69832 research outputs found
Sort by
Prostate Assessment using Comparative Interventions - Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial.
Get PDFBACKGROUND: Multiparametric MRI (mpMRI) with contrast medium is recommended in the prostate cancer diagnostic pathway. It is unclear if MRI without contrast medium (biparametric [bp]) can be used instead whilst remaining sensitive to detection of clinically significant cancers. For those with a positive MRI, is image-fusion targeting better than visual-registration (cognitive) targeting in detecting clinically significant prostate cancer? And does bpMRI represent better value for money than mpMRI? A randomised controlled trial testing clinical utility and cost-effectiveness of these approaches is vital before changes in practice. METHODS: IP7-PACIFIC is a prospective, multicentre, co-enrolment trial with two randomisations and embedded economic evaluation. The first randomisation will evaluate non-inferiority of bpMRI compared to mpMRI in those with clinical suspicion of prostate cancer. Men with a suspicious MRI will undergo a second randomisation to evaluate if image-fusion targeting is superior to standard visual-registration targeted biopsy. Ethics committee approval has been granted by the London Bromley Research Ethics Committee. RESULTS: The primary objective for Randomisation 1 is to determine non-inferiority of bpMRI to detect Gleason score ≥ 7 [ISUP Grade Group ≥2] cancer compared to mpMRI. The objective for Randomisation 2 is to determine if image-fusion targeted biopsy is superior to visual-registration targeted biopsy. An internal pilot phase will enrol 700 patients; the overall recruitment target is 3600. DISCUSSION: IP7-PACIFIC aims to provide randomised comparative evidence for the clinical utility and cost-effectiveness of using bpMRI and image-fusion biopsy. The findings will inform guidelines. The sequential randomised co-enrolment design allows simultaneous evaluation of two research questions and avoids heterogeneity of trial populations. By contrast to previous paired-cohort studies, the randomised design will reduce reporter bias, providing the highest level of diagnostic evidence
Evaluating adherence in an active-controlled HIV pre-exposure prophylaxis trial (PrEPVacc) to inform the estimation of HIV incidence in a counterfactual placebo arm.
Get PDFBACKGROUND: Inferring the counterfactual placebo HIV incidence using the estimated effectiveness of Emtricitabine/Tenofovir (TDF/FTC) in active-controlled pre-exposure prophylaxis (PrEP) trials has been suggested. However, it has not yet been widely applied. In this article, we evaluate adherence to TDF/FTC in the PrEPVacc trial (NCT04066881) and consider how such adherence data could be used to estimate the effectiveness of TDF/FTC and subsequently, HIV incidence in a counterfactual placebo arm in a predominantly female population. METHODS: From December 2020 to March 2023 participants were recruited into the trial which included a comparison of Emtricitabine/Tenofovir Alafenamide (TAF/FTC) to TDF/FTC as PrEP over 26 weeks of follow-up, in Uganda, Tanzania, and South Africa. PrEP adherence was assessed in various ways. RESULTS: Of 697 participants dispensed TDF/FTC, 87% were female, 54% were ≥ 25 years, and 59% were sex workers. In a random sample (41%) assessed at visit 6 (week 8), 76% had detectable TFV-DP levels, with 22% reaching levels consistent with ≥2 pills/week. Males, Verulam and Mbeya participants, those ≥ 25 years, not single, subsistence fisheries workers, and those who had any STI at baseline were more likely to have higher adherence. Of those assessed at visit 6, 29% were identified as white coat dosing. Estimated (crude) HIV incidence risk reduction ranged from 10% to 65%. CONCLUSIONS: TDF/FTC adherence in the PrEPVacc trial was low, with considerable levels of white coat dosing. Inferring the counterfactual placebo HIV incidence using the estimated effectiveness of TDF/FTC is a promising approach, however, the approach requires further elaboration and evaluation
Length of hospital stay and associated treatment costs for patients with susceptible and antibiotic-resistant Salmonella infections: a systematic review and meta-analysis.
