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COVID-19 vaccination status and associated factors among patients presenting with COVID-19-like symptoms in Uganda.
Get PDFINTRODUCTION: The emergence of new SARS-CoV-2 variants threatens the effectiveness of global vaccination campaigns. This study examines the vaccination status and associated factors among patients presenting with COVID-19-like symptoms at 19 healthcare facilities in Uganda. MATERIALS AND METHODS: A cross-sectional analysis was conducted using data collected at health facilities to evaluate the effectiveness of COVID-19 vaccines in Uganda from March 2023 to March 2024. Participants were individuals aged 12 years and older with COVID-19-like symptoms who underwent a SARS-CoV-2 qPCR test within 10 days of symptom onset. The study involved obtaining informed consent, collecting medical and vaccination histories (confirmed using vaccination cards and Ministry of Health COVID-19 database), performing physical examinations, administering a questionnaire, and taking oral/nasopharyngeal swabs for SARS-CoV-2 qPCR testing. Vaccination coverage was defined as receiving at least one vaccine dose. Logistic regression was used to identify factors associated with vaccination status. RESULTS: Among 1398 participants enrolled (55.4 % female), the median age was 30.0 years (IQR: 24.0-41.0). Vaccination coverage, was 66.6 %. Residing in Wakiso district compared to the Capital, Kampala was associated with a higher likelihood of vaccination (adjusted odds ratio [aOR] = 1.4, 95 % CI: 1.0-1.8, p = 0.021). Frontline and healthcare workers were more likely to be vaccinated (aOR = 5.0, 95 % CI: 3.6-7.3, p < 0.001), as were individuals with a previous COVID-19 diagnosis (aOR = 2.4, 95 % CI: 1.6-3.9, p < 0.001). CONCLUSIONS: Our results underscore the need for targeted public health messaging and support to promote vaccination, especially among non-healthcare workers. Addressing these gaps is crucial for maintaining high vaccination coverage and mitigating the impact of new SARS-CoV-2 variants on the population
Better floors, better health: a theory of change for an improved household flooring intervention in rural communities in Kwale and Bungoma counties, Kenya.
Get PDFBACKGROUND: Household flooring is increasingly being investigated as a determinant of health, however the pathways through which flooring may impact health and wellbeing are not yet well understood. The SABABU study is a cluster-randomised controlled trial evaluating the impact of an improved flooring intervention on soil-transmitted helminthiasis, tungiasis, and enteric infections in Bungoma and Kwale counties, Kenya. This paper presents the findings from a theory of change development process that was undertaken as part of the formative research phase of the SABABU project. METHODS: A co-creation workshop (n = 1), stakeholder meetings (n = 2), and community meetings (n = 2) were held with a range of participants including community members (n = 36), village-level leaders (n = 28), and local government stakeholders (n = 14) to draft and refine the theory of change framework. These meetings were informed by a previous formative research phase conducted in study communities - comprised of household observations, in-depth interviews, and focus group discussions with community members - to investigate daily routines, use of space within homes, and attitudes towards home improvement. RESULTS: The theory of change framework demonstrates how the improved household flooring intervention aims to reduce prevalence of soil-transmitted helminthiasis, enteric infections and tungiasis and improve psychological wellbeing among children and caregivers. Reductions in infections are predicated on limited contact between improved floors and animals, regular floor cleaning, and household members conducting their daily routines on the new floors. Gains in psychological wellbeing are tied to increased feelings of pride, self-efficacy, and social progress, as well as improved quality of life through reduced morbidity from enteric and parasitic infections. CONCLUSION: This study presents a theory of change framework mapping the pathways through which an improved flooring intervention may impact health and wellbeing. The results can be of use to researchers or programmes that are in the design or evaluation phase of a household flooring project in Kenya or other settings where access to improved floors is limited
Infant Feeding Practices in Ethiopia: Birth Cohort Study in Five Regions.
