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.

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.

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.