Publications by authors named "Patricia S Coffey"

34 Publications

Unveiling the silent threat among us: leveraging health information technology in the search for asymptomatic COVID 19 healthcare workers.

J Am Med Inform Assoc 2021 02;28(2):377-383

Health Information Management Department, NIH CC, Bethesda, Maryland, USA.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/jamia/ocaa237DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717249PMC
February 2021

A randomized crossover trial comparing the Nifty cup to a medicine cup in preterm infants who have difficulty breastfeeding at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana.

PLoS One 2019 17;14(10):e0223951. Epub 2019 Oct 17.

Devices/Tools Global Program, PATH, Seattle, Washington, United States of America.

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.

Materials And Methods: We conducted a randomized clinical trial in Ghana. We hypothesized infants would prefer the Nifty cup and that it would have less spillage as compared to a medicine cup. We enrolled mothers and preterm infants with breastfeeding difficulties indicated to cup feed at Komfo Anokye Teaching Hospital. Each mother-infant pair used the Nifty cup and a standard medicine cup; and two feeding assessments with each cup were conducted. We employed an intent-to-treat analysis comparing cup preference using a Wilcoxon signed rank test and spillage using generalized estimating equations.

Results: We enrolled 200 mothers and 237 infants. Many infants were very low birth weight (62%), less than two weeks old (62%), and multiple birth (29%). In response to separate questions about each cup, more mothers reported liking the Nifty cup a lot as compared to the medicine cup (85% versus 57%, p<0.001). When asked to choose between the two cups, more than 75% preferred the Nifty cup (p < 0.001). There was slightly less spillage with the Nifty cup (8.9%) versus the medicine cup (9.3%), which was not statistically significant (p = 0.35). Mothers reported greater confidence and ease of using the Nifty cup and greater use one-month post-discharge compared to the medicine cup (p-values <0.001). Nearly all mothers were breastfeeding and cup feeding their infants at study initiation and at one-month post-discharge.

Discussion: This is the first randomized clinical trial of cup feeding in sub-Saharan Africa. Mothers prefer the Nifty cup to a medicine cup for supplemental feeds to their preterm infant. The Nifty cup was used with greater ease and confidence. The Nifty cup can offer an improved feeding experience for the mother-infant pair.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223951PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797128PMC
March 2020

Functional performance study of an adapted design of the woman's condom: a crossover, noninferiority, randomized clinical trial.

Eur J Contracept Reprod Health Care 2019 Jun 21;24(3):233-239. Epub 2019 May 21.

b PATH , Seattle , WA , USA.

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. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type. Noninferiority was demonstrated for the WC2 with respect to the reference condom FC2 for all condom functions. The WC2 was found to be superior to the FC2 reference condom for clinical failure ( = .000), total female condom failure ( = .001), misdirection ( = .000) and slippage ( = .004). The WC2 female condom performs as well as the FC2 female condom and offers good stability during use. Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman's Condom.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/13625187.2019.1610940DOI Listing
June 2019

Cost for sickle cell disease screening using isoelectric focusing with dried blood spot samples and estimation of price thresholds for a point-of-care test in Uganda.

J Blood Med 2019 5;10:59-67. Epub 2019 Feb 5.

Devices and Tools Global Program, PATH, Seattle, WA, USA,

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.

Methods: We estimated the financial and economic costs per child screened for SCD using data from health facilities and the Central Public Health Laboratory. These costs included sample collection, transportation, and laboratory processing. Price thresholds for a POC test were estimated using two scenarios.

Results: The price threshold of an SCD POC test used for diagnosis would be $3.77 when taking into account only financial costs and $5.14 when taking into account economic costs. Thresholds for a POC test used for screening would be $3.07-$3.51 and $4.38-$5.09, respectively, depending on test specificity.

Conclusion: The price threshold of a POC test for SCD will depend on the assumptions on how it will be used - either as a screening or diagnostic test. If used for screening, test specificity will have significant impact. Results from this type of costing study can allow developers to incorporate quantitatively estimated price thresholds for innovative products into target product profiles early in the product development cycle.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2147/JBM.S186528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6368125PMC
February 2019

Current perspectives and practices of newborn vitamin K administration in low and middle income countries.

Res Rep Neonatol 2018 Apr 5;8:45-51. Epub 2018 Apr 5.

PATH, Seattle, WA, USA.

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.

Methods: We conducted an online survey of stakeholders involved in newborn health. We sent the survey via e-mail to 109 individuals who were based primarily in LMIC and 23 responses were received, resulting in a response rate of 21%. Respondents were generally health or development professionals from sub-Saharan Africa and Asia.