Get PDFAppropriate infant feeding is crucial to ensure optimal child growth and survival. We aimed to assess infants' breastfeeding and complementary feeding practices from 0 to 12 months in Ethiopia. This study was a secondary analysis of data from the Ethiopia Performance Monitoring for Action panel study performed from July 2020 to August 2021. One thousand eight hundred and fifty infants were included from five Ethiopian regions: Addis Ababa City Administration, Oromia, Amhara, Afar, and Southern Nations, Nationalities, and Peoples Regions. Appropriate infant feeding practices were assessed using the World Health Organization measurement criteria and descriptive analysis. One-year-old infants were considered to have a diversified diet if they had complementary feeding comprising five or more food groups. Two-thirds (67%, 95% CI: 63, 71) of newborns were put to the breast within 1 h after delivery. The median duration of exclusive breastfeeding was 6.5 months, and 69% (95% CI: 67, 71) were exclusively breastfed at 5 months. Almost all (97%; 95% CI: 96, 98) were still breastfeeding at 12 months. Sixteen percent (95% CI: 13, 19) of infants (boys 15%, girls 16%) aged 12 months had a diversified diet, and 49% (95% CI: 44, 55) consumed sugary foods or beverages. Most Ethiopian infants had appropriate breastfeeding practices, while almost all had poor-quality complementary food at 1 year. Increasing access to high-quality education on infant feeding is crucial to maintaining and enhancing appropriate breastfeeding practices and complementary food quality. Intensifying poverty reduction efforts are essential to improve infants' dietary diversity and nutrient-dense food consumption
How integrated knowledge translation worked to reduce federal policy barriers to the implementation of medication abortion in Canada: a realist evaluation.
Get PDFBACKGROUND: Initial Canadian federal regulations for the abortion pill, mifepristone, had the potential to impede safe and equitable access to this medication. To catalyze evidence-based regulatory change, we engaged health policy, health system, and health services decision makers, and health professional organizations in integrated knowledge translation (iKT), a research approach that engages the users of research as equal partners. METHODS: We conducted a realist evaluation of what iKT strategies worked, for whom, and in what context to impact federal mifepristone regulations. We constructed initial program theories (if-then statements about how iKT worked). We tested the initial program theories using interviews with researchers and knowledge partners and triangulated with analysis of research programme documents. We configured the evidence in relation to the initial program theories, and refined program theories into causal explanatory configurations. RESULTS: We analyzed 38 interviews with researchers, health professional leaders, advocacy group leaders, and administrative government policy makers, as well as 49 program documents. Our results indicated that researcher partnerships with stakeholders had a meaningful impact on the removal of restrictions. We found key components of the causal explanatory configurations included: researcher motivation to move evidence into action, trusted reputations as credible sources of evidence, strategic partnerships, understanding of health policy processes, and researcher roles as a trusted convenor between key groups and decision makers. CONCLUSIONS: Our study identifies several practical and transferable approaches to impactful iKT. The findings may be of relevance to researchers focused on public health topics subject to stigma
Applying the Estimands Framework to Non-Inferiority Trials: Guidance on Choice of Hypothetical Estimands for Non-Adherence and Comparison of Estimation Methods.
Get PDFA common concern in non-inferiority (NI) trials is that non-adherence due, for example, to poor study conduct can make treatment arms artificially similar. Because intention-to-treat analyses can be anti-conservative in this situation, per-protocol analyses are sometimes recommended. However, such advice does not consider the estimands framework, nor the risk of bias from per-protocol analyses. We therefore sought to update the above guidance using the estimands framework, and compare estimators to improve on the performance of per-protocol analyses. We argue the main threat to validity of NI trials is the occurrence of "trial-specific" intercurrent events (IEs), that is, IEs which occur in a trial setting, but would not occur in practice. To guard against erroneous conclusions of non-inferiority, we suggest an estimand using a hypothetical strategy for trial-specific IEs should be employed, with handling of other non-trial-specific IEs chosen based on clinical considerations. We provide an overview of estimators that could be used to estimate a hypothetical estimand, including inverse probability weighting (IPW), and two instrumental variable approaches (one using an informative Bayesian prior on the effect of standard treatment, and one using a treatment-by-covariate interaction as an instrument). We compare them, using simulation in the setting of all-or-nothing compliance in two active treatment arms, and conclude both IPW and the instrumental variable method using a Bayesian prior are potentially useful approaches, with the choice between them depending on which assumptions are most plausible for a given trial
Diagnostic accuracy of an antigen-based point-of-care test versus nucleic acid amplification testing for genital trichomoniasis among pregnant women attending antenatal care facilities in Zambia.
