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Good while it lasted? Estimating the long-term and withdrawal effects of results-based financing in Malawi on maternal care utilisation using routine data

Por: Dasgupta · T. · De Allegri · M. · Brenner · S. · Kaminjolo-Kambala · C. · Lohmann · J.
Objectives

This study aimed to evaluate the effect of introduction and subsequent withdrawal of the Results-based Financing for Maternal and Newborn Health Initiative (RBF4MNH) in Malawi on utilisation of facility-based childbirths, antenatal care (ANC) and postnatal care (PNC).

Design

A controlled interrupted time series design was used with secondary data from the Malawian Health Management Information System.

Setting

Healthcare facilities at all levels identified as providing maternity services in four intervention districts and 20 non-intervention districts in Malawi.

Participants

Routinely collected, secondary data of total monthly service utilisation of facility-based childbirths, ANC and PNC services.

Interventions

The intervention is the RBF4MNH initiative, introduced by the Malawian government in 2013 to improve maternal and infant health outcomes and withdrawn in 2018 after ceasing of donor funding.

Outcome measures

Differences in total volume and trends of utilisation of facility-based childbirths, ANC and PNC services, compared between intervention versus non-intervention districts, for the study period of 90 consecutive months.

Results

No significant effect was observed, on utilisation trends for any of the three services during the first 2.5 years of intervention. In the following 2.5 years after full implementation, we observed a small positive increase for facility-based childbirths (+0.62 childbirths/month/facility) and decrease for PNC (–0.55 consultations/month/facility) trends of utilisation respectively. After withdrawal, facility-based childbirths and ANC consultations dropped both in immediate volume after removal (–10.84 childbirths/facility and –20.66 consultations/facility, respectively), and in trends of utilisation over time (–0.27 childbirths/month/facility and -1.38 consultations/month/facility, respectively). PNC utilisation levels seemed unaffected in intervention districts against a decline in the rest of the country.

Conclusions

Concurrent with wider literature, our results suggest that effects of complex health financing interventions, such as RBF4MNH, can take a long time to be seen. They might not be sustained beyond the implementation period if measures are not adopted to reform existing health financing structures.

Developing blood-brain barrier arterial spin labelling as a non-invasive early biomarker of Alzheimers disease (DEBBIE-AD): a prospective observational multicohort study protocol

Por: Padrela · B. · Mahroo · A. · Tee · M. · Sneve · M. H. · Moyaert · P. · Geier · O. · Kuijer · J. P. A. · Beun · S. · Nordhoy · W. · Zhu · Y. D. · Buck · M. A. · Hoinkiss · D. C. · Konstandin · S. · Huber · J. · Wiersinga · J. · Rikken · R. · de Leeuw · D. · Grydeland · H. · Tippett · L. · Caw
Introduction

Loss of blood-brain barrier (BBB) integrity is hypothesised to be one of the earliest microvascular signs of Alzheimer’s disease (AD). Existing BBB integrity imaging methods involve contrast agents or ionising radiation, and pose limitations in terms of cost and logistics. Arterial spin labelling (ASL) perfusion MRI has been recently adapted to map the BBB permeability non-invasively. The DEveloping BBB-ASL as a non-Invasive Early biomarker (DEBBIE) consortium aims to develop this modified ASL-MRI technique for patient-specific and robust BBB permeability assessments. This article outlines the study design of the DEBBIE cohorts focused on investigating the potential of BBB-ASL as an early biomarker for AD (DEBBIE-AD).

Methods and analysis

DEBBIE-AD consists of a multicohort study enrolling participants with subjective cognitive decline, mild cognitive impairment and AD, as well as age-matched healthy controls, from 13 cohorts. The precision and accuracy of BBB-ASL will be evaluated in healthy participants. The clinical value of BBB-ASL will be evaluated by comparing results with both established and novel AD biomarkers. The DEBBIE-AD study aims to provide evidence of the ability of BBB-ASL to measure BBB permeability and demonstrate its utility in AD and AD-related pathologies.

