resource settings, we developed an integrated DQA system, combining auditing, rapid data feedback, and supportive supervision, which ensured high-quality data and could serve as a model for future health systems research trials. Future efforts should focus on standardization of DQA processes for health systems research. Trial Registration ClinicalTrials.gov identifier, NCT02148952 . Registered on 13 February 2014.
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- 2017
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6. The influence of quality maternity waiting homes on utilization of facilities for delivery in rural Zambia
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Elizabeth G. Henry, Katherine Semrau, Davidson H. Hamer, Taryn Vian, Mary Nambao, Kaluba Mataka, and Nancy A. Scott
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Maternity waiting home ,Facility-based delivery ,Maternal health ,Newborn health ,Skilled birth attendance ,Zambia ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Residential accommodation for expectant mothers adjacent to health facilities, known as maternity waiting homes (MWH), is an intervention designed to improve access to skilled deliveries in low-income countries like Zambia where the maternal mortality ratio is estimated at 398 deaths per 100,000 live births. Our study aimed to assess the relationship between MWH quality and the likelihood of facility delivery in Kalomo and Choma Districts in Southern Province, Zambia. Methods We systematically assessed and inventoried the functional capacity of all existing MWH using a quantitative facility survey and photographs of the structures. We calculated a composite score and used multivariate regression to quantify MWH quality and its association with the likelihood of facility delivery using household survey data collected on delivery location in Kalomo and Choma Districts from 2011–2013. Results MWH were generally in poor condition and composite scores varied widely, with a median score of 28.0 and ranging from 12 to 66 out of a possible 75 points. Of the 17,200 total deliveries captured from 2011–2013 in 40 study catchment area facilities, a higher proportion occurred in facilities where there was either a MWH or the health facility provided space for pregnant waiting mothers compared to those with no accommodations (60.7% versus 55.9%, p
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- 2017
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7. Evaluation of a call center to assess post-discharge maternal and early neonatal outcomes of facility-based childbirth in Uttar Pradesh, India.
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Jonathon D Gass, Katherine Semrau, Fatima Sana, Anup Mankar, Vinay Pratap Singh, Jennifer Fisher-Bowman, Brandon J Neal, Danielle E Tuller, Bharath Kumar, Stuart Lipsitz, Narender Sharma, Bhala Kodkany, Vishwajeet Kumar, Atul Gawande, and Lisa R Hirschhorn
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Medicine ,Science - Abstract
BACKGROUND:Maternal and neonatal outcomes in the immediate post-delivery period are critical indicators of quality of care. Data on childbirth outcomes in low-income settings usually require home visits, which can be constrained by cost and access. We report on the use of a call center to measure post-discharge outcomes within a multi-site improvement study of facility-based childbirth in Uttar Pradesh, India. METHODS:Of women delivering at study sites eligible for inclusion, 97.9% (n = 157,689) consented to follow-up. All consenting women delivering at study facilities were eligible to receive a phone call between days eight and 42 post-partum to obtain outcomes for the seven-day period after birth. Women unable to be contacted via phone were visited at home. Outcomes, including maternal and early neonatal mortality and maternal morbidity, were ascertained using a standardized script developed from validated survey questions. Data Quality Assurance (DQA) included accuracy (double coding of calls) and validity (consistency between two calls to the same household). Regression models were used to identify factors associated with inconsistency. FINDINGS:Over 23 months, outcomes were obtained by the call center for 98.0% (154,494/157,689) consenting women and their neonates. 87.9% of call center-obtained outcomes were captured by phone call alone and 12.1% required the assistance of a field worker. An additional 1.7% were obtained only by a field worker, 0.3% were lost-to-follow-up, and only 0.1% retracted consent. The call center captured outcomes with a median of 1 call (IQR 1-2). DQA found 98.0% accuracy; data validation demonstrated 93.7% consistency between the first and second call. In a regression model, significant predictors of inconsistency included cases with adverse outcomes (p
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- 2018
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8. Early infant diagnosis of HIV infection in Zambia through mobile phone texting of blood test results
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Phil Seidenberg, Stephen Nicholson, Merrick Schaefer, Katherine Semrau, Maximillian Bweupe, Noel Masese, Rachael Bonawitz, Lastone Chitembo, Caitlin Goggin, and Donald M Thea
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Public aspects of medicine ,RA1-1270 - Abstract
OBJECTIVE: To see if, in the diagnosis of infant infection with human immunodeficiency virus (HIV) in Zambia, turnaround times could be reduced by using an automated notification system based on mobile phone texting. METHODS: In Zambia's Southern province, dried samples of blood from infants are sent to regional laboratories to be tested for HIV with polymerase chain reaction (PCR). Turnaround times for the postal notification of the results of such tests to 10 health facilities over 19 months were evaluated by retrospective data collection. These baseline data were used to determine how turnaround times were affected by customized software built to deliver the test results automatically and directly from the processing laboratory to the health facility of sample origin via short message service (SMS) texts. SMS system data were collected over a 7.5-month period for all infant dried blood samples used for HIV testing in the 10 study facilities. FINDINGS: Mean turnaround time for result notification to a health facility fell from 44.2 days pre-implementation to 26.7 days post-implementation. The reduction in turnaround time was statistically significant in nine (90%) facilities. The mean time to notification of a caregiver also fell significantly, from 66.8 days pre-implementation to 35.0 days post-implementation. Only 0.5% of the texted reports investigated differed from the corresponding paper reports. CONCLUSION: The texting of the results of infant HIV tests significantly shortened the times between sample collection and results notification to the relevant health facilities and caregivers.
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- 2012
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9. Testing the validity and reliability of the shame questionnaire among sexually abused girls in Zambia.
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Lynn T M Michalopoulos, Laura K Murray, Jeremy C Kane, Stephanie Skavenski van Wyk, Elwyn Chomba, Judith Cohen, Mwiya Imasiku, Katherine Semrau, Jay Unick, and Paul A Bolton
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Medicine ,Science - Abstract
PURPOSE:The aim of the current study is to test the validity and reliability of the Shame Questionnaire among traumatized girls in Lusaka, Zambia. METHODS:The Shame Questionnaire was validated through both classical test and item response theory methods. Internal reliability, criterion validity and construct validity were examined among a sample of 325 female children living in Zambia. Sub-analyses were conducted to examine differences in construct validity among girls who reported sexual abuse and girls who did not. RESULTS:All girls in the sample were sexually abused, but only 61.5% endorsed or reported that sexual abuse had occurred. Internal consistency was very good among the sample with alpha = .87. Criterion validity was demonstrated through a significant difference of mean Shame Questionnaire scores between girls who experienced 0-1 trauma events and more than one traumatic event, with higher mean Shame Questionnaire scores among girls who had more than one traumatic event (p = .004 for 0-1 compared to 2 and 3 events and p = .016 for 0-1 compared to 4+ events). Girls who reported a history of witnessing or experiencing physical abuse had a significantly higher mean Shame Questionnaire score than girls who did not report a history of witnessing or experiencing physical abuse (p
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- 2015
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10. Prevention and management of neonatal hypothermia in rural Zambia.
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Karsten Lunze, Kojo Yeboah-Antwi, David R Marsh, Sarah Ngolofwana Kafwanda, Austen Musso, Katherine Semrau, Karen Z Waltensperger, and Davidson H Hamer
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Medicine ,Science - Abstract
BACKGROUND: Neonatal hypothermia is increasingly recognized as a risk factor for newborn survival. The World Health Organization recommends maintaining a warm chain and skin-to-skin care for thermoprotection of newborn children. Since little is known about practices related to newborn hypothermia in rural Africa, this study's goal was to characterize relevant practices, attitudes, and beliefs in rural Zambia. METHODS AND FINDINGS: We conducted 14 focus group discussions with mothers and grandmothers and 31 in-depth interviews with community leaders and health officers in Lufwanyama District, a rural area in the Copperbelt Province, Zambia, enrolling a total of 171 participants. We analyzed data using domain analysis. In rural Lufwanyama, community members were aware of the danger of neonatal hypothermia. Caregivers' and health workers' knowledge of thermoprotective practices included birthplace warming, drying and wrapping of the newborn, delayed bathing, and immediate and exclusive breastfeeding. However, this warm chain was not consistently maintained in the first hours postpartum, when newborns are at greatest risk. Skin-to-skin care was not practiced in the study area. Having to assume household and agricultural labor responsibilities in the immediate postnatal period was a challenge for mothers to provide continuous thermal care to their newborns. CONCLUSIONS: Understanding and addressing community-based practices on hypothermia prevention and management might help improve newborn survival in resource-limited settings. Possible interventions include the implementation of skin-to-skin care in rural areas and the use of appropriate, low-cost newborn warmers to prevent hypothermia and support families in their provision of newborn thermal protection. Training family members to support mothers in the provision of thermoprotection for their newborns could facilitate these practices.
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- 2014
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11. Local perceptions, cultural beliefs and practices that shape umbilical cord care: a qualitative study in Southern Province, Zambia.
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Julie M Herlihy, Affan Shaikh, Arthur Mazimba, Natalie Gagne, Caroline Grogan, Chipo Mpamba, Bernadine Sooli, Grace Simamvwa, Catherine Mabeta, Peggy Shankoti, Lisa Messersmith, Katherine Semrau, and Davidson H Hamer
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Medicine ,Science - Abstract
Global policy regarding optimal umbilical cord care to prevent neonatal illness is an active discussion among researchers and policy makers. In preparation for a large cluster-randomized control trial to measure the impact of 4% chlorhexidine as an umbilical wash versus dry cord care on neonatal mortality in Southern Province, Zambia, we performed a qualitative study to determine local perceptions of cord health and illness and the cultural belief system that shapes umbilical cord care knowledge, attitudes, and practices.This study consisted of 36 focus group discussions with breastfeeding mothers, grandmothers, and traditional birth attendants, and 42 in-depth interviews with key community informants. Semi-structured field guides were used to lead discussions and interviews at urban and rural sites. A wide variation in knowledge, beliefs, and practices surrounding cord care was discovered. For home deliveries, cords were cut with non-sterile razor blades or local grass. Cord applications included drying agents (e.g., charcoal, baby powder, dust), lubricating agents (e.g., Vaseline, cooking oil, used motor oil) and agents intended for medicinal/protective purposes (e.g., breast milk, cow dung, chicken feces). Concerns regarding the length of time until cord detachment were universally expressed. Blood clots in the umbilical cord, bulongo-longo, were perceived to foreshadow neonatal illness. Management of bulongo-longo or infected umbilical cords included multiple traditional remedies and treatment at government health centers.Umbilical cord care practices and beliefs were diverse. Dry cord care, as recommended by the World Health Organization at the time of the study, is not widely practiced in Southern Province, Zambia. A cultural health systems model that depicts all stakeholders is proposed as an approach for policy makers and program implementers to work synergistically with existing cultural beliefs and practices in order to maximize effectiveness of evidence-based interventions.