Get PDFBACKGROUND: Infection with Trichomonas vaginalis (TV) is the most prevalent curable sexually transmitted infection (STI) globally and is associated with prelabour rupture of membranes, preterm delivery, and low birthweight. Point-of-care (POC) testing for TV during pregnancy may facilitate rapid antenatal case detection and treatment. This study, part of the World Health Organization's global ProSPeRo study, aimed to evaluate the performance of OSOM® Trichomonas Rapid Test, an antigen-based POC test, against a reference nucleic acid amplification test (NAAT) among pregnant women in Zambia. We also assessed the operational characteristics and patient acceptability of the POC test, within the context of WHO's target product profiles for STI POC tests. METHODS: We enrolled pregnant women attending four health centres in Nchelenge, Zambia, for antenatal care between 15 February and 26 May 2023. Vaginal swabs for the TV POC test and a reference NAAT (Aptima® Trichomonas vaginalis assay) were obtained. POC test results were read independently by two study staff members. Study staff filled a questionnaire on the operational characteristics of the POC test, and participants were asked about their willingness to wait for results. RESULTS: Paired POC and reference test samples were collected from 1,015 participants. Overall, 23.0% (233/1015) tested positive for TV by NAAT, and 15.3% (155/1015) tested positive by the POC test, with three inconclusive results. The overall sensitivity and specificity of the POC test were 66.4% (95% confidence intervals [CI] 57.7-74.1%) and 99.6% (95% CI: 98.8-99.9%), respectively. Sensitivity was higher among those with TV-associated symptoms compared to those without (83.6% versus 60.4%, relative ratio 1.39, 95% CI 1.14-1.68). Inter-rater agreement was 99.7% (Cohen's Kappa 0.989). The study staff (n = 14) found the test easy to use and interpret, with most staff (12/14) reporting results were available within 25 min. CONCLUSION: Overall, the TV POC test showed lower sensitivity than WHO's 85% target, but exceeded the 99% specificity target. Among symptomatic pregnant women, sensitivity nearly reached the WHO target. The assay was user-friendly, required minimal training, and delivered results quickly. Further studies are needed to determine the optimal antenatal settings for this technology. TRIAL REGISTRATION: PACTR202302766902029
How, why, and under what circumstances can supportive supervision programs improve malaria case management? A realist program theory.
No full textSupportive supervision (SS) programs aim to enhance the quality of care by strengthening the performance of health providers. Commonly part of broader quality improvement efforts, SS programs are increasingly used in low-and middle-income countries to improve malaria case management. Despite substantial investments and some positive outcomes, little is known about what drives their effectiveness. A realist evaluation was conducted in Tanzania and Benin to explain how, why, and under what circumstances SS programs can improve the facility-based management of uncomplicated malaria in children <5 years. A program theory was developed through a team-based analysis of empirical data collected in both countries at two time points. Data included 218 in-depth and 12 structured interviews with stakeholders, 154 audits of febrile case management decisions, and 4 health facility audits. Stakeholder perspectives identified three acceptability mechanisms driving SS program outcomes in the studied contexts: the affective attitude, self-efficacy, and burden of the program as perceived by key actors. The pathway through which these mechanisms were perceived to shape malaria case management (diagnosis and treatment) practices was defined by the (i) extent to which the program was integrated into the public health system; (ii) frequency with which SS visits were conducted by appropriate supervisors; (iii) degree to which supervisors coached, rather than policed, supervisees; and (iv) level of collaboration achieved between supervisees and supervisors. The program actors' perception of the program's effectiveness was also found to be crucial to its sustainability. This study explains the dynamics driving SS program outcomes and underscores the role played by the cognitive and emotional responses of program actors. These insights are likely to be transferable to other settings with similar contexts and can help inform the design, implementation, monitoring, and evaluation of new and ongoing SS programs
Emulating an existing trial of treatments for prostate cancer using real-world data: challenges and lessons learned.