Ethics and dissemination

Ethics approval was obtained for 10 cohorts, and is pending for 3 cohorts. The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)

Por: Kong · Y. · Chen · R. · Xu · M. · Zhang · J. · Chen · G. · Hong · Z. · Zhang · H. · Dai · X. · Ma · Y. · Zhao · X. · Peng · Y. · Zhang · C. · Xing · P. · Zhang · L.
Introduction

The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.

Objective

The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.

Methods and analysis

The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.

Trial registration number

NCT05790447.

Symptomology following COVID-19 among adults in Alberta, Canada: an observational survey study

Por: Chen · X. · Norris · C. · Whitten · T. · Ho · C. · Mann · B. · Bakal · J.
Objective

Fatigue, headache, problems sleeping and numerous other symptoms have been reported to be associated with long COVID. However, many of these symptoms coincide with symptoms reported by the general population, possibly exacerbated by restrictions/precautions experienced during the COVID-19 pandemic. This study examines the symptoms reported by individuals who tested positive for COVID-19 compared with those who tested negative.

Design

Observational study.

Setting

The study was conducted on adult residents in Alberta, Canada, from October 2021 to February 2023.

Participants

We evaluated self-reported symptoms in 7623 adults with positive COVID-19 tests and 1520 adults who tested negative, using surveys adapted from the internationally standardised International Severe Acute Respiratory and emerging Infection Consortium (ISARIC)-developed COVID-19 long-term follow-up tools. These individuals had an index COVID-19 test date between 1 March 2020 and 31 December 2022 and were over 28 days post-COVID-19 testing.

Primary outcome measures

The primary outcomes were to identify the symptoms associated with COVID-19 positivity and risk factors for reporting symptoms.

Results

Fatigue was the top reported symptom (42%) among COVID-19-positive respondents, while headache was the top reported symptom (32%) in respondents who tested negative. Compared with those who tested negative, COVID-19-positive individuals reported 1.5 times more symptoms and had higher odds of experiencing 31 out of the 40 listed symptoms during the postinfectious period. These symptoms included olfactory dysfunction, menstruation changes, cardiopulmonary and neurological symptoms. Female sex, middle age (41–55 years), Indigeneity, unemployment, hospital/intensive care unit (ICU) admission at the time of testing and pre-existing health conditions independently predicted a greater number and variety of symptoms.

Conclusions

Our results provide evidence that COVID-19 survivors continue to experience a significant number and variety of symptoms. These findings can help inform targeted strategies for the unequally affected population. It is important to offer appropriate management for symptom relief to those who have survived the acute COVID-19 illness.

Do they stay, or do they go? Children presenting to five emergency departments across New South Wales, Australia with acute burn injuries: a retrospective review

Por: Phillips · W. · Southern · E. · Cattell · C. · Owens · P. · Jaques · M. · Melbourne · G. · Kezhekkekara · S. · Frost · S. A.
Objective

The overall objective of the study was to describe the disposition status of children presenting with a burn injury to five emergency departments (ED) across New South Wales (NSW), Australia.

Design

A retrospective study design was used to review routinely collected ED data.

Setting

Study sites included five acute hospitals across NSW, Australia.

Participants

During the 5-year study period between 1 January 2015 to 31 December 2020, there were 5213 paediatric burn injury presentations.

Results

The mean age of burn injury presentations was 24 months (Inter-Quartile-Range (IQR) 12–84), of which 57% (2951/5213) were males. The most common presentation time was between 16:00 and 23:59 hours (63%, 3297/5213), and the median time spent in the ED was 3 hours (IQR 1–4). The majority (80%, 4196/5213) of the burn injuries presentations did not require hospital admission. The most common principal diagnoses were ‘Burn body region unspecified’ (n=1916) and ‘Burn of wrist and hand’ (n=1060).

Conclusion

Most children who presented to the hospital with a burn injury were not admitted. Often the details of these burns were poorly recorded and a complete picture of the true burden of burn injury in children, especially the ongoing care given outside the acute hospital setting, is missing. This information is crucial, as it would inform future models of care as the paradigm shifts rapidly towards primary, ambulatory and outpatient models of care.

