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Pilot implementation of short message service for randomisation in a multisite pragmatic factorial clinical trial in Kenya.
Get PDFBACKGROUND: The traditional use of sealed envelopes for randomisation is susceptible to manipulation and the risk of damage to envelopes during shipping and storage. Additionally, the filling and sealing of envelopes are tedious, time-consuming, and error-prone. Other randomisation alternatives such as web-based methods are preferred. However, they are expensive and unsuitable in settings with poor internet infrastructure. Mobile phone-based randomisation using short message service (SMS) potentially offers a low-cost and reliable alternative. METHODS: We developed an SMS-based method for random allocation of treatments. Plain text messaging or an Android app was used to formulate text messages using a fixed syntax consisting of the participant's unique identifier, trial site, stratum, and the trial name as input parameters. The system verified the input parameters and obtained an allocation from the database before returning a response to the sender. The text response contained the details of the treatment allocation. This was a Study Within A Trial (SWAT) conducted in two sites of a multi-site 3 × 2 factorial clinical trial in Kenya involving two interventions with up to nine possible allocations. SMS randomisation feasibility was assessed by comparing treatment allocations against the master randomisation list for each processed SMS, measuring SMS latency (in seconds), and gathering user feedback via a post-implementation survey. RESULTS: A total of 218 participants were randomised between the 7th of February 2022 and the 11th of April 2022, out of which 179 were randomised to only one arm while 39 were randomised to both treatment arms. Allocation accuracy was 100%. Median latency was 22 s with the fastest message processed in 10 s and the slowest (non-network delayed) message processed in 2129 s. Four users completed a post-implementation survey. CONCLUSIONS: The pilot study demonstrated that SMS randomisation is easy, user-friendly, fast, accurate, and a feasible alternative randomisation technique
Efficacy of BCG vaccination on incidence, severity and clinical progression of COVID-19: A BCG-REVAC population analysis.
Get PDFBACKGROUND: Can vaccination with Bacille Calmette-Guérin prevent clinical progression of COVID-19? Data from the BCG-REVAC trial was archived in a database, creating an excellent opportunity to link it to notified cases of COVID-19 to evaluate the efficacy of BCG against incidence, severity and clinical progression to severe COVID-19 when given at birth day, at school age as a first dose or as a second dose. METHODS: This study was conducted in the population of the BCG-REVAC cluster randomisation trial including 354,403 schoolchildren, aged 7 to 14 years, from 767 schools from two cities, Salvador and Manaus. Cases of COVID-19 from the System for Notification of Infectious Diseases and the System for Notification of Severe Respiratory Illnesses were record linked to BCG-REVAC population. The exposure was Vaccination or revaccination obtained by the BCG-REVAC. The outcomes of interest in this study were incidence COVID-19; incidence of severe COVID-19; and clinical progression of COVID-19. This project was approved by the Ethics Committee of the Institute of Collective Health, Federal University of Bahia, Brazil. RESULTS: The neonatal dose and a first dose of BCG at school age protect against the incidence of severe COVID-19 in multivariate models, whose efficacies were 30 % (95 %CI:1-51) and 64 % (95 %CI: 22-84), respectively. The neonatal dose showed an effect on severe clinical progression of symptomatic COVID-19 disease in COVID-19 infected subjects 39 % (95 %CI:11 % - 58 %). CONCLUSION: Even 23 years after BCG vaccination and revaccination of school-age children our results suggesting a protective effect of BCG first dose against incidence of severe COVID-19 in infected individuals, a smaller effect of the neonatal dose and no effect of the second dose at school age
Crises and complexity: how can we make health interventions succeed?
Get PDFThe end of the COVID-19 global health emergency presents an opportunity to reflect on actions needed to enhance the effectiveness of responses to any future shocks. We highlight critical areas requiring attention from researchers and research commissioners to enhance the identification and adoption of 'good value' interventions, and we discuss the complexities of evidence-informed decision-making across multiple sectors, the evolving role of modeling, and the need for improved stakeholder engagement and institutional coordination to effectively address interconnected health and policy challenges. We conclude the commentary by making a set of related recommendations to support intervention identification and implementation. Researchers, policymakers, and other key stakeholders should: renew efforts to step out of silos and to develop methods and frameworks that link and synthesize evidence from multiple sources and perspectives, to support planetary health goals and the 'One Health' concept; support more research into understanding the constraints to adopting interventions regarded as good value for money, to enhance evaluation methods ex ante and to better inform systems and stakeholders of the implementation requirements; and maintain an ongoing commitment to equitable research partnerships to ensure that evidence use is relevant for the target settings
Regulator experiences of trials during Ebola epidemics in Sierra Leone, Guinea, and the Democratic Republic of the Congo.