Get PDFOBJECTIVES: If randomized controlled trials can be successfully emulated using real-world data (RWD), confidence in the validity of RWD for estimating treatment effects for questions that have not been assessed in trials increases. We used routinely collected administrative and clinical national linked datasets from England to emulate the PR07 trial for high-risk prostate cancer patients, which compared the effects of radiotherapy added to hormone therapy (RT+HT) within 8 weeks of randomization (the "grace period") and hormone therapy (HT) only on all-cause mortality. We highlight methodological choices required and challenges encountered in emulating this trial. STUDY DESIGN AND SETTING: Patients diagnosed with prostate cancer from 2014 to 2020 were identified from the routine national linked datasets. Diagnosis was taken as the time zero. As few patients initiated radiotherapy within 8 weeks of diagnosis, we considered target trials with grace periods of 4-6 months. Estimands of interest were hazard ratios (HRs) and survival probabilities over 7 years. The cloning-censoring-and-weighting (CCW) approach was used to control for measured confounding and to allow for the grace period. We also used an extension (the "landmark-CCW" approach), in which we consider several time-origins post-diagnosis, enabling us to use a grace period of 8 weeks as in PR07. RESULTS: A total of 2,690 patients were eligible for inclusion in the emulated trial. The CCW analysis using a grace period of 6 months gave an estimated HR of 0.48 (95% confidence interval [CI]: 0.34-0.60) and 7-year survival estimates of 80.7% (95% CI: 74.3-87.0) for the RT+HT strategy and 65.6% (95% CI: 62.8-68.1) for HT only strategy, and corresponding risk difference of 15.1% (95% CI: 11.5-18.9). The corresponding HR from the landmark-CCW approach was 0.58 (95% CI: 0.51-0.65) and with survival estimates of 80.7% (95% CI: 77.7-83.8) for RT+HT strategy and 69.8% (95% CI: 68.2-71.4) for the HT only strategy, and a risk difference of 10.9% (95% CI: 6.3-15.9). CONCLUSION: Our findings from the emulated trial using RWD are broadly consistent with those from PR07, with RT+HT estimated to result in better survival compared to HT only. However, the findings were not replicated exactly, with PR07 reporting an HR of 0.77 (95% CI: 0.61-0.98) over 7 years of follow-up. Differences may be in part due to challenges in defining time zero and allowing for a treatment grace period of the same duration as in PR07. Our study considered ways in which these challenges can be addressed, and our findings affirm the utility of RWD for estimating treatment effects. PLAIN LANGUAGE SUMMARY: Clinical trials are the best way to test whether treatments work, but they are expensive, take years to complete, and focus on narrow research questions. If we can use real-world data (RWD) such as patient health records to mimic these trials, we may be able to answer additional medical questions relevant to patients who are prescribed these medications. This study aimed to see if we could recreate the results of a past clinical trial (PR07) using national health data from England. The PR07 trial looked at two treatments for high-risk prostate cancer: hormone therapy (HT) alone and radiotherapy added to hormone therapy (RT+HT) within 8 weeks of starting the study. This trial was chosen for several reasons. It included high-risk patients who were studied for up to 7 years, meaning that there was enough information to study survival outcomes. Being a major UK-based trial, it was useful for comparing with the data recorded in UK national health data. The trial also allowed some flexibility in when treatment started, which was an interesting factor to examine. Its main goal was to see if adding radiotherapy to hormone therapy provided extra benefits to patients. We wanted to see whether the trial results were replicated using the UK health data. If results were replicated, it would provide confidence in further exploration of questions not covered by the trial. In a trial, randomization time is the point where doctors allocate patients to one of the treatments being assessed, usually 1 new treatment and 1 control treatment. Patients in the study are then followed up from that point. However, defining a starting point in a non-trial setting, using UK national health data, is not as straightforward. In the PR07 trial, patients started RT+HT within 8 weeks of randomization. In the UK datasets, we use diagnosis as a starting point, because it is available for both treatment groups. However, very few patients started RT+HT within 8 weeks of diagnosis. To address this, we allowed for longer periods of 4-6 months from diagnosis for RT+HT initiation. Recent developments provided statistical methods for estimating the cause-effect relationship between treatment received and survival patterns. In this study, we show how these approaches can be used to estimate survival patterns if all patients had RT+HT within 4-6 months from diagnosis compared with if no patients had any RT within 4-6 months. We account for the different treatment initiation times and the main differences between the RT+HT and HT only patients. Using these methods, we estimate that RT+HT has an 11%-15% higher survival rate at 7 years compared to HT only. We discuss similarities and differences between these findings and those in the original PR07 trial
Emergency Surgery Or noT for common Vascular conditions in the periods before and during COVID-19 (ESORT-V): Study Protocol
Get PDFIntroduction
Uncertainty exists around the optimal timing of most vascular surgery operations. Clinical guidelines suggest delivering urgent surgery, but there is little evidence demonstrating this approach is more clinically and cost effective than later surgery, which can allow time for patients to prepare for major surgery. The delivery of rapid surgery poses significant service delivery challenges, and many vascular centres in the UK National Health Service (NHS) do not meet targets for surgical delivery. This challenge of meeting criteria was compounded by the COVID-19 pandemic.
