Pre-diabetes virtual health management community (VHMC) intervention and group interaction management model in China: a randomised clinical trial protocol

Introduction
Individuals with pre-diabetes are at high risk for developing type 2 diabetes mellitus (T2DM), which makes them prone to serious complications such as stroke, kidney failure, blindness and lower-limb amputation. Pre-diabetes can be reversed, and lifestyle modification is considered the best intervention method for diabetes prevention. However, it is difficult for individuals with pre-diabetes to maintain a long-term modified healthy lifestyle owing to psychological burnout in daily management over time due to poor adherence. We developed a novel virtual health management community (VHMC) model based on group interaction management. We present the protocol for the VHMC model applied to the pre-diabetic population—a randomised controlled trial (RCT).

Methods and analysis
This study will be conducted to determine the effectiveness of the pre-diabetes VHMC–group interaction management model on improving long-term lifestyle intervention adherence to reduce the incidence of T2DM in China. We will conduct a prospective, multicentre, single-blinded, two-arm, RCT, and a total of 706 patients will be recruited. Those randomly assigned to the intervention group will receive group interaction management based on the VHMC platform. Measures of incidence of T2DM, diabetes outcomes, lifestyle modification and psychosocial outcomes will be assessed at baseline, 3, 6, 12, 24 and 36 months. If the VHMC–group interaction management model shows efficacy in improving the self-management of pre-diabetes or metabolic control, similar interventions may be applied to other chronic conditions. The cost-utility analysis of this model may indicate that this platform could be a potentially cost-effective and efficient way to integrate the VHMC platform into the health management of patients with pre-diabetes.

Ethics and dissemination
The Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University approved this study (No. RG2023-262-02). The results of this study will be disseminated through conference presentations and peer-reviewed publications.

Trial registration number
ChiCTR2400081268. Study start: 1 July 2024, completion: 1 December 2026.

Leggi
Dicembre 2024

Basic ENT training for enhanced healthcare worker knowledge, attitudes and practices in a resource-limited setting: a pre-post and post-post cross-sectional study

Introduction
Diagnostic errors in ear, nose and throat (ENT) diseases are prevalent among healthcare workers (HCWs) in resource-limited settings, yet comprehensive data that describe HCW knowledge, attitudes and practices (KAP) regarding ENT disease management remains scarce. Further, the impact of basic ENT training on HCW KAP in such settings is largely undetermined.

Objective
We assessed HCW KAP before and after basic training in ENT disease management.

Methods
This questionnaire-based pre-post-test cross-sectional survey employed HCW training in public hospitals in a resource-limited setting. We conducted a 2-day training, preceded by a pretraining survey, followed by immediate and 5-month post-training assessments using a prevalidated questionnaire. 416 HCWs participated and were selected through probability-proportionate-to-size random sampling. Wilcoxon matched-pairs signed-rank and Kruskal-Wallis tests were used to assess pre-post training KAP variations.

Results
At baseline, the median (IQR) percentage knowledge scores for HCWs in general ENT, ear, sinonasal and head and neck disease management were 60 (40), 55 (18), 58.3 (25) and 56 (22.6), respectively. Only 33.8% (133/394) of HCWs had access to an otoscope, 25.5% (101/396) to a headlight and 12.1% (48/397) to a nasal speculum. While 99.2% (390/393) of HCWs considered ENT important, 57.8% (226/391) of them lacked the confidence to correctly diagnose and manage most ENT conditions. At the immediate post-training assessment, HCWs’ median knowledge scores increased by 20%, 18%, 25% and 33% for general ENT, ear, sinonasal and head and neck disease management, respectively (p

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Dicembre 2024

Pre-eclampsia as a predictor of early-onset cardiovascular impairment among young women (PREECARDIA study): protocol for a prospective cohort study

Introduction
Pre-eclampsia is a pregnancy-related complication estimated to affect up to 8% of pregnancies worldwide. It is associated with an increased risk of postpartum sustained hypertension, coronary artery disease, cerebrovascular disease, peripheral arterial disease and cardiovascular-related mortality. Nevertheless, these associations have seldom been addressed in younger women from sub-Saharan Africa (SSA). Hence, this study aims to assess the association between pre-eclampsia and cardiovascular impairment within the first year after delivery, among younger women in SSA.