Get PDFINTRODUCTION: During the 2014-2016 Ebola epidemic in West Africa and the Ebola outbreaks between 2018 and 2020 in the Democratic Republic of Congo, vaccines and other tools for prevention and treatment had to be taken through trials in exceptional circumstances using accelerated processes. MATERIALS AND METHODS: We interviewed members of ethics committees, health authorities, health professionals, and political authorities in the Democratic Republic of Congo in 2021 and held a workshop with ethics committee members and regulatory authorities from Sierra Leone and Guinea in 2022 in order to document their experiences of reviewing, approving, and regulating current and new studies during epidemics and outbreaks, and to document lessons learnt and their recommendations for the rapid review of clinical trial protocols during public health emergencies. RESULTS: Similar barriers were identified in the three countries. These were related to weak legal frameworks and partnerships between ethics committees and regulatory bodies. Inadequate human resources, outdated standard operating procedures and guidelines, and lack of finance to support timely reviews were identified. We also noted a lack of awareness from politicians, scientists, and communities about the existence and functions of regulatory bodies/ethics committees, a lack of independence, and low interest in research. Opportunities identified by the institutions in the countries concerned included training ethics committee members and networking with experienced international platforms like the African Vaccine Regulatory Forum. Laws on regulating research have been updated in Sierra Leone and in Guinea, but not yet in the Democratic Republic of Congo. CONCLUSION: Regulatory bodies have been facing many challenges in terms of a lack of a legal framework, a lack of finance, and a lack of support from politicians, scientists, and communities. Networking has been an opportunity for these regulators to mitigate these impediments
Tajikistan: Health System Review.
Get PDFThis analysis of the Tajik health system reviews developments in its organization, governance, financing, provision of services, health reforms and health system performance. Tajikistan has made progress in reforming its health system away from the model inherited from the Soviet period, but challenges remain. In 2022 the country had the second lowest health spending per capita in the WHO European Region, and health spending is dominated by private out-of-pocket payments (both formal and informal) which undermines a range of health system goals, including financial protection. A basic benefits package was piloted for over 15 years but ended in 2023, and while a new package is in development it had not been introduced as of August 2024. Public financing depends primarily on regional and local authorities, which contributes to regional inequalities in funding. Health system efficiency is undermined by outdated provider payment mechanisms, although there have been efforts to introduce changes such as partial capitation-based payments. Quality of care is an ongoing concern, with challenges including insufficient health data, underinvestment in infrastructure and equipment, staff turnover, deficiencies in the training of health workers, and limited access to pharmaceuticals. The number of doctors and nurses per population in Tajikistan is lower than in other countries in Central Asia, although the number of nurses has increased in recent years. There is a particularly pronounced shortage of doctors in rural areas and a high rate of medical staff migration. Medical education has been a key area of reform, but family medicine continues to suffer from low prestige. Health reforms have aimed to strengthen primary health care, with other priorities including health financing, regulation and financial protection. Under its current national health strategy, the government is committed to promoting universal health coverage for the population by 2030, and has established strategic priorities for health system development in key areas such as governance, financing, workforce and health service quality. A substantial number of reforms and an increase in government spending will be required to deliver this vision
Parents' perspectives of the new neonatal BCG vaccination pathway in England: a qualitative study.
Get PDFBACKGROUND: The neonatal Bacillus Calmette-Guérin (BCG) selective vaccination pathway in England was revised in September 2021 due to the introduction of a national evaluation of newborn screening for Severe Combined Immunodeficiency (SCID). BCG is a live attenuated vaccine that is contraindicated in infants with SCID, hence BCG vaccination was moved from soon after birth to after SCID results were available, typically at 14-17 days. The transition also shifted vaccination delivery from maternity units to community clinics, raising concerns about potential barriers to access and lower vaccine uptake. This study explored parents' experiences of navigating the new neonatal BCG vaccination pathway and identified access barriers and enablers. METHODS: A qualitative study was conducted involving semi-structured interviews with 30 parents of infants eligible (or invited) for BCG vaccination in two urban areas where SCID screening was implemented. Participants were recruited through vaccine providers and community centres. Thematic analysis of interview transcripts was conducted using the 'Framework Method', incorporating an inductive approach. RESULTS: Parents were unaware of SCID screening and the changes to the neonatal BCG vaccination schedule and encountered diverse challenges in accessing the vaccine. Assessment errors led to eligibility confusion, with some ineligible infants receiving vaccine invitations. Many parents first learned about BCG vaccination on the postnatal ward, describing it as a "surprise vaccine," with limited antenatal discussion diminishing informed decision-making. Appointment notification systems were inconsistent, with some parents receiving short-notice invitations or no notification at all. Physical access barriers included unfamiliar and distant clinic locations, transport, and the physical challenges of traveling soon after birth with a newborn. Parents with limited social support or financial constraints faced additional difficulties. CONCLUSION: Parents were generally accepting of the need to amend the BCG timeline on account of SCID screening; however, we identified distinct accessibility concerns that varied from those associated with the routine immunisation programme. These barriers, and the separateness of the BCG programme from routine services, impacted parental experiences and vaccine uptake. Addressing these challenges is important to meet neonatal BCG uptake targets and support tuberculosis prevention efforts in England
Long-term quality of life and quality adjusted life years after breast cancer: Impact of detection mode, tumor characteristics and treatment.
