Early pregnancy loss in Belagavi, Karnataka, India 2014-2017: a prospective population-based observational study in a low-resource setting.

BACKGROUND: The prevalence of early pregnancy loss through miscarriage and medically terminated pregnancy (MTP) is largely unknown due to lack of early registration of pregnancies in most regions, and especially in low- and middle-income countries. Understanding the rates of early pregnancy loss as well as the characteristics of pregnant women who experience miscarriage or MTP can assist in better planning of reproductive health needs of women. METHODS: A prospective, population-based study was conducted in Belagavi District, south India. Using an active surveillance system of women of childbearing age, all women were enrolled as soon as possible during pregnancy. We evaluated rates and risk factors of miscarriage and MTP between 6 and 20 weeks gestation as well as rates of stillbirth and neonatal death. A hypothetical cohort of 1000 women pregnant at 6 weeks was created to demonstrate the impact of miscarriage and MTP on pregnancy outcome. RESULTS: A total of 30,166 women enrolled from 2014 to 2017 were included in this analysis. The rate of miscarriage per 1000 ongoing pregnancies between 6 and 8 weeks was 115.3, between 8 and 12 weeks the miscarriage rate was 101.9 per 1000 ongoing pregnancies and between 12 and 20 weeks the miscarriage rate was 60.3 per 1000 ongoing pregnancies. For those periods, the MTP rate was 40.2, 45.4, and 48.3 per 1000 ongoing pregnancies respectively. The stillbirth rate was 26/1000 and the neonatal mortality rate was 24/1000. The majority of miscarriages (96.6%) were unattended and occurred at home. The majority of MTPs occurred in a hospital and with a physician in attendance (69.6%), while 20.7% of MTPs occurred outside a health facility. Women who experienced a miscarriage were older and had a higher level of education but were less likely to be anemic than those with an ongoing pregnancy at 20 weeks. Women with MTP were older, had a higher level of education, higher parity, and higher BMI, compared to those with an ongoing pregnancy, but these results were not consistent across gestational age periods. CONCLUSIONS: Of women with an ongoing pregnancy at 6 weeks, about 60% will have a living infant at 28 days of age. Two thirds of the losses will be spontaneous miscarriages and one third will be secondary to a MTP. High maternal age and education were the risk factors associated with miscarriage and MTP. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475 .

Costs and Effectiveness of Treating Homeless Persons with Cocaine Addiction with Alternative Contingency Management Strategies.

BACKGROUND: Between 1990 and 2006 in Birmingham, Alabama USA, 4 separate randomized controlled studies, called "Homeless 1" through "Homeless 4", treated cocaine substance abuse among chronically homeless adults, largely black men, many with non-psychotic mental health problems. The 4 studies had 9 treatment arms that used various counseling methods plus, in some arms, the provision of housing and work therapy usually with a contingent requirement of urine-test verified abstinence from substances. Participants in the abstinent-contingent arms who lapsed on abstinence were removed from housing and sent to an evening public shelter from which they were daily transported to day treatment until they returned to abstinence. AIMS OF THE STUDY: This paper compares the cost effectiveness of the treatment arms. METHODS: Societal cost per participant (in 2014 dollars) for each arm is defined as direct treatment cost plus cost of jail or hospital plus societal expense of public shelter use by lapsed participants. An untreated Base Case is defined as 5 percent abstinence with 95 percent usage of a public shelter. Incremental Cost Effectiveness Ratios (ICERs) for paired arms are defined as the change in cost per participant divided by the change in abstinence. Bootstrapping estimates confidence intervals. RESULTS: Average cost per participant at the end of 6 months of active treatment in 7 arms with comparable data ranged from USD 10,447 to USD 36,194 with corresponding average weeks abstinent ranging from 6.1 to 15.3 out of a possible 26 weeks. In contrast, the Base Case would cost USD 6,123 for 1.3 weeks of abstinence. Compared to the Base Case, the least expensive "DT2" treatment has an ICER of USD 901 (95% CI = USD 571 to USD 1,681) per additional week of abstinence and the most expensive "CMP4" has an ICER of USD 2,147 (95% CI = USD 1,701 to USD 2,848). Additionally, the Homeless 3 study found that the abstinent contingent housing (ACH3) treatment compared to the Non Abstinent Contingent Housing (NAC3), analogous to "Housing First", achieved better abstinence (12.1 v. 10 weeks) at higher average cost (USD 22,512 v. USD 17,541) yielding an ICER for this comparison of (USD 2,367, 95% CI=USD -10,587 to USD 12,467). Similar results are found at 12 months (6 months after active treatment). DISCUSSION: More intensive methods of counseling improved abstinence but 4 of the 7 treatments were inefficient ("dominated"). Bootstrapping shows that results are sensitive to which individuals were randomly assigned to each arm. A limitation of the analysis is that it does not consider the full societal cost of lost wages, crime costs beyond jail expenses and deterioration of neighborhood quality of life. Additionally, populations treated by Housing First programs may differ from the Birmingham Homeless studies in the severity of addiction or co-occuring psychological problems. IMPLICATIONS FOR TREATMENT: The Homeless studies show that abstinent contingent safe housing with counseling can substantially improve abstinence for homeless cocaine abusers. Incremental costs rise sharply with more intensive counseling; modest programs of counseling may be more cost effective in a stepped treatment strategy.

Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings.

BACKGROUND: To describe quantitative data quality monitoring and performance metrics adopted by the Global Network's (GN) Maternal Newborn Health Registry (MNHR), a maternal and perinatal population-based registry (MPPBR) based in low and middle income countries (LMICs). METHODS: Ongoing prospective, population-based data on all pregnancy outcomes within defined geographical locations participating in the GN have been collected since 2008. Data quality metrics were defined and are implemented at the cluster, site and the central level to ensure data quality. Quantitative performance metrics are described for data collected between 2010 and 2013. RESULTS: Delivery outcome rates over 95% illustrate that all sites are successful in following patients from pregnancy through delivery. Examples of specific performance metric reports illustrate how both the metrics and reporting process are used to identify cluster-level and site-level quality issues and illustrate how those metrics track over time. Other summary reports (e.g. the increasing proportion of measured birth weight compared to estimated and missing birth weight) illustrate how a site has improved quality over time. CONCLUSION: High quality MPPBRs such as the MNHR provide key information on pregnancy outcomes to local and international health officials where civil registration systems are lacking. The MNHR has measures in place to monitor data collection procedures and improve the quality of data collected. Sites have increasingly achieved acceptable values of performance metrics over time, indicating improvements in data quality, but the quality control program must continue to evolve to optimize the use of the MNHR to assess the impact of community interventions in research protocols in pregnancy and perinatal health. TRIAL REGISTRATION NUMBER: NCT01073475.

Institutional deliveries and perinatal and neonatal mortality in Southern and Central India.

BACKGROUND: Skilled birth attendance and institutional delivery have been advocated for reducing maternal, perinatal and neonatal mortality (PMR and NMR). India has successfully implemented various strategies to promote skilled attendance and incentivize institutional deliveries in the last 5 years. OBJECTIVES: The study evaluates the trends in institutional delivery, PMR, NMR, and their risk factors in two Eunice Kennedy Shriver NICHD Global Network for Women's and Children's Health Research sites, in Belgaum and Nagpur, India, between January 2010 and December 2013. DESIGN/METHODS: Descriptive data stratified by level of delivery care and key risk factors were analyzed for 36 geographic clusters providing 48 months of data from a prospective, population-based surveillance system that registers all pregnant permanent residents in the study area, and their pregnancy outcomes irrespective of where they deliver. Log binomial models with generalized estimating equations to control for correlation of clustered observations were used to test the trends significance RESULTS: 64,803 deliveries were recorded in Belgaum and 39,081 in Nagpur. Institutional deliveries increased from 92.6% to 96.1% in Belgaum and from 89.5% to 98.6% in Nagpur (both p<0.0001); hospital rates increased from 63.4% to 71.0% (p=0.002) and from 63.1% to 72.0% (p<0.0001), respectively. PMR declined from 41.3 to 34.6 (p=0.008) deaths per 1,000 births in Belgaum and from 47.4 to 40.8 (p=0.09) in Nagpur. Stillbirths also declined, from 22.5 to 16.3 per 1,000 births in Belgaum and from 29.3 to 21.1 in Nagpur (both p=0.002). NMR remained unchanged. CONCLUSIONS: Significant increases in institutional deliveries, particularly in hospitals, were accompanied by reductions in stillbirths and PMR, but not by NMR.

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial.

We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6 months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.

Toward cost-effective initial care for substance-abusing homeless.

In a randomized controlled trial, behavioral day treatment, including contingency management (CM+), was compared to contingency management components alone (CM). All 206 cocaine-dependent homeless participants received a furnished apartment with food and work training/employment contingent on drug-negative urine tests. CM+ also received cognitive-behavioral therapy, therapeutic goal management, and other intervention components. Results revealed that CM+ treatment attendance and abstinence were not significantly different from CM during 24 weeks of treatment. After treatment and contingencies ended, however, CM+ showed more abstinence than CM, indicating a delayed effect of treatment from 6 to 18 months. CM+ had more consecutive weeks abstinent across 52 weeks, but not during active treatment. We conclude that CM alone may be viable as initial care for cocaine-dependent homeless persons. That CM+ yields more durable abstinence indicates that it may be appropriate as stepped-up care for clients not responding to CM (Clinical Trials.gov, no. NCT00368524).