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- 2013
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12. A Qualitative Study of Georgian Youth Who Are on the Street or Institutionalized
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Laura K. Murray, Namrita S. Singh, Pamela J. Surkan, Katherine Semrau, Judy Bass, and Paul Bolton
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Pediatrics ,RJ1-570 - Abstract
Street children, or children who live and/or spend time on the streets, are a vulnerable group of considerable concern to the global public health community. This paper describes the results of two linked qualitative studies conducted with children living or spending time on the street and in orphanages in and around urban areas in the Republic of Georgia between 2005 and 2006. The studies examined perceived causes of children going to the street, as well as indicators of healthy functioning and psychosocial problems among these children. Results on causes indicated a range of “push” factors leading children to the street and “pull” factors that keep children living on the street. Findings also showed a range of internalizing and externalizing mental health symptoms among children on the street and within orphanages. Some differences in responses were found between children living on the street and in institutions. It is important to understand the perspectives of these vulnerable populations to guide decisions on appropriate interventions that address their primary problems.
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- 2012
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13. Analyzing media coverage of the global fund diseases compared with lower funded diseases (childhood pneumonia, diarrhea and measles).
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David L Hudacek, Shyama Kuruvilla, Nora Kim, Katherine Semrau, Donald Thea, Shamim Qazi, Andrew Pleasant, and James Shanahan
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Medicine ,Science - Abstract
BackgroundPneumonia, diarrhea and measles are the leading causes of death in children worldwide, but have a disproportionately low share of international funding and media attention. In comparison, AIDS, tuberculosis and malaria--diseases that also significantly affect children--receive considerably more funding and have relatively high media coverage. This study investigates the potential relationship between media agenda setting and funding levels in the context of the actual burden of disease.MethodsThe news databases Lexis Nexis, Factiva, and Google News Archive were searched for the diseases AIDS, TB and Malaria and for lower funded pediatric diseases: childhood pneumonia, diarrhea, and measles. A sample of news articles across geographic regions was also analyzed using a qualitative narrative frame analysis of how the media stories were told.ResultsThere were significantly more articles addressing the Global Fund diseases compared to the lower funded pediatric diseases between 1981 and 2008 (1,344,150 versus 291,865 articles). There were also notable differences in the framing of media narratives: 1) There was a high proportion of articles with the primary purpose of raising awareness for AIDS, TB and malaria (46.2%) compared with only 17.9% of the pediatric disease articles. 2) Nearly two-thirds (61.5%) of the AIDS, tuberculosis and malaria articles used a human rights, legal or social justice frame, compared with 46.2% for the lower funded pediatric disease articles, which primarily used an ethical or moral frame.ConclusionThis study demonstrates that lower funded pediatric diseases are presented differently in the media, both quantitatively and qualitatively, than higher funded, higher profile diseases.
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- 2011
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14. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial.
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Kojo Yeboah-Antwi, Portipher Pilingana, William B Macleod, Katherine Semrau, Kazungu Siazeele, Penelope Kalesha, Busiku Hamainza, Phil Seidenberg, Arthur Mazimba, Lora Sabin, Karen Kamholz, Donald M Thea, and Davidson H Hamer
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Medicine - Abstract
Pneumonia and malaria, two of the leading causes of morbidity and mortality among children under five in Zambia, often have overlapping clinical manifestations. Zambia is piloting the use of artemether-lumefantrine (AL) by community health workers (CHWs) to treat uncomplicated malaria. Valid concerns about potential overuse of AL could be addressed by the use of malaria rapid diagnostics employed at the community level. Currently, CHWs in Zambia evaluate and treat children with suspected malaria in rural areas, but they refer children with suspected pneumonia to the nearest health facility. This study was designed to assess the effectiveness and feasibility of using CHWs to manage nonsevere pneumonia and uncomplicated malaria with the aid of rapid diagnostic tests (RDTs).Community health posts staffed by CHWs were matched and randomly allocated to intervention and control arms. Children between the ages of 6 months and 5 years were managed according to the study protocol, as follows. Intervention CHWs performed RDTs, treated test-positive children with AL, and treated those with nonsevere pneumonia (increased respiratory rate) with amoxicillin. Control CHWs did not perform RDTs, treated all febrile children with AL, and referred those with signs of pneumonia to the health facility, as per Ministry of Health policy. The primary outcomes were the use of AL in children with fever and early and appropriate treatment with antibiotics for nonsevere pneumonia. A total of 3,125 children with fever and/or difficult/fast breathing were managed over a 12-month period. In the intervention arm, 27.5% (265/963) of children with fever received AL compared to 99.1% (2066/2084) of control children (risk ratio 0.23, 95% confidence interval 0.14-0.38). For children classified with nonsevere pneumonia, 68.2% (247/362) in the intervention arm and 13.3% (22/203) in the control arm received early and appropriate treatment (risk ratio 5.32, 95% confidence interval 2.19-8.94). There were two deaths in the intervention and one in the control arm.The potential for CHWs to use RDTs, AL, and amoxicillin to manage both malaria and pneumonia at the community level is promising and might reduce overuse of AL, as well as provide early and appropriate treatment to children with nonsevere pneumonia.ClinicalTrials.govNCT00513500
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- 2010
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15. Restriction of HIV-1 genotypes in breast milk does not account for the population transmission genetic bottleneck that occurs following transmission.
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Laura Heath, Susan Conway, Laura Jones, Katherine Semrau, Kyle Nakamura, Jan Walter, W Don Decker, Jason Hong, Thomas Chen, Marintha Heil, Moses Sinkala, Chipepo Kankasa, Donald M Thea, Louise Kuhn, James I Mullins, and Grace M Aldrovandi
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Medicine ,Science - Abstract
Breast milk transmission of HIV-1 remains a major route of pediatric infection. Defining the characteristics of viral variants to which breastfeeding infants are exposed is important for understanding the genetic bottleneck that occurs in the majority of mother-to-child transmissions. The blood-milk epithelial barrier markedly restricts the quantity of HIV-1 in breast milk, even in the absence of antiretroviral drugs. The basis of this restriction and the genetic relationship between breast milk and blood variants are not well established.We compared 356 HIV-1 subtype C gp160 envelope (env) gene sequences from the plasma and breast milk of 13 breastfeeding women. A trend towards lower viral population diversity and divergence in breast milk was observed, potentially indicative of clonal expansion within the breast. No differences in potential N-linked glycosylation site numbers or in gp160 variable loop amino acid lengths were identified. Genetic compartmentalization was evident in only one out of six subjects in whom contemporaneously obtained samples were studied. However, in samples that were collected 10 or more days apart, six of seven subjects were classified as having compartmentalized viral populations, highlighting the necessity of contemporaneous sampling for genetic compartmentalization studies. We found evidence of CXCR4 co-receptor using viruses in breast milk and blood in nine out of the thirteen subjects, but no evidence of preferential localization of these variants in either tissue.Despite marked restriction of HIV-1 quantities in milk, our data indicate intermixing of virus between blood and breast milk. Thus, we found no evidence that a restriction in viral genotype diversity in breast milk accounts for the genetic bottleneck observed following transmission. In addition, our results highlight the rapidity of HIV-1 env evolution and the importance of sample timing in analyses of gene flow.
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- 2010
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16. 4E10-resistant HIV-1 isolated from four subjects with rare membrane-proximal external region polymorphisms.
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Kyle J Nakamura, Johannes S Gach, Laura Jones, Katherine Semrau, Jan Walter, Frederic Bibollet-Ruche, Julie M Decker, Laura Heath, William D Decker, Moses Sinkala, Chipepo Kankasa, Donald Thea, James Mullins, Louise Kuhn, Michael B Zwick, and Grace M Aldrovandi
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Medicine ,Science - Abstract
Human antibody 4E10 targets the highly conserved membrane-proximal external region (MPER) of the HIV-1 transmembrane glycoprotein, gp41, and has extraordinarily broad neutralizing activity. It is considered by many to be a prototype for vaccine development. In this study, we describe four subjects infected with viruses carrying rare MPER polymorphisms associated with resistance to 4E10 neutralization. In one case resistant virus carrying a W680G substitution was transmitted from mother to infant. We used site-directed mutagenesis to demonstrate that the W680G substitution is necessary for conferring the 4E10-resistant phenotype, but that it is not sufficient to transfer the phenotype to a 4E10-sensitive Env. Our third subject carried Envs with a W680R substitution causing variable resistance to 4E10, indicating that residues outside the MPER are required to confer the phenotype. A fourth subject possessed a F673L substitution previously associated with 4E10 resistance. For all three subjects with W680 polymorphisms, we observed additional residues in the MPER that co-varied with position 680 and preserved charged distributions across this region. Our data provide important caveats for vaccine development targeting the MPER. Naturally occurring Env variants described in our study also represent unique tools for probing the structure-function of HIV-1 envelope.
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- 2010
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17. Integration of Services for Victims of Child Sexual Abuse at the University Teaching Hospital One-Stop Centre
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Elwyn Chomba, Laura Murray, Michele Kautzman, Alan Haworth, Mwaba Kasese-Bota, Chipepo Kankasa, Kaunda Mwansa, Mia Amaya, Don Thea, and Katherine Semrau
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Arctic medicine. Tropical medicine ,RC955-962 - Abstract
Objective. To improve care of sexually abused children by establishment of a “One Stop Centre” at the University Teaching Hospital. Methodology. Prior to opening of the One Stop Centre, a management team comprising of clinical departmental heads and a technical group of professionals (health workers, police, psychosocial counselors lawyers and media) were put in place. The team evaluated and identified gaps and weaknesses on the management of sexually abused children prevailing in Zambia. A manual was produced which would be used to train all professionals manning a One Stop Centre. A team of consultants from abroad were identified to offer need based training activities and a database was developed. Results. A multidisciplinary team comprising of health workers, police and psychosocial counselors now man the centre. The centre is assisted by lawyers as and when required. UTH is offering training to other areas of the country to establish similar services by using a Trainer of Trainers model. A comprehensive database has been established for Lusaka province. Conclusion. For establishment of a One Stop Centre, there needs to be a core group comprising of managers as well as a technical team committed to the management and protection of sexually abused children.