Effects of task shifting from primary care physicians to nurses: a protocol for an overview of systematic reviews

Por: Paier-Abuzahra · M. · Posch · N. · Spary-Kainz · U. · Radl-Karimi · C. · Semlitsch · T. · Jeitler · K. · Siebenhofer · A.
Introduction

Task-shifting from primary care physicians (PCPs) to nurses is one option to better and more efficiently meet the needs of the population in primary care and to overcome PCP shortages. This protocol outlines an overview of systematic reviews to assess the effects of delegation or substitution by nurses of PCPs’ activities regarding clinical, patient-relevant, professional and health services-related outcomes.

Methods and analysis

We will conduct a systematic literature search for secondary literature in PubMed/MEDLINE, EMBASE, CINAHL and Cochrane databases. Systematic reviews, meta-analyses and Health Technology Assessments in German and English comprising randomised controlled trials and prospective controlled trials will be considered for inclusion. Search terms will include Medical Subject Headings combined with free text words. At least one-third of abstracts and full-text articles are reviewed by two independent reviewers. Methodological quality will be assessed using the Overview Quality Assessment Questionnaire. We will only consider reviews if they include controlled trials, if the profession that substituted or delegated tasks was a nurse, if the profession of the control was a PCP, if the assessed intervention was the same in the intervention and control group and if the Overview Quality Assessment Questionnaire score is ≥5. The corrected covered area will be calculated to describe the degree of overlap of studies in the reviews included in the study. We will report the overview according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Ethics and dissemination

The overview of secondary literature does not require the approval of an Ethics Committee and will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42020183327.

Interprofessional education interventions in undergraduate students of musculoskeletal healthcare professions: a scoping review protocol

Por: Ismail · F. · Myburgh · C. · Downing · C.
Introduction

Enhancing interprofessional education (IPE) fosters collaborative efforts among healthcare professionals specializing in musculoskeletal (MSK) care. This approach presents a valuable opportunity to address the pressing MSK disease burden in developing countries, with high prevalence rates and limited resources. While an abundance of literature on the various elements of IPE among healthcare students and professionals exists, shared contexts of practice of South African MSK disciplines are not currently developed through IPE at higher education level, establishing a need for South African formalised curricular IPE interventions with an explicit focus on undergraduate students of MSK healthcare professions.

Methods and analysis

The intended scoping review protocol is guided by the framework set out by Arksey and O’Malley, where the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews will guide the process of reporting. English sources (qualitative and quantitative methodological studies, conference papers and proceedings, systematic reviews, grey literature, unpublished materials, theses and dissertations) from the electronic databases PubMed, Scopus, ERIC and ProQuest with no date restriction will be included. A researcher, an independent reviewer and research librarian will search and extract data from abstracts and full texts for this scoping review, where any arising disagreements will be resolved by discussion. Reference lists of relevant literature will be scrutinised. Relevant literature will be recorded on a referencing software and deduplicated. The data collection will take place between May and October 2023. The findings will be reported narratively with the use of tables.

Ethics and dissemination

This scoping review does not require ethical approval as all literature used already exists in the public domain with no involvement of human participants. The findings from this planned review will be submitted to peer-reviewed journals and will be presented at higher education conferences. This scoping review protocol was registered on Open Science Framework with the registration osf.io/c27n4.

Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial

Por: Li · X. · Lin · J. · Hu · C. · Liu · B. · Li · F. · Li · J. · Zeng · X. · Li · S. · Mi · Y. · Yin · X. · Xu · S.
Introduction

Obesity has been identified as a significant risk factor for several chronic conditions, including diabetes, tumours and cardiovascular disease, and has been associated with increased mortality rates. Despite the well-established clinical practice of electroacupuncture (EA) as a potential treatment option for obesity, its efficacy remains questionable, primarily due to the paucity of empirical evidence supporting its therapeutic benefits.

Methods and analysis

The present study aims to investigate the efficacy and safety of EA for weight loss in obese individuals with pre-diabetes, using a randomised, placebo-controlled clinical trial design. A total of 256 eligible patients will be randomly assigned to one of two groups: EA (comprising EA treatment with health education) or superficial acupuncture (SA) (comprising SA treatment with health education). The intervention will be administered three times per week for the initial 12 weeks, two times per week for the subsequent 8 weeks and one time per week for the final 4 weeks, with a 24-week follow-up period. The primary outcome measure will be the percentage of patients who achieve a reduction of 10% or more in their body weight at week 24. Secondary outcome measures will include changes in body weight and body mass index, blood test results, data collected by the body composition analyser, size of adipose tissue scanned by MRI of the abdomen and the Impact of Weight on Quality of Life, the 21-item Three-Factor Eating Questionnaire-Revised and the Food Craving Questionnaire-Trait. The Treatment Emergent Symptom Scale will be employed to monitor every adverse reaction from baseline to follow-up.