Get PDFOBJECTIVES: The global disease burden of Salmonella infections in 2017 included 135 900 deaths caused by Salmonella Typhi and Paratyphi and 77 500 deaths caused by invasive non-typhoidal Salmonella, with increasing antimicrobial resistance (AMR) exacerbating morbidity, mortality and costs. The aim of our systematic review and meta-analysis is to estimate the length of hospital stay and associated treatment costs for patients with susceptible and antibiotic-resistant Salmonella Typhi, Paratyphi and non-typhoidal Salmonella infections. DESIGN: Systematic review and meta-analysis. DATA SOURCES: We searched EMBASE, Medline/PubMed, Scopus, Hinari and LILACS databases for studies published between 1 January 2005 and 15 May 2024, with no language restrictions. ELIGIBILITY CRITERIA: We included 30 studies that reported the length of hospital stay or treatment costs for patients with susceptible or antibiotic-resistant Salmonella Typhi, Paratyphi and non-typhoidal Salmonella infections. We excluded studies with sample sizes of less than 30 patients, those focused on non-human subjects and those not reporting our outcomes of interest. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently screened studies and extracted data on the length of hospital stay and associated costs, with monetary values converted to 2019 USD. We aggregated data according to GDP per capita quantiles using a random-effects meta-analysis. We conducted a quality assessment using an adapted Joanna Briggs Institute tool. RESULTS: Patients with drug-resistant Salmonella infections had longer hospital stays, with an additional 0.5-2.2 days compared with drug-susceptible Salmonella infections. Based on our meta-analysis, the mean hospital stay for typhoidal Salmonella infections was 6.4 days (95% CI 4.9 to 7.8) for drug-susceptible cases and 8.4 days (95% CI 5.1 to 11.7) for resistant cases in the lowest income quartiles. While there were insufficient data to perform a pooled analysis, individual studies inferred that treatment costs for resistant typhoidal Salmonella infections were higher than for susceptible infections, and resistant non-typhoidal Salmonella infections had longer hospital stays and higher costs compared with susceptible infections. Data were scarce from high-Salmonella-burden countries, particularly in sub-Saharan Africa and parts of Asia. CONCLUSIONS: Patients with antibiotic-resistant Salmonella infections experience a greater healthcare burden in terms of hospitalisation length and direct costs compared with those with susceptible infections. We highlight the economic burden of AMR in Salmonella infections and emphasise the need for preventive measures
'We're not there yet!': a qualitative study exploring the commissioning of adult Community Health Services in England to support the avoidance of hospital admissions.
Get PDFOBJECTIVES: The increased use of Community Health Services (CHS) is central to UK policy visions of moving more care out of hospital to reduce pressure across the healthcare system and, in particular, the demand on secondary care, hospital services. CHS are under-researched, and little is known about how they can best contribute towards this aim. The National Health Service (NHS) in England has recently undergone a significant reorganisation, with an increased emphasis on collaborative service delivery. In the aftermath of this reorganisation, the objective of this study was to explore how commissioners and providers of CHS think about the need for services and how decisions are made about the commissioning and allocation of resources in order to facilitate out-of-hospital care. DESIGN: A qualitative, semi-structured interview study with participants from four case study sites in England. Semi-structured interviews were conducted virtually and transcripts analysed using a reflexive thematic approach. SETTING: Adult CHS, which included two sites with CHS providers embedded in acute hospital Trusts, one standalone CHS Trust and a CHS provider collaborative. Sites were selected for both geographical (two sites in the north of England and two in the South) and organisational model diversity. PARTICIPANTS: 40 participants were interviewed across all four case study sites (site A, n=10; site B, n=17; site C, n=10; and site D, n=3). To be included in the study, participants were required to have a management role in providing or commissioning adult CHS and/or their understanding of this at strategic level within the Integrated Care Systems. RESULTS: Themes from current literature on commissioning (organisation, assessing needs, service design and development, contracting and funding, and performance management and support) were used to structure the data. Participants from all sites reported that the reorganisation of the NHS away from Clinical Commissioning Groups to Integrated Care Boards has resulted in confusion around the commissioning function, with a lack of clarity about current roles and responsibilities. All sites were undertaking some form of service review. However, participants highlighted the fact that current population health and CHS service data do not adequately support proactive planning of services to meet rising demand. CHS find it particularly difficult to evidence their contribution to hospital avoidance. Current block contract funding models also limit the extent to which CHS can provide the flexible services required if hospital admission is to be avoided. We also found some tension around the implementation of additional hospital avoidance services (eg, 'virtual wards') which did not necessarily integrate with or complement core CHS services. CONCLUSIONS: Our focus on the commissioning of CHS has highlighted the fact that the new collaborative approach to service design and delivery embodied by the creation of Integrated Care Boards has led to some confusion around decision-making. In addition, the lack of appropriate data and the funding and contractual model used to procure CHS impacts their ability to contribute to the policy agenda of treating more people in the community. These factors should be addressed if CHS are to fulfil ambitions of preventing hospital admissions
Born too soon: global epidemiology of preterm birth and drivers for change.