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- 2010
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18. Differential effects of early weaning for HIV-free survival of children born to HIV-infected mothers by severity of maternal disease.
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Louise Kuhn, Grace M Aldrovandi, Moses Sinkala, Chipepo Kankasa, Katherine Semrau, Prisca Kasonde, Mwiya Mwiya, Wei-Yann Tsai, Donald M Thea, and Zambia Exclusive Breastfeeding Study (ZEBS)
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Medicine ,Science - Abstract
BACKGROUND:We previously reported no benefit of early weaning for HIV-free survival of children born to HIV-infected mothers in intent-to-treat analyses. Since early weaning was poorly accepted, we conducted a secondary analysis to investigate whether beneficial effects may have been hidden. METHODS:958 HIV-infected women in Lusaka, Zambia, were randomized to abrupt weaning at 4 months (intervention) or to continued breastfeeding (control). Children were followed to 24 months with regular HIV PCR tests and examinations to determine HIV infection or death. Detailed behavioral data were collected on when all breastfeeding ended. Most participants were recruited before antiretroviral treatment (ART) became available. We compared outcomes among mother-child pairs who weaned earlier or later than intended by study design adjusting for potential confounders. RESULTS:Of infants alive, uninfected and still breastfeeding at 4 months in the intervention group, 16.1% who weaned as instructed acquired HIV or died by 24 months compared to 16.0% who did not comply (p = 0.98). Children of women with less severe disease during pregnancy (not eligible for ART) had worse outcomes if their mothers weaned as instructed (RH = 2.60 95% CI: 1.06-6.36) compared to those who continued breastfeeding. Conversely, children of mothers with more severe disease (eligible for ART but did not receive it) who weaned early had better outcomes (p-value interaction = 0.002). In the control group, weaning before 15 months was associated with 3.94-fold (95% CI: 1.65-9.39) increase in HIV infection or death among infants of mothers with less severe disease. CONCLUSION:Incomplete adherence did not mask a benefit of early weaning. On the contrary, for women with less severe disease, early weaning was harmful and continued breastfeeding resulted in better outcomes. For women with more advanced disease, ART should be given during pregnancy for maternal health and to reduce transmission, including through breastfeeding. TRIAL REGISTRATION:(ClinicalTrials.gov) NCT00310726.
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- 2009
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19. High uptake of exclusive breastfeeding and reduced early post-natal HIV transmission.
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Louise Kuhn, Moses Sinkala, Chipepo Kankasa, Katherine Semrau, Prisca Kasonde, Nancy Scott, Mwiya Mwiya, Cheswa Vwalika, Jan Walter, Wei-Yann Tsai, Grace M Aldrovandi, and Donald M Thea
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Medicine ,Science - Abstract
Empirical data showing the clear benefits of exclusive breastfeeding (EBF) for HIV prevention are needed to encourage implementation of lactation support programs for HIV-infected women in low resource settings among whom replacement feeding is unsafe. We conducted a prospective, observational study in Lusaka, Zambia, to test the hypothesis that EBF is associated with a lower risk of postnatal HIV transmission than non-EBF.As part of a randomized trial of early weaning, 958 HIV-infected women and their infants were recruited and all were encouraged to breastfeed exclusively to 4 months. Single-dose nevirapine was provided to prevent transmission. Regular samples were collected from infants to 24 months of age and tested by PCR. Detailed measurements of actual feeding behaviors were collected to examine, in an observational analysis, associations between feeding practices and postnatal HIV transmission. Uptake of EBF was high with 84% of women reporting only EBF cumulatively to 4 months. Post-natal HIV transmission before 4 months was significantly lower (p = 0.004) among EBF (0.040 95% CI: 0.024-0.055) than non-EBF infants (0.102 95% CI: 0.047-0.157); time-dependent Relative Hazard (RH) of transmission due to non-EBF = 3.48 (95% CI: 1.71-7.08). There were no significant differences in the severity of disease between EBF and non-EBF mothers and the association remained significant (RH = 2.68 95% CI: 1.28-5.62) after adjusting for maternal CD4 count, plasma viral load, syphilis screening results and low birth weight.Non-EBF more than doubles the risk of early postnatal HIV transmission. Programs to support EBF should be expanded universally in low resource settings. EBF is an affordable, feasible, acceptable, safe and sustainable practice that also reduces HIV transmission providing HIV-infected women with a means to protect their children's lives.ClinicalTrials.gov NCT00310726.
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- 2007
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20. Principled Subpopulation Analysis of the BetterBirth Study and the Impact of WHO's Safe Childbirth Checklist Intervention.
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Girmaw Abebe Tadesse, Megan Marx Delaney, Victor Akinwande, William Ogallo, Claire-Helene Mershon, Katherine Semrau, and Skyler Speakman
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- 2022
21. Safe recovery after cesarean in rural Africa: Technical consensus guidelines for post‐discharge care
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Fredrick Kateera, Bethany Hedt‐Gauthier, Amy Luo, Anne Niyigena, Grace Galvin, Sadoscar Hakizimana, Rose L. Molina, Adeline A. Boatin, Prisca Kasonde, Juliet Musabeyezu, Joseph Ngonzi, Robert Riviello, Katherine Semrau, and Félix Sayinzoga
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Obstetrics and Gynecology ,General Medicine - Abstract
Despite increasing cesarean rates in Africa, there remain extensive gaps in the standard provision of care after cesarean birth. We present recommendations for discharge instructions to be provided to women following cesarean delivery in Rwanda, particularly rural Rwanda, and with consideration of adaptable guidelines for sub-Saharan Africa, to support recovery during the postpartum period. These guidelines were developed by a Technical Advisory Group comprised of clinical, program, policy, and research experts with extensive knowledge of cesarean care in Africa. The final instructions delineate between normal and abnormal recovery symptoms and advise when to seek care. The instructions align with global postpartum care guidelines, with additional emphasis on care practices more common in the region and address barriers that women delivering via cesarean may encounter in Africa. The recommended timeline of postpartum visits and visit activities reflect the World Health Organization protocols and provide additional activities to support women who give birth via cesarean. These guidelines aim to standardize communication with women at the time of discharge after cesarean birth in Africa, with the goal of improved confidence and clinical outcomes among these individuals.
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- 2022
22. Principled Subpopulation Analysis of the BetterBirth Study and the Impact of WHO’s Safe Childbirth Checklist Intervention
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Girmaw Abebe Tadesse, Victor Akinwande, Megan Marx Delaney, William Ogallo, Katherine Semrau, Skyler Speakman, and Claire-Helene Mershon
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History ,medicine.medical_specialty ,education.field_of_study ,Polymers and Plastics ,business.industry ,Public health ,Population ,Declaration ,Articles ,Industrial and Manufacturing Engineering ,Checklist ,Family medicine ,Intervention (counseling) ,Statistical significance ,medicine ,Global health ,Childbirth ,Business and International Management ,education ,business - Abstract
Background: World Health Organization (WHO) developed the Safe Childbirth Checklist as an intervention to improve care and outcomes in maternal and newborn health. In the primary BetterBirth traditional trial analysis, the intervention did not significantly improve . However, a novel subgroup-based analysis could identify subpopulations that benefited from the intervention. Methods: In this work, we employ data-driven analysis methods to identify differentiated subgroups with unexpected characteristics compared to the average population. Specifically, we aim to identify: 1) vulnerable subgroups and 2) subpopulation in the intervention arm with significantly reduced outcome. The method utilizes the existing subset scanning literature that searches over a combination of features to identify the differentiated groups. Findings: We found that low birthweight (
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- 2023
23. Coaching Intensity, Adherence to Essential Birth Practices, and Health Outcomes in the BetterBirth Trial in Uttar Pradesh, India
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Katherine Semrau, Corwin M. Zigler, Dale A. Barnhart, Lisa R. Hirschhorn, Tapan Kalita, Nabihah Kara, Megan Marx Delaney, Donna Spiegelman, and Pinki Maji
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medicine.medical_specialty ,education ,Psychological intervention ,India ,Nurses ,Midwifery ,Coaching ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Intervention (counseling) ,Humans ,Childbirth ,Medicine ,030212 general & internal medicine ,Perinatal Mortality ,Quality of Health Care ,030219 obstetrics & reproductive medicine ,business.industry ,Health Policy ,Behavior change ,Infant, Newborn ,Parturition ,Public Health, Environmental and Occupational Health ,Mentoring ,Original Articles ,Puerperal Disorders ,medicine.disease ,Checklist ,Obstetric Labor Complications ,3. Good health ,Maternal Mortality ,Family medicine ,Birth attendant ,Female ,Guideline Adherence ,Health Facilities ,business ,human activities - Abstract
Frequent coaching was associated with increased adherence to evidence-based essential birth practices among birth attendants but not with improved maternal and perinatal health outcomes in the BetterBirth Trial, which assessed the impact of a complex intervention to implement the World Health Organization's Safe Childbirth Checklist. To promote sustainable behavior change, future coaching-based interventions may need to explore cost-effective, feasible mechanisms for providing more frequent coaching delivered with high coverage among health care workers for longer durations., Background: Coaching can improve the quality of care in primary-level birth facilities and promote birth attendant adherence to essential birth practices (EBPs) that reduce maternal and perinatal mortality. The intensity of coaching needed to promote and sustain behavior change is unknown. We investigated the relationship between coaching intensity, EBP adherence, and maternal and perinatal health outcomes using data from the BetterBirth Trial, which assessed the impact of a complex, coaching-based implementation of the World Health Organization's Safe Childbirth Checklist in Uttar Pradesh, India. Methods: For each birth, we defined multiple coaching intensity metrics, including coaching frequency (coaching visits per month), cumulative coaching (total coaching visits accrued during the intervention), and scheduling adherence (coaching delivered as scheduled). We considered coaching delivered at both facility and birth attendant levels. We assessed the association between coaching intensity and birth attendant adherence to 18 EBPs and with maternal and perinatal health outcomes using regression models. Results: Coaching frequency was associated with modestly increased EBP adherence. Delivering 6 coaching visits per month to facilities was associated with adherence to 1.3 additional EBPs (95% confidence interval [CI]=0.6, 1.9). High-frequency coaching delivered with high coverage among birth attendants was associated with greater improvements: providing 70% of birth attendants at a facility with at least 1 visit per month was associated with adherence to 2.0 additional EBPs (95% CI=1.0, 2.9). Neither cumulative coaching nor scheduling adherence was associated with EBP adherence. Coaching was generally not associated with health outcomes, possibly due to the small magnitude of association between coaching and EBP adherence. Conclusions: Frequent coaching may promote behavior change, especially if delivered with high coverage among birth attendants. However, the effects of coaching were modest and did not persist over time, suggesting that future coaching-based interventions should explore providing frequent coaching for longer periods.
