Decentralized facility financing versus performance-based payments in primary health care: a large-scale randomized controlled trial in Nigeria.

BACKGROUND: Health system financing presents a challenge in many developing countries. We assessed two reform packages, performance-based financing (PBF) and direct facility financing (DFF), against each other and business-as-usual for maternal and child healthcare (MCH) provision in Nigeria. METHODS: We sampled 571 facilities (269 in PBF; 302 in DFF) in 52 districts randomly assigned to PBF or DFF, and 215 facilities in 25 observable-matched control districts. PBF facilities received $2 ($1 for operating grants plus $1 for bonuses) for every $1 received by DFF facilities (operating grants alone). Both received autonomy, supervision, and enhanced community engagement, isolating the impact of additional performance-linked facility and health worker payments. Facilities and households with recent pregnancies in facility catchments were surveyed at baseline (2014) and endline (2017). Outcomes were Penta3 immunization, institutional deliveries, modern contraceptive prevalence rate (mCPR), four-plus antenatal care (ANC) visits, insecticide-treated mosquito net (ITN) use by under-fives, and directly observed quality of care (QOC). We estimated difference-in-differences with state fixed effects and clustered standard errors. RESULTS: PBF increased institutional deliveries by 10% points over DFF and 7% over business-as-usual (p<0.01). PBF and DFF were more effective than business-as-usual for Penta3 (p<0.05 and p<0.01, respectively); PBF also for mCPR (p<0.05). Twenty-one of 26 QOC indicators improved in both PBF and DFF relative to business-as-usual (p<0.05). However, except for deliveries, PBF was as or less effective than DFF: Penta3 immunization and ITN use were each 6% less than DFF (p<0.1 for both) and QOC gains were also comparable. Utilization gains come from the middle of the rural wealth distribution (p<0.05). CONCLUSIONS: Our findings show that both PBF and DFF represent significant improvements over business-as-usual for service provision and quality of care. However, except for institutional delivery, PBF and DFF do not differ from each other despite PBF disbursing $2 for every dollar disbursed by DFF. These findings highlight the importance of direct facility financing and decentralization in improving PHC and suggest potential complementarities between the two approaches in strengthening MCH service delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT03890653 ; May 8, 2017. Retrospectively registered.

Investigating the quality of family planning counselling as part of routine antenatal care and its effect on intended postpartum contraceptive method choice among women in Nepal.

BACKGROUND: Though modern contraceptive use among married women in Nepal has increased from 26% in 1996 to 43% in 2016, it remains low among postpartum women. Integration of counselling on family planning (FP) at the time of antenatal care (ANC) and delivery has the potential to increase post-partum contraceptive use. This study investigates the quality of FP counselling services provided during ANC visits and women's perceptions of its effectiveness in assisting them to make a post-partum family planning (PPFP) decision. METHODS: In-depth interviews (IDIs) were conducted with 24 pregnant women who had attended at least two ANC visits in one of the six public hospitals that had received an intervention that sought to integrate FP counselling in maternity care services and introduce postpartum intrauterine device insertion in the immediate postpartum period. IDIs data were collected as part of a process evaluation of this intervention. Women were selected using maximum variation sampling to represent different socio-demographic characteristics. IDIs were audio recorded, transcribed verbatim in Nepali, and translated into English. Data were organized using Bruce-Jain quality of care framework and analyzed thematically. RESULTS: Overall, the quality of FP counselling during ANC was unsatisfactory based on patient expectations and experience of interactions with providers, as well as FP methods offered. Despite their interest, most women reported that they did not receive thorough information about FP, and about a third of them said that they did not receive any counselling services on PPFP. Reasons for dissatisfaction with counselling services included very crowded environment, short time with the provider, non-availability of provider, long waiting times, limited number of days for ANC services, and lack of comprehensive FP-related information, education and counselling (IEC) materials. Women visiting hospitals with a dedicated FP counselor reported higher quality of FP counselling. CONCLUSIONS: There is an urgent need to re-visit the format of counselling on PPFP during ANC visits, corresponding IEC materials, counselling setting, and to strengthen availability and interaction with providers in order to improve quality, experience and satisfaction with FP counselling during ANC visits. Improvements in infrastructure and human resources are also needed to adequately meet women's needs.

Effect of a postpartum family planning intervention on postpartum intrauterine device counseling and choice: evidence from a cluster-randomized trial in Tanzania.