Results: Incidence rates at the country level were mostly unknown or not supported by adequate data. Many respondents (17/23) indicated that vitamin K prophylaxis is included in their national newborn care guidelines and policies, while 12 respondents indicated that administration at birth was widely practiced. Around half of respondents reported that health workers were trained in the diagnosis and treatment of VKDB. The most frequently cited barriers to more widespread vitamin K prophylaxis were (in rank order) high rates of home birth (which preclude injections that must be given by skilled health workers), lack of access to and availability of vitamin K, perception that vitamin K prophylactic treatment is not a priority among health workers, lack of vitamin K formulations appropriate for infants, cultural practices suggesting that injection at birth is not acceptable to parents, and vitamin K not being included in national guidelines and policies. There was no consensus as to the ideal formulation, respondents preferring both the current intramuscular (IM) injection and oral formulation. Reported product attributes of IM and oral formulations are summarized.

Conclusion: Prophylactic administration of vitamin K to newborns is relatively well integrated into policy at the global and country levels, but its practice is underutilized. Barriers to use are access, supply chain logistics, provider attitudes, and restrictions on the use of injections by providers at the community level. Technology innovation may offer some promise to mitigate these barriers, although advocacy and health system strengthening might be more likely to yield improved coverage. Further investigation using in-depth bottleneck analysis at the country level could help identify specific health system improvements.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2147/RRN.S154652DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745116PMC
April 2018

Effective Collaboration for Scaling Up Health Technologies: A Case Study of the Chlorhexidine for Umbilical Cord Care Experience.

Glob Health Sci Pract 2018 03 30;6(1):178-191. Epub 2018 Mar 30.

Consultant, Global Health and Human Rights, Seattle, WA, USA.

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. Questions included: how current and past CWG members characterized the effectiveness, productivity, collaboration, and leadership of the CWG; what factors facilitated or hindered group function; institutional or individual reasons for participating and length of participation in the CWG; and lessons that might be relevant for future global collaborative partnerships. Data were collected through in-depth, semistructured individual interviews with 19 group members and a review of key guiding documents. Six domains of internal coalition functioning (leadership, interpersonal relationships, task focus, participant benefits and costs, sustainability planning, and community support) were used to frame and describe the functioning of the CWG. Collaboration effectiveness was found to depend on: (1) leadership that maintained a careful balance between discipline and flexibility, (2) a strong secretariat structure that supported the evolution of trust and transparent communication in interpersonal relationships, (3) shared goals that allowed for task focus, (4) diverse membership and active involvement from country-level participants, which created a positive benefit-cost ratio for participants, (5) sufficient resources to support the partnership and build sustainable capacity for members to accelerate the transfer of knowledge, and (6) support from the global health community across multiple organizations. Successful introduction and scale-up of new health interventions require effective collaboration across multiple organizations and disciplines, at both global and country levels. The participatory collaborative partnership approach utilized by the Chlorhexidine Working Group offers an instructive learning case.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.9745/GHSP-D-17-00380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5878071PMC
March 2018

Transdermal delivery of vitamin K using dissolving microneedles for the prevention of vitamin K deficiency bleeding.

Int J Pharm 2018 Apr 19;541(1-2):56-63. Epub 2018 Feb 19.

School of Pharmacy, Queen's University, Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom. Electronic address:

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. Evidence from multiple surveillance studies shows that the introduction of vitamin K prophylaxis reduces the incidence of vitamin K deficiency bleeding. Despite these recommendations, coverage of vitamin K prophylactic treatment in low-resource settings is limited. An intramuscular injection is the most common method of vitamin K administration in neonates. In low- and middle-income countries, needle sharing may occur, which may result in the spread of bloodborne diseases. The objective of our study was to investigate the manufacture of microneedles for the delivery of vitamin K. Following microneedle fabrication, we performed insertion studies to assess the microneedle's mechanical properties. Results indicate that vitamin K in a microneedle array was successfully delivered in vitro across neonatal porcine skin with 1.80 ± 0.08 mg delivered over 24 h. Therefore, this initial study shows that microneedles do have the potential to prevent vitamin K deficiency bleeding. Future work will assess delivery of vitamin K in microneedle array in vivo.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijpharm.2018.02.031DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5884307PMC
April 2018

A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery.

AIDS Behav 2018 01;22(1):127-132

PATH, PO Box 900922, Seattle, WA, 98119, USA.

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. Experience of gel leakage after sex was greater when inserted via applicator. More women were interested in SILCS/gel for multipurpose protection (68%) than in either SILCS alone (17%) or microbicide gel alone (14%).

Conclusions: A SILCS gel delivery system for multipurpose prevention seems feasible and acceptable.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s10461-017-1913-4DOI Listing
January 2018

Evaluation of Simulated Ventilation Techniques With the Upright and Conventional Self-Inflating Neonatal Resuscitators.

Respir Care 2017 Nov 22;62(11):1428-1436. Epub 2017 Aug 22.

Devices and Tools Program, PATH, Seattle, Washington.

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).