The aim of the Emergency Surgery Or noT for common Vascular conditions study (ESORT-V) is to provide a rigorous evaluation of the relative clinical and cost-effectiveness of ‘early’ or ‘later’ surgery for patients with common vascular conditions, including abdominal aortic aneurysms (AAA) and peripheral arterial disease (PAD). This study recognises the impact of the COVID-19 pandemic on vascular surgery provision. ESORT-V was commissioned by the National Institute for Health Research for Patient Benefit (NIHR RfPB) programme.
Methods and Analysis
The National Vascular Registry (NVR), Hospital Episode Statistics (HES), and Office for National Statistics (ONS) linked data will be used to identify patients with non-ruptured AAA undergoing AAA repair and PAD undergoing lower limb revascularisation between January 2014 to December 2023. We will combine an emulated target trial with an instrumental variable analysis to minimise the risk of bias, including unmeasured confounding. Our instrumental variable will be each vascular centre’s ‘tendency to expedite surgery’, defined as the propensity to perform surgery before (early) or after (later) defined timepoints. The primary outcome will be days alive and out of hospital. Incremental cost-effectiveness will be reported by assessing the incremental net monetary benefits of early versus later surgery at 1 year follow-up. We will report clinical and cost-effectiveness overall and for pre-defined subgroups.
Ethics & Dissemination
The study is approved by the LSHTM research ethics committee (project ID 27065). Data sharing agreements have been obtained with National Health Service Digital and the NVR. Results will be disseminated via NIHR RfPB reporting, peer-reviewed journals, and conferences
Global, regional, and national burden of headache disorders, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023.
Get PDFBACKGROUND: The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2023 estimates health loss from migraine, tension-type headache, and medication-overuse headache. This study presents updated results on headache-attributed burden from 1990 to 2023, along with clinical and public health implications. METHODS: Data on the prevalence, incidence, or remission of migraine, tension-type headache, and medication-overuse headache were extracted from published population-based studies. We used hierarchical Bayesian meta-regression modelling to estimate global, regional, and country-level prevalence of headache disorders. For the first time in GBD 2023, age-specific and sex-specific estimates of time in symptomatic state were applied by meta-analysing individual participant data from 41 653 individuals from the general populations of 18 countries from all parts of the world. Disability weights were applied to calculate years lived with disability (YLDs). Since medication-overuse headache is a sequela of a mistreated primary headache (due to medication overuse), its burden was reattributed to migraine or tension-type headache, informed by a meta-analysis of three longitudinal studies. FINDINGS: In 2023, 2·9 billion individuals (95% uncertainty interval 2·6-3·1) were affected by headache disorders, with a global age-standardised prevalence of 34·6% (31·6-37·5) and a YLD rate of 541·9 (373·4-739·9) per 100 000 population, with 487·5 (323·0-678·8) per 100 000 population attributed to migraine. The prevalence rates of these headache disorders have remained stable over the past three decades. YLD rates due to headache disorders were more than twice as high in females (739·9 [511·2-1011·5] per 100 000) as in males (346·1 [240·4-481·8] per 100 000). Medication-overuse headache contributed 58·9% of the YLD estimates for tension-type headache in males and 56·1% in females, as well as 22·6% of the YLD estimates for migraines in males and 14·1% in females. INTERPRETATION: Headache disorders, in particular migraine, continue to be a major global health challenge, emphasising the need for effective management and prevention strategies. Much headache-attributed burden could be averted or eliminated by avoiding overuse of medication (including over-the-counter medication), underscoring the importance of public education. FUNDING: Gates Foundation