BACKGROUND: The World Health Organization recommends postpartum family planning (PPFP) for healthy birth spacing. This study is an evaluation of an intervention that sought to improve women's access to PPFP in Tanzania. The intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services for women electing PPIUD in the immediate postpartum period. METHODS: This cluster-randomized controlled trial recruited 15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016. We present the effectiveness of the intervention using a difference-in-differences approach to compare outcomes, receipt of PPIUD counseling and choice of PPIUD after delivery, between the pre- and post-intervention period in the treatment and control group. We also present an intervention adherence-adjusted analysis using an instrumental variables estimation. RESULTS: We estimate linear probability models to obtain effect sizes in percentage points (pp). The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp). The adherence-adjusted estimates demonstrate that if all women had been counseled, we would have observed a 31.6 pp increase in choice of PPIUD (95% CI: 24.3 - 35.8 pp). Among women counseled, determinants of choosing PPIUD included receiving an informational leaflet during counseling and being counseled after admission for delivery services. CONCLUSIONS: The intervention modestly increased the rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling among women delivering in study facilities. With universal PPIUD counseling, large increases in choice of PPIUD would have been observed. Giving women informational materials on PPIUD and counseling after admission for delivery are likely to increase the proportion of women choosing PPIUD. TRIAL REGISTRATION: Registered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.

Integrating postpartum contraceptive counseling and IUD insertion services into maternity care in Nepal: results from stepped-wedge randomized controlled trial.

BACKGROUND: In Nepal, 54% of women have an unmet need for family planning within the 2 years following a birth. Provision of a long-acting and reversible contraceptive method at the time of birth in health facilities could improve access to postpartum family planning for women who want to space or limit their births. This paper examines the impact of an intervention that introduced postpartum contraceptive counseling in antenatal care and immediate postpartum intra-uterine device (PPIUD) insertion services following institutional delivery, with the intent to eventually integrate PPIUD counseling and insertion services as part of routine maternity care in Nepal. METHODS: This study took place in six large tertiary hospitals. All women who gave birth in these hospitals in the 18-month period between September 2015 and March 2017 were asked to participate. A total of 75,587 women (99.6% consent rate) gave consent to be interviewed while in postnatal ward after delivery and before discharge from hospital. We use a stepped-wedge cluster randomized design with randomization of the intervention timing at the hospital level. The baseline data collection began prior to the intervention in all hospitals and the intervention was introduced into the hospitals in two steps, with first group of three hospitals implementing the intervention 3 months after the baseline had begun, and second group of three hospitals implementing the intervention 9 months after the baseline had begun. We estimate the overall effect using a linear regression with a wild bootstrap to estimate valid standard errors given the cluster randomized design. We also estimate the effect of being counseled on PPIUD uptake. RESULTS: Our Intent-to-Treat analysis shows that being exposed to the intervention increased PPIUD counseling among women by 25 percentage points (pp) [95% CI: 14-40 pp], and PPIUD uptake by four percentage points [95% CI: 3-6 pp]. Our adherence-adjusted estimate shows that, on average, being counseled due to the intervention increased PPIUD uptake by about 17 percentage points [95% CI: 14-40 pp]. CONCLUSIONS: The intervention increased PPIUD counseling rates and PPIUD uptake among women in the six study hospitals. If counseling had covered all women in the sample, PPIUD uptake would have been higher. Our results suggest that providing high quality counseling and insertion services generates higher demand for PPIUD services and could reduce unmet need. TRIAL REGISTRATION: Trial registered on March 11, 2016 with ClinicalTrials.gov, NCT02718222 .

Delivering postpartum family planning services in Nepal: are providers supportive?

BACKGROUND: Health service providers play a key role in addressing women's need for pregnancy prevention, especially during the postpartum period. Yet, in Nepal, little is known about their views on providing postpartum family planning (PPFP) services and postpartum contraceptive methods such as immediate postpartum intra-uterine devices (PPIUD). This paper explores the perspectives of different types of providers on PPFP including PPIUD, their confidence in providing PPFP services, and their willingness to share their knowledge and skills with colleagues after receiving PPFP and PPIUD training. METHODS: In-depth interviews were conducted with 14 obstetricians/gynecologists and nurses from six tertiary level public hospitals in Nepal after they received PPFP and PPIUD training as part of an intervention aimed at integrating PPFP counseling and insertion into routine maternity care services. The interviews were audio recorded, transcribed, and analyzed using a thematic approach. RESULTS: Providers identified several advantages of PPFP, supported the provision of such services, and were willing to transfer their newly acquired skills to colleagues in other facilities who had not received PPFP and PPIUD training. However, many providers identified several supply-side and training-related barriers to providing high quality PPFP services, such as, (i) lack of adequate human resources, particularly a FP counselor; (ii) work overload; (iii) lack of private space for counseling; (iv) lack of IUDs and information, education and counseling materials; and (v) lack of support from hospital management. CONCLUSIONS: Providers appeared to be motivated to deliver quality PPFP services and transfer their knowledge to colleagues but identified several barriers which prevented them from doing so. Future efforts to improve provision of quality PPFP services should address the barriers identified by providers.

Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster-randomized stepped-wedge trial.

BACKGROUND: During the year following the birth of a child, 40% of women are estimated to have an unmet need for contraception. The copper IUD provides safe, effective, convenient, and long-term contraceptive protection that does not interfere with breastfeeding during the postpartum period. Postpartum IUD (PPIUD) insertion should be performed by a trained provider in the early postpartum period to reduce expulsion rates and complications, but these services are not widely available. The International Federation of Obstetricians and Gynecologists (FIGO) will implement an intervention that aims to institutionalize PPIUD training as a regular part of the OB/GYN training program and to integrate it as part of the standard practice at the time of delivery in intervention hospitals. METHODS: This trial uses a cluster-randomized stepped wedge design to assess the causal effect of the FIGO intervention on the uptake and continued use of PPIUD and of the effect on subsequent pregnancy and birth. This trial also seeks to measure institutionalization of PPIUD services in study hospitals and diffusion of these services to other providers and health facilities. This study will also include a nested mixed-methods performance evaluation to describe intervention implementation. DISCUSSION: This study will provide critical evidence on the causal effects of hospital-based PPIUD provision on contraceptive choices and reproductive health outcomes, as well as on the feasibility, acceptability and longer run institutional impacts in three low- and middle-income countries. TRIAL REGISTRATION: Trial registered on March 11, 2016 with ClinicalTrials.gov, NCT02718222 .

Adverse birth outcomes among women with 'low-risk' pregnancies in India: findings from the Fifth National Family Health Survey, 2019-21.

Background: Despite substantial progress in improving maternal and newborn health, India continues to experience high rates of newborn mortality and stillbirths. One reason may be that many births happen in health facilities that lack advanced services-such as Caesarean section, blood transfusion, or newborn intensive care. Stratification based on pregnancy risk factors is used to guide 'high-risk' women to advanced facilities. To assess the utility of risk stratification for guiding the choice of facility, we estimated the frequency of adverse newborn outcomes among women classified as 'low risk' in India. Methods: We used the 2019-21 Fifth National Family Health Survey (NFHS-5)-India's Demographic and Health Survey-which includes modules administered to women aged 15-49 years. In addition to pregnancy history and outcomes, the survey collected a range of risk factors, including biomarkers. We used national obstetric risk guidelines to classify women as 'high risk' versus 'low risk' and assessed the frequency of stillbirths, newborn deaths, and unplanned Caesarean sections for the respondent's last pregnancy lasting 7 or more months in the past five years. We calculated the proportion of deliveries occurring at non-hospital facilities in all the Indian states. Findings: Using data from nearly 176,699 recent pregnancies, we found that 46.6% of India's newborn deaths and 56.3% of stillbirths were among women who were 'low risk' according to national guidelines. Women classified as 'low risk' had a Caesarean section rate of 8.4% (95% CI 8.1-8.7%), marginally lower than the national average of 10.0% (95% CI 9.8-10.3%). In India as a whole, 32.0% (95% CI 31.5-32.5%) of deliveries occurred in facilities that were likely to lack advanced services. There was substantial variation across the country, with less than 5% non-hospital public facility deliveries in Punjab, Kerala, and Delhi compared to more than 40% in Odisha, Madhya Pradesh, and Rajasthan. Newborn mortality tended to be lower in states with highest hospital delivery rates. Interpretation: Individual risk stratification based on factors identified in pregnancy fails to accurately predict which women will have delivery complications and experience stillbirth and newborn death in India. Thus a determination of 'low risk' should not be used to guide women to health facilities lacking key life saving services, including Caesarean section, blood transfusion, and advanced newborn resuscitation and care. Funding: Bill and Melinda Gates Foundation and the World Bank. The findings, interpretations and conclusions expressed in the paper are entirely those of the authors, and do not represent the views of the Gates Foundation or of the World Bank, its Executive Directors, or the countries they represent.

The effect of antenatal counseling and intrauterine device insertion services on postpartum contraceptive use in Nepal: Results from a stepped-wedge randomized controlled trial.