Results: V and PIP values were higher when using the upright resuscitator than when using the conventional resuscitator. With low compliance, differences in V were insignificant except with the use of the OK/C hold, (upright, 29.6 ± 4.0 mL, vs conventional, 24.8 ± 6.0 mL, = .02). PIP was significantly higher when using the upright resuscitator with the OK hold (upright, 36.3 ± 4.4 mL, vs conventional, 30.3 ± 6.6 mL, = .009) and when the bag was squeezed by more than half (upright, 33.8 ± 16.3 mL, vs conventional, 29.3 ± 9.5 mL, = .046). With normal compliance, V was high with both resuscitators, being significantly higher when using the upright resuscitator with the OK hold (upright, 64.3 ± 9.5 mL, vs conventional, 45.8 ± 9.4 mL; < .001), and when the bag was squeezed using more than 2 fingers (upright, 58.0 ± 17.2 mL, vs conventional, 45.7 ± 12.6 mL, = .01) and by more than half (upright, 58.7 ± 16.6 mL, vs conventional, 45.8 ± 12.2 mL, = .004). PIP, too, was significantly higher when using the upright resuscitator with the OK hold (upright, 29.3 ± 3.5 mL, vs conventional, 21.5 ± 4.0 mL, = <.001) and when the bag was squeezed using more than 2 fingers (upright, 27.2 ± 7.0 mL, vs conventional, 21.6 ± 5.7 mL, = .005), and by more than half (upright, 27.6 ± 6.6 mL, vs conventional, 21.7 ± 5.4 mL, = .001).

Conclusions: Improved mask design, larger bag volume, and upright orientation of the upright resuscitator likely contributed to higher V and PIP. However, high V was observed with resuscitators, possibly due to excessive squeezing of the bag, especially during low compliance. Thus, the design of the resuscitator and manner in which the device is utilized can both significantly influence the V and PIP attained.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4187/respcare.05328DOI Listing
November 2017

Umbilical cord-care practices in low- and middle-income countries: a systematic review.

BMC Pregnancy Childbirth 2017 02 20;17(1):68. Epub 2017 Feb 20.

PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, 98121, USA.

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. The purpose of this review of cord care practices is to assist in the development of behavior-change strategies to support introduction of novel cord-care regimens, particularly 7.1% chlorhexidine digluconate for umbilical cord care.

Methods: We searched domestic and international databases for articles that were published in English between January 1, 2000, and August 24, 2016. We found 321 articles and reviewed 65 full-text articles using standardized inclusion criteria. The primary criteria for inclusion was a description of substances applied to the umbilical cord stump in the days following birth.

Results: We included 46 articles in this review of umbilical cord-care practices. Articles included data from 15 low- and middle-income countries in sub-Saharan Africa (8 countries), Asia (5 countries), North Africa (1 country), and Latin America and the Caribbean (1 country). Findings from this review suggest that documentation of cord-care practices is not consistent throughout low- and middle-income countries, yet existing literature depicts a firm tradition of umbilical cord care in every culture. Cord-care practices vary by country and by regions or cultural groups within a country and employ a wide range of substances. The desire to promote healing and hasten cord separation are the underlying beliefs related to application of substances to the umbilical cord. The frequency of application of the substance (either the number of days or the number of times per day the substance was applied), and source and cost of products used is not well-characterized.

Conclusions: This desire to actively care for the umbilical cord of a newborn-as noted in the variety of cord care practices and beliefs identified in this review-points toward the need to contextualize any behavior change approach to align with the local culture.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12884-017-1250-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5319165PMC
February 2017

Can preeclampsia be considered a renal compartment syndrome? A hypothesis and analysis of the literature.

J Am Soc Hypertens 2016 11 15;10(11):891-899. Epub 2016 Sep 15.

Department of Nephrology, Seattle Children's Hospital, Seattle, WA.

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. Renal venous outflow obstruction also causes a Page kidney phenomenon, providing a hypothesis for the increased vulnerability of a subset of women who have what we are hypothesizing is a "renal compartment syndrome" due to inadequate ipsilateral collateral renal venous circulation consistent with well-known variation in normal venous anatomy. Dynamic changes in renal venous anatomy and physiology in pregnancy appear to correlate with disease onset, severity, and recurrence. Since maternal recumbent position is well known to affect renal perfusion and since chronic outflow obstruction makes women vulnerable to the ischemic/inflammatory sequelae, heightened awareness of renal compartment syndrome physiology is critical. The anatomic and physiologic insights provide immediate strategies to predict and prevent preeclampsia with straightforward, low-cost interventions that make renewed global advocacy for pregnant women a realistic goal.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jash.2016.09.002DOI Listing
November 2016

Short-Term Acceptability of the Woman's Condom among Married Couples in Shanghai.

J Sex Transm Dis 2016 28;2016:6201421. Epub 2016 Jul 28.

PATH, Seattle, WA 98121, USA.

