by Adedapo Olufemi Bashorun, Larry Kotei, Abdoulie F. Jallow, Ousubie Jawla, Emmanuel U. Richard-Ugwuadu, Muhammed Jagana, Lamin Bah, Amadou Tijan Bah, Karamo Conteh, Mamadou S.K. Jallow, Mehrab Karim, Bai Lamin Dondeh, Anne Segonds-Pichon, Gary M. Clifford, Iacopo Baussano, Bruno Pichon, David Jeffries, Ed Clarke
Human papillomavirus (HPV) infection is a primary cause of preventable deaths from cervical cancer, a condition of profound inequality with approximately 90% of deaths occurring in low- and middle-income countries, particularly in sub-Saharan Africa. In May 2018, the WHO Director-General declared a Joint Global Commitment to Cervical Cancer Elimination, highlighting the critical role of HPV vaccines in achieving this goal. However, there is a lack of systemically collected data on HPV prevalence in The Gambia, and impact data from high-income countries may not be reliably extrapolated to West African settings due to geographical variation in HPV types and distinct behavioural, biological, and sociodemographic exposures. The Gambia introduced a two-dose HPV vaccination schedule in 2019, but coverage has been very low, interrupted mainly by the COVID-19 pandemic. This presents a key opportunity to generate vital baseline data on HPV prevalence in the population before potential scale-up of vaccination efforts. The PHASE survey, a multi-stage cluster survey, aims to establish the baseline, population prevalence estimates of high-risk and low-risk, vaccine-type and non-vaccine-type HPV infection in 15- to 49-year-old females in The Gambia by measuring urinary HPV-DNA. The survey will also quantify the effects of various exposures on HPV prevalence, including sexual behaviour, the presence of other sexually-transmitted infections (STIs) - Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), syphilis, as well as blood borne viruses, human immunodeficiency virus (HIV), hepatitis B and hepatitis C; obstetric history, socio-demographic characteristics, and cervical cancer screening and/or treatment. Additionally, the study will provide important antimicrobial resistance (AMR) data for NG and MG in sub-Saharan Africa, a region poorly represented in global surveillance programs. This data is needed to guide regional treatment guidelines and advocate for new solutions, including gonococcal vaccines. The AMR data are expected to immediately influence recommendations regarding the appropriate choice of antibiotics for syndromic STI management in West Africa and hence to address an important driver of AMR in the sub-region. Leveraging on the Medical Research Council Unit The Gambia funded Health Demographic Surveillance system (HDSS) as its sampling frame, the survey will utilize validated diagnostic assays and culturally sensitive data collection methods, to ensure both scientific rigor and local relevance. Tools such as Audio Computer-Assisted Self-Interviewing (ACASI) technology, developed in consultation with local community advisory boards, are included to reduce social desirability bias in reporting sexual behaviour. This approach aims to maximize both the reliability and cultural appropriateness of the findings. This study directly addresses the critical need for baseline epidemiological data on HPV in a West African setting to accelerate vaccine impact and drive new interventions towards cervical cancer elimination. By understanding other factors that influence HPV (like other STIs, sexual behaviour, etc.), the study aims to ensure that, when the vaccine’s impact is measured later, changes in other confounding factors that may impact on HPV prevalence can be accounted for. The study will also establish the population prevalence of the measured STIs and their relationship to common symptoms and other adverse health outcomes related to STIs.Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.
The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.
Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.
ACTRN12624001409561.
High-quality clinical practice guidelines and hospital standards on falls prevention and management now exist, yet their implementation into clinical practice is variable. Insights from consumers could help to guide the development of a process to improve the implementation of falls prevention and management, particularly in rehabilitation hospitals where fall rates are high.
A qualitative descriptive study will incorporate semistructured interviews and focus groups to explore the perspectives of hospital consumers on how hospital falls prevention evidence can best be implemented into rehabilitation practice. Thematic analysis of the data will be conducted in NVivo using a six-phase thematic coding process guided by Braun and Clarke. Evaluation and synthesis of the data will also follow the Consolidated Criteria for Reporting Qualitative Research checklist. Consideration of the results from the interviews and focus groups will provide insights into the views of people with lived experience of hospitalisation and falls. Thematic analysis will be supported by direct quotes for each key theme and will highlight how the themes relate to the study aims and the rehabilitation context.
The study was approved by La Trobe University Human Research Ethics Committee (HEC24526). The study will be published in a peer-reviewed journal, and findings will be presented at conferences, workshops and online events.
