Premarket Notifications and Patents for Breast Pumps Before and After the ACA.

This study investigates whether ACA policies to increase access to breast pumps and lactation care were associated with innovation in the market for breast pumps.

Evidence-based geriatric knowledge among healthcare providers in Vietnam: adaptation, validation, and pilot of the knowledge about older patients quiz.

BACKGROUND: Vietnam's aging population is growing rapidly, but its health workforce's capacity to provide quality geriatric care is not clearly understood. We aimed to provide a cross-culturally relevant and validated instrument to assess evidence-based geriatric knowledge among healthcare providers in Vietnam. METHODS: We translated the Knowledge about Older Patients Quiz from English to Vietnamese using cross-cultural adaptation methods. We validated the translated version by evaluating its relevance to the Vietnamese context, as well as its semantic and technical equivalence. We fielded the translated instrument on a pilot sample of healthcare providers in Hanoi, Vietnam. RESULTS: The Vietnamese Knowledge about Older Patients Quiz (VKOP-Q) had excellent content validity (S-CVI/Ave) and translation equivalence (TS-CVI/Ave) of 0.94 and 0.92, respectively. The average VKOP-Q score was 54.2% (95% CI: 52.5-55.8) and ranged from 33.3 to 73.3% among 110 healthcare providers in the pilot study. Healthcare providers in the pilot study had low scores on questions related to the physiopathology of geriatric conditions, communication techniques with sensory impaired older adults, and differentiating age related changes from abnormal changes or symptoms. CONCLUSIONS: The VKOP-Q is a validated instrument to assess geriatric knowledge among healthcare providers in Vietnam. The level of geriatric knowledge among healthcare providers in the pilot study was unsatisfactory, which supports the need for further assessment of geriatric knowledge among a nationally representative sample of healthcare providers.

Patient-centered care and geriatric knowledge translation among healthcare providers in Vietnam: translation and validation of the patient-centered care measure.

BACKGROUND: People are living longer, and the majority of aging people reside in low- and middle-income countries (LMICs). However, inappropriate healthcare contributes to health disparities between populations of aging people and leads to care dependency and social isolation. Tools to assess and evaluate the effectiveness of quality improvement interventions for geriatric care in LMICs are limited. The aim of this study was to provide a validated and culturally relevant instrument to assess patient-centered care in Vietnam, where the population of aging people is growing rapidly. METHODS: The Patient-Centered Care (PCC) measure was translated from English to Vietnamese using forward-backward method. The PCC measure grouped activities into sub-domains of holistic, collaborative, and responsive care. A bilingual expert panel rated the cross-cultural relevance and translation equivalence of the instrument. We calculated Content Validity Indexing (CVI) scores at both the item (I-CVI) and scale (S-CVI/Ave) levels to evaluate the relevance of the Vietnamese PCC (VPCC) measure to geriatric care in the Vietnamese context. We piloted the translated instrument VPCC measure with 112 healthcare providers in Hanoi, Vietnam. Multiple logistic regression models were specified to test the a priori null hypothesis that geriatric knowledge is not different among healthcare providers with perception of high implementation compared with low implementation of PCC measures. RESULTS: On the item level, all 20 questions had excellent validity ratings. The VPCC had excellent content validity (S-CVI/Ave of 0.96) and translation equivalence (TS- CVI/Ave of 0.94). In the pilot study, the highest-rated PCC elements were the holistic provision of information and collaborative care, while the lowest-rated elements were the holistic attendance to patients' needs and responsive care. Attention to the psychosocial needs of aging people and poor coordination of care within and beyond the health system were the lowest-rated PCC activities. After controlling for healthcare provider characteristics, the odds of the perception of high implementation of collaborative care were increased by 21% for each increase in geriatric knowledge score. We fail to reject the null hypotheses for holistic care, responsive care and PCC. CONCLUSION: The VPCC is a validated instrument that may be utilized to systemically evaluate the practice of patient-centered geriatric care in Vietnam.

Variations in pediatric hospitalization in seven European countries.