Ethics and dissemination

This trial has received ethical clearance from the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine under the registration number 2021SHL-KY-74. All participants will provide their written informed consent prior to their enrolment. The findings of this investigation will be disseminated through peer-reviewed publications and scholarly conferences.

Trial registration number

NCT05237089.

Silhouette showcards confirm altered obesity-associated body image perception in international cohort study of African-origin populations

Por: Choo-Kang · C. · Reese · T. O. · Micklesfield · L. K. · Bovet · P. · Bedu-Addo · K. · Forrester · T. · Gilbert · J. A. · Goedecke · J. H. · Plange-Rhule · J. · Lambert · E. V. · Layden · B. T. · Rae · D. E. · Viswanathan · B. · Luke · A. · Dugas · L.
Objectives

Given the increasing prevalence of obesity and need for effective interventions, there is a growing interest in understanding how an individual’s body image can inform obesity prevention and management. This study’s objective was to examine the use of silhouette showcards to measure body size perception compared with measured body mass index, and assess body size dissatisfaction, in three different African-origin populations spanning the epidemiological transition. An ancillary objective was to investigate associations between body size perception and dissatisfaction with diabetes and hypertension.

Setting

Research visits were completed in local research clinics in respective countries.

Participants

Seven hundred and fifty-one African-origin participants from the USA and the Republic of Seychelles (both high-income countries), and Ghana (low/middle-income country).

Primary and secondary outcome measures

Silhouette showcards were used to measure perceived body size and body size dissatisfaction. Objectively measured body size was measured using a scale and stadiometer. Diabetes was defined as fasting blood glucose ≥126 mg/dL and hypertension was defined as ≥130 mm Hg/80 mm Hg.

Results

Most women and men from the USA and Seychelles had ‘Perceived minus Actual weight status Discrepancy’ scores less than 0, meaning they underestimated their actual body size. Similarly, most overweight or obese men and women also underestimated their body size, while normal weight men and women were accurately able to estimate their body size. Finally, participants with diabetes were able to accurately estimate their body size and similarly desired a smaller body size.

Conclusions

This study highlights that overweight and obese women and men from countries spanning the epidemiological transition were unable to accurately perceive their actual body size. Understanding people’s perception of their body size is critical to implementing successful obesity prevention programmes across the epidemiological transition.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol

Por: Ho · C. · Ha · N. T. · Youens · D. · Abhayaratna · W. P. · Bulsara · M. K. · Hughes · J. D. · Mishra · G. · Pearson · S.-A. · Preen · D. B. · Reid · C. M. · Ruiter · R. · Saunders · C. M. · Stricker · B. H. · van Rooij · F. J. A. · Wright · C. · Moorin · R.
Introduction

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

Methods and analysis

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethics and dissemination

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

Trial registration number

NCT05972785.

Artificial intelligence driven malnutrition diagnostic model for patients with acute abdomen based on GLIM criteria: a cross-sectional research protocol

Por: Ma · W. · Cai · B. · Wang · Y. · Wang · L. · Sun · M.-W. · Lu · C. D. · Jiang · H.
Background

Patients with acute abdomen often experience reduced voluntary intake and a hypermetabolic process, leading to a high occurrence of malnutrition. The Global Leadership Initiative on Malnutrition (GLIM) criteria have rapidly developed into a principal methodological tool for nutritional diagnosis. Additionally, machine learning is emerging to establish artificial intelligent-enabled diagnostic models, but the accuracy and robustness need to be verified. We aimed to establish an intelligence-enabled malnutrition diagnosis model based on GLIM for patients with acute abdomen.

