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Exploring adaptive health technology assessment for evaluating 10 cancer interventions: insights and lessons from a pilot study in India.
Get PDFBACKGROUND: Health technology assessment (HTA) is a valuable tool for informing the efficient allocation of resources in healthcare. However, the resource-intensive nature of HTA can limit its application, especially in low-resource settings. Adapting HTA processes by assessing the available international evidence offers a pragmatic approach to provide evidence for decision-making where resources are constrained. OBJECTIVE: This study piloted an adaptive HTA (aHTA) method to evaluate 10 cancer interventions. METHODS: We arranged a joint collaboration with the International Decision Support Initiative and the National Cancer Grid in India to form a working group of clinicians and health economists. We conducted a rapid review of HTA reports and economic evaluations for ten prioritised common cancer interventions for breast, lung, and head and neck cancers. We extracted data on cost-effectiveness, conducted a price benchmarking analysis, estimated treatment costs and calculated the treatment's share of the national insurance family allowance. Finally, we determined through qualitative appraisal whether the intervention would likely to be considered cost-effective in the Indian context. RESULTS: Of the 10 interventions assessed, 9 had sufficient evidence to make determinations on the likely cost-effectiveness. Three were potentially cost-effective (one after a price discount and another by using the generic price), while five were not, and one was only cost-effective in a subgroup. One intervention required a full HTA due to remaining uncertainty. Information on the likely cost-effectiveness, clinical and safety benefits, and treatment costs was consistently found through publicly available evidence. Assessment methods were modified slightly across the 10 interventions, including expanding the data extraction criteria, updating the calculations and broadening the evidence retrieval. CONCLUSION: The aHTA method is a feasible resource-sensitive alternative to traditional HTA for informing decision-making in resource-constrained settings when ample international data on cost-effectiveness for a given topic is available
Born Too Soon: Progress and priorities for respectful and rights-based preterm birth care.
Get PDFPROGRESS: Human rights related to preterm birth encompass access to respectful, evidence-based care; informed consent; protection from discrimination, detention, and unnecessary separation of mother and newborn; and broader social entitlements, such as parental leave and early disability support. Since the 2012 Born Too Soon report, global recognition of these rights has expanded through international treaties, global guidelines, national legal reforms, and social movements. Demand for respectful care, including respectful maternity care and family centred care, has led to its incorporation into global guidelines and policies and a greater evidence-base. However, persistent challenges, such as workforce shortages, discriminatory policies, and the erosion of sexual and reproductive rights, continue to threaten progress. PROGRAMMATIC PRIORITIES: Ensuring respectful and rights-based preterm birth care requires coordinated action across the continuum of care and across sectors, with the mother-baby dyad at the centre. Programmatic priorities at the individual level include implementing respectful maternity care and family-centred care. Ensuring high-quality, respectful care demands that providers themselves are supported, protected, and empowered to deliver such care. Their well-being is a critical enabler of the rights of patients and an essential component of effective, compassionate service delivery. At the facility-level, health systems must be purposefully designed to safeguard the fundamental human rights of the individuals with them, both care seekers and care providers. Implementing respectful, rights-based care relating to preterm birth requires structural and social changes, as well as robust data systems for accountability. Multi-stakeholder action requires strengthening accountability mechanisms at all levels and partnering with those affected by preterm birth-particularly women, families and healthcare providers-in policy processes, and the design, implementation and monitoring of care. At national-level, action requires the adoption, implementation and monitoring of international and regional human rights instruments, with multisectoral collaboration and social mobilization where violations continue. PIVOTS: To operationalize respectful and rights-based care for preterm birth, four primary shifts are needed: scale up respectful care; empower and partner with women and families; address the shortage of healthcare providers and protect their rights; and strengthen policy action and accountability
Evaluation of the diagnostic accuracy of the ReLASV Pan-Lassa Antigen Rapid Test for Lassa Fever in Nigeria.
Get PDFLassa fever is a zoonotic disease found in several countries across West Africa, with estimates of up to 300,000 infections and 10,000 deaths yearly. The highest incidence is in Nigeria. Suspected cases are often seen in areas with limited infrastructure and diagnostics capacity, hence the availability of an accurate rapid diagnostic test (RDT) that could be used in the community would be an important public health tool. Unfortunately, few RDTs for Lassa fever exist and have not been thoroughly validated. Toward that end, we conducted a Phase 2 performance evaluation to assess the diagnostic accuracy of the ReLASV Pan-Lassa Antigen Rapid Test (Zalgen Labs, Frederick, MD, USA) using archived, frozen whole blood, plasma, and serum samples collected from individuals in Nigeria to determine its suitability for widespread use as a screening tool for Lassa fever. The overall performance of this RDT was measured against the reference test, the Altona RealStar LASV real-time reverse transcription polymerase chain reaction 2.0 (Altona Diagnostics, Hamburg, Germany). The sensitivity and specificity of the ReLASV Pan-Lassa Antigen Test were 65% and 50.7%, respectively. The low diagnostic accuracy indicated in our and other independent evaluations of the ReLASV Pan-Lassa Antigen Rapid Test suggests that this test, at least until further developed, refined, and validated, is not suitable for making critical diagnostic or treatment decisions for Lassa fever, at least for lineages that commonly circulate in Nigeria. These findings underscore the importance of thoroughly assessing the performance characteristics of tests to ensure their reliability and accuracy
Evaluation of a novel point-of-care lateral flow assay screening for Neisseria gonorrhoeae infection among pregnant women in Zimbabwe.