Get PDFPROGRESS: There has been no measurable change in global preterm birth rates in the past decade, in any region. A handful of countries have reduced their preterm birth rates, but only marginally (0.5 percentage points annually), and there has been little progress in availability of preterm birth data globally. An estimated 13.4 million (95% credible interval (CrI): [12.3, 15.2 million]) newborns were preterm or "born too soon" in 2020, 9.9% (95% CrI: [9.1, 11.2%]) of births worldwide. Preterm birth complications remained the top cause of under-5 child mortality globally in 2022, accounting for about 1 million neonatal deaths, similar to figures a decade ago. More encouragingly, some countries have improved data systems to better capture preterm birth information and advancements have been made in gestational age measurement, highlighting targeted efforts towards improving data for action. This paper is part of a series based on the report "Born too soon: decade of action on preterm birth". PROGRAMMATIC PRIORITIES: Preventing preterm birth is a critical priority and could be accelerated by focusing on context-specific risk factors, and addressing spontaneous and provider-initiated preterm births, including non-medically indicated caesarean sections. Effective care can prevent 900 000 deaths from complications of preterm birth, particularly among those born before 32 weeks' gestation. Stillbirths should be included in data, policies and programmes relating to preterm birth. Most stillbirths occur preterm (an estimated 74.3%) and have a profound, long-lasting impact on families. Addressing stillbirths is essential for reducing the overall burden of preterm birth and minimising loss of human capital. PIVOTS: It is important that the data are available and of high quality, plus are used to drive action. We focus on three pivots to improve in the next decade: (1) counting every baby everywhere, including those stillborn, and accurately recording gestational age and birthweight; (2) strengthening national data systems to improve the availability of individual-level data for action, including quality improvement in maternity wards and small and sick newborn care units, plus follow-up for long-term health outcomes including disabilities; and (3) using data to strengthen shared accountability at all levels, from the community to global levels
Validity and reliability of the Sanitation-related Quality of Life index (SanQoL-5) in six countries
Get PDFAbstract
Sustainable Development Goal 6.2 measures sanitation progress by type of toilet service. Improving people’s subjective sanitation experiences is also important but rarely rigorously measured. The Sanitation-related Quality of Life index (SanQoL-5) combines answers to five simple questions (disgust, privacy, disease risk, shame and safety) into an overall score ranging from 0 to 1. Here we evaluated the validity and reliability of SanQoL-5 by interviewing 6,165 people across rural and urban areas of six countries: Ethiopia, India, Kenya, Malawi, Mozambique and Zambia. We found good evidence for construct validity, with support (P < 0.05) for 87% of hypothesized associations between SanQoL-5 and toilet quality characteristics. In 75 intercountry comparisons, only 9% of instances showed evidence of meaningful differential item functioning, suggesting good cross-cultural comparability. SanQoL-5 conformed to expectations in item response theory models, and we found evidence of convergent, discriminant and known groups validity. SanQoL-5 can be used in impact evaluation, monitoring, needs assessment and benefit–cost analysis
Global health and care worker migration requires a global response.
Get PDFThe global migration of the health and care workforce (HCWF) has intensified, leading to complex policy scenarios and diverse migration patterns. While the traditional narrative of individual health and care workers (HCWs) migrating from low- and middle-income countries to high-income countries in search of higher income, career prospects and working conditions remains relevant, it now coexists with many other drivers, incentives, and dynamics at individual and policy level. The evolving dynamics of HCW migration have profound implications extending far beyond health labour markets, influencing broader societal and political landscapes. Despite their significance, the qualitative shifts in HCWF migration patterns and the governance challenges they present are poorly understood and under-researched, and policies have thus been limited in their effectiveness. In this policy comment we argue for a global response and an enhanced focus on policy implementation, using selected case studies to illustrate the argument. The cases highlight complexities of HCW migration patterns and opportunities for strengthening implementation of the WHO Global Code of Practice to respond effectively to the diverse needs of health systems and individual HCWs
Comparative effect of aspirin versus clopidogrel monotherapy on incident type 2 diabetes in patients with atherosclerotic cardiovascular diseases: A target trial emulation study.