Background. The Woman's Condom, a second-generation female condom designed for acceptability, is poised for introduction in China. Method. This single-arm study was conducted among 60 couples in China in 2010 to assess acceptability of the Woman's Condom. Results. Male participants reported that ease of handling, inserting, and removing the device improved significantly from first to fourth use. Female and male participants reported that comfort during insertion, feel of lubricant during insertion, comfort/fit of outer ring during use, and overall comfort improved significantly from first to fourth use. Further, at fourth use, female participants reported significant improvement in the comfort of the feel of the condom material and lubricant. Female and male participants reported that satisfaction with stability and sensation during sex and ability to achieve orgasm improved significantly from first to fourth use. At fourth use, female participants reported statistically significant improvement in sensation compared to using nothing. A majority of participants (78%) stated that they would use the Woman's Condom in the future, primarily due to its dual protection profile. Conclusion. This study has shown that, in China, the Woman's Condom appears to be acceptable to married couples. User experience contributes to improvement in many aspects of device acceptability.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1155/2016/6201421DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4980527PMC
August 2016

Selecting an appropriate strategy to make quality 7.1 % chlorhexidine digluconate accessible for umbilical cord care.

J Pharm Policy Pract 2016 8;9:14. Epub 2016 Apr 8.

PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121 USA.

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 7.1 % chlorhexidine digluconate for umbilical cord care in low- and middle-income countries to reduce neonatal mortality due to infection. The working group initially considered two strategies for manufacture of this commodity: (1) production and global distribution by a multinational company; and (2) production and regional distribution by locally owned companies or subsidiaries of multinational companies based in low- and middle-income countries. Local production may be beneficial to public health and economic development in these countries, yet capability and capacity of pharmaceutical manufacturers, regulatory and legal provisions, and market factors must be carefully assessed and addressed to ensure that local production is the correct strategy and that it contributes to improved access to the medicine. To date, this effort to implement a local production strategy has resulted in successful registration of 7.1 % chlorhexidine digluconate for umbilical cord care by manufacturers in Bangladesh, Kenya, Nepal, and Nigeria. Additionally, the product is now available in domestic and export markets.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s40545-016-0063-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4826508PMC
April 2016

Transformative Innovations in Reproductive, Maternal, Newborn, and Child Health over the Next 20 Years.

PLoS Med 2016 Mar 2;13(3):e1001969. Epub 2016 Mar 2.

Center for Global Child Health, Sick Kids, Toronto, Ontario, Canada.

As part of the "Grand Convergence: Aligning Technologies and Realities in Global Health" Collection, Cyril Engmann and colleagues discuss promising innovations that have the potential to move the RMNCH agenda forward.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1371/journal.pmed.1001969DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4774905PMC
March 2016

Count every newborn; a measurement improvement roadmap for coverage data.

BMC Pregnancy Childbirth 2015 11;15 Suppl 2:S8. Epub 2015 Sep 11.

Background: The Every Newborn Action Plan (ENAP), launched in 2014, aims to end preventable newborn deaths and stillbirths, with national targets of ≤12 neonatal deaths per 1000 live births and ≤12 stillbirths per 1000 total births by 2030. This requires ambitious improvement of the data on care at birth and of small and sick newborns, particularly to track coverage, quality and equity.

Methods: In a multistage process, a matrix of 70 indicators were assessed by the Every Newborn steering group. Indicators were graded based on their availability and importance to ENAP, resulting in 10 core and 10 additional indicators. A consultation process was undertaken to assess the status of each ENAP core indicator definition, data availability and measurement feasibility. Coverage indicators for the specific ENAP treatment interventions were assigned task teams and given priority as they were identified as requiring the most technical work. Consultations were held throughout.

Results: ENAP published 10 core indicators plus 10 additional indicators. Three core impact indicators (neonatal mortality rate, maternal mortality ratio, stillbirth rate) are well defined, with future efforts needed to focus on improving data quantity and quality. Three core indicators on coverage of care for all mothers and newborns (intrapartum/skilled birth attendance, early postnatal care, essential newborn care) have defined contact points, but gaps exist in measuring content and quality of the interventions. Four core (antenatal corticosteroids, neonatal resuscitation, treatment of serious neonatal infections, kangaroo mother care) and one additional coverage indicator for newborns at risk or with complications (chlorhexidine cord cleansing) lack indicator definitions or data, especially for denominators (population in need). To address these gaps, feasible coverage indicator definitions are presented for validity testing. Measurable process indicators to help monitor health service readiness are also presented. A major measurement gap exists to monitor care of small and sick babies, yet signal functions could be tracked similarly to emergency obstetric care.

Conclusions: The ENAP Measurement Improvement Roadmap (2015-2020) outlines tools to be developed (e.g., improved birth and death registration, audit, and minimum perinatal dataset) and actions to test, validate and institutionalise proposed coverage indicators. The roadmap presents a unique opportunity to strengthen routine health information systems, crosslinking these data with civil registration and vital statistics and population-based surveys. Real measurement change requires intentional transfer of leadership to countries with the greatest disease burden and will be achieved by working with centres of excellence and existing networks.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/1471-2393-15-S2-S8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4577758PMC
June 2016

Exploring vaginal ring acceptability for contraception and sexually transmissible infection protection in India: a qualitative research study.

