Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, ‘24/7’) has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes.

The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed.

Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals.

DRKS00024381.

Emerging developments in applications of artificial intelligence (AI) in healthcare offer the opportunity to improve diagnostic capabilities in obstetrics and gynaecology (O&G), ensuring early detection of pathology, optimal management and improving survival. Consensus on a robust AI healthcare framework is crucial for standardising protocols that promote data privacy and transparency, minimise bias, and ensure patient safety. Here, we describe the study protocol for a systematic review and meta-analysis to evaluate current applications of AI in O&G diagnostics with consideration of reporting standards used and their ethical implications. This protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist.

The study objective is to explore the current application of AI in O&G diagnostics and assess the reporting standards used in these studies. Electronic bibliographic databases MEDLINE, EMBASE and Cochrane will be searched. Study selection, data extraction and subsequent narrative synthesis and meta-analyses will be carried out following the PRISMA-P guidelines. Included papers will be English-language full-text articles from May 2015 to March 2024, which provide original data, as AI has been redefined in recent literature. Papers must use AI as the predictive method, focusing on improving O&G diagnostic outcomes.

We will evaluate the reporting standards including the risk of bias, lack of transparency and consider the ethical implications and potential harm to patients. Outcome measures will involve assessing the included studies against gold-standard criteria for robustness of model development (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis, model predictive performance, model risk of bias and applicability (Prediction model Risk Of Bias Assessment Tool and study reporting (Consolidated Standards of Reporting Trials-AI) guidance.

Ethical approval is not required for this systematic review. Findings will be shared through peer-reviewed publications.There will be no patient or public involvement in this study.

CRD42022357024.

Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood. The Environmental Reproductive and Glucose Outcomes (ERGO) Study was established to investigate the associations of environmental exposures during the perinatal period with post-pregnancy parental cardiometabolic health.

Pregnant individuals aged ≥18 years without pre-existing diabetes were recruited at

We enrolled 653 unique pregnancies and retained 633 through delivery. Participants had a mean age of 33 years, 10% (n=61) developed gestational diabetes and 8% (n=50) developed pre-eclampsia. Participant pregnancy and postpartum urinary phthalate metabolite concentrations and postpartum glycaemic biomarkers were quantified. To date, studies within ERGO found higher exposure to phthalates and phthalate mixtures, and separately, higher exposure to radioactive ambient particulate matter, were associated with adverse gestational glycaemic outcomes. Additionally, certain personal care products used in pregnancy, notably hair oils, were associated with higher urinary phthalate metabolite concentrations, earlier gestational age at delivery and lower birth weight.

Future work will leverage the longitudinal data collected on