Methods and analysis
This is a prospective cohort study conducted at Hospital Nacional Simão Mendes in Bissau, Guinea-Bissau. A total of 230 pregnant women aged below 25 years (115 diagnosed with pre-eclampsia and 115 normotensive age-matched pregnancies), will be enrolled after their 20th gestational week. Exclusion criteria include diabetes, hypertension or other serious maternal diseases present before pregnancy. Participants will be assessed at baseline (pre-labour period), 4 and 12 months after delivery; evaluations started in March 2023 and are expected to end in December 2026. At each follow-up assessment, the women will have their blood pressure measured with a digital sphygmomanometer and a 24-hour ambulatory blood pressure monitor. Cardiac and renal function will be assessed using echocardiography and laboratory testing, respectively. Primary outcomes include the mean differences in cardiovascular and renal parameters between women who had pre-eclampsia and those who had normotensive pregnancies. Age, parity, age at first pregnancy, family history of cardiovascular diseases, smoking habits, gestational diabetes diagnosed before pre-eclampsia, body mass index and labour complications will be considered a priori as potential confounders of the association between pre-eclampsia and postpartum cardiovascular impairment.

Ethics and dissemination
This study was approved by the Comité Nacional de Ética em Pesquisa na Saúde, Guinea-Bissau (008/CNES/INASA/2023), and participants provide written informed consent. Results will be disseminated among the scientific community and the public.

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Dicembre 2024

Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial

Introduction
Young women are disproportionately affected by HIV in South Africa and have a high incidence of unintended pregnancies. Access to sexual and reproductive health (SRH) services, including HIV pre-exposure prophylaxis (PrEP), contraception and screening for seally transmitted infections (STIs), remains limited in South Africa, in part due to inadequate infrastructure and individual barriers to care. Integrated, community-based SRH services have the potential to overcome barriers to clinic-based care for women at risk of HIV, unintended pregnancy and STIs. We are evaluating the feasibility, acceptability and preliminary effectiveness of a novel intervention offering PrEP, contraception and STI screening in hair salons.

Methods and analysis
We will conduct a pilot cluster randomised controlled trial in hair salons in urban KwaZulu-Natal, South Africa. Salons serving primarily female clients will be randomised either to an SRH service package (offer of PrEP, contraception, STI screening and health education) or to health education only. Interested female salon clients≥18 years old will be referred by trained stylists. In intervention salons, women who meet inclusion criteria will be offered HIV and pregnancy testing; if eligible, they will be offered oral PrEP, contraception (oral or injectable) and STI screening. Follow-up visits including monitoring side effects will be conducted at baseline and 3, 6, 9 and 12 months. We will measure intervention uptake as the proportion of eligible women who agree to salon-based PrEP and separately to salon-based contraception. We will assess feasibility by collecting process measures and evaluate retention as continued use of PrEP and contraception separately, defined as one additional visit within 6 months with continued use of PrEP and/or contraception.

Ethics and dissemination
The study has been approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee and the Massachusetts General Brigham Institutional Review Board. The results will be disseminated to local and provincial Departments of Health, at scientific conferences and in peer-reviewed scientific journals.

Trial registration number
NCT04222504. Registered January 2020.

Leggi
Dicembre 2024

Identifying pre-diabetes 'hotspots in Northern California using geospatial analysis: opportunities to target diabetes prevention strategies and improve health equity

Objectives
The US Preventive Services Task Force recommends screening of adults aged 35–70 with a body mass index ≥25 kg/m2 for type 2 diabetes and referral of individuals who screen positive for pre-diabetes to evidence-based prevention strategies. The diabetes burden in the USA is predicted to triple by 2060 necessitating strategic diabetes prevention efforts, particularly in areas of highest need. This study aimed to identify pre-diabetes hotspots using geospatial mapping to inform targeted diabetes prevention strategies. A ‘hotspot’ is defined as a cluster of 3 or more neighbouring census tracts with elevated pre-diabetes prevalence.

Design
A cross-sectional study using ArcGIS software to geospatially map pre-diabetes prevalence hotspots. We used health system and census data to identify pre-diabetes hotspots using a systematic five-step geoprocessing approach that made use of incremental spatial autocorrelation and Getis-Ord Gi*.

Setting
This study was set in Kaiser Permanente Northern California (KPNC), an integrated health delivery system with over four million members.

Participants
KPNC adults ages 35–70 who underwent a haemoglobin A1c (HbA1c) or fasting plasma glucose (FPG) screening test in 2019 were mapped to census tracts in Northern California. People were considered to have pre-diabetes with an HbA1c of 5.7%–6.4% (39–46 mmol/mol) or FPG 100–125 mg/dL.