Sex Health 2015 Nov;12(6):532-40

PATH, PO Box 900922, Seattle, Washington, 98109, USA.

Unlabelled: Background New vaginal rings are being developed as single and multipurpose prevention technologies to protect women from pregnancy and/or sexually transmissible infections, such as HIV. Data on ring acceptability in low-resource settings is critical for new technologies to meet user needs.

Methods: Women from slum and lower-income areas around Delhi, India, participated in focus group discussions on vaginal ring product perceptions and preferences. Participants were recruited based on following eligibility categories: age, marital status, contraceptive use, and number of children. The translated transcriptions of the qualitative data were analysed using a coding scheme generated from the areas of inquiry and relevant literature.

Results: A total of 103 women from lower-middle-class or slum areas in Delhi participated in 13 focus group discussions between December 2012 and January 2013. Participants shared perceptions of vaginal ring product attributes, including size, colour, intended use (single indication or dual purpose), duration of use, side effects, biodegradability, and various preferences regarding product use, including access, use during sex, wear patterns, cleaning, and disposal. Participants also reflected on willingness to pay and male partner acceptability.

Conclusions: The results of this hypothetical acceptability study indicate that these low-income women in Delhi are: willing to try vaginal rings; unconcerned about wearing them during sex; very interested in protection from infections and unintended pregnancy; indifferent about colour of new rings; emphatic about being told that rings may change colour from menstrual blood staining; comfortable with thinner rings; willing to try thicker rings once familiar with thinner rings; in favour of starting with 1-month rings and then transitioning to longer-term rings; and in favour of first accessing rings at a facility and then managing resupply independently.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1071/SH15045DOI Listing
November 2015

Performance and Acceptability of Two Self-Inflating Bag-Mask Neonatal Resuscitator Designs.

Respir Care 2015 Sep 7;60(9):1227-37. Epub 2015 Jul 7.

Department of Respiratory Therapy, Seattle Children's Hospital, and the Center for Developmental Therapeutics, Seattle Children's Hospital Research Institute, Seattle, Washington.

Background: A self-inflating bag-mask device is specified by international policy guidelines as standard prototype of care for newborn resuscitation. Our hypothesis is that a new bag-mask design would be as effective and easy to use as a standard, self-inflating resuscitation bag-mask.

Methods: We conducted a comparative evaluation of the performance and acceptability of the Laerdal 220-mL resuscitator with a size-1 mask (NeoNatalie) and a Laerdal prototype Upright resuscitator with a modified mask. Participants evaluated the devices in random order using a commercially available test lung and training mannikin with an integrated chest-rise module. The test lung was configured with healthy and sick newborn lung mechanics. Two user groups participated: (1) frequent users who had used manual resuscitators to resuscitate infants and (2) infrequent users who received competency-based training and had not previously used manual resuscitators to resuscitate infants.

Results: Thirty-eight individuals participated in the study during March 2013. Both resuscitators are capable of delivering the minimum required tidal volumes to newborns. The Upright device provided a significant reduction in the percentage of inadequate ventilations (< 12.5 mL) compared with the NeoNatalie. Although the test sequences with low-compliance lung settings showed no difference in the percentage of excessive ventilations (> 37.5 mL) between the Upright and NeoNatalie, the test sequences with normal-compliance lung settings showed a higher percentage of excessive ventilations with both, and the increase was greater with the Upright than with the NeoNatalie (85.92% vs 71.39%, P < .001). The subjective acceptability and disassembly/reassembly tests were supportive of the new device design.

Conclusions: The performance and acceptability of the Upright device in this user population suggest that the device may be suitable for effective ventilation by infrequent users in low-resource settings. The Upright device should be tested in such a setting.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4187/respcare.03867DOI Listing
September 2015

Estimating the hypothetical dual health impact and cost-effectiveness of the Woman's Condom in selected sub-Saharan African countries.

Int J Womens Health 2015 5;7:271-7. Epub 2015 Mar 5.

Technology Solutions Global Program, PATH, Seattle, WA, USA.

Background: Female condoms are the only currently available woman-initiated option that offers dual protection from pregnancy and sexually transmitted infections, including HIV. The Woman's Condom is a new female condom designed to provide dual protection and to be highly pleasurable and acceptable.

Objective: We sought to estimate the potential dual health impact and cost-effectiveness of a Woman's Condom distribution program in 13 sub-Saharan African countries with HIV prevalence rates >4% among adults aged 15-49 years. We used two separate, publicly available models for this analysis, the Impact 2 model developed by Marie Stopes International and the Population Services International disability-adjusted life years (DALY) calculator program. We estimated the potential numbers of pregnancies and DALYs averted when the Woman's Condom is used as a family planning method and the HIV infections and DALYs averted when it is used as an HIV prevention method.