OBJECTIVE: There is high unmet need for family planning in the postpartum period in Nepal. The current study assessed the effects of a contraceptive counseling and postpartum intrauterine device (PPIUD) insertion intervention on use of contraception in the postpartum period. STUDY DESIGN: We utilized a cluster, stepped-wedge design to randomly assign two hospital clusters (compromised of six hospitals) to begin the intervention at time one or time two. From 2015 to 2017, women completed surveys after delivery but before discharge (n = 75,893), and then at one year and two years postpartum. We estimated the intent-to-treat effect of the intervention using weighted, linear probability models and the adherence-adjusted effect (antenatal counseling) using an instrumental variable approach. Outcomes included modern contraceptive use and method mix measured at one and two years postpartum in a sample of 19,298 women (year I follow-up sample) and a sample of 19,248 women (year II follow-up sample). We used inverse probability weights to adjust for incomplete follow-up and bootstrap methods to give correct causal inference with the small number of six clusters. RESULTS: The intervention increased use of modern contraceptives by 3.8 percentage points [95% CI: -0.1, 9.5] at one-year postpartum, but only 0.3 percentage points [95% CI: -3.7, 4.1] at two years. The intervention significantly increased the use of PPIUDs at one year and two years postpartum, but there was less use of sterilization. Only 42% of women were counseled during the intervention period. The adherence-adjusted effects (antenatal counseling) were four times larger than the intent-to-treat effects. CONCLUSIONS: Providing counseling during the antenatal period and PPIUD services in hospitals increased use of PPIUDs in the one- and two-year postpartum period and shifted the contraceptive method mix. IMPLICATIONS: In order for antenatal counseling to increase postpartum contraceptive use, counseling may need to be provided in a wider range of prenatal care settings and at multiple time points. Healthcare providers should be trained on contraceptive counseling and PPIUD insertion, with the goal of expanding the available method mix and meeting postpartum women's contraceptive needs.

Standardized Sensitivity Analysis in BCA: An Education Case Study.

Benefit-cost analyses of education policies in low- and middle-income countries have historically used the effect of education on future wages to estimate benefits. Strong evidence also points to female education reducing both the under-five mortality rates of their children and adult mortality rates. A more complete analysis would thus add the value of mortality risk reduction to wage increases. This paper estimates how net benefits and benefit-cost ratios respond to the values used to estimate education's mortality-reducing impact including variation in these estimates. We utilize a 'standardized sensitivity analysis' to generate a range of valuations of education's impact on mortality risks. We include alternative ways of adjusting these values for income and age differences. Our analysis is for one additional year of schooling in lower-middle-income countries, incremental to the current mean. Our analysis shows a range of benefit-cost ratios ranging from 3.2 to 6.7, and net benefits ranging from $2,800 to $7,300 per student. Benefits from mortality risk reductions account for 40% to 70% of the overall benefits depending on the scenario. Thus, accounting for changes in mortality risks in addition to wage increases noticeably enhances the value of already attractive education investments.

Determinants of imbalanced sex ratio at birth in Nepal: evidence from secondary analysis of a large hospital-based study and nationally-representative survey data.

OBJECTIVES: To quantify sex ratios at births (SRBs) in hospital deliveries in Nepal, and understand the socio-demographic correlates of skewed SRB. Skewed SRBs in hospitals could be explained by sex selective abortion, and/or by decision to have a son delivered in a hospital-increased in -utero investments for male fetus. We use data on ultrasound use to quantify links between prenatal knowledge of sex, parity and skewed SRBs. DESIGN: Secondary analysis of: (1) de-identified data from a randomizedrandomised controlled trial, and (2) 2011 Nepal Demographic and Health Survey (NDHS). SETTING: Nepal. PARTICIPANTS: (1) 75 428 women who gave birth in study hospitals, (2) NDHS: 12 674 women aged 15-49 years. OUTCOME MEASURES: SRB, and conditional SRB of a second child given first born male or female were calculated. RESULTS: Using data from 75 428 women who gave birth in six tertiary hospitals in Nepal between September 2015 and March 2017, we report skewed SRBs in these hospitals, with some hospitals registering deliveries of 121 male births per 100 female births. We find that a nationally representative survey (2011 NDHS) reveals no difference in the number of hospital delivery of male and female babies. Additionally, we find that: (1) estimated SRB of second-order births conditional on the first being a girl is significantly higher than the biological SRB in our study and (2) multiparous women are more likely to have prenatal knowledge of the sex of their fetus and to have male births than primiparous women with the differences increasing with increasing levels of education. CONCLUSIONS: Our analysis supports sex-selective abortion as the dominant cause of skewed SRBs in study hospitals. Comprehensive national policies that not only plan and enforce regulations against gender-biased abortions and, but also ameliorate the marginalizedmarginalised status of women in Nepal are urgently required to change this alarming manifestation of son preference. TRIAL REGISTRATION NUMBER: NCT02718222.