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- 2020
24. Operationalizing respectful maternity care at the healthcare provider level: a systematic scoping review
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Jigyasa Sharma, Ana Langer, Neena Kapoor, Katherine Semrau, R. Rima Jolivet, and Jewel Gausman
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Program evaluation ,Health Personnel ,media_common.quotation_subject ,Respectful maternity care ,Professional guidelines ,Nursing ,Midwifery ,Respect ,Dignity ,Pregnancy ,Informed consent ,Health care ,Humans ,Maternal Health Services ,Obstetrics & gynecology ,Confidentiality ,media_common ,Measurement ,Operationalization ,business.industry ,Operational definition ,Research ,Parturition ,Quality of care ,Obstetrics and Gynecology ,Gynecology and obstetrics ,Grey literature ,Obstetrics ,Reproductive Medicine ,RG1-991 ,Female ,Maternal health ,business ,Psychology - Abstract
Background Ensuring the right to respectful care for maternal and newborn health, a critical dimension of quality and acceptability, requires meeting standards for Respectful Maternity Care (RMC). Absence of mistreatment does not constitute RMC. Evidence generation to inform definitional standards for RMC is in an early stage. The aim of this systematic review is clear provider-level operationalization of key RMC principles, to facilitate their consistent implementation. Methods Two rights-based frameworks define the underlying principles of RMC. A qualitative synthesis of both frameworks resulted in seven fundamental rights during childbirth that form the foundation of RMC. To codify operational definitions for these key elements of RMC at the healthcare provider level, we systematically reviewed peer-reviewed literature, grey literature, white papers, and seminal documents on RMC. We focused on literature describing RMC in the affirmative rather than mistreatment experienced by women during childbirth, and operationalized RMC by describing objective provider-level behaviors. Results Through a systematic review, 514 records (peer-reviewed articles, reports, and guidelines) were assessed to identify operational definitions of RMC grounded in those rights. After screening and review, 54 records were included in the qualitative synthesis and mapped to the seven RMC rights. The majority of articles provided guidance on operationalization of rights to freedom from harm and ill treatment; dignity and respect; information and informed consent; privacy and confidentiality; and timely healthcare. Only a quarter of articles mentioned concrete or affirmative actions to operationalize the right to non-discrimination, equality and equitable care; less than 15%, the right to liberty and freedom from coercion. Provider behaviors mentioned in the literature aligned overall with seven RMC principles; yet the smaller number of available research studies that included operationalized definitions for some key elements of RMC illustrates the nascent stage of evidence-generation in this area. Conclusions Lack of systematic codification, grounded in empirical evidence, of operational definitions for RMC at the provider level has limited the study, design, implementation, and comparative assessment of respectful care. This qualitative systematic review provides a foundation for maternity healthcare professional policy, training, programming, research, and program evaluation aimed at studying and improving RMC at the provider level., Plain Language Summary Respectful care for mothers and newborns is a right and important part of ensuring that their care is high quality and acceptable to them. Just because there is no mistreatment does not mean that Respectful Maternity Care (RMC) was given. Without a clear framework for provider behaviors that reflect RMC principles, it is hard to ensure every woman and newborn gets respectful care in practice. We compared and combined two frameworks summarizing maternal and newborn rights and came out with seven categories. Then we searched for articles that mentioned provider behaviors reflecting RMC. We found 514 articles and ended up with 54 after careful review, from which we pulled the observable behaviors for providers in each category. Almost all papers mentioned actions to protect women and newborns from harm and mistreatment, to treat them with dignity and respect, and to give information and respect choices. About half of papers mentioned actions to protect privacy and to make sure every mother and newborn gets care when needed. Only 25% of papers mentioned actions to make sure all women and newborns receive equal care, and only 15% included actions to make sure women and newborns are physically free to leave facilities at will, and get care whether or not they can pay. This framework defining RMC behaviors for providers is based on data from many studies and can be useful to look at whether maternal newborn care in facilities meets these standards and to inform training and more research to improve RMC.
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- 2021
25. Simplified models to assess newborn gestational age in low-middle income countries: findings from a multicountry, prospective cohort study
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Bowen Banda, Caitlin Shannon, Said M. Ali, Nazma Begum, Usma Mehmood, Alexander Manu, Usha Dhingra, Lisa Hurt, Sachiyo Yoshida, Rajiv Bahl, Julie M. Herlihy, Arup Dutta, Atifa Mohammed Suleiman, Dipak Kumar Mitra, Sunil Sazawal, Muhammad Karim, Fyezah Jehan, Muhammad Sajid, Mahmoodur Rahman, Caroline Grogan, Karen Edmond, Monica Kapasa, Atiya Hussain, Fahad Aftab, Corneille Bashagaluke Akonkwa, Muhammad Imran Nisar, Jayson Wilbur, Anne Lee, Davidson H. Hamer, Rina Paul, Blair J. Wylie, Marina Straszak-Suri, Mohammad J. Uddin, Saikat Deb, Katherine Semrau, Betty R. Kirkwood, Farzana Kausar, Fern Mweene, Sayedur Rahman, Naila Nadeem, Parvez Ahmed, Salahuddin Ahmed, Muhammad Ilyas, Pratibha Dhingra, Mohammed K. Mohammed, and Abdullah H Baqui
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medicine.medical_specialty ,Medicine (General) ,Birth weight ,Population ,Gestational Age ,Infectious and parasitic diseases ,RC109-216 ,R5-920 ,Pregnancy ,Medicine ,Humans ,Prospective Studies ,education ,Prospective cohort study ,Child ,Developing Countries ,education.field_of_study ,Receiver operating characteristic ,business.industry ,Obstetrics ,Health Policy ,Public Health, Environmental and Occupational Health ,Infant, Newborn ,Gestational age ,Infant ,Anthropometry ,Child mortality ,Gestation ,Premature Birth ,Female ,business ,Infant, Premature - Abstract
IntroductionPreterm birth is the leading cause of child mortality. This study aimed to develop and validate programmatically feasible and accurate approaches to estimate newborn gestational age (GA) in low resource settings.MethodsThe WHO Alliance for Maternal and Newborn Health Improvement (AMANHI) study recruited pregnant women from population-based cohorts in five countries (Bangladesh, Ghana, Pakistan, Tanzania and Zambia). Women Results7428 liveborn infants were included (n=536 preterm, ConclusionThe best machine-learning model (10 neonatal characteristics and LMP) estimated GA within ±15.7 days of early ultrasound dating. Simpler models performed reasonably well with marginal increases in prediction error. These models hold promise for newborn GA estimation when ultrasound dating is unavailable.
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- 2021
26. Implementing the Dubowitz assessment of gestational age in India and Malawi: a cross-sectional study of participants in a training workshop
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Melda Phiri, Roopa M. Bellad, Linda Vesel, Anne C C Lee, Veena Herekar, Krysten North, Katherine Semrau, Irving F. Hoffman, Carl L. Bose, Tisungane Mvalo, Sunil S Vernekar, Friday Saidi, Shivaprasad S. Goudar, and Sangappa M. Dhaded
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medicine.medical_specialty ,Cross-sectional study ,Trainer ,business.industry ,Concordance ,education ,Gold standard ,Exploratory research ,Gestational age ,General Medicine ,Clinical trial ,Family medicine ,medicine ,Public aspects of medicine ,RA1-1270 ,business ,Competence (human resources) - Abstract
Background Accurate assignment of the gestational age of newborns is important for the identification of prematurity. The Dubowitz assessment is the gold standard among postnatal examinations used to assign gestational age, but implementation has been limited because of examination complexity and training requirements. The objective of this study was to explore factors related to teaching and implementing the Dubowitz examination that may influence its uptake in India and Malawi. Methods This cross-sectional study was conducted in India and Malawi during the preparation for a low-birthweight infant feeding exploratory study. Twenty trainees participated in a Dubowitz examination training workshop that occurred over two half-day sessions. Trainees completed pretraining and posttraining surveys related to their perceptions of the Dubowitz training, the examination, and factors affecting the administration of the examination in their setting. Results All survey respondents expressed confidence in their ability to perform the Dubowitz examination after the training. Less than a third expressed concerns about the time required to learn (30%) or perform the examination (25%). Eighty-five percent of trainees identified concerns related to parental perception of the examination that may inhibit implementation. Trainees averaged 14 minutes (standard deviation: 4.5 minutes) to complete the examination. More than 80% of trainee answers were within one point of the trainer for 16 of the 22 Dubowitz signs. Trainee composite scores were within ±3 weeks of the trainer for 95% of assessments based on Bland-Altman analysis. Conclusions The Dubowitz examination at birth is a method to improve identification of premature infants in the absence of prenatal dating. We found widespread acceptance for the Dubowitz assessment among participants in training workshops in India and Malawi, despite the complexity and length of the examination. The high level of trainee-trainer concordance on individual examination signs suggests that an acceptable level of competence is feasible after a short, concentrated workshop. Further investigation into barriers that hinder implementation such as negative parental perceptions is warranted. Registration details Clinical Trials Registration: NCT04002908 (www.clinicaltrials.gov) and CTRI/2019/02/017475 (Clinical Trial Registry of India - http://ctri.nic.in).