Results: Programming 100,000 Woman's Condoms in each of 13 countries in sub-Saharan Africa during a 1-year period could potentially prevent 194 pregnancies and an average of 21 HIV infections in each country. When using the World Health Organization CHOosing Interventions that are Cost-Effective (WHO-CHOICE) criteria as a threshold to infer the potential cost-effectiveness of the Woman's Condom, we found that the Woman's Condom would be considered cost-effective.

Conclusion: This was a first and successful attempt to estimate the impact of dual protection of female condoms. The health impact is greater for the use of the Woman's Condom as an HIV prevention method than for contraception. Dual use of the Woman's Condom increases the overall health impact. The Woman's Condom was found to be very cost-effective in all 13 countries in our sample.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2147/IJWH.S75040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4356704PMC
March 2015

Potential for revitalisation of the diaphragm for family planning in Uganda: a rapid assessment of the feasibility of introducing the SILCS Diaphragm.

Afr J Reprod Health 2014 Jun;18(2):77-86

This health systems assessment evaluated the feasibility of introducing a new contraceptive device, the SILCS single-size diaphragm, into the existing family planning method mix in Uganda. A total of 26 focus group discussions with 201 female and 77 male potential users and 98 key informant interviews with policymakers and providers were conducted between June and August 2010. Potential users, providers, and policymakers recognised that the SILCS Diaphragm could fill a gap in the method mix and expressed eagerness to make the SILCS Diaphragm available, particularly because it is nonhormonal and woman initiated. The diaphragm was viewed by all stakeholders as a method that would increase choice and could improve women's reproductive health in Uganda. Like many countries, Uganda's family planning programme is financially stretched, and clear support for the SILCS Diaphragm by end-users will need to be demonstrated before the product will be considered for public-sector introduction.
View Article and Find Full Text PDF

Download full-text PDF

Source
June 2014

"Female condoms are_____": bringing local voices to decision-makers through a film contest.

Reprod Health Matters 2014 May;22(43):135-40

Director, POW PDP, PATH, Seattle, WA, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S0968-8080(14)43752-2DOI Listing
May 2014

Prioritizing investments in innovations to protect women from the leading causes of maternal death.

BMC Pregnancy Childbirth 2014 Jan 9;14:10. Epub 2014 Jan 9.

PATH, PO Box 900922, Seattle, WA 98109, USA.

PATH, an international nonprofit organization, assessed nearly 40 technologies for their potential to reduce maternal mortality from postpartum hemorrhage and preeclampsia and eclampsia in low-resource settings. The evaluation used a new Excel-based prioritization tool covering 22 criteria developed by PATH, the Maternal and Neonatal Directed Assessment of Technology (MANDATE) model, and consultations with experts. It identified five innovations with especially high potential: technologies to improve use of oxytocin, a uterine balloon tamponade, simplified dosing of magnesium sulfate, an improved proteinuria test, and better blood pressure measurement devices. Investments are needed to realize the potential of these technologies to reduce mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/1471-2393-14-10DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3890511PMC
January 2014

Willingness to pay for a 4% chlorhexidine (7.1% chlorhexidine digluconate) product for umbilical cord care in rural Bangladesh: a contingency valuation study.

BMC Int Health Hum Rights 2013 Oct 18;13:44. Epub 2013 Oct 18.

Technology Solutions Global Program, PATH, 2201 Westlake Ave, Seattle, WA, 98121, USA.

Background: Recent trials in Bangladesh, Nepal, and Pakistan have shown that chlorhexidine is an effective antiseptic for umbilical cord care compared to existing community-based cord care practices. Because of the aggregate reduction in neonatal mortality in these trials, interest is high in introducing a 7.1% chlorhexidine digluconate liquid or gel that delivers 4% chlorhexidine for umbilical cord care in Bangladesh and elsewhere.

Methods: In 2010, we conducted a household survey applying a contingent valuation method with 1717 eligible couples (pregnant women or women with a first child younger than 6 months old, and their husbands) in the rural subdistricts of Abhoynagar and Mirsarai in Bangladesh to assess their willingness to pay for three types of umbilical cord care products at different price points. Each respondent was asked about willingness to pay prefixed prices for any one of three 7.1% chlorhexidine digluconate products: 1) a single-dose liquid, 2) a multi-dose liquid, or 3) a gel formulation. Each also reported the maximum price they were independently willing to pay for their selected product. We compared participant willingness-to-pay responses to the prefixed prices with their independently reported maximum prices for each type of the product separately. The comparison identified to what extent the respondents' positive responses to the prefixed prices matched their independently reported maximum prices.

Results: This cross matching revealed that willingness to pay the prefixed prices was 41% for the single-dose liquid, 33% for the multi-dose liquid, and 31% for the gel formulation. Although the majority of the respondents were unwilling to pay the prefixed prices, all were willing to pay some amount and reported they could borrow money if necessary. Subsequent analysis of responses to the multi-dose liquid showed borrowing money would not be required if the unit price was Bangladeshi taka 15-25.