Get PDFAffordable, easy-to-use and rapid diagnostics may support a move away from syndromic management for sexually transmitted infections (STIs) in resource-constrained settings. A lateral flow assay for Neisseria gonorrhoeae (NG-LFA) has shown high sensitivity and specificity (>90%) in symptomatic individuals. We investigated the performance and acceptability of this assay as a screening tool for NG among pregnant women. This evaluation was embedded within a prospective study evaluating point-of-care STI screening in pregnant women attending antenatal care (ANC) in Harare, Zimbabwe. Participants were included regardless of symptom status, ANC visit number, or gestational age. Nurse-collected vaginal swabs were tested on-site using the NG-LFA and the Xpert CT/NG assay (Xpert) (reference test). The implementation team members (n=4) were interviewed to assess acceptability and usability of NG-LFA. Of 912 participants, 4.8% (44/912) self-reported presence of abnormal vaginal discharge. Xpert NG prevalence was 4.2% (38/912); 81.6% (31/38) of infections were asymptomatic. The sensitivity, specificity, positive predictive value, and negative predictive value (NPV) of the NG-LFA were 65.8% (25/38; 95% CI 48.6%-80.4%), 99.2% (867/874; 95% CI 98.4-99.7%), 78.1% (25/32; 95% CI 60.0-90.7%), and 98.5% (867/880; 95% CI 97.5-99.2%). The NG-LFA was considered easy-to-use and interpret but discordant results led to issues of trust in the NG-LFA results. Among predominantly asymptomatic pregnant women, the NG-LFA had high specificity, but relatively low sensitivity meaning one in three cases of gonorrhoea were not detected. Further studies are warranted to assess the clinical performance and cost-effectiveness of the NG-LFA in other settings and populations
Doctors taking bribes from pharmaceutical companies is common and not substantially reduced by an educational intervention: a pragmatic randomised controlled trial in Pakistan.
Get PDFINTRODUCTION: Incentive-linked prescribing, which is when healthcare providers accept incentives from pharmaceutical companies for prescribing promoted medicines, is a form of bribery that harms patients and health systems globally. We developed a novel method using data collectors posing as pharmaceutical company sales representatives to evaluate private doctors' engagement in incentive-linked prescribing and the impact of a multifaceted educational intervention on reducing this practice in Karachi, Pakistan.
METHODS: We made a sampling frame of all doctors running for-profit, primary-care clinics and randomly allocated participants to control and intervention groups (1:1). The intervention group received a multifaceted seminar on ethical prescribing and reinforcement messages over 6 weeks. The control group attended a seminar without mention of ethical prescribing. The primary outcome was the proportion of participants agreeing to accept incentives in exchange for prescribing promoted medicines from data collectors posing as pharmaceutical company representatives, 3 months after the seminars.
RESULTS: We enrolled 419 of 440 eligible participants. Of 210 participants randomly allocated to the intervention group, 135 (64%) attended the intervention seminar and of 209 participants allocated to the control group, 132 (63%) attended the placebo seminar. The primary outcome was assessed in 130 (96%) and 124 (94%) of intervention and control participants, respectively. No participants detected the covert data collectors. 52 control group doctors (41.9%) agreed to accept incentives as compared with 42 intervention group doctors (32.3%). After adjusting for doctors' age, sex and clinic district, there was no evidence of the intervention's impact on the primary outcome (OR 0.70 [95% CI 0.40 to 1.20], p=0.192).
CONCLUSIONS: This first study to covertly assess deal-making between doctors and pharmaceutical company representatives demonstrated that the practice is strikingly widespread in the study setting and suggested that substantial reductions are unlikely to be achieved by educational interventions alone. Our novel method provides an opportunity to generate evidence on deal-making between doctors and pharmaceutical companies elsewhere
Estimating prevalence and identifying predictors of zero-dose pentavalent and never-immunized children under two years of age in Kashmore and Sujawal Districts of Sindh, Pakistan: An analysis of household survey data.