OBJECTIVE: To compare rates of pediatric hospital utilization across seven European countries. METHODS: Secondary data from WHO's European Hospital Morbidity Database from 2009 to 2012. Cross- country comparison of rates of admissions and bed days per 100 person-years by clinical service. We tabulated counts of admissions and bed days by principal diagnosis and age group for Ireland, Austria, Hungary, Belgium, Spain, Germany, and France. ICD 9 or ICD 10 or ISHMT diagnosis codes were allocated to clinical services. Normal newborn admissions were excluded from the analysis. Simple linear regression models, weighted by pediatric population size, were constructed to estimate the relationships between health care utilization and factors that may influence variation in care. RESULTS: Hospital admission across the seven countries ranged from 9.41 (Spain) to 19.59 (Germany) admissions per 100 person-years. Bed days ranged from a low of 52.50 (Spain) to 135.44 (Germany) per 100 person-years. General pediatrics and neonatology led in clinical volume across all countries. Infectious disease admissions were the third most common. Bed supply and nurse supply were positively associated with health care utilization. Out-of-pocket payment was inversely associated with health care utilization CONCLUSIONS: A wide range of utilization of pediatric inpatient care was observed across seven European countries that have universal coverage. Variation in the provision of effective, supply-sensitive, and preference-sensitive care may explain some of the variations. Our study shows that it is probable that preventable hospital admissions are occurring in the pediatric population.

Helmet use among motorcycle riders in Ho Chi Minh City, Vietnam: results of a five-year repeated cross-sectional study.

OBJECTIVE: In Vietnam, motorcycle riders comprise about three-quarters of road traffic fatalities, the most common cause of which is head injuries that can be prevented by wearing a helmet. This study aims to assess helmet-wearing behaviors in Ho Chi Minh City, the largest city in Vietnam. METHODS: Eight rounds of observational studies were conducted in six randomly selected locations between July 2015 and April 2019. Given the multinomial nature of the outcome measure (not wearing a helmet; wearing a substandard helmet; wearing an unstrapped standard helmet; wearing a strapped standard helmet), a multinomial model was developed to estimate the level and trend of helmet use and identify the related individual and environmental factors. FINDINGS: A total of 479,892 motorcycle riders were observed, over 90 % of whom were wearing helmets (range over the eight rounds: 92.5 %-96.0 %). However, the prevalence of correct helmet use (defined as wearing a strapped standard helmet) gradually declined from 80.8 % in round 1-55.6 % in round 8. Results from a multinomial model showed the probability of wearing a strapped standard helmet had declined by 22.4 percentage points from round 3 to round 8 while holding other factors constant (95 % CI: 21.8-23.0). The prevalence of correct use is 11.3 percentage points higher for adults than for children (95 % CI: 10.5-12.1). During the same period, unstrapped standard helmet use increased by 24.5 percentage points (95 % CI: 24.1-24.9); substandard helmet use declined but remained high. CONCLUSION: The upward trend of incorrect helmet wearing behaviors and wearing substandard helmets sends a rallying call for multisectoral interventions.

Seatbelt and child restraint use among vehicle occupants in Ho Chi Minh City: an observational study in Vietnam.

This paper presents the trend of seatbelt use, disaggregated by vehicle occupants, in Ho Chi Minh City between 2016 and 2018. We conducted statistical analyses to identify the determinants of seatbelt use, including the effect of a new fine imposed against seatbelt law violation in the rear seats that became effective in January 2018. Seatbelt use was observed in at least half of all vehicle occupants, and drivers were more likely to use seatbelts than passengers. Only 4.4% of children younger than 5-years and 2.5% of 5 to12-year-olds used a child restraint system. Seatbelt use increased among all occupants after the imposed fine, especially among rear-seat passengers. Imposing new or increasing fixed penalties, with enforcement and public education, may increase seatbelt use to prevent road traffic injuries.

Strengthening Existing Laboratory-Based Systems vs. Investing in Point-of-Care Assays for Early Infant Diagnosis of HIV: A Model-Based Cost-Effectiveness Analysis.

