Conectar
Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.
This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.
The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.
Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.
To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.
Scoping review.
Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews—Cochrane Methodology Registry (Final issue, third Quarter 2012).
Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs.
Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology.
A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.
The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.
Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.
This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.
Pre-eclampsia is a hypertensive disorder affecting up to 8% of pregnancies. After pre-eclampsia, women are at increased risk of cognitive problems, and cerebrovascular and cardiovascular disorders. These sequelae could result from microvascular dysfunction persisting after pre-eclampsia. This study will explore differences in cerebral and myocardial microvascular function between women after pre-eclampsia and women after normotensive gestation. We hypothesise that pre-eclampsia alters cerebral and myocardial microvascular functions, which in turn are related to diminished cognitive and cardiac performance.
The cross-sectional ‘DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia’ (DECONNECT) pilot study includes women after pre-eclampsia and controls after normotensive pregnancy between 6 months and 20 years after gestation. We recruit women from the Queen of Hearts study, a study investigating subclinical heart failure after pre-eclampsia. Neuropsychological tests are employed to assess different cognitive domains, including attention, processing speed, and cognitive control. Cerebral images are recorded using a 7 Tesla MRI to assess blood–brain barrier integrity, perfusion, blood flow, functional and structural networks, and anatomical dimensions. Cardiac images are recorded using a 3 Tesla MRI to assess cardiac perfusion, strain, dimensions, mass, and degree of fibrosis. We assess the effect of a history of pre-eclampsia using multivariable regression analyses.
This study is approved by the Ethics Committee of Maastricht University Medical Centre (METC azM/UM, NL47252.068.14). Knowledge dissemination will include scientific publications, presentations at conferences and public forums, and social media.
To determine whether integrated maternity care is associated with reduced preterm births (PTB) and fewer small-for-gestational-age infants (SGA), and whether its implementation leads to a reduction of secondary care consultations.
Retrospective study.
Integrated maternity care organisation in the southwestern region of the Netherlands.
All singleton pregnancies (≥24 weeks) within integrated maternity care organisation Annature between 2015 and 2020.
Implementation of a shared maternity record in primary and secondary care.
Data of 20 818 women were derived from patient records and from the Netherlands Perinatal Registry. Intervention was the introduction of integrated maternity care in January 2018. Through multivariate logistic regression and segmented regression analysis we assessed the combined prevalence of SGA and PTB (SGA-PTB) before (2015–2017), and after the intervention (2018–2020). Regional rates were contrasted with nationwide rates (n=782 176).
SGA-PTB prevalence and mean number of secondary care consultations per pregnancy.
SGA-PTB prevalence declined from 618/3443 (17.9%) in 2015 to 560/3501 (16.0%) in 2017 to 507/3459 (14.7%) in 2020 (p
Our results suggest that implementation of integrated maternity care was associated with reduced PTBs and/or low birth weight, and fewer secondary care consultations. These encouraging findings were observed in a less favourable sociodemographic profile and should be confirmed in other regions with sufficiently large populations, and the possibility to test individual components of integrated maternity care.
Glial brain tumours are highly mortal and are noted as major neurosurgical challenges due to frequent recurrence or progression. Despite standard-of-care treatment for gliomas, the prognosis of patients with higher-grade glial tumours is still poor, and hence empowering antitumour immunity against glioma is a potential future oncological prospect. This review is designed to improve our understanding of the efficacy of cell-based immunotherapies for glioma.
This systematic review will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of main electronic databases: PubMed/MEDLINE, Scopus, ISI Web of Science EMBASE and ProQuest will be done on original articles, followed by a manual review of review articles. Only records in English and only clinical trials will be encountered for full-text review. All the appropriate studies that encountered the inclusion criteria will be screened, selected and then will undergo data extraction step by two independent authors. For meta-analyses, data heterogeneity for each parameter will be first evaluated by Cochran’s Q and I2 statistics. In case of possible heterogeneity, a random-effects meta-analysis will be performed and for homogenous data, fixed-effects models will be selected for reporting the results of the proportional meta-analysis. Bias risk will be assessed through Begg’s and Egger’s tests and will also be visualised by Funnel plots.