Get PDFBACKGROUND: Health-related quality of life (HRQoL) of breast cancer survivors has been extensively evaluated. However, HRQoL differences for women diagnosed by organized mammographic screening and women diagnosed due to symptoms have been sparsely described. We aimed to compare self-reported long-term HRQoL and quality adjusted life years (QALYs) between women with screen-detected breast cancer and women with symptomatic breast cancer, adjusting for histopathologic tumor characteristics and treatment. METHODS: This study was nested within a cohort of women diagnosed with breast cancer by organized mammographic screening or due to symptoms 2006-2017 who responded a questionnaire measuring HRQoL (VAS, 0-100) and EQ-5D-5L 2019-2020. Responses to EQ-5D-5L were transformed into health utility values using a tariff based on preferences elicited in a national survey. Multivariable linear regression models were used to compare VAS-scores adjusting for tumor characteristics and treatment. QALYs were estimated by summing up the health utility values between the third and the fifth year since breast cancer diagnosis adjusting for breast cancer survival. RESULTS: Mean HRQoL (VAS) was 66.2 (standard deviation, SD: 21.1) for women with screen-detected breast cancer (n = 1141) and 62.5 (SD: 21.2) for women with symptomatic breast cancer (n = 1561). Women with screen-detected breast cancer had 3.8 (95 % confidence interval, CI, 2.3, 5.4) and 3.7 (95 %CI 2.1, 5.2) higher HRQoL VAS-scores compared to women with symptomatic breast cancer in the models adjusted for tumor characteristics and treatment, respectively. Women with screen-detected breast cancer and women with symptomatic breast cancer accrued 2.30 and 2.06 QALYs, respectively. CONCLUSION: Women with screen-detected breast cancer demonstrated higher estimates of long-term HRQoL and QALYs compared to women with symptomatic cancer. POLICY SUMMARY: More favorable long-term quality of life outcomes were shown for women diagnosed with breast cancer by organized mammographic screening compared to women diagnosed due to symptoms
Large connected components in sexual networks and their role in HIV transmission in Sub-Saharan Africa: A model-based analysis of HPTN 071(PopART) data.
Get PDFThe HIV epidemic in sub-Saharan Africa is historically characterised by high levels of prevalence and incidence. With the global effort to reach UNAIDS 95-95-95 targets, the scaling-up of HIV treatment, and focused preventive interventions, incidence has been declining over the past decade, albeit non-consistently across different sex and age groups. Two questions remain to be addressed to help tailor setting-specific interventions and allocate resources optimally. Firstly, are there unidentified demographic groups that are sources of transmission? Secondly, what are the patterns of decline in incidence across different groups? Model-based assessment is a valuable tool for the design of focused interventions and to answer these questions. PopART-IBM, an individual-based model calibrated to (anonymised) age-and-sex stratified data, was developed in the context of the HPTN-071 (PopART) trial, and it offers a unique opportunity to explore such questions in the context of high-burden HIV communities in Zambia and South Africa. The outputs of the model include the full HIV transmission and partnership networks. In this work, we explore these and show that the sexual partnership network exhibits a large connected component, usually comprising over 40 % of the population, in each of the studied communities. An analysis of the large connected component reveals that it is formed by young people (20-40 years old) and is centered around the most sexually active individuals of the community. At the same time, many individuals in the large connected component only have one partner, highlighting the complex dynamics of risk correlations in a population. Inspecting the transmission network reveals that, on average, more than 80% of transmissions occur among individuals belonging to the large connected component. These findings indicate that populations consisting of young and highly sexually active individuals should be given high priority when designing or deploying interventions
Feasibility of interrupting the transmission of soil-transmitted helminths: the DeWorm3 community cluster-randomised controlled trial in Benin, India, and Malawi.