Conclusions: A unit price of Bangladeshi taka 15-25 (US$0.21-0.35) for multi-dose 7.1% chlorhexidine digluconate liquid would be affordable to the primary target population in Bangladesh. Although a large market demand could be generated if the product were available at this price point, subsidization may be required to achieve optimal coverage, especially among poorer families.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/1472-698X-13-44DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4016526PMC
October 2013

Initial reactions to the Woman's Condom by potential user groups in Shanghai, China.

J Fam Plann Reprod Health Care 2013 Apr 20;39(2):111-20. Epub 2012 Aug 20.

Senior Program Officer, PATH, Seattle, WA, USA.

Background: The Woman's Condom, a second-generation female condom, is currently being manufactured in China by the Shanghai Dahua Medical Apparatus Company. The manufacturer plans to launch the product in China.

Methods: A survey and focus group discussions were conducted with 73 women and 57 men from nine potential user groups in the Shanghai area to explore, on the basis of visual inspection of the Woman's Condom and product information, their perceptions and attitudes toward the Woman's Condom and lubricant. The potential user groups were male and female university students, male and female college-educated young people, married women and men, migrant women and men, and women working in the entertainment industry.

Results: Female condoms were a new concept for almost all study participants. Women (49%) and men (51%) reported that the Woman's Condom would make "some" or a "great" difference in their lives. Participants reported interest in using the Woman's Condom for sexually transmitted infection (STI) (50%) or dual protection (43%) rather than for pregnancy prevention alone (33%). Findings highlighted comfort, partner approval and lubricant as possible concerns.

Conclusions: Product introduction activities should be oriented toward the most likely early adopter groups (i.e. university students, college-educated young people, migrant women and women working in the entertainment industry). Lack of interest in using the new device by married women/men and migrant men may indicate that they do not perceive a need for a dual protection product since they are already using a contraceptive method and/or do not perceive themselves at risk of STIs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/jfprhc-2011-100211DOI Listing
April 2013

An exploratory, randomized, crossover MRI study of microbicide delivery with the SILCS diaphragm compared to a vaginal applicator.

Contraception 2013 Feb 13;87(2):187-92. Epub 2012 Aug 13.

University of Pennsylvania, Philadelphia, PA 19104, USA.

Background: Microbicide gels studied for HIV prevention often are delivered via a single-use vaginal applicator. Using a contraceptive diaphragm such as the SILCS diaphragm for gel delivery could have advantages, including lower cost and additional pregnancy prevention.

Study Design: We performed an exploratory, nonblinded, randomized, crossover study among healthy, sexually active, nonpregnant women. Using BufferGel, we evaluated three microbicide delivery methods for gel distribution and retention: SILCS single-sided gel delivery, SILCS double-sided gel delivery and a vaginal applicator (without SILCS). Magnetic resonance images were taken at baseline, after gel insertion, and immediately and 6 h after simulated intercourse. Three women completed all gel delivery methods described in this article.

Results: Magnetic resonance imaging analysis indicated similar gel spread in the vagina among all three methods. SILCS single-sided gel application resulted in the most consistent longitudinal coverage; SILCS double-sided gel application was the most consistent in the transverse dimension.

Conclusions: Gel coverage was similar with all three methods. These results suggest that the SILCS microbicide delivery system is comparable to vaginal applicators for delivery of gel products intravaginally.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.contraception.2012.06.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3580797PMC
February 2013

Performance of the woman's condom among couples in Shanghai, China.

Eur J Contracept Reprod Health Care 2012 Jun 12;17(3):212-8. Epub 2012 Apr 12.

Obstetrics and Gynaecology Hospital of the Fudan University Medical Centre, Shanghai, China.

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

Study Design: This single-arm couples' use study was conducted in China in 2010 to assess performance and safety of the Woman's Condom and feasibility of mobile phone technology to record adherence data.

Results: Sixty couples were enrolled in this study, and 59 couples completed all four of the condom uses, resulting in 234 condom uses. Two condoms were opened but not used. Total breakage was 0.85% (two non-clinical breakages). Misdirection (2%), invagination (0.85%) and slippage (1%) were consistent with data on condom failure from other studies. Total clinical failure was 4%. Fifteen mild and no serious adverse events were reported during the study.

Conclusions: This study has shown that in China, the Woman's Condom performs well. Mobile phones cannot yet replace the use of a coital log and questionnaire. Further work on effectiveness is required.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3109/13625187.2012.663016DOI Listing
June 2012

A review of the effectiveness and acceptability of the female condom for dual protection.

Sex Health 2012 Mar;9(1):18-26

Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.