As this study will be a systematic review without human participants’ involvement, no ethical registration is required and meta-analysis will be presented at a peer-reviewed journal.
CRD42022373297
Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.
The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR≤0.8 and minimal lumen area (MLA)≤3 mm2 or 3 mm2
The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.
FLAVOUR II was approved by the institutional review board at each participating site (The Second Affiliated Hospital of Zhejiang University School of Medicine Approval No: 2020LSYD410) and will be conducted in line with the Declaration of Helsinki. Informed consent would be obtained from each patient before their participation. The study results will be submitted to a scientific journal.
To determine the socio-demographic profile of all students enrolled to study medicine in Aotearoa New Zealand (NZ).
Observational, cross-sectional study. Data were sought from the Universities of Auckland and Otago, the two NZ tertiary education institutions providing medical education, for the period 2016–2020 inclusive. These data are a subset of the larger project ‘Mirror on Society’ examining all regulated health professional enrolled students in NZ. Variables of interest: gender, citizenship, ethnicity, rural classification, socioeconomic deprivation, school type and school socioeconomic scores. NZ denominator population data (18–29 years) were sourced from the 2018 census.
2858 students were enrolled to study medicine between 2016 and 2020 inclusive.
There were more women (59.1%) enrolled to study medicine than men (40.9%) and the majority (96.5%) were in the 18–29 years age range. Māori students (rate ratio 0.92; 95% CI 0.84 to 1.0) and Pacific students (rate ratio 0.85; 95% CI 0.73 to 0.98) had lower overall rates of enrolment. For all ethnic groups, irrespective of rural or urban origin, enrolment rates had a nearly log-linear negative relationship with increasing socioeconomic deprivation. Enrolments were lower for students from rural areas compared with those from urban areas (rate ratio 0.53; 95% CI 0.46–0.61). Overall NZ’s medical students do not reflect the diverse communities they will serve, with under-representation of Māori and Pacific students and students who come from low socioeconomic and rural backgrounds.
To meaningfully address these issues, we suggest the following policy changes: universities commit and act to Indigenise institutional ways of knowing and being; selection policies are reviewed to ensure that communities in greatest need of doctors are prioritised for enrolment into medicine (specifically, the impact of low socioeconomic status should be factored into selection decisions); and the government fund more New Zealanders to study medicine.
To explore the experiences and consequences of bariatric surgery stigma from the perspective of bariatric surgery patients and to identify knowledge gaps in the literature.
A scoping review.
Studies published between December 2002 and January 2022 were identified from the following databases: PubMed, Web of Science, PsycINFO and MEDLINE.
We screened 3092 records and included 28 studies. Findings were grouped thematically using the health stigma discrimination framework.
Patients experienced several types of stigmas, including perceived, experienced, anticipated and internalized stigma, related to undergoing bariatric surgery. Patients were confronted with negative comments and judgement from others when they disclosed their decision to have surgery or when they revealed that they had undergone surgery. These experiences led to conflicts in the decision-making process, such as delaying the choice for surgery, seeking surgery abroad or opting out. Patients who internalized stigma often reported feelings of shame and embarrassment for choosing surgery and felt the need for secrecy or selective disclosure. Stigma experiences were influenced by gender and differed between different subgroups of patients.
The stigma surrounding bariatric surgery has detrimental consequences for eligible individuals and bariatric surgery patients. However, the evidence from patients' perspective remains limited. More research into patient's experiences is needed to improve patient care and further educate healthcare professionals. In addition, to better understand the nature and implications of bariatric surgery stigma, future research should be founded on stigma theories and distinguish between the different types of stigmas.
This scoping review contributes to a better understanding of the implications the stigma surrounding bariatric surgery has for bariatric surgery patients before and after surgery. The knowledge generated by this review can inform improvements in the education and management of people living with obesity and bariatric surgery patients.
The scoping review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews checklist.
No Patient or Public Contribution.
A protocol was not registered for this scoping review.
FreshRSS 