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- 2021
27. Adaptation and implementation of the WHO Safe Childbirth Checklist around the world
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Anne-Caroline Benski, Katherine Semrau, Rose L. Molina, Lauren Bobanski, and Danielle E. Tuller
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Medicine (General) ,Medical education ,Data collection ,Descriptive statistics ,Safe Childbirth Checklist ,business.industry ,030503 health policy & services ,Short Report ,Quality of care ,Health services research ,Context (language use) ,Coaching ,Checklist ,Health administration ,03 medical and health sciences ,R5-920 ,0302 clinical medicine ,Implementation ,Maternal health ,030212 general & internal medicine ,Adaptation ,Thematic analysis ,0305 other medical science ,Psychology ,business - Abstract
Background The World Health Organization (WHO) published the WHO Safe Childbirth Checklist in 2015, which included the key evidence-based practices to prevent the major causes of maternal and neonatal morbidity and mortality during childbirth. We assessed the current use of the WHO Safe Childbirth Checklist (SCC) and adaptations regarding the SCC tool and implementation strategies in different contexts from Africa, Southeast Asia, Europe, and North America. Methods This explanatory, sequential mixed methods study—including surveys followed by interviews—of global SCC implementers focused on adaptation and implementation strategies, data collection, and desired improvements to support ongoing SCC use. We analyzed the survey results using descriptive statistics. In a subset of respondents, follow-up virtual semi-structured interviews explored how they adapted, implemented, and evaluated the SCC in their context. We used rapid inductive and deductive thematic analysis for the interviews. Results Of the 483 total potential participants, 65 (13.5%) responded to the survey; 55 completed the survey (11.4%). We analyzed completed responses from those who identified as having SCC implementation experience (n = 29, 52.7%). Twelve interviews were conducted and analyzed. Ninety percent of respondents indicated that they adapted the SCC tool, including adding clinical and operational items. Adaptations to structure included translation into local language, incorporation into a mobile app, and integration into medical records. Respondents reported variation in implementation strategies and data collection. The most common implementation strategies were meeting with stakeholders to secure buy-in, incorporating technical training, and providing supportive supervision or coaching around SCC use. Desired improvements included clarifying the purpose of the SCC, adding guidance on relevant clinical topics, refining items addressing behaviors with low adherence, and integrating contextual factors into decision-making. To improve implementation, participants desired political support to embed SCC into existing policies and ongoing clinical training and coaching. Conclusion Additional adaptation and implementation guidance for the SCC would be helpful for stakeholders to sustain effective implementation.
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- 2021
28. Multi-prong quality improvement initiatives improve sepsis prevention and reduce surgical site infection after childbirth
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Emma Sacks and Katherine Semrau
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medicine.medical_specialty ,Quality management ,business.industry ,Health Policy ,Parturition ,Public Health, Environmental and Occupational Health ,General Medicine ,Delivery, Obstetric ,medicine.disease ,Quality Improvement ,Sepsis ,Pregnancy ,medicine ,Humans ,Surgical Wound Infection ,Childbirth ,Female ,Intensive care medicine ,business ,Surgical site infection - Published
- 2021
29. Modification of oxytocin use through a coaching-based intervention based on the WHO Safe Childbirth Checklist in Uttar Pradesh, India: a secondary analysis of a cluster randomised controlled trial
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Tapan Kalita, Brandon J. Neal, Rose L. Molina, Megan Marx Delaney, Rachel Ketchum, Becky Hawrusik, Katherine Semrau, Kate Miller, Shambhavi Singh, and Vishwajeet Kumar
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Adult ,medicine.medical_specialty ,Resuscitation ,Population ,India ,Oxytocin ,World Health Organization ,law.invention ,Randomized controlled trial ,law ,Pregnancy ,medicine ,Childbirth ,Cluster Analysis ,Humans ,Cluster randomised controlled trial ,education ,reproductive and urinary physiology ,Perinatal Mortality ,education.field_of_study ,Obstetrics ,business.industry ,Infant, Newborn ,Parturition ,Obstetrics and Gynecology ,Mentoring ,Delivery, Obstetric ,Quality Improvement ,Checklist ,Female ,Guideline Adherence ,business ,Neonatal resuscitation ,medicine.drug - Abstract
OBJECTIVE To understand the prevalence of intrapartum oxytocin use, assess associated perinatal and maternal outcomes, and evaluate the impact of a WHO Safe Childbirth Checklist intervention on oxytocin use at primary-level facilities in Uttar Pradesh, India. DESIGN Secondary analysis of a cluster-randomised controlled trial. SETTING Thirty Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017. POPULATION Women admitted to a study facility for childbirth at baseline, 2, 6 or 12 months after intervention initiation. METHODS The BetterBirth intervention aimed to increase adherence to the WHO Safe Childbirth Checklist. We used Rao-Scott Chi-square tests to compare (1) timing of oxytocin use between study arms and (2) perinatal mortality and resuscitation of infants whose mothers received intrapartum oxytocin versus who did not. MAIN OUTCOME MEASURES Intrapartum and postpartum oxytocin administration, perinatal mortality, use of neonatal bag and mask. RESULTS We observed 5484 deliveries. At baseline, intrapartum oxytocin was administered to 78.2% of women. Two months after intervention initiation, intrapartum oxytocin (I) was administered to 32.1% of women compared with 70.6% in the control (C) (P
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- 2021
30. 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
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Arup Dutta, Caitlin Shannon, Serge Ngaima, Sam Newton, Julie M. Herlihy, Usma Mehmood, Seeba Amenga-Etego, Kojo Yeboah-Antwi, Fyezah Jehan, Salahuddin Ahmed, Alok Kumar, Michel Kalonji, Usha Dhingra, M. A. Quaiyum, Shabina Ariff, Yaqub Wasan, Vinay Pratap Singh, Peter Gisore, Katherine Semrau, Mamun Ibne Moin, Antoinette Tshefu, Imran Ahmed, Nazma Begum, Fahad Aftab, Atifa Mohammed Suleiman, Betty R. Kirkwood, Vinita Das, Davidson H. Hamer, Sajid Bashir Soofi, Said M. Ali, Dipak Kumar Mitra, John Otomba, Aarti Kumar, Anita K. M. Zaidi, Thandassery Ramachandran Dilip, Rajiv Bahl, Muhammad Imran Nisar, Irene Marete, Lisa Hurt, Mohammed Hamad Juma, Sachiyo Yoshida, Godfrey Biemba, Abdullah H Baqui, Alexander Manu, Venantius Sunday, Seyi Soremekun, Shambhavi Mishra, Amit Kumar Ghosh, Muhammad Ilyas, Sunil Sazawal, Karen Edmond, Zulfiqar A Bhutta, Sophie Sarrassat, Rasheda Khanam, Fabian Esamai, Nicole Minckas, Vishwajeet Kumar, Saikat Deb, Karim Muhammad, Caroline Grogan, Simon Cousens, and Andre Nguwo
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Gestational hypertension ,Maternal Health ,Blood Pressure ,Vascular Medicine ,Geographical Locations ,0302 clinical medicine ,Pregnancy ,Risk Factors ,Infant Mortality ,Medicine and Health Sciences ,wq_200 ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,wq_240 ,education.field_of_study ,030219 obstetrics & reproductive medicine ,Obstetrics ,Pregnancy Outcome ,Obstetrics and Gynecology ,General Medicine ,Stillbirth ,Maternal Mortality ,Hypertension ,Population study ,Medicine ,Female ,Stillbirths ,Research Article ,Adult ,medicine.medical_specialty ,Asia ,Adolescent ,Population ,wa_395 ,wa_310 ,Risk Assessment ,03 medical and health sciences ,Young Adult ,Hypertensive Disorders in Pregnancy ,wq_225 ,medicine ,Humans ,education ,Africa South of the Sahara ,Obstructed labour ,Eclampsia ,Antepartum haemorrhage ,business.industry ,Infant, Newborn ,Biology and Life Sciences ,Neonates ,Infant ,medicine.disease ,Health Care ,Pregnancy Complications ,People and Places ,Africa ,Birth ,Women's Health ,Health Statistics ,Morbidity ,business ,Developmental Biology - Abstract
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., Author summary Why was this study done? Estimates of severe direct maternal morbidity are largely based on hospital-based studies with inconsistent definitions and varying selection criteria. Limited data are available from South Asia and sub-Saharan Africa, the 2 regions with the highest maternal and newborn morbidity and mortality, where a larger proportion of births occur at home. What did the researchers do and find? We collected data on maternal morbidities from a cohort of women in the community in multiple sites in sub-Saharan Africa and in South Asia. Out of a cohort of >114,000 women, we found that about 1 in 3 women suffer a maternal morbidity, which was notably higher than the previously reported data. We found that the prevalence of preeclampsia and eclampsia was about 1%, which was lower than previously reported. About 11% of women reported having prolonged or obstructed labour, which was somewhat higher than published estimates. The burden of pregnancy-related infection in postpartum period was higher in South Asia than in sub-Saharan Africa. This is the first study, to our knowledge, to describe the burden of antepartum haemorrhage and late antepartum infection and to clearly demonstrate the association of direct maternal morbidity with adverse pregnancy outcomes. What do these findings mean? Higher burden of direct maternal morbidity and its association with adverse outcomes highlights the need for improving health of women and mothers, including promotion of preconception health and nutrition, and high-quality antepartum, intrapartum and postpartum care.