Method

This study is a single-centre, cross-sectional observational investigation into the prevalence of malnutrition in patients with acute abdomen using the GLIM criteria. Data collection occurs on the day of admission, at 3 and 7 days post-admission, including biochemical analysis, body composition indicators, disease severity scoring, nutritional risk screening, malnutrition diagnosis and nutritional support information. The occurrence rate of malnutrition in patients with acute abdomen is analysed with the GLIM criteria based on the Nutritional Risk Screening 2002 and the Mini Nutritional Assessment Short-Form to investigate the sensitivity and accuracy of the GLIM criteria. After data cleansing and preprocessing, a machine learning approach is employed to establish a predictive model for malnutrition diagnosis in patients with acute abdomen based on the GLIM criteria.

Ethics and dissemination

This study has obtained ethical approval from the Ethics Committee of the Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital on 28 November 2022 (Yan-2022–442). The results of this study will be disseminated in peer-reviewed journals, at scientific conferences and directly to study participants.

Trial registration number

ChiCTR2200067044.

Sex-specific Impact of the first COVID-19 Lockdown on Age Structure and Case Acuity at Admission in a Patient Population in southwestern Germany: a retrospective comparative Study in Neuroradiology

Por: Reder · S. R. · Herrlich · N. · Grauhan · N. F. · Othman · A. E. · Müller-Eschner · M. · Brockmann · C. · Brockmann · M. A.
Objectives

A hard lockdown was presumed to lead to delayed diagnosis and treatment of serious diseases, resulting in higher acuity at admission. This should be elaborated based on the estimated acuity of the cases, changes in findings during hospitalisation, age structure and biological sex.

Design

Retrospective monocentric cross-sectional study.

Setting

German Neuroradiology Department at a .

Participants

In 2019, n=1158 patients were admitted in contrast to n=884 during the first hard lockdown in 2020 (11th–13th week).

Main outcome measures

Three radiologists evaluated the initial case acuity, classified them into three groups (not acute, subacute and acute), and evaluated if there was a relevant clinical deterioration. The data analysis was conducted using non-parametric methods and multivariate regression analysis.

Results

A 24% decrease in the number of examinations from 2019 to 2020 (p=0.025) was revealed. In women, the case acuity increased by 21% during the lockdown period (p=0.002). A 30% decrease in acute cases in men was observable (in women 5% decrease). Not acute cases decreased in both women and men (47%; 24%), while the subacute cases remained stable in men (0%) and decreased in women (28%). Regression analysis revealed the higher the age, the higher the acuity (p

Conclusion

The lockdown led to a decrease in neuroradiological consultations, with delays in seeking medical care. In women, the number of most severe cases remained stable, whereas the mean case acuity and age increased. This could be due to greater pandemic-related anxiety among women, however, with severe symptoms they were seeking for medical help. In contrast in men, the absolute number of most severe cases decreased, whereas the mean acuity and age remained nearly unaffected. This could be attributable to a reduced willingness to seek for medical consultation.

Diabetes care in the pandemic era in the Midwestern USA: a semi-structured interview study of the patient perspective

Por: Gonzalez Bravo · C. · Sabree · S. A. · Dukes · K. · Adeagbo · M. J. · Edwards · S. · Wainwright · K. · Schaeffer · S. E. · Villa · A. · Wilks · A. D. · Carvour · M. L.
Objectives

To understand patients’ experiences with diabetes care during the COVID-19 pandemic, with an emphasis on rural, medically underserved, and/or minoritised racial and ethnic groups in the Midwestern USA.

Design

Community-engaged, semi-structured interviews were conducted by medical student researchers trained in qualitative interviewing. Transcripts were prepared and coded in the language in which the interview was conducted (English or Spanish). Thematic analysis was conducted, and data saturation was achieved.

Setting

The study was conducted in communities in Eastern and Western Iowa.

Participants

Adults with diabetes (n=20) who were fluent in conversational English or Spanish were interviewed. One-third of participants were residents of areas designated as federal primary healthcare professional shortage areas and/or medically underserved areas, and more than half were recruited from medical clinics that offer care at no cost.