The female condom remains the sole female-initiated method of dual protection against unintended pregnancy and sexually transmissible infections (STIs), including HIV. We reviewed published data on the effectiveness and acceptability of the female condom for protection against pregnancy and infection. Overall, use of the female condom is low and several barriers hinder the wider adoption of the use of the method. Research on effectiveness has focussed on pregnancy, STIs and biological markers of semen exposure. Although the data available suggest that female condoms (or a mixture of female and male condoms) may provide similar degrees of protection against pregnancy and STIs as do latex male condoms alone, this conclusion has not been demonstrated and thus comparative research is urgently needed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1071/SH11037DOI Listing
March 2012

Couples' acceptability of the SILCS diaphragm for microbicide delivery.

Contraception 2012 Jan 11;85(1):99-107. Epub 2011 Aug 11.

California Family Health Council, Los Angeles, CA 90010, USA.

Background: Disposable plastic applicators used in microbicide gel studies are expensive and have a negative environmental impact. The SILCS diaphragm is a barrier contraceptive that could offer a reusable delivery system.

Study Design: Thirty-six couples in this randomized, cross-over study evaluated single- and double-sided gel delivery from a SILCS diaphragm compared with gel from an applicator. Couples used each gel scenario during two acts of intercourse and completed acceptability questionnaires after each.

Results: All three scenarios received favorable ratings for ease of application, acceptability and perceived effectiveness. Both female and male participants tended to rate the gel applicator significantly more favorably than either SILCS gel delivery scenarios for all attributes except messiness/leakage and effectiveness. Additionally, about 60% of female participants and about half of male participants preferred the gel applicator to either of the gel delivery systems using SILCS. The preference for the SILCS scenario for pregnancy protection was statistically significant for both sexes. Male participants were also significantly more likely to prefer the SILCS single-sided delivery system to the gel applicator for protection from sexually transmitted infection.

Conclusions: In this study population, participants found the gel applicator to be more acceptable than either single- or double-sided gel delivery from a SILCS diaphragm. Further research of the SILCS as a microbicide delivery system should be implemented to assess its acceptability among study populations that reflect diverse potential user groups such as women and men from both low and high HIV prevalence settings including HIV-positive populations and with and without experience using female barrier methods.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.contraception.2011.04.003DOI Listing
January 2012

Wear and care of the SILCS diaphragm: experience from three countries.

Sex Health 2010 Jun;7(2):159-64

PATH, Program for Appropriate Technology in Health, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.

Background: Women have been regularly underestimated in their ability to care for and wear cervical barrier devices such as diaphragms appropriately.

Methods: Data from two non-randomised, non-blinded, non-significant risk acceptability studies of a novel cervical barrier device, the SILCS diaphragm, conducted in the Dominican Republic (n = 20), South Africa (n = 21) and Thailand (n = 20), are used to provide insights into the fundamental question of how women actually use an intravaginal device within the constraints of low-resource settings. In all sites, couples not at risk of pregnancy and at low risk of sexually transmissible infections used the SILCS diaphragm four times and provided feedback on acceptability, care and use of the device via product use questionnaires and gender-specific debriefing interviews.

Results: Data from user acceptability studies in these three countries provide an intimate view of how women care for and store the SILCS diaphragm, and both female and male perceptions about handling and re-using it. Results support the view that women are able to wear and care for diaphragms successfully in a variety of settings. In general, male partners were also supportive of care and reuse of the diaphragm.

Conclusions: While the results from these studies indicate that women are able to find ways to cope successfully with the logistics of wearing and caring for an intravaginal device, further supportive evidence from a woman-centred perspective is crucial for reproductive health policymakers and program managers. The authors contend that it is time to reassess perceived constraints to barrier protection.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1071/SH09049DOI Listing
June 2010

Improving quality of prevention of mother-to-child HIV transmission services in Ukraine: a focus on provider communication skills and linkages to community-based non-governmental organizations.

Cent Eur J Public Health 2009 Mar;17(1):20-4

PATH, Ukraine Office, Kyiv, Ukraine.

Background: Ukraine has the highest rate of HIV infection in Europe, with an estimated adult prevalence of 1.6 percent. The epidemic in Ukraine remains largely driven by injection drug use, and women of reproductive age are being increasingly affected. Prior research has highlighted the need to improve the quality of services for prevention of mother-to-child transmission (PMTCT) and to address other issues related to HIV counseling, testing, and care, especially in the context of antenatal and obstetric services.

Methods: From 2004 to 2007, PATH led a collaborative effort to improve the quality of PMTCT services in Ukraine. Initial assessments included focus groups with Ukrainian women and review of existing educational materials. Interventions focused on training providers to improve skills in communication and referral to community-based support; they also addressed the underlying issue of stigma.

Results: Observational data demonstrated that providers who participated in the training intervention delivered PMTCT counseling of a consistently higher quality than did providers who did not undergo training. Exit interviews with clients confirmed these findings.

Conclusions: An intervention focused on strengthening voluntary counseling and testing for HIV, forging partnerships with local organizations, and undoing HIV-related stigma can help to improve access to and quality of PMTCT services in antenatal care clinics.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.21101/cejph.a3478DOI Listing
March 2009