The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka.

BACKGROUND: The International Federation of Gynaecology and Obstetrics (FIGO), in collaboration with the Sri Lankan College of Obstetrics and Gynaecologists (SLCOG), launched an initiative in 2014 to institutionalize immediate postpartum IUD (PPIUD) services as a routine part of antenatal counseling and delivery room services in Sri Lanka. In this study, we evaluate the effect of the FIGO-SLCOG PPIUD intervention in six hospitals by means of a cluster-randomized stepped-wedge trial. METHODS/DESIGN: Six hospitals were randomized into two groups of three using matched pairs. Following a 3-month baseline period, the intervention was administered to the first group, while the second group received the intervention after 9 months of baseline data collection. We collected data from 39,084 women who delivered in these hospitals between September 2015 and January 2017. We conduct an intent-to-treat (ITT) analysis to determine the impact of the intervention on PPIUD counseling and choice of PPIUD, as measured by consent to receive a PPIUD, as well as PPIUD uptake (insertion following delivery). We also investigate how factors related to counseling, such as counseling timing and quality, are linked to choice of PPIUD. RESULTS: We find that the intervention increased rates of counseling, from an average counseling rate of 12% in all hospitals prior to the intervention to an average rate of 51% in all hospitals after the rollout of the intervention (0.307; 95% CI 0.148-0.465). In contrast, we find the impact of the intervention on choice of PPIUD to be less robust and mixed, with 4.1% of women choosing PPIUD prior to the intervention compared to 9.8% of women choosing PPIUD after the rollout of the intervention (0.027; 95% CI 0.000-0.054). CONCLUSIONS: This study demonstrates that incorporating PPIUD services into postpartum care is feasible and potentially effective. Taking the evidence on both counseling and choice of PPIUD together, we find that the intervention had a generally positive impact on receipt of PPIUD counseling and, to a lesser degree, on choice of the PPIUD. Nevertheless, it is clear that the intervention's effectiveness can be improved to be able to meet the demand for postpartum family planning of women. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02718222 . Registered on 11 March 2016 (retrospectively registered).

The Differential Impact of User-Fee Exemption Compared to Conditional Cash Transfers on Safe Deliveries in Nepal.

OBJECTIVE: To assess the differential impact of a copayment exemption compared to a cash incentive on increasing skilled birth attendance (i.e., birth attended by a skilled health worker) in Nepal. DATA SOURCES/STUDY SETTING: This study used data on 8,785 children born between July 2005 and December 2008, obtained from the nationally representative Demographic and Health Surveys, 2006 and 2011. STUDY DESIGN: Twenty-five districts received both the policy interventions, and the remaining 50 control districts received only the cash incentive. We employed a difference-in-differences model to compare children born in districts with both interventions to those in districts with conditional cash transfers only. Average marginal effects of the difference-in-difference coefficient on skilled birth attendance measures are estimated. PRINCIPAL FINDINGS: Skilled birth attendance in districts with both interventions was no higher on average than in districts with only the cash incentive. In areas with adequate road networks, however, significantly higher skilled birth attendance was observed in districts with both interventions compared to those with only the cash incentive. CONCLUSIONS: The added incentive of the user-fee exemption did not significantly increase skilled birth attendance relative to the presence of the cash incentive. User-fee exemptions may not be effective in areas with inadequate road infrastructure.

RAD001 enhances the potency of BEZ235 to inhibit mTOR signaling and tumor growth.

The mammalian target of rapamycin (mTOR) is regulated by oncogenic growth factor signals and plays a pivotal role in controlling cellular metabolism, growth and survival. Everolimus (RAD001) is an allosteric mTOR inhibitor that has shown marked efficacy in certain cancers but is unable to completely inhibit mTOR activity. ATP-competitive mTOR inhibitors such as NVP-BEZ235 can block rapamycin-insensitive mTOR readouts and have entered clinical development as anti-cancer agents. Here, we show the degree to which RAD001 and BEZ235 can be synergistically combined to inhibit mTOR pathway activation, cell proliferation and tumor growth, both in vitro and in vivo. RAD001 and BEZ235 synergized in cancer lines representing different lineages and genetic backgrounds. Strong synergy is seen in neuronal, renal, breast, lung, and haematopoietic cancer cells harboring abnormalities in PTEN, VHL, LKB1, Her2, or KRAS. Critically, in the presence of RAD001, the mTOR-4EBP1 pathway and tumorigenesis can be fully inhibited using lower doses of BEZ235. This is relevant since RAD001 is relatively well tolerated in patients while the toxicity profiles of ATP-competitive mTOR inhibitors are currently unknown.