Get PDFINTRODUCTION: Despite intensified global efforts to enhance immunization coverage, one in five children continue to miss out on life-saving vaccines, leaving them vulnerable to a range of vaccine-preventable diseases. In 2022, 14.3 million children failed to receive even a single dose of the pentavalent vaccine (Penta-1) by their first birthday, classified as "zero-dose penta". Additionally, some children have not received any vaccinations at all and have had no contact with healthcare services-these are referred to as "never-immunized" children. Collectively, both groups-zero-dose penta and never-immunized children-are termed "true zero-dose" to emphasize the critical need for targeted interventions that ensure no child is left behind in immunization efforts. METHODS: We conducted a household (HH) survey from August 10 to December 19, 2022, in Kashmore and Sujawal, two districts in Sindh, Pakistan, with low immunization coverage. The survey targeted children aged 12-23 months who had not received the Penta-1 vaccine by their first birthday. Our study aimed to determine the community-based prevalence of zero-dose penta and never-immunized children, compare their sociodemographic characteristics and immunization histories, and identify predictors of these outcomes. RESULTS: Of the 2,091 children surveyed, 497 (23.8%) were zero-dose penta, and 587 (28.1%) were never-immunized. Together, these groups constitute 51.9% of the survey population, referred to as 'true zero-dose'. The remaining 1,007 (48.1%) were either fully or partially immunized. Multivariate analysis indicated that absence of antenatal care (ANC) significantly increased the risk of children being classified as zero-dose penta (RRR = 1.68; 95% CI: 1.04-2.72; p < 0.035) and never-immunized (RRR = 2.07; 95% CI: 1.25-3.45; p < 0.005). Furthermore, the absence of Lady Health Worker (LHW) visits significantly increased the risk of children being classified as zero-dose penta (RRR = 2.55; 95% CI: 1.26-5.16; p < 0.009), and the absence of vaccinator visits significantly increased the risk of being never-immunized (RRR = 4.44; 95% CI: 2.68-7.36; p < 0.001). CONCLUSION: Despite global efforts for achieving universal immunization, half of the surveyed children remained true zero-dose, highlighting significant gaps in the ability of immunization programs to reach underserved communities. To address this issue, it is essential to enhance ANC coverage and leverage frontline health workers (FHWs) to identify and engage with clusters of zero-dose children effectively. These measures will ensure that no child is left behind, advancing health equity and safeguarding future generations
Association between social determinants of health and hearing loss in South African children: A secondary data analysis.
Get PDFGlobally, 34 million children below 15 years have hearing loss (HL) and while research shows associations between social determinants of health and disability in general, research on the associations between these determinants and HL in children is limited. Therefore, this study sought to examine the association between social determinants of health and HL in children using the parental socioeconomic status, such as educational attainment level, employment status and income level, non-medical determinants of health (rurality, housing, type of toilet, availability of piped drinking water, and exposure to cigarette smoke) as proxy factors for social determinants of health in children. This was a secondary data analysis of a cross-sectional survey conducted with 517 children in South Africa. We conducted multivariable logistic regression to test for the association between HL and exposure variables such as non-medical determinants of health and parental socioeconomic status using Stata v18 for Macintosh. Odds ratios (OR) with 95% confidence intervals (CIs) were used to ascertain the odds of HL with exposure variables. One hundred and two participants (n = 102, 19.7%) had HL, including 57 (55.9%) females. Crude analysis showed increased odds of HL in females (OR:1.6; 95%CI: 1.0 - 2.5, P = 0.03) and children younger than9 years (OR: 2.0; 95%CI: 1.3 - 3.1, P = 0.003). After adjusting for age and sex, exposure to cigarette smoke (aOR: 4.0; 95%CI:2.4 - 6.4, P < 0.001), living in a mud house (aOR: 1.6; 95%CI:1.2 - 2.7, P = 0.04), lack of piped drinking water (aOR: 1.9; 95%CI:1.1 - 3.1, P < 0.02), using pit latrines (aOR: 4.1; 95%CI:1.3 - 13.0, P = 0.01), having parents who (i) did not complete high school (aOR: 2.8; 95%CI:1.4 - 2.4, P = 0.01), or those earning a combined annual household income (iii) less than 2,883 and $8,006 (aOR:5.0; 95%CI:2.5 - 43.5, P = 0.05) increased the odds of HL. Based on these findings, we recommend public health interventions targeting these social determinants to reduce the global burden of HL, and further research to understand the pathophysiology of HL in those exposed to smoking or using pit latrines
All-Cause and Cause-Specific Mortality in Children With Congenital Zika Syndrome in Brazil.
Get PDFIMPORTANCE: Congenital Zika syndrome (CZS) can lead to a range of developmental and neurological issues, which increases the risk of early death. However, the all-cause and cause-specific mortality in children with CZS in the first 5 years of life remain unknown.