Physical performance measures in the clinical setting.

OBJECTIVES: To assess the ability of gait speed alone and a three-item lower extremity performance battery to predict 12-month rates of hospitalization, decline in health, and decline in function in primary care settings serving older adults. DESIGN: Prospective cohort study. SETTING: Primary care programs of a Medicare health maintenance organization (HMO) and Veterans Affairs (VA) system. PARTICIPANTS: Four hundred eighty-seven persons aged 65 and older. MEASUREMENTS: Lower extremity performance Established Population for Epidemiologic Studies of the Elderly (EPESE) battery including gait speed, chair stands, and tandem balance tests; demographics; health care use; health status; functional status; probability of repeated admission scale (Pra); and primary physician's hospitalization risk estimate. RESULTS: Veterans had poorer health and higher use than HMO members. Gait speed alone and the EPESE battery predicted hospitalization; 41% (21/51) of slow walkers (gait speed <0.6 m/s) were hospitalized at least once, compared with 26% (70/266) of intermediate walkers (0.6-1.0 m/s) and 11% (15/136) of fast walkers (>1.0 m/s) (P <.0001). The relationship was stronger in the HMO than in the VA. Both performance measures remained independent predictors after accounting for Pra. The EPESE battery was superior to gait speed when both Pra and primary physician's risk estimate were included. Both performance measures predicted decline in function and health status in both health systems. Performance measures, alone or in combination with self-report measures, were more able to predict outcomes than self-report alone. CONCLUSION: Gait speed and a physical performance battery are brief, quantitative estimates of future risk for hospitalization and decline in health and function in clinical populations of older adults. Physical performance measures might serve as easily accessible "vital signs" to screen older adults in clinical settings.

Costs and effectiveness of substance abuse treatments for homeless persons.

BACKGROUND: Several reviews of the effectiveness of drug abuse treatment have concluded that treatment works. However, studies analyzing cost-effectiveness or cost-benefits of drug treatment have been limited. Consequently, policy decisions regarding substance abuse treatment have utilized educated guesses or consensus of experts in the absence of controlled and scientifically rigorous studies of the benefits and costs of treatment. AIMS OF THE STUDY: This study presents a cost analysis of two randomized controlled studies comparing four drug addiction interventions for homeless persons. The studies controlled for some limitations of previous research in this area including random assignment. Findings are based on treatment costs obtained from actual expenditures and treatment outcomes of drug abstinence from toxicology tests. Cost-effectiveness is considered from the viewpoint of the treatment program. Cost-effectiveness from a societal viewpoint is discussed, but not calculated. METHODS: This is a retrospective analysis of treatment and treatment outcome costs from two randomized controlled drug addiction treatment outcome studies: Homeless 1 and Homeless 2. Both studies were two-group-usual versus enhanced-care designs with similar treatment components, outcome variables and assessment points, but different research questions. Both studies investigated the efficacy of a contingency management intervention specifically designed for persons who are homeless. This costs analysis reports direct costs of treatment by service category and costs of abstinence at 2-, 6-, and 12-month points by study and study treatment group. Treatment costs and costs per week abstinent are reported for four substance abuse treatments across two studies for persons homeless and addicted primarily to crack cocaine. Treatment components for each program included counseling, housing, work, administrative, and other expenses. RESULTS: Drug abstinence rates by treatment program for each study revealed superior outcomes for the enhanced interventions with the greatest abstinence found at the earlier time points (up to 6 months) as established by previous research. Abstinence rates at 12 months failed to differentiate treatment groups. Average costs per abstinent week were generally greater for the enhanced programs compared to usual care, except early in treatment where these were similar. The incremental direct cost ratios (in year 2000 dollars) for these enhanced programs to increase abstinence by one average week were similar ($1,244 and $1,007) for the Homeless 1 and 2 projects at 12-months. These figures are compared to figures of other life saving events. DISCUSSION: When only the direct costs of programs and their abstinence rates are considered, treatments that involve abstinent contingent work and housing have incremental cost ratios that are within the range of many other common social and medical interventions. These enhanced programs are more cost effective earlier in treatment than at 12-month follow-up due to relapse common among existing drug treatment. A methodological limitation of this study is that direct program costs do not measure the societal value of reducing homelessness itself. IMPLICATIONS FOR HEALTH POLICIES: Usual and improved treatment methods offer a cost-effective approach to improving abstinence among addicted homeless persons. Policy makers might reasonably choose to implement enhanced treatment programs that also reduce homelessness because the incremental cost of these programs is within a reasonable range compared to other common societal interventions. IMPLICATIONS FOR FURTHER RESEARCH: Methods and data need to be developed to better measure the societal benefit to communities of reducing the numbers of homeless persons with addictive drug problems.