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☐ ☆ ✇ BMJ Open

Randomised controlled community trial assessing efficacy of the AWACAN-ED public toolkit to improve cancer symptom awareness and intention to seek help in South Africa and Zimbabwe: study protocol

Por: Scott · S. · Lurgain · J. G. · Day · S. · Guzha · B. T. · Pazukhina · E. · Arendse · K. D. · Govender · S. · Chirenje · M. · Sills · V. A. · Harries · J. · Jacobs · R. · Moodley · J. · Walter · F. M. — Enero 14th 2026 at 15:37
Introduction

Despite the benefits of early diagnosis, most cancers in sub-Saharan African (SSA) countries are diagnosed at an advanced stage due to late presentation of symptoms, inadequate referral systems and poor diagnostic capacity. Health communication interventions have been used extensively in high-income countries to increase people’s awareness of cancer symptoms and encourage timely help-seeking. However, in SSA, there is still limited evidence on the effectiveness of these interventions and existing evaluations are mainly focused on communicable diseases rather than cancer.

Methods and analysis

A randomised, multisite, controlled community trial will evaluate a culturally tailored health infographic toolkit delivered in rural and urban settings in the Western Cape Province in South Africa and Harare and surrounding provinces in Zimbabwe. Participants will be randomised to receive one of three African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) cancer awareness tools, coproduced with local communities, comprising health communication infographics with descriptions of breast, cervical and colorectal cancer symptoms plus messages to encourage consultation with primary care providers if symptoms occur, all presented in English and four local languages. We will recruit 144 participants in each of the three intervention groups (N=432). The primary outcome will be recall of symptoms and the secondary outcomes will be (1) intention to seek help, (2) emotional impact and (3) acceptability of the toolkit. Outcomes will be measured preintervention and at two points postintervention: after 15 min and 1 month.

Ethics and dissemination

Ethical approval was obtained in both participating countries, South Africa (148/2025) and Zimbabwe (363/2021). All participants will be required to provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and the AWACAN-ED programme website.

Trial registration number

PACTR202505475803308.

☐ ☆ ✇ BMJ Open

Hemopurifier device in patients with solid tumours who have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab: protocol for an Australian safety, feasibility and dose-finding study

Por: Brown · M. P. · Matos · M. · Clarke · S. · Coates · P. T. · Pollock · C. · Kurtkoti · J. · Grau · G. · Edinburg · K. · Bloesch · A. · de Necochea Campion · R. · Khin · N. Y. · Shin · J. · LaRosa · S. P. — Enero 6th 2026 at 00:50
Background

Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.

Methods

This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.

The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.

Ethics and dissemination

The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Trial registration number

Australia New Zealand registration number ACTRN12624000732583.

☐ ☆ ✇ BMJ Open

Assessment of regional variation in the management of heart failure with a preserved ejection fraction between the Russian Federation and the European Union: the results of the international survey

Por: Kuzheleva · E. · Saldarriaga · C. · Mewton · N. · Komarova · I. · Mukhina · N. · Cherkasova · N. · Sitnikova · V. · Anzhela · S. · Novitsky · N. · Baglikov · A. · Dyachuk · I. · Bibarsova · A. · Rogova · A. · Lezhneva · V. · Stepanenko · E. · Goldfeder de Gracia · S. · Giverts · I. · Tun — Agosto 14th 2025 at 04:49
Objectives

Regional differences in heart failure with preserved ejection fraction (HFpEF) care have been reported. We aimed to assess a physician-reported HFpEF management in the Russian Federation (RF) and a variation in the diagnosis and treatment of HFpEF between the RF and the European Union (EU).

Design/settings

It is a post hoc analysis of an academic web-based international HFpEF designed as a cross-sectional survey and conducted between May 2023 and July 2023.

Participants

Medical doctors who work in the fields of cardiology and general medicine.

Results

Among 1460 medical doctors who completed the study were 166 Russian and 646 European specialists. The responders were comparable across the groups in most of the baseline characteristics, except that RF specialists were less likely to be heart failure specialists (RF: 2% vs EU: 26%) and less often worked in academic environments (RF: 17% vs EU: 61%). The utilisation of specific echocardiography parameters (RF: 66% vs EU: 80%) and natriuretic peptides (RF: 83% vs EU: 91%) to establish a diagnosis of HFpEF was less frequent in RF compared with EU, while HFpEF scores were more likely to be used by Russian physicians (RF: 58% vs EU: 40%). In the settings when all HF medications are available, responders of both regions prioritised sodium-glucose co-transporter type 2 inhibitors (SGLT2is) (mean rank: RF: 2.6 (IQR: 2.3–3) vs EU: 2.3 (IQR: 2.2–2.5)), followed by diuretics in the EU and ACE inhibitors in the RF. Every second responder in both regions preferred SGLT-2is if only one drug was available (RF: 57% vs EU 51%).

Conclusions

The results reveal discrepancies in physician-reported HFpEF management between RF and EU responders, particularly in the diagnostic workup. Although the utilisation of relevant diagnostic tests was lower in the RF compared with the EU, these were used by two-thirds of Russian respondents. Nevertheless, further measures are required to improve the care of HFpEF patients in the RF.

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