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- 2021
31. Components of clean delivery kits and newborn mortality in the Zambia Chlorhexidine Application Trial (ZamCAT): An observational study
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Reuben Mbewe, Davidson H. Hamer, Julie M. Herlihy, Nancy A. Scott, Kojo Yeboah-Antwi, Katherine Semrau, and Jason H. Park
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Male ,Physiology ,Epidemiology ,Perinatal Death ,Maternal Health ,law.invention ,Labor and Delivery ,0302 clinical medicine ,Randomized controlled trial ,law ,Infant Mortality ,Medicine and Health Sciences ,Medicine ,Childbirth ,Birth Weight ,030212 general & internal medicine ,Neonatal sepsis ,Obstetrics ,Mortality rate ,Chlorhexidine ,Obstetrics and Gynecology ,General Medicine ,Chemistry ,Physiological Parameters ,Physical Sciences ,Female ,Stillbirths ,Research Article ,medicine.medical_specialty ,Death Rates ,030231 tropical medicine ,Zambia ,Lower risk ,Soaps ,03 medical and health sciences ,Population Metrics ,Humans ,Perinatal Mortality ,Population Biology ,business.industry ,Body Weight ,Infant, Newborn ,Chemical Compounds ,Infant ,Biology and Life Sciences ,Neonates ,Odds ratio ,medicine.disease ,Infant mortality ,Health Care ,Neonatal infection ,Health Care Facilities ,Medical Risk Factors ,Anti-Infective Agents, Local ,Birth ,Women's Health ,Salts ,business ,Developmental Biology - Abstract
Background Neonatal infection, a leading cause of neonatal death in low- and middle-income countries, is often caused by pathogens acquired during childbirth. Clean delivery kits (CDKs) have shown efficacy in reducing infection-related perinatal and neonatal mortality. However, there remain gaps in our current knowledge, including the effect of individual components, the timeline of protection, and the benefit of CDKs in home and facility deliveries. Methods and findings A post hoc secondary analysis was performed using nonrandomized data from the Zambia Chlorhexidine Application Trial (ZamCAT), a community-based, cluster-randomized controlled trial of chlorhexidine umbilical cord care in Southern Province of Zambia from February 2011 to January 2013. CDKs, containing soap, gloves, cord clamps, plastic sheet, razor blade, matches, and candle, were provided to all pregnant women. Field monitors made a home-based visit to each participant 4 days postpartum, during which CDK use and newborn outcomes were ascertained. Logistic regression was used to study the association between different CDK components and neonatal mortality rate (NMR). Of 38,579 deliveries recorded during the study, 36,996 newborns were analyzed after excluding stillbirths and those with missing information. Gloves, cord clamps, and plastic sheets were the most frequently used CDK item combination in both home and facility deliveries. Each of the 7 CDK components was associated with lower NMR in users versus nonusers. Adjusted logistic regression showed that use of gloves (odds ratio [OR] 0.33, 95% CI 0.24–0.46), cord clamp (OR 0.51, 95% CI 0.38–0.68), plastic sheet (OR 0.46, 95% CI 0.34–0.63), and razor blade (OR 0.69, 95% CI 0.53–0.89) were associated with lower risk of newborn mortality. Use of gloves and cord clamp were associated with reduced risk of immediate newborn death (, Jason Park and co-workers assess components of clean delivery kits for possible contributions to reduced newborn mortality in a trial done in Zambia., Author summary Why was this study done? Infection during childbirth is a major cause of newborn mortality and morbidity in rural and resource-limited settings. Clean delivery kits can prevent pathogen transmission during infection by providing sterile equipment and encouraging hygienic behaviors. A more nuanced understanding of the benefits of clean delivery kits and their components would aid global implementation to help reduce newborn mortality. What did the researchers do and find? We analyzed the data from the Zambia Chlorhexidine Application Trial (ZamCAT), a cluster-randomized controlled trial conducted in Zambia in 2011–2013. During ZamCAT, we provided clean delivery kits to all mothers in the community and tracked the health outcomes of all women and newborns through the neonatal period. Analysis of 38,579 deliveries showed us that use of gloves, cord clamps, plastic sheets, and razor blades during intrapartum care were associated with lower newborn mortality, in both home and facility deliveries. Components of clean delivery kits were associated with lower risk of perinatal and newborn mortality in the first 7 days of life, but not with mortality between 7 and 28 days of life. What do these findings mean? Components of clean delivery kits that showed highest usage and association with newborn mortality reduction should be included in future clean delivery kit interventions. As this is a post hoc secondary data analysis and the trial was not meant to specifically study the impact of clean delivery kits, causality cannot be inferred. Nevertheless, the large sample size, variation in component use, and study design focused on community settings provide support for clean delivery kits as an intervention that may improve newborn health outcomes in both home and facility deliveries.
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- 2021
32. Unpacking the null: a post-hoc analysis of a cluster-randomised controlled trial of the WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth)
- Author
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Megan Marx Delaney, Atul A. Gawande, Lauren Bobanski, Ami Karlage, Kate Miller, Shambhavi Singh, Vishwajeet Kumar, Danielle E. Tuller, and Katherine Semrau
- Subjects
Adult ,Counseling ,Evidence-based practice ,030231 tropical medicine ,India ,Context (language use) ,World Health Organization ,Coaching ,Article ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Pregnancy ,Environmental health ,Medicine ,Childbirth ,Cluster Analysis ,Humans ,030212 general & internal medicine ,Cluster randomised controlled trial ,Perinatal Mortality ,business.industry ,lcsh:Public aspects of medicine ,Infant, Newborn ,Parturition ,lcsh:RA1-1270 ,General Medicine ,medicine.disease ,Delivery, Obstetric ,Checklist ,Maternal Mortality ,Evidence-Based Practice ,Female ,Guideline Adherence ,business - Abstract
Summary: Background: A coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh, India, improved adherence to evidence-based practices, but did not reduce perinatal mortality, maternal morbidity, or maternal mortality. We examined facility-level correlates of the outcomes, which varied widely across the 120 study facilities. Methods: We did a post-hoc analysis of the coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh. We used multivariable modelling to identify correlations between 30 facility-level characteristics and each health outcome (perinatal mortality, maternal morbidity, or maternal mortality). To identify contexts in which the intervention might have had an effect, we then ran the models on data restricted to the period of intensive coaching and among patients not referred out of the facilities. Findings: In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality. Maternal morbidity was only associated with geographical location. No facility-level predictors were associated with maternal mortality. Among facilities in the lowest tertile of birth volume (
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- 2019
33. Delivery practices and care experience during implementation of an adapted safe childbirth checklist and respectful care program in Chiapas, Mexico
- Author
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Lindsay Palazuelos, Rose L. Molina, Jimena Villar, A. Reyes, James Elliott, Daniel Palazuelos, Katherine Semrau, Mark Begley, Michael Johnson, Mariana Montaño, and Hugo Flores
- Subjects
Adult ,medicine.medical_specialty ,Logistic regression ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Surveys and Questionnaires ,medicine ,Hospital discharge ,Humans ,Childbirth ,Maternal Health Services ,030212 general & internal medicine ,Quality of care ,Mexico ,Quality of Health Care ,030219 obstetrics & reproductive medicine ,business.industry ,Obstetrics and Gynecology ,Professional-Patient Relations ,General Medicine ,Odds ratio ,Delivery, Obstetric ,Quality Improvement ,Checklist ,Family medicine ,Female ,Thematic analysis ,Care program ,business - Abstract
Objective To evaluate changes in quality of care after implementing an adapted safe childbirth checklist (SCC) in Chiapas, Mexico. Methods A convergent mixed-methods study was conducted among 447 women in labor who attended a rural community hospital between September 1, 2016, and June 30, 2017. Logistic regression analysis was used to evaluate adherence to evidence-based practices over time, adjusting for provider. Participants were surveyed about their perceptions of care after hospital discharge. A purposefully sampled subgroup also completed in-depth interviews. Thematic analysis was performed to evaluate perceptions of care. Results 384 (85.9%) women were attended by staff that used the adapted SCC during delivery. Of these, 221 and 28 completed the hospital discharge survey and in-depth interview, respectively. Adherence with offering a birth companion (odds ratio [OR] 3.06, 95% CI 1.40-6.68), free choice of birth position (2.75, 1.21-6.26), and immediate skin-to-skin contact (4.53, 1.97-10.39) improved 6-8 months after implementation. Participants' perceived quality of care improved over time. Provider communication generated positive perceptions. Reprimanding women for arriving in early labor or complaining of pain generated negative perceptions. Conclusion Use of the adapted SCC improved quality of care through increased adherence with essential and respectful delivery practices.
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- 2019
34. Historical Perspectives: Lessons from the BetterBirth Trial: A Practical Roadmap for Complex Intervention Studies
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Katherine Semrau, Rose L. Molina, and Lauren Bobay
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Quality management ,Perinatal Death ,Best practice ,India ,Stakeholder engagement ,Population health ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Nursing ,Pregnancy ,law ,030225 pediatrics ,Humans ,Medicine ,030212 general & internal medicine ,Intersectoral Collaboration ,Randomized Controlled Trials as Topic ,business.industry ,Infant, Newborn ,Theory of change ,Delivery, Obstetric ,Institutional review board ,Checklist ,Perinatal Care ,Maternal Mortality ,Pediatrics, Perinatology and Child Health ,Female ,Biostatistics ,business - Abstract
* Abbreviations: RCT: : randomized controlled trial ToC: : theory of change WHO: : World Health Organization Complex interventions—those that contain several interacting components—to improve clinical outcomes and population health are growing because of the increasing recognition that multilevel approaches are needed to solve complex problems in health systems and care delivery. (1) In maternal and neonatal health, complex interventions are needed to improve quality of care. Yet few studies of these complex interventions are powered to detect true differences in mortality because of the numbers needed for a relatively rare outcome, such as maternal mortality. Although perinatal mortality is more common, large sample sizes are still required. Studies are often powered to examine outcomes or process measures proximal to mortality, such as morbidity or complications that could lead to mortality. The BetterBirth Trial was one of the largest cluster randomized controlled trials (RCTs) to target maternal and perinatal mortality as primary outcomes. Given its scale, this trial has led to important lessons learned that could be applied to other large-scale studies with complex interventions in maternal and newborn health. Many epidemiology and biostatistics textbooks have described how to theoretically design RCTs to maximize scientific rigor. (2) However, there are few, if any, resources on how to actually implement complex interventions on a large scale, evaluate their impact, and disseminate the results. (3) Balancing an unbiased and robust study design with the reality of implementing a complex intervention in the real world can pose ongoing challenges for research teams. Some generally accepted best practices to minimize common challenges of trial implementation do exist, such as for institutional review board navigation, site selection, and stakeholder engagement. This perspective reflects on the experience of the BetterBirth Trial and provides insights around best practices of important components of trial design and implementation that may be initially overlooked. The BetterBirth Trial was a matched-pair cluster RCT designed to establish whether the …
- Published
- 2019
35. Low Birthweight Infant Feeding Practices and Growth Patterns in the First Six Months of Life in Resource-Limited Settings
- Author
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Linda Vesel, Rodrick Kisenge, Murugaraj Koujalagi, Varun Kusagur, Karim Manji, Tisungane Mvalo, Rashmita Nayak, Melda Phiri, Friday Saidi, Katherine Semrau, and Christopher Sudfeld
- Subjects
Nutrition and Dietetics ,Medicine (miscellaneous) ,Food Science - Published
- 2022
36. In-Facility Infant Feeding and Discharge Practices for Moderately Low Birthweight Newborns in 12 Hospitals Across India, Malawi, and Tanzania
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Rana Mokhtar, Katherine Semrau, Roopa Bellad, Sangappa Dhaded, Gowdar Guruprasad, Tisungane Mvalo, Melda Phiri, Friday Saidi, Karim Manji, Nahya Salim, and Christopher Sudfeld
- Subjects
Nutrition and Dietetics ,Medicine (miscellaneous) ,Food Science - Published
- 2022
37. The effect of milk type and fortification on the growth of low‐birthweight infants: An umbrella review of systematic reviews and meta‐analyses
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Carl L. Bose, Linda Vesel, Linda S. Adair, Krysten North, Katherine Semrau, Megan Marx Delaney, and Anne C C Lee
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0301 basic medicine ,medicine.medical_specialty ,RC620-627 ,growth ,Fortification ,fortification ,Review Article ,formula ,Pediatrics ,low birthweight ,RJ1-570 ,03 medical and health sciences ,Strength of evidence ,0302 clinical medicine ,medicine ,Birth Weight ,Humans ,Infant, Very Low Birth Weight ,030212 general & internal medicine ,Nutritional diseases. Deficiency diseases ,Child ,Infant Nutritional Physiological Phenomena ,Review Articles ,030109 nutrition & dietetics ,Nutrition and Dietetics ,umbrella review ,Milk, Human ,Obstetrics ,business.industry ,Public Health, Environmental and Occupational Health ,Head growth ,Infant, Newborn ,Obstetrics and Gynecology ,human milk ,Infant ,Gynecology and obstetrics ,Confidence interval ,Infant Formula ,Systematic review ,Pediatrics, Perinatology and Child Health ,RG1-991 ,Fat supplementation ,medicine.symptom ,Linear growth ,business ,Weight gain ,Infant, Premature ,Systematic Reviews as Topic - Abstract
Approximately 15% of infants worldwide are born with low birthweight (
- Published
- 2021
38. Training the Dubowitz Gestational Age Assessment in Low- and Middle-Income Countries: Feasibility and Inter-rater Agreement
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Veena Herekar, Katherine Semrau, Carl L. Bose, Roopa M. Bellad, Krysten North, Sangappa M. Dhaded, and Anne C C Lee
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Inter-rater reliability ,Low and middle income countries ,business.industry ,Medicine ,Ballard Maturational Assessment ,business ,Demography - Published
- 2021
39. Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India
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Vinay Pratap Singh, Lisa R. Hirschhorn, Kate Miller, Jennifer Fisher-Bowman, Atul A. Gawande, Margaret Krasne, Bhalachandra S. Kodkany, Ami Karlage, Stuart R. Lipsitz, Shambhavi Singh, Megan Marx Delaney, Vishwajeet Kumar, Bridget A. Neville, Katherine Semrau, Amanda Jurczak, and Jonathon D Gass
- Subjects
medicine.medical_specialty ,Evidence-based practice ,Perinatal Death ,India ,maternal health ,Odds ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Pregnancy ,Environmental health ,Post-hoc analysis ,Medicine ,Childbirth ,Humans ,030212 general & internal medicine ,Perinatal Mortality ,Original Research ,030219 obstetrics & reproductive medicine ,obstetrics ,business.industry ,Health Policy ,Public health ,public health ,Public Health, Environmental and Occupational Health ,Infant, Newborn ,Delivery, Obstetric ,Checklist ,Maternal Mortality ,Evidence-Based Practice ,Observational study ,Female ,business - Abstract
BackgroundEvidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality.MethodsWithin the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants’ practice adherence to perinatal mortality.FindingsAcross 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality.InterpretationAdherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex.FundingBill & Melinda Gates Foundation.Trial registration detailsClinicalTrials.gov:NCT02148952; Universal Trial Number: U1111-1131-5647.