BACKGROUND: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. SETTING: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. METHODS: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER <$580/YLS (reflecting programs providing 2 vs. 1 ART regimens). In sensitivity analyses, we varied differences between S-LAB and POC in result return probability, result return time, ART initiation probability, and cost. RESULTS: For infants who acquired HIV, LAB/S-LAB/POC led to projected one-year survival of 67.3%/69.9%/75.6% and undiscounted LE of 21.74/22.71/24.49 years. For all HIV-exposed infants, undiscounted LE was 63.35/63.38/63.43 years, at discounted lifetime costs of $200/220/240 per infant. In cost-effectiveness analysis, S-LAB was an inefficient use of resources; the ICER of POC vs. LAB was $830/YLS. CONCLUSIONS: Current EID programs will attain greater benefit from investing in POC EID rather than strengthening laboratory-based systems.

Estimating the Cost of Point-of-Care Early Infant Diagnosis in a Program Setting: A Case Study Using Abbott m-PIMA and Cepheid GeneXpert IV in Zimbabwe.

BACKGROUND: Point-of-care early infant diagnosis (POC EID) increases access to HIV test results and shortens time to result-return and antiretroviral therapy initiation, as compared to central laboratory-based EID. However, to scale-up POC EID, governments need more information about programmatic costs. METHODS: We evaluated POC EID costs from a health systems perspective. Our primary analysis assessed the Abbott m-PIMA and 2 versions of the Cepheid GeneXpert IV platforms-with a solar battery or gel battery-used in Zimbabwe, with instrument purchase. We also included the following 2 scenarios with zero upfront equipment purchase: (1) m-PIMA using a reagent rental model, with an all-inclusive price when the buyer commits to an average testing volume, and (2) GeneXpert IV, reflecting contexts where GeneXpert is already in place for tuberculosis diagnosis or HIV viral load monitoring. We collected data from project expenditures, observations of health workers, and from government salary scales. We calculated cost per EID test based on number of EID tests performed on each machine per day. RESULTS: The cost per successfully completed test was $44.55 for m-PIMA with platform purchase and $25.89 for m-PIMA reagent rental. Costs for GeneXpert IV with platform purchase were $25.70 using a solar battery, $25.29 using a gel battery, and $23.85 under a scenario assuming no equipment costs. In our primary analyses, materials costs comprised 73%-74% total costs, equipment 14%-20%, labor 5%-8%, training 1%, facility upgrades 1%, and monitoring 1%. CONCLUSIONS: As countries consider scaling up POC EID, these data are important for budgeting and planning.

Front-Line Human Resource Time-Use for Early Infant HIV Diagnosis: A Comparative Time-Motion Study at Centralized and Point-of-Care Health Facilities in Zimbabwe.

BACKGROUND: Point-of-care (POC) assays for early infant diagnosis of HIV (EID) increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy when compared with laboratory-based assays. However, there is a significant gap in our understanding of its human resource impact at the facility level. This study evaluates front-line health workers' (HWs') time associated with EID. SETTING: Using time-motion methodology, we collected time-use data on EID tasks performed by HWs at 3 EID facility types in Zimbabwe-5 POC hubs, 9 POC spokes, and 11 facilities that used centralized laboratories. METHODS: Data collectors observed 30 EID processes and 30 HWs' provided self-reported time. Comparisons of mean differences of HWs' time-use between centralized and POC EID were performed with a 2-sample t test with unequal variances. RESULTS: Observed average total labor time per EID test at POC facilities was 28 minutes, 22 seconds [95% confidence interval (CI): 22:51 to 35:48], which was equivalent to the average preresult time at facilities using centralized EID. HWs performed other tasks while the machine processed samples. Observed average preresult time (counseling to sample preparation) was 18 minutes, 6 Supported by seconds (95% CI: 13:00 to 23:42) for POC compared with 27 minutes, 48 seconds (95% CI: 23:48 to 32:50) for facilities using centralized laboratories. The mean difference of 9 minutes, 42 seconds (95% CI: 03:04 to 16:18) was statistically significant. The differences in self-reported average total labor time per EID test between HWs at facilities using centralized laboratories or POC were not statistically significant. CONCLUSION: Use of POC assays did not incur additional human resource time compared with sending dried blood spots to a centralized laboratory for EID.