Publications by authors named "Patricia S Coffey"

Objective: To assess the appropriateness, acceptability and feasibility of implementing the Test-it PrCr Urinalysis Dipstick Test (LifeAssay Diagnostics, South Africa) in referral hospitals in Ghana.

Participants: 96 healthcare professionals were trained on the protein-to-creatinine (PrCr) test, which was integrated into protocols alongside standard-of-care tests between November 2021 and April 2022. Test users completed questionnaires post training.

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Reaching the Sustainable Development Goal 2030 global mortality and morbidity targets will require increased access to essential health services. Scaling high-impact health interventions within the public sector is complex; delineation of the pathway to scale for each intervention within each distinct geography is important for prioritising actions to advance interventions towards effective coverage. Following a review of 38 theoretical frameworks describing pathways for scaling health system interventions, we developed, tested and refined a new schema-the Stages of Achieving Effective Coverage and Equity Framework-for use to describe the status of policy adoption, implementation and coverage of key maternal, newborn, child health and nutrition (MNCHN) interventions.

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We document the effort over the last 30 years to respond to the call by women advocates at the International Conference on Population and Development for more woman-initiated single or dual-purpose contraceptive methods by developing the Caya contoured diaphragm, an innovative diaphragm designed to meet the needs of women and their partners and expand options for nonhormonal barrier contraception. We describe the complex and interrelated set of activities undertaken to develop the product using a human-centered design process and how we are working to create a corollary sustainable market. This review includes the evidence generated around improved acceptability among couples in low- and middle-income countries and depicts challenges and practical actions on how to dispel misconceptions about diaphragm use.

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Background: Effective infection prevention and control programs can positively influence quality of care, increase patient safety, and protect health care providers. Chlorine, a widely used and effective chemical disinfectant, is recommended for infection prevention and control in health care settings. However, lack of consistent chlorine availability limits its use.

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Inequitable coverage of evidence-based MNCHN interventions is particularly pronounced in low and middle income countries where access and delivery of these interventions can vary dramatically at the subnational level. We conducted health system assessments in nine subnational geographies in five countries (Burkina Faso, Ethiopia, India, Kenya and Nigeria) to explore progress toward scale of 14 evidence-based MNCHN interventions (iron-folic acid, oxytocin, magnesium sulfate, misoprostol; 7.1% chlorhexidine for umbilical cord care, neonatal resuscitation, kangaroo mother care, community regimen for the treatment of possible severe bacterial infection; amoxicillin dispersible tablets, multiple micronutrient supplements, balanced energy protein supplementation, early and exclusive breastfeeding, feeding of small and sick newborns, and management of severe and moderate acute malnutrition in children less than five years old).

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Background: Limited information is available about the approaches used and lessons learned from low- and middle-income countries that have implemented inpatient services for small and sick newborns. We developed descriptive case studies to compare the journeys to establish inpatient newborn care across Ethiopia, India, Malawi, and Rwanda.

Methods: A total of 57 interviews with stakeholders in Ethiopia (n=12), India (n=12), Malawi (n=16), and Rwanda (n=17) informed the case studies.

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Background: Microarray patches (MAPs), a novel drug delivery system, are being developed for HIV pre-exposure prophylaxis (PrEP) delivery and as a multipurpose prevention technology (MPT) to protect from both HIV and unintended pregnancy. Prevention technologies must meet the needs of target audiences, be acceptable, easy to use, and fit health system requirements.

Methodology: We explored perceptions about MAP technology and assessed usability, hypothetical acceptability, and potential programmatic fit of MAP prototypes using focus group discussions (FGD), usability exercises, and key informant interviews (KII) among key populations in Kiambu County, Kenya.

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Introduction: Healthcare organizations faced unique operational challenges during the COVID-19 pandemic. Assuring the safety of both patients and healthcare workers in hospitals has been the primary focus during the COVID-19 pandemic.

Methods: The NIH Vaccine Program (VP) with the Vaccine Management System (VMS) was created based on the commitment of NIH leadership, program leadership, the development team, and the program team; defining Key Performance Indicators (KPIs) of the VP and the VMS; and the NIH Clinical Center's (NIH CC) interdisciplinary approach to deploying the VMS.

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Background: Preterm birth and resulting respiratory failure is a leading cause of newborn death- the majority of which occur in resource-constrained settings and could be prevented with bubble continuous positive airway pressure (bCPAP). Commercialized devices are expensive, however, and sites commonly use improvised devices utilizing 100% oxygen which can cause blindness. To address this, PATH and a multidisciplinary team developed a very low-cost bCPAP device including fixed-ratio oxygen blenders.

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Purpose: Bubble continuous positive airway pressure (bCPAP) is often used to treat respiratory distress experienced by some 15 million preterm infants born globally every year. In low- and middle-income countries, improvised bCPAP devices are used, often without a blender that protects the infant from the sequelae of excessive oxygen exposure.