Get PDFAIMS: To compare the effects of low-dose aspirin and clopidogrel on the risk of incident type 2 diabetes among patients with ASCVD. METHODS: This target trial emulation study was performed usingthe IQVIA Medical Research Data UK primary care database, including adults with an incident first ASCVD event who initiated low-dose aspirin or clopidogrel between 2004 and 2021. We applied an overlap weighting approach to balance treatment groups. The observational analogues of intention-to-treat and per-protocol effects were estimated using pooled logistic regression. RESULTS: A total of 111,292 ASCVD patients who initiated aspirin (n = 78,012) or clopidogrel (n = 33,280) were included. In intention-to-treat analyses, aspirin and clopidogrel had similar risks of diabetes (Hazard ratio [HR] 1.02, 95 % Confidence interval [CI] 0.96 to 1.07), cardiovascular events (1.00, 0.95 to 1.05), and bleeding events (1.02, 0.97 to 1.08). In per-protocol analyses, risks remained comparable for diabetes (1.06, 0.97 to 1.15), cardiovascular events (0.96, 0.89 to 1.03), and bleeding events (1.01, 0.92 to 1.10). CONCLUSIONS: Aspirin and clopidogrel have similar risks of incident diabetes, cardiovascular events, and bleeding events among patients with ASCVD. The choice between these agents may thus be influenced more by factors like cost, patient preference, or tolerance than by clinical outcomes alone
Barriers and facilitators to addressing mental health needs among Asian, Black and Latin American men who have sex with men (MSM) in England and Wales: A qualitative study.
Get PDFEthnic and sexual minority groups are underserved by mental health services globally despite having potentially greater need. This study aimed to explore how the intersections between sexual orientation and ethnicity shape mental health experiences and service access for Asian, Black and Latin American men who have sex with men (MSM) in the UK. This research was drawn from a qualitative sub-study of a larger HIV self-testing randomised controlled trial (SELPHI). Cis-gender Black, Asian and Latin American MSM who participated in SELPHI were recruited purposively to ensure sample diversity. Semi-structured interviews including a focused section on mental health were conducted between April and July 2020. A thematic framework approach was used to analyse the transcribed interview data. Twenty-nine participants were interviewed, comprising thirteen Black, eleven Asian and five Latin American MSM. The data were organised into three meta-themes exploring 1) Background, culture and upbringing, 2) Sexuality and manifestation of mental health issues, and 3) Barriers and facilitators to accessing mental health services. Childhood experiences of hypermasculine norms shaped the development of self-reliant coping strategies for mental distress. Peer support was protective of mental health, but alcohol, party drugs and chemsex could exacerbate feelings of isolation. Intersectional stigma restricted mental health service access, highlighting the need for culturally competent services. Previous use of mental health services and openness about mental health among social groups were facilitators to access. Private mental health services were often favoured due to perceptions of a superior quality of care and the speed of access, although participants recognised this as a financial barrier which further deepened structural inequities in access to mental healthcare. This study highlights the importance of multi-system and interdisciplinary interventions to facilitate discussions surrounding mental health within Asian, Black and Latin American MSM communities. In particular, services must be mindful of the barriers and facilitators faced by these groups when accessing mental health services, including norms linking self-reliance and masculinity
Optimizing ISO standard microbiological techniques for isolating Campylobacter from poultry samples amidst challenges from extended spectrum beta lactamase producing Escherichia coli.
Get PDFIsolation of zoonotic Campylobacter species has been standardized through the ISO 10272:2017 protocol. However, application of the protocol in a LMIC country failed to isolate Campylobacter due to extended-spectrum beta-lactamase (ESBL) producing Escherichia coli overgrowth during the Campylobacter selective enrichment phase. The aim of the study was to identify the contaminants and explore ways to mitigate them. A set of 25 non-Campylobacter contaminants isolated from chicken cecal samples grown on modified charcoal-cefoperazone-deoxycholate agar (mCCDA) during Campylobacter isolation were included. All isolates were screened for species identification and the presence of selected ESBL producing genes. Minimum inhibitory concentrations of tazobactam were measured using a microbroth dilution technique. The Campylobacter isolation protocol was then modified to inhibit the contaminants by adding the required tazobactam supplement to Preston broth or to mCCDA. All contaminants were found to be E. coli carrying at least one of the ESBL-producing genes blaTEM, blaCTX or blaSHV. The MIC of tazobactam sodium for ESBL-producing E. coli strains grown in Preston broth was at least 128 mg/L. Preston broth supplemented with tazobactam at 128 mg/L inhibited the growth of ESBL-producing E. coli but did not inhibit the growth of C. jejuni or C. coli. Interestingly, mCCDA plates supplemented with tazobactam at a much lower concentration of 4 mg/L could also prevent growth of ESBL-producing E. coli even without broth enrichment, increasing the efficiency of isolation of Campylobacter. Direct inoculation of cecal materials to mCCDA supplemented with tazobactam at 4 mg/L was recommended as the most cost-effective way to conduct Campylobacter surveillance targeting the cecal matrix instead of directly following ISO 10272:2017 protocol