- Published
- 2020
40. Just-in-time postnatal education programmes to improve newborn care practices: needs and opportunities in low-resource settings
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Archana Mishra, Prasad Bogam, Megan Marx Delaney, Anindita Bhowmik, Katherine Semrau, Lauren Bobanski, Baljit Kaur, Laura Subramanian, Nikhil Ramnarayan, Rebecca Hawrusik, Shahed S Alam, Christian D.G. Goodwin, Seema Murthy, Sehj Kashyap, Arjun S Rangarajan, Griffith Bell, Shirley Yan, and N Rajkumar
- Subjects
medicine.medical_specialty ,Low resource ,Aftercare ,India ,Mothers ,Context (language use) ,03 medical and health sciences ,0302 clinical medicine ,Nursing ,Patient Education as Topic ,Pregnancy ,medicine ,Humans ,030212 general & internal medicine ,Newborn care ,Developing Countries ,030219 obstetrics & reproductive medicine ,Cesarean Section ,Health Policy ,Public health ,public health ,Public Health, Environmental and Occupational Health ,Health services research ,Infant, Newborn ,Infant ,Investment (macroeconomics) ,health services research ,Patient Discharge ,Work (electrical) ,child health ,Survey data collection ,Female ,Psychology ,Analysis - Abstract
Worldwide, many newborns die in the first month of life, with most deaths happening in low/middle-income countries (LMICs). Families’ use of evidence-based newborn care practices in the home and timely care-seeking for illness can save newborn lives. Postnatal education is an important investment to improve families’ use of evidence-based newborn care practices, yet there are gaps in the literature on postnatal education programees that have been evaluated to date. Recent findings from a 13 000+ person survey in 3 states in India show opportunities for improvement in postnatal education for mothers and families and their use of newborn care practices in the home. Our survey data and the literature suggest the need to incorporate the following strategies into future postnatal education programming: implement structured predischarge education with postdischarge reinforcement, using a multipronged teaching approach to reach whole families with education on multiple newborn care practices. Researchers need to conduct robust evaluation on postnatal education models incorporating these programee elements in the LMIC context, as well as explore whether this type of education model can work for other health areas that are critical for families to survive and thrive.
- Published
- 2020
41. Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial
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Dale A. Barnhart, Megan Marx Delaney, Donna Spiegelman, Katherine Semrau, Lisa R. Hirschhorn, Corwin M. Zigler, and Rose L. Molina
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lcsh:R5-920 ,Intervention development ,Process management ,Computer science ,Research ,030503 health policy & services ,Health services research ,India ,WHO Safe Childbirth Checklist ,Theory of change ,Checklist ,Health administration ,03 medical and health sciences ,Identification (information) ,0302 clinical medicine ,Complex intervention ,Childbirth ,Intervention (counseling) ,030212 general & internal medicine ,Cluster randomised controlled trial ,lcsh:Medicine (General) ,0305 other medical science ,Health policy - Abstract
Background Despite extensive efforts to develop and refine intervention packages, complex interventions often fail to produce the desired health impacts in full-scale evaluations. A recent example of this phenomenon is BetterBirth, a complex intervention designed to implement the World Health Organization’s Safe Childbirth Checklist and improve maternal and neonatal health. Using data from the BetterBirth Program and its associated trial as a case study, we identified lessons to assist in the development and evaluation of future complex interventions. Methods BetterBirth was refined across three sequential development phases prior to being tested in a matched-pair, cluster randomized trial in Uttar Pradesh, India. We reviewed published and internal materials from all three development phases to identify barriers hindering the identification of an optimal intervention package and identified corresponding lessons learned. For each lesson, we describe its importance and provide an example motivated by the BetterBirth Program’s development to illustrate how it could be applied to future studies. Results We identified three lessons: (1) develop a robust theory of change (TOC); (2) define optimization outcomes, which are used to assess the effectiveness of the intervention across development phases, and corresponding criteria for success, which determine whether the intervention has been sufficiently optimized to warrant full-scale evaluation; and (3) create and capture variation in the implementation intensity of components. When applying these lessons to the BetterBirth intervention, we demonstrate how a TOC could have promoted more complete data collection. We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial. Finally, we show how variation in components’ implementation intensities could have been used to identify effective intervention components. Conclusion These lessons learned can be applied during both early and advanced stages of complex intervention development and evaluation. By using examples from a real-world study to demonstrate the relevance of these lessons and illustrating how they can be applied in practice, we hope to encourage future researchers to collect and analyze data in a way that promotes more effective complex intervention development and evaluation. Trial registration ClinicalTrials.gov, NCT02148952; registered on May 29, 2014
- Published
- 2020
42. What is meant by validity in maternal and newborn health measurement? A conceptual framework for understanding indicator validation
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Claudia Hanson, Ann-Beth Moller, Kathleen Hill, Lenka Benova, Alison Morgan, Shams Al Arifeen, Katherine Semrau, Lara M. E. Vaz, and Allisyn C. Moran
- Subjects
Research Validity ,Maternal Health ,Applied psychology ,Global Health ,Pediatrics ,Neonatal Care ,Labor and Delivery ,0302 clinical medicine ,Health care ,Medicine and Health Sciences ,Global health ,Public and Occupational Health ,030212 general & internal medicine ,Health Systems Strengthening ,030219 obstetrics & reproductive medicine ,Multidisciplinary ,Obstetrics and Gynecology ,Research Assessment ,Convergent validity ,Medicine ,Psychology ,Research Article ,Death Rates ,Science ,MEDLINE ,Research and Analysis Methods ,Nonprobability sampling ,03 medical and health sciences ,Population Metrics ,Humans ,Infant Health ,Quality Indicators, Health Care ,Health Care Policy ,Population Biology ,business.industry ,Infant, Newborn ,Biology and Life Sciences ,Neonates ,Reproducibility of Results ,Construct validity ,Health indicator ,Health Care ,Conceptual framework ,Birth ,Women's Health ,Neonatology ,Health Statistics ,Morbidity ,business ,Developmental Biology - Abstract
BACKGROUND: Rigorous monitoring supports progress in achieving maternal and newborn mortality and morbidity reductions. Recent work to strengthen measurement for maternal and newborn health highlights the existence of a large number of indicators being used for this purpose. The definitions and data sources used to produce indicator estimates vary and challenges exist with completeness, accuracy, transparency, and timeliness of data. The objective of this study is to create a conceptual overview of how indicator validity is defined and understood by those who develop and use maternal and newborn health indicators. METHODS: A conceptual framework of validity was developed using mixed methods. We were guided by principles for conceptual frameworks and by a review of the literature and key maternal and newborn health indicator guidance documents. We also conducted qualitative semi-structured interviews with 32 key informants chosen through purposive sampling. RESULTS: We categorised indicator validity into three main types: criterion, convergent, and construct. Criterion or diagnostic validity, comparing a measure with a gold standard, has predominantly been used to assess indicators of care coverage and content. Studies assessing convergent validity quantify the extent to which two or more indicator measurement approaches, none of which is a gold-standard, relate. Key informants considered construct validity, or the accuracy of the operationalisation of a concept or phenomenon, a critical part of the overall assessment of indicator validity. CONCLUSION: Given concerns about the large number of maternal and newborn health indicators currently in use, a more consistent understanding of validity can help guide prioritization of key indicators and inform development of new indicators. All three types of validity are relevant for evaluating the performance of maternal and newborn health indicators. We highlight the need to establish a common language and understanding of indicator validity among the various global and local stakeholders working within maternal and newborn health.