Secure mental health pathways are complex. They are typically based around secure hospitals, but also interface with justice agencies and other clinical services, including in the community. Consideration of risk is fundamental to clinical care and to decisions relating to a patient’s stepwise journey through the pathway. Patient autonomy and involvement in decision-making are policy priorities for health services. However, improving collaboration in risk-related decisions in secure services is complicated by potential issues with insight and capacity and the necessary involvement of other agencies. In addition, although some collaborative approaches are feasible and effective, their impact, mechanisms and the contexts in which they work are not well understood. Therefore, using realist methodology, this review will outline what works, for whom, why and under what circumstances in terms of collaborative risk assessment and management in secure services.
The review will consist of four stages: (1) Development of an initial programme theory to explain how and why collaborative risk assessment and management works for different groups of people, (2) search for evidence, (3) data selection and extraction and (4) evidence synthesis and development of a final programme theory. Our initial programme theory will be informed by an informal search of the literature and consultation with experts and patient and public involvement and engagement representatives. Following this, our formal literature search will include both the published and unpublished literature. During full text screening, each document will be assessed according to the principles of rigour and relevance and, if included, data will be extracted and synthesised to refine the programme theory.
This protocol is for a review of published literature and so does not require ethical approval. The main output will be the final programme theory. Remaining gaps will inform planned future work to further refine the theory using mixed methods. Our dissemination strategy will be codeveloped with our public and patient involvement group and will include publishing findings in a peer-reviewed journal and presenting findings at relevant professional conferences, as well as engaging patient, carer and clinician groups directly.
by Mayuko Takezaki, Biaoru Li, Hongyan Xu, Nikhil Patel, Rudolf Lucas, Ryan E. Cerbone, Sivanagireddy Koti, Clifford L. Hendrick, Louis H. Junker, Betty S. Pace
The most common hemoglobin disorder worldwide is sickle cell disease (SCD) caused by a point mutation in the adult β-globin gene. As a result, hemoglobin S production occurs leading to clinical symptoms including vaso-occlusive pain, organ damage, and a shortened lifespan. Hydroxyurea is the only FDA-approved fetal hemoglobin (HbF) inducer in the United States that ameliorates the clinical severity of SCD. Due to challenges with hydroxyurea, our study aimed to address the unmet need for the development of non-chemotherapeutic HbF inducers. We investigated the ability of CT-101, a Class 1 histone deacetylase inhibitor, to flip the γ-globin to β-globin switch in a humanized SCD mouse model. Pharmacokinetic parameters were assessed in CD-1 and Townes SCD mice after a single intraperitoneal drug dose. Similar drug uptake and half-life were observed in both animals. Subsequent studies in β-YAC mice expressing human γ-globin and β-globin genes established the optimal dose of CT-101 that induces HbF without peripheral blood toxicity. Subsequent confirmatory studies were conducted in the SCD mouse treated with intraperitoneal CT-101, demonstrating increases in F-cells, HbF, and γ-globin gene mRNA levels. Hydroxyurea combined with CT-101 significantly decreased spleen size and hemorrhagic infarcts and improved splenic extramedullary hematopoiesis. Our novel agent, CT-101, flipped the switch by activating γ-globin gene transcription and HbF protein synthesis in the preclinical SCD mouse model without significant toxicity in the peripheral blood. These findings support the development of an oral CT-101 formulation for clinical testing in SCD.To investigate whether chronic diseases are associated with higher COVID-19 vaccine hesitancy and explore factors that influence COVID-19 vaccine hesitancy in patients with chronic diseases.
Vaccine hesitancy has been acknowledged as one of the greatest hazards to public health. However, little information is available about COVID-19 vaccine hesitancy among patients with chronic diseases who may be more susceptible to COVID-19 infection, severe disease or death.
From 6 to 9 August 2021, we performed an internet-based cross-sectional survey with 22,954 participants (14.78% participants with chronic diseases). Propensity score matching with 1:1 nearest neighbourhood was used to reduce confounding factors between patients with chronic diseases and the general population. Using a multivariable logistic regression model, the factors impacting COVID-19 vaccine hesitancy were identified among patients with chronic diseases.
Both before and after propensity score matching, patients with chronic diseases had higher COVID-19 vaccine hesitancy than the general population. In addition, self-reported poor health, multiple chronic diseases, lower sociodemographic backgrounds and lower trust in nurses and doctors were associated with COVID-19 vaccine hesitancy among patients with chronic diseases.
Patients with chronic diseases were more hesitant about the COVID-19 vaccine. Nurses should focus on patients with chronic diseases with poor health conditions, low socioeconomic backgrounds and low trust in the healthcare system.
Clinical nurses are recommended to not only pay more attention to the health status and sociodemographic characteristics of patients with chronic diseases but also build trust between nurses and patients by improving service levels and professional capabilities in clinical practice.
Patients or the public were not involved in setting the research question, the outcome measures, or the design or implementation of the study. However, all participants were invited to complete the digital informed consent and questionnaires.