Results

Themes across both English and Spanish transcripts included: (1) perspectives of diabetes, care providers and care management; (2) challenges and barriers affecting diabetes care; and (3) participant feedback and recommendations. Participants reported major constraints related to provider availability, costs of care, access to nutrition counselling and mental health concerns associated with diabetes care during the pandemic. Participants also reported a lack of shared decision-making regarding some aspects of care, including amputation. Finally, participants recognised systems-level challenges that affected both patients and providers and expressed a preference for proactive collaboration with healthcare teams.

Conclusions

These findings support enhanced engagement of rural, medically underserved and minoritised groups as stakeholders in diabetes care, diabetes research and diabetes provider education.

Students perceptions and experiences of an online well-being programme: a phenomenological study protocol

Por: Escuadra · C. J. · Chiong Maya · A. · Nava · J. B. P. · Vergara · J. A. · Bea · T. C. · Javier · A. M. · Karamihan · F. · Padilla · D. P. · Reyes · A. J. · Samonte · J. · Serrano · S. I.
Background

The pandemic has ensued challenges across all sections of the human population such as livelihood and educational changes, which involve the abrupt shift to online learning, immensely affecting the students’ well-being. Negative health consequences of e-learning among students stem from the increased demand for new technological skills, productivity, information overload and restriction of students to spend time with their peers.

Objective

To explore the experiences of the students from the University of Santo Tomas—College of Rehabilitation Sciences (UST-CRS) who participated in the online well-being programme.

Methodology

A phenomenological design will be used to determine the participants’ perceptions and experiences. Purposive sampling will be used to recruit 8–10 undergraduate students from UST-CRS ages 18–22 years, who participated in the well-being programme, and completed the study’s quantitative counterpart. Semistructured, in-depth questions will be used to conduct a focus group discussion. The transcripts will be analysed using thematic analysis via the NVivo V.12 software.

Ethics and dissemination

The study protocol is approved by the UST-CRS Ethical Review Committee (Protocol Number: SI-2022–034 (V.4)). It will be implemented in accordance with the Declaration of Helsinki and the National Ethical Guidelines for Health and Health-Related Research, and Data Privacy Act. Findings will be published in accredited journals and presented in related scientific fora.

Registration ID

PHRR230214-005419; Philippine Health Research Registry.

Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L.
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

Randomised trials conducted using cohorts: a scoping review

Por: Nickolls · B. J. · Relton · C. · Hemkens · L. · Zwarenstein · M. · Eldridge · S. · McCall · S. J. · Griffin · X. L. · Sohanpal · R. · Verkooijen · H. M. · Maguire · J. L. · McCord · K. A.
Introduction

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.

Objective

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.

Design

Scoping review.

Data sources

Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews—Cochrane Methodology Registry (Final issue, third Quarter 2012).

Eligibility criteria

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 extraction and synthesis

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.

Results

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.

Conclusion

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.

Impacts of income inequality and the mediation role of reporting delays on COVID-19 deaths during 2020 and 2021 in Hong Kong: an observational study

Por: Yuan · H.-Y. · Wong · W. H. · Khairunnasa · F. · Ho · H. C. · Chung · G. K.-K.
Objective

To estimate the impacts of demographic factors and income disparities on the case fatality rate (CFR) of COVID-19 in Hong Kong, taking into account the influence of reporting delays (ie, the duration between symptom onset and case confirmation).

Design

Retrospective observational longitudinal study.

Participants

A total of 7406 symptomatic patients with residence information reported between 23 January 2020 and 2 October 2021.

Main outcome measures

The study examined the disparity in COVID-19 deaths associated with the factors such as age (≥65 vs 0–64 years old groups), gender and the income level of districts (low income vs non-low income). The severe reporting delay (>10 days) was considered as the mediator for mediation analysis. A Cox proportional hazards regression model was constructed.

Results

We found that CFR was 3.07% in the low-income region, twofold higher than 1.34% in the other regions. Although the severe reporting delay was associated with a hazard ratio (HR) of about 1.9, its mediation effect was only weakly present for age, but not for gender or income level. Hence, high CFR in Hong Kong was largely attributed to the direct effects of the elderly (HR 25.967; 95% CI 14.254 to 47.306) and low income (HR 1.558; 95% CI 1.122 to 2.164).