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- 2020
43. Can community health workers identify omphalitis? A validation study from Southern Province, Zambia
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Katherine Semrau, Sara Gille, Davidson H. Hamer, Tina Chisenga, Julie M. Herlihy, Bashagaluke Akonkwa, Caroline Grogan, Kelvin Simpamba, and Lauren Bobay
- Subjects
Male ,Validation study ,Pediatrics ,medicine.medical_specialty ,Maternal-Child Health Services ,education ,030231 tropical medicine ,Zambia ,Sensitivity and Specificity ,Umbilical cord ,Umbilical Cord ,03 medical and health sciences ,0302 clinical medicine ,Infant Mortality ,Humans ,Medicine ,Community health workers ,Community Health Services ,030212 general & internal medicine ,Omphalitis ,Low correlation ,Community Health Workers ,business.industry ,Chlorhexidine ,Gold standard ,Infant, Newborn ,Public Health, Environmental and Occupational Health ,Infant ,Reproducibility of Results ,Skin Diseases, Bacterial ,Checklist ,Infectious Diseases ,medicine.anatomical_structure ,Clinical diagnosis ,Anti-Infective Agents, Local ,Female ,Parasitology ,business ,Algorithms - Abstract
Objective Omphalitis, or umbilical cord infection, is an important cause of newborn morbidity and mortality in low-resource settings. We tested an algorithm that task-shifts omphalitis diagnosis to community-level workers in sub-Saharan Africa. Methods Community-based field monitors and Zambian paediatricians independently evaluated newborns presenting to health facilities in Southern Zambia using a signs and symptoms checklist. Responses were compared against the paediatrician's gold standard clinical diagnosis. Results Of 1009 newborns enrolled, 6.2% presented with omphalitis per the gold standard clinical diagnosis. Paediatricians' signs and symptoms with the highest sensitivity were presence of pus (79.4%), redness at the base (50.8%) and newborn flinching when cord was palpated (33.3%). The field monitor's signs and symptoms answers had low correlation with paediatrician's answers; all signs and symptoms assessed had sensitivity Conclusion Despite extensive training, field monitors could not consistently identify signs and symptoms associated with omphalitis in the sub-Saharan African setting.
- Published
- 2018
44. Effectiveness of a WHO Safe Childbirth Checklist Coaching-based intervention on the availability of Essential Birth Supplies in Uttar Pradesh, India
- Author
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Brandon J. Neal, Ian Solsky, Jenny J Maisonneuve, Katherine Semrau, Vishwajeet Kumar, Jigyasa Sharma, Natalie Panariello, Pinki Maji, Tapan Kalita, Nabihah Kara, Neeraj Dixit, Lisa R. Hirschhorn, Kate Miller, Vinay Pratap Singh, and Janaka Lagoo
- Subjects
Psychological intervention ,India ,WHO Safe Childbirth Checklist ,World Health Organization ,maternal and newborn health ,supply availability ,Coaching ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Procurement ,Randomized controlled trial ,Pregnancy ,law ,Environmental health ,Humans ,Childbirth ,Medicine ,030212 general & internal medicine ,Public Sector ,030219 obstetrics & reproductive medicine ,business.industry ,Health Policy ,Infant, Newborn ,Public Health, Environmental and Occupational Health ,Mentoring ,General Medicine ,Delivery, Obstetric ,Quality Improvement ,Confidence interval ,Checklist ,Editor's Choice ,Equipment and Supplies ,Quartile ,Female ,Health Facilities ,business ,Research Article - Abstract
Objective Evaluate the impact of a World Health Organization Safe Childbirth Checklist coaching-based intervention (BetterBirth Program) on availability and procurement of essential childbirth-related supplies. Design Matched pair, cluster-randomized controlled trial. Setting Uttar Pradesh, India. Participants 120 government-sector health facilities (60 interventions, 60 controls). Supply-availability surveys were conducted quarterly in all sites. Coaches collected supply procurement sources from intervention sites. Interventions Coaching targeting implementation of Checklist with data feedback and action planning. Main Outcome Measures Mean supply availability by study arm; change in procurement sources for intervention sites. Results At baseline, 6 and 12 months, the intervention sites had a mean of 20.9 (95% confidence interval (CI): 20.2–21.5); 22.4 (95% CI: 21.8–22.9) and 22.1 (95% CI:21.4–22.8) items, respectively. Control sites had 20.8 (95% CI: 20.3–21.3); 20.9 (95% CI: 20.3–21.5) and 21.7 (95% CI: 20.8–22.6) items at the same time-points. There was a small but statistically significant higher availability in intervention sites at 6 months (difference-in-difference (DID) = 1.43, P < 0.001), which was not seen by 12 months (DID = 0.37, P = 0.53). Greater difference between intervention and control sites starting in the bottom quartile of supply availability was seen at 6 months (DID = 4.0, P = 0.0002), with no significant difference by 12 months (DID = 1.5, P = 0.154). No change was seen in procurement sources with ~5% procured by patients with some rates as high as 29% (oxytocin). Conclusions Implementation of the BetterBirth Program, incorporating supply availability, resulted in modest improvements with catch-up by control facilities by 12 months. Supply-chain coaching may be most beneficial in sites starting with lower supply availability. Efforts are needed to reduce reliance on patient-funding for some critical medications. Trial Registration ClinicalTrials.gov #NCT02148952; Universal Trial Number: U1111-1131–5647
- Published
- 2018
45. Coherence in measurement and programming in maternal and newborn health: experience from the BetterBirth trial
- Author
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Amanda Jurczak, Vishwajeet Kumar, Katherine Semrau, Natalie Panariello, and Jonathan M. Spector
- Subjects
Adult ,Male ,Epidemiology ,business.industry ,Child Health Services ,Infant, Newborn ,Infant ,Coherence (statistics) ,Delivery, Obstetric ,Article ,Maternal Mortality ,Pregnancy ,Infant Mortality ,Humans ,Optometry ,Medicine ,Female ,Maternal Health Services ,business - Published
- 2019
46. Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol
- Author
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Jnanindra Nath Behera, Danielle E. Tuller, Lauren Spigel, Christopher Duggan, Emily Benotti, Krysten North, Stephanie L. Martin, Latha G Shamanur, Tisungane Mvalo, Sanghamitra Panda, Sujata Misra, Natalie Henrich, Rodrick Kisenge, Leena Das, Kate Miller, Kiersten Israel-Ballard, Melda Phiri, Linda S. Adair, Melissa F Young, Sarah Somji, Kimberly L Mansen, Friday Saidi, Eliza Fishman, Sunil S Vernekar, Laura Subramanian, Megan Marx Delaney, Katelyn Fleming, Linda Vesel, Nahya Salim, Anne C C Lee, Roopa M. Bellad, Karim Manji, Gowdar Guruprasad, Shivaprasad S. Goudar, Irving F. Hoffman, Christopher R. Sudfeld, Sangappa M. Dhaded, Bethany A. Caruso, and Katherine Semrau
- Subjects
Malawi ,medicine.medical_specialty ,Global Health ,Tanzania ,neonatology ,Cohort Studies ,Environmental health ,Epidemiology ,medicine ,Birth Weight ,Humans ,Neonatology ,Child ,nutrition & dietetics ,biology ,business.industry ,Public health ,Mortality rate ,public health ,Infant, Newborn ,Infant ,General Medicine ,Infant, Low Birth Weight ,biology.organism_classification ,Child development ,Observational Studies as Topic ,Medicine ,Female ,epidemiology ,business ,qualitative research ,Qualitative research ,Cohort study - Abstract
IntroductionEnding preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, Methods and analysisLIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants.Ethics and disseminationThis study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities.Trial registration numbersNCT04002908and CTRI/2019/02/017475.
- Published
- 2021
47. Authors reply re: Modification of oxytocin use through a coaching‐based intervention based on the WHO Safe Childbirth Checklist in Uttar Pradesh, India: a secondary analysis of a cluster randomised controlled trial
- Author
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Megan Marx Delaney, Vishwajeet Kumar, and Katherine Semrau
- Subjects
Obstetrics and Gynecology - Published
- 2021
48. Training the Dubowitz Gestational Age Assessment in Low- and Middle-Income Countries: Feasibility and Inter-rater Agreement
- Author
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Krysten North, Katherine Semrau, Carl Bose, Roopa Bellad, S M Dhaded, Veena Herekar, and Anne CC Lee
- Subjects
Pediatrics, Perinatology and Child Health - Published
- 2021
49. Improving Adherence to Essential Birth Practices Using the WHO Safe Childbirth Checklist With Peer Coaching: Experience From 60 Public Health Facilities in Uttar Pradesh, India
- Author
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Pinki Maji, Katherine Semrau, Simon Cousens, Atul A. Gawande, Bhala Kodkany, Tapan Kalita, Darpan Rana, Lisa R. Hirschhorn, Jenny Masoinneuve, Vinay Pratap Singh, Rajiv Saurastri, Krishan Kumar, Narender Sharma, Vishwajeet Kumar, Nabihah Kara, Rebecca Firestone, and Megan Marx Delaney
- Subjects
medicine.medical_specialty ,030219 obstetrics & reproductive medicine ,business.industry ,Public health ,education ,Breastfeeding ,Developing country ,Peer group ,General Medicine ,Coaching ,Checklist ,03 medical and health sciences ,0302 clinical medicine ,Nursing ,Intervention (counseling) ,medicine ,Childbirth ,030212 general & internal medicine ,business - Abstract
Background Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. Methods We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. Results Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: -1% to 62%). Conclusion Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale.Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth intervention were pending publication in another journal. After the impact findings have been published, we will update this article on the effect of the intervention on birth practices with a reference to the impact findings.
- Published
- 2017
50. Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial
- Author
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Andisen Zulu, Reuben Mbewe, Portipher Pilingana, Jonathon L Simon, Davidson H. Hamer, Pascalina Chanda-Kapata, Katherine Semrau, Bowen Banda, Caroline Grogan, Julie M. Herlihy, Chipo Mpamba, Kojo Yeboah-Antwi, William B. MacLeod, Godfrey Biemba, Fern M. Hamomba, Kebby Musokotwane, and Donald M. Thea
- Subjects
Pediatrics ,medicine.medical_specialty ,Pregnancy ,education.field_of_study ,Cord ,business.industry ,Mortality rate ,lcsh:Public aspects of medicine ,030231 tropical medicine ,Chlorhexidine ,Population ,lcsh:RA1-1270 ,General Medicine ,medicine.disease ,Umbilical cord ,Infant mortality ,03 medical and health sciences ,0302 clinical medicine ,medicine.anatomical_structure ,medicine ,Childbirth ,030212 general & internal medicine ,business ,education ,medicine.drug - Abstract
Background: Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the effect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia. Methods: We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facility-based clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratified, restricted randomisation to divide clusters into urban or two rural groups (located
- Published
- 2016
- Full Text
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