Materials And Methods: The aim of this bench testing was to assess the mechanical safety and performance of the PATH bCPAP and blenders device, which provides a stable and reliable source of pressurized blended gas without the requirement for a source of compressed medical air or electricity.

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An information technology governance (ITG) program has helped the National Institutes of Health (NIH) Clinical Center (CC) in the implementation of many systems and has guided the organization through the maturity of its project management methodology. The NIHCC Department of Clinical Research Informatics (DCRI) maintains an electronic health record (EHR) called the clinical research information system (CRIS) along with many clinical information systems (CIS) and research information systems, supporting approximately 3,200 users. ITG involves establishing processes to guide the review, selection, implementation, management, and setting of the IT strategy representing the business owners, stakeholders, and IT.

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Background: Umbilical cord hygiene prevents sepsis, a leading cause of neonatal mortality. The World Health Organization recommends 7.1% chlorhexidine digluconate (CHX) application to the umbilicus after home birth in high mortality contexts.

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Assuring the safety of both patients and healthcare workers (HCWs) in hospitals has been the primary focus of every healthcare organization during the COVID 19 pandemic. This article discusses the NIH Clinical Center's interdisciplinary approach to deploying an organizational Asymptomatic Staff Testing System.

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Introduction: Preterm infants make up the majority of the 9 million babies born in Africa and South Asia requiring supplemental feedings as they transition to exclusive breastfeeding. The World Health Organization recommends the use of a cup to feed newborns with breastfeeding difficulties in low-resource settings. We set out to evaluate the Nifty cup, a new feeding cup designed specifically for infants with breastfeeding difficulties.

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We aimed to assess the functional performance and safety of a modified Woman's Condom (WC2) against the existing FC2 female condom. This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure.

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Background: Early identification through newborn screening is the first step in active management of sickle cell disease (SCD). Uganda currently screens newborns and infants under 2 years for SCD in high HIV-burden districts using isoelectric focusing with dried blood spot samples. Our analysis sought to estimate the costs per child screened for SCD using this method in Uganda and then to use those data to estimate the price threshold for screening with a point-of-care (POC) test.

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Background: Vitamin K prophylaxis can prevent vitamin K deficiency bleeding (VKDB), and current global recommendations support universal prophylactic use in newborns. Data about access to and use of vitamin K in low and middle income countries (LMIC) are scarce. To address this gap, we explored current perspectives and practices of newborn vitamin K administration in LMIC in order to better understand the barriers to more widespread coverage of this lifesaving preventative treatment.

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The global health field is replete with examples of cross-organizational collaborative partnerships, such as networks, alliances, coalitions, task forces, and working groups, often established to tackle a shared global health concern, condition, or threat affecting low-income countries or communities. The purpose of this article is to review factors influencing the effectiveness of a multi-agency global health collaborative effort using the Chlorhexidine Working Group (CWG) as our case study. The CWG was established to accelerate the introduction and global scale-up of chlorhexidine for umbilical cord care to reduce infection-related neonatal morbidity and mortality in low-income countries.

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Vitamin K deficiency within neonates can result in vitamin K deficiency bleeding. Ensuring that newborns receive vitamin K is particularly critical in places where access to health care and blood products and transfusions is limited. The World Health Organization recommends that newborns receive a 1 mg intramuscular injection of vitamin K at birth.

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Introduction: This study aimed to assess acceptability and preferences for the SILCS diaphragm for vaginal gel delivery compared to a prefilled applicator.

Methods: A randomized crossover study among 115 women in South Africa, using both methods during five sex acts.

Results: We found no significant differences in acceptability between the two products.

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Background: The study assessed the impact of simulated ventilation techniques using upright and conventional self-inflating neonatal resuscitators on delivered tidal volume (V) and pressure.

Methods: We analyzed videos of participants ventilating a manikin using an upright (upright, = 33) and a conventional resuscitator (conventional, = 32) under normal and low lung compliance. Mask hold, number of fingers squeezing the bag, and degree of bag squeeze were compared with V and peak inspiratory pressure (PIP).

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Background: Neonatal sepsis is the third leading cause of deaths for infants in their first month of life. The newly cut umbilical cord can be a pathway for bacteria that can cause newborn sepsis and death. Optimal umbilical cord care practices for newborns and during the first week of life, especially in settings with poor hygiene, has the potential to avoid these preventable neonatal deaths.

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The morbidity and mortality associated with preeclampsia is staggering. The physiology of the Page kidney, a condition in which increased intrarenal pressure causes hypertension, appears to provide a unifying framework to explain the complex pathophysiology. Page kidney hypertension is renin-mediated acutely and ischemia-mediated chronically.

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Background. The Woman's Condom, a second-generation female condom designed for acceptability, is poised for introduction in China. Method.

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Achieving increased access to medicines in low- and middle-income countries is a complex issue that requires a holistic approach. Choosing an appropriate manufacturing strategy that can ensure a sustainable supply of these medicines is an essential component of that approach. The Chlorhexidine Working Group, a consortium of more than 25 international organizations, donors, and manufacturers led by PATH, has been working to increase access to 7.

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