OBJECTIVE: To compare the hazard of all-cause and cause-specific mortality before age 5 years among children with and without CZS in Brazil.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study used nationwide linked routine data including all children born from January 2015 to December 2018 in Brazil. They were followed-up until age 5 years, death, or December 2020, whichever occurred first. All analysis were conducted in May 2024.
EXPOSURES: Confirmed or probable cases of CZS.
MAIN OUTCOMES AND MEASURES: All-cause and cause-specific deaths from respiratory, infectious and parasitic, and nervous system diseases were the outcomes. Hazard ratios (HRs), comparing children with and without CZS, for all and cause-specific mortality were estimated using Cox proportional hazard models adjusted for region and year of birth, maternal characteristics (age, education, race and/or ethnicity, and marital status), and sex of the newborn. The analysis was conducted in May 2024.
RESULTS: In total, there were 11 387 431 live births (5 832 594 male newborns [51.2%]). Of 3080 children notified as CZS cases, 444 (14.4%) died, including 154 (34.7%) from respiratory diseases, 152 (34.2%) from infectious and parasitic diseases, and 82 (18.5%) from nervous system diseases. Children with CZS were predominantly preterm (596 newborns [20.0%] vs 1 122 378 newborns [10.1%]) and had low birth weight (1095 newborns [35.7%] vs 805 373 newborns [7.1%]), compared with children without CZS. After controlling for confounders, children with CZS were 13.10 (95% CI, 11.86-14.46) times more likely to die in the first 5 years of life compared with those without the syndrome. The cause-specific mortality HRs were 30.28 (95% CI, 25.59-35.83) for respiratory diseases, 28.26 (95% CI, 23.85-33.48) for infectious and parasitic diseases, and 57.11 (95% CI, 45.23-72.11) for nervous system diseases. After excluding newborns who were preterm, low birth weight, and/or small for gestational age, the HRs for all-cause and cause-specific deaths were even higher.
CONCLUSIONS AND RELEVANCE: In this cohort study, children born with CZS had strikingly higher risk of overall and cause-specific mortality. These findings may support the development of clinical protocols to prevent early mortality and improve survival in these children
Investigating microbial population structure and function in the chicken caeca and large intestine over time using metagenomics.
Get PDFOBJECTIVES: Although taxonomic variations in chicken gut microbiota have been previously documented, their functional capacity remain poorly understood. To gain a better understanding, we incorporated whole genome shotgun metagenomics to analyse microbial communities of two different organs: the caeca and the large intestine. RESULTS: Using 24 samples obtained from the caeca and the large intestine of commercial chickens, we assembled Metagenome-Assembled Genomes (MAGs) and characterise their functional profiles. Afterwards, using 8 samples, we integrated this sequencing data with chicken performance metadata body weight (BW), weight gain, feed intake (FI), feed conversion ratio (FCR) and age. MAGs belonging to specific families were found to be positively associated with changes in performance parameters. Functional analyses suggest changes in nutrient geochemical cycles including hydrogen generation within the carbon-cycle. Furthermore, 108 CAZymes were identified for MAGs belonging to two major families - glycoside hydrolase (GH) and polysaccharide lyase (PL), which are important for breakdown of dietary carbohydrates and fibres. A total of 13 polysaccharide lyases were identified functioning on day 20 with enzymes were specific to organs. Overall, our results provide a deeper understanding of microbial-mediated metabolism concerning key performance parameters in chicken production
Maternal vaccination decision-making in urban and rural Bengaluru, India: A mixed methods study.
Get PDFMaternal immunization is key to reducing morbidity and mortality among both pregnant women and infants; however, improving maternal vaccination uptake remains a challenge globally. We conducted a mixed methods study using a social ecological model in urban and rural sites in Bengaluru, India, to examine vaccination decision-making and factors influencing vaccination during pregnancy at the individual, interpersonal, organizational, community and policy levels. We conducted semi-structured interviews with pregnant women and new mothers (n = 70) and family members (n = 11), four focus group discussions with 35 women, and in-depth interviews with healthcare providers (HCPs, n = 26) and policymakers (n = 16). A majority (67%) of women were not included in decisions regarding their own pregnancy-related healthcare, which were typically made by other family members, such as husbands and mothers-in-law. HCPs, including community workers, were most influential in maternal vaccination decision-making, followed by family members. Although national guidelines were the next most important influencer, policymakers tended to underestimate communities' trust in and reliance on these guidelines. Traditional media are considered more trustworthy and influential than social media. Trust in HCPs and long-standing community use and experience with tetanus vaccines promoted what may be characterized as passive acceptance as they were given as a matter of course at antenatal appointments. Use of a social ecological framework indicates that many influences beyond individual-level factors influence maternal vaccine acceptance in developing settings. Clear government priority and policy along with engagement with families, communities and various types of HCPs are likely to be critical in maximizing acceptance of newer maternal vaccines