Get PDFBACKGROUND: Soil-transmitted helminths are targeted for elimination as a public health problem. This study assessed whether, with high coverage, community-wide mass drug administration (MDA) could lead to transmission interruption. METHODS: DeWorm3 is an open-label, community cluster-randomised controlled trial in Benin, India, and Malawi. In each country, a single governmental administrative unit (population ≥80 000 individuals) with soil-transmitted helminth endemicity and participation in at least five rounds of community-wide MDA for lymphatic filariasis, was divided into 40 clusters (population ≥1650 individuals), which were randomly assigned (1:1) to community-wide MDA versus school-based deworming. Laboratory personnel were masked to exposure status and all investigators were masked to post-baseline outcome data until unmasking. In all clusters, preschool-aged and school-aged children received school-based deworming as per national guidelines for 3 years. In intervention clusters, door-to-door community-wide MDA (a single oral dose of 400 mg albendazole) was delivered to all eligible individuals biannually by community drug distributors for 3 years. All individuals aged 12 months and older in India and Benin and aged 24 months and older in Malawi were eligible for treatment, except women in the first trimester of pregnancy, those with adverse reactions to benzimidazoles, those who were acutely ill or intoxicated, or those reporting treatment within the previous 2 weeks. The co-primary outcomes were individual-level prevalence and cluster-level transmission interruption (ie, weighted prevalence of predominant species of ≤2%) of the predominant soil-transmitted helminth species, assessed by quantitative PCR (qPCR) 24 months after the last round of MDA. The analysis set contained a subset of randomly selected participants per cluster who enrolled in the endline assessment, provided a stool sample, and had a qPCR result. All individuals who received treatment were eligible for inclusion in the safety population. This trial is registered with ClinicalTrials.gov (NCT03014167), and is active but not recruiting. FINDINGS: Between Oct 10, 2017, and Feb 17, 2023, 120 clusters (40 clusters per country, comprising 357 716 individuals) were randomly assigned, 60 to community-wide MDA and 60 to school-based deworming. 184 030 (51·4%) individuals in the clusters at baseline were female, 173 663 (48·5%) were male, and 23 (<0·1%) were other. The analysis set consisted of 58 827 individuals in the control group and 58 554 in the intervention group 24 months after the cessation of all deworming, Necator americanus prevalence (the predominant species at all sites) in the community-wide MDA group was lower than the school-based deworming group in Benin (adjusted prevalence ratio [aPR] 0·44 [95% CI 0·34-0·58]), India (0·41 [0·32-0·52]), and Malawi (0·40 [0·34-0·46]). Transmission interruption was achieved for N americanus in 11 (55%) of 20 intervention clusters versus six (30%) of 20 control clusters in Benin (p=0·20), in one (5%) intervention cluster versus no control clusters in India (p=1·00), and in no clusters in either group in Malawi (p=1·00). 984 adverse events were reported among 487 participants over the study, of which 32 among 13 participants resulted in hospitalisation and were classified as serious adverse events (three of which were related to study procedures). INTERPRETATION: Soil-transmitted helminth transmission interruption might be possible in focal geographies but does not appear to be programmatically feasible within the evaluated timeframe. Community-wide MDA should be considered as an alternative strategy to school-based deworming programmes to improve equity and outcomes in helminth-endemic areas. FUNDING: The Gates Foundation
Comparing In-Person and Remote Qualitative Data Collection Methods for Data Quality and Inclusion: A Scoping Review
Get PDFBackground: In-person data collection has long been considered the ‘gold standard’ for qualitative data collection. Societal changes and the rapid increase in the use of remote methods during the Covid-19 pandemic intensified debate about the limitations and opportunities of remote data collection, while reigniting questions about data quality and inclusion.
Objective: We sought to map available evidence exploring the characteristics and quality of remotely collected qualitative data compared to in-person qualitative data.
Eligibility Criteria: A scoping review was conducted of empirical research studies that employed both remote and in-person methods with similar participants, to address the same research question. Sources of Evidence: Searches were conducted in MEDLINE, CINHAL, Web of Science, Scopus and Applied Social Science Index and Abstracts (ASSIA). The review includes peer reviewed articles published in English since 2000.
Methods: Data were extracted from included papers using a data extraction tool based on JBI guidance, adapted to address our research questions.
Results: A total of 58 articles are included. These cover a range of research methods and participant groups. Overall, remotely collected data is likely to generate similar themes to data collected in person but more concisely. Sensitive topics may be the exception. Non-verbal data and interaction between participants may be lost but the significance of this for data quality is not as well understood as participants may disclose more information remotely.
Conclusions: Researchers should consider the fit of epistemology, population and topic when making decisions about remote data collection. If the benefits of remote data collection for qualitative research are to be fully realised, further research is needed to identify which elements of in-person and remote qualitative data collection are most effective, with which populations and research topics, and how remote data differs from in-person data