Conclusion

The disparity in COVID-19 deaths between income regions is not due to reporting delays, but rather to health inequities in Hong Kong. These risks may persist after the discontinuation of test-and-trace measures and extend to other high-threat respiratory pathogens. Urgent actions are required to identify vulnerable groups in low-income regions and understand the underlying causes of health inequities.

Determinants of iron-rich food deficiency among children under 5 years in sub-Saharan Africa: a comprehensive analysis of Demographic and Health Surveys

Por: Osei Bonsu · E. · Addo · I. Y. · Boadi · C. · Boadu · E. F. · Okeke · S. R.
Background

Iron deficiency is a major public health problem that affects the physical and cognitive development of children under 5 years of age (under-5 children) in sub-Saharan Africa (SSA). However, the factors associated with the limited consumption of iron-rich foods in the region are poorly understood.

Objective

This study examined the prevalence and determinants of iron-rich food deficiency among under-5 children in 26 SSA countries.

Design

This nationally representative quantitative study employed pooled data from Demographic and Health Surveys conducted between 2010 and 2019.

Methods

Representative samples comprising 296 850 under-5 children from the various countries were used. Bivariate and multivariate logistic regression models were used to determine the associations between the lack of iron-rich food uptake and various sociodemographic factors.

Result

The overall prevalence of iron-rich food deficiency among the children in the entire sample was 56.75%. The prevalence of iron-rich food deficiency varied widely across the 26 countries, ranging from 42.76% in Congo Democratic Republic to 77.50% in Guinea. Maternal education, particularly primary education (OR 0.62, 95% CI 0.57 to 0.68) and higher education (OR 0.58, 95% CI 0.52 to 0.64), demonstrated a reduced likelihood of iron-rich food deficiency in the sample. Likewise, paternal education, with both primary education (OR 0.69, 95% CI 0.63 to 0.75) and higher education (OR 0.66, 95% CI 0.60 to 0.73) showed decreased odds of iron-rich food deficiency. Postnatal visits contributed significantly to reducing the odds of iron-rich food deficiency (OR 0.90, 95% CI 0.83 to 0.95), along with antenatal visits, which also had a positive impact (OR 0.84, 95% CI 0.74 to 0.95). Finally, residents in rural areas showed slightly higher odds of iron-rich food deficiency (OR 1.12, 95% CI 1.10 to 1.28).

Conclusion

Based on the findings, interventions targeting iron-food deficiency in the SSA region should take into strong consideration the key determinants highlighted in this study.

National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol

Por: Lopes · C. · Joao · J. C. · Lowbridge · C. · Martins · N. · dos Santos · R. I. G. · da Silva · E. · Dias · J. · Ramalingam · S. · Amaral · S. · Oakley · T. · Ico · L. d. C. · Sarmento · N. · Yan · J. · Francis · J. R.
Introduction

Timor-Leste has one of the world’s highest estimated tuberculosis (TB) incidences, yet the data which informs this estimate is limited and the true burden of TB disease is not known. TB prevalence surveys offer the best means of determining robust estimates of disease burden. This study aims to provide an estimate of the prevalence of bacteriologically confirmed pulmonary TB in Timor-Leste and provide additional insights into diagnostic coverage and health-seeking behaviour of persons with symptoms suggestive of TB.

Methods and analysis

A national population-based cross-sectional cluster survey will be conducted in which participants aged 15 years and older will be screened for pulmonary TB using an algorithm consisting of symptom screening and digital X-ray of the chest with computer-aided detection software for X-ray interpretation. Xpert Ultra and liquid culture methods will be used to confirm survey TB cases. Additional data will be collected from persons reporting symptoms suggestive of TB to assess health-seeking behaviour and access to TB diagnosis and care. The survey aims to screen a target sample population of 20 068 people, living within 50 clusters, representing every municipality of Timor-Leste. Bacteriologically confirmed pulmonary TB prevalence will be estimated using WHO-recommended methods.

Ethics and dissemination

Research ethics approval has been granted by the human research ethics committee of the Northern Territory, Australia, and the Instituto Nacional da Saúde, Timor-Leste. The results will be published in a peer-reviewed scientific journal and disseminated with relevant stakeholders.

Trial registration number

ACTRN12623000718640.

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