Primary and secondary outcome measures
Individual and census-level characteristics were compared between hotspots and non-hotspots using 2 and Wilcoxon rank sum tests, as well as risk differences (RDs) and Hodges-Lehmann (HL) estimates of location shift. Individual-level characteristics were derived from electronic health records and administrative data, while census-level characteristics were derived from the 2019 American Community Survey.

Results
A total of 760 044 adults met the study inclusion criteria and 40% had pre-diabetes. Individuals in pre-diabetes hotspots were less likely to be non-Hispanic white (33.6% vs 50.6%, RD: –17.04%, 95% CI –17.26% to –16.81%, p

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Dicembre 2024

Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study

Introduction
Patients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE. This study aims to investigate the effect and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE) compared with usual care. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations and systematic use of patient-reported outcome measures to assess the patient’s physical and psychological well-being.

Methods and analysis
The study is conducted in Denmark, where the healthcare system is tax-funded and services are freely available for all citizens, with an expected inclusion of 2000 patients in total. A pre-post-intervention study design is used to compare outcomes in the post-implementation cohort with the pre-implementation cohort. The co-primary outcomes are (1) health-related quality of life (patient-reported outcome, PRO) and (2) adherence to medical treatment (register-based data). Secondary outcomes include PROs on disability, treatment satisfaction, self-management, anxiety, depression and work productivity, and register-based outcomes, including recurrent PE, bleeding, mortality and healthcare use. Register-based data will be assessed at baseline (date of PE event), 6 and 12 months, while PRO-data will be assessed at 6 and 12 months after the PE event. The health economic evaluation of the Attend-PE model will include a cost-effectiveness analysis and a cost-utility analysis.

Ethics and dissemination
The project will be conducted by the Declaration of Helsinki. In accordance with the Danish Act on Health Research Ethics §14, the study is exempt from approval. The use of survey responses in research (in anonymous form) is, however, contingent on participants’ consent, and the invitation letter therefore included information about the purpose of the study and participants’ rights to withdraw consent at any time, and that completion of the questionnaire is considered as consent to their survey data to be included in research.
Study findings will be disseminated in scientific peer-reviewed journals, at national and international conferences, and for staff and decision-makers at participating hospitals and patients and relatives via the Danish Heart Association.

Trial registration number
Clinicaltrials.gov NCT06037096.

Leggi
Dicembre 2024

Efficacy of combining aspirin with hydroxychloroquine in pregnancies at high risk for pre-eclampsia: a prospective, multicentre, open-label, single-arm clinical trial, investigator-initiated study (HUGS study)

Introduction
The use of hydroxychloroquine (HCQ) during pregnancies complicated by systemic lupus erythematosus or refractory antiphospholipid antibody syndrome has demonstrated a significant ability to prevent pre-eclampsia (PE). As such, the potential for the administration of HCQ to prevent PE in other high-risk pregnancies is an important clinical research agenda among maternal and fetal medicine specialists. Mechanistically, the anti-inflammatory and immunomodulatory effects of HCQ can offer vascular protection and inhibit the placental dysfunction-associated thrombotic changes underlying the pathophysiology of PE, fetal growth restriction (FGR) and fetal death in utero (FDIU). Placenta-mediated complications exhibit a distinctive overlapping syndrome between pregnancies, and low-dose aspirin is the only prevention method currently in use. This study investigated the effects of improvements in outcomes with HCQ administration in high-risk pregnancies complicated by a previous experience of PE, FGR or FDIU.

Methods and analysis
This multicentre, open-label, single-arm trial commenced on 31 May 2022, in three tertiary hospitals in Korea. Pregnant women with a prior history of PE, FGR or FDIU are eligible to participate. This single-arm study set the previous study with the most similar inclusion criteria, aspirin dose and drug administration period as the comparison group. The required sample size was determined to be 58, with an expected dropout rate of 10%.

Ethics and dissemination
This study protocol was approved by the following institutions and committees: Institutional Review Boards of Chung-Ang University Gwangmyeong Hospital (2304-082-056), Samsung Medical Center (2021-11-087-003) and Kyungpook National University Chilgok Hospital (2021-06-005-006) and the Ministry of Food and Drug Safety. The results will be disseminated to the general public, grant funder, maternal–fetal medicine specialists and other researchers.

Trial registration number
NCT05287321.

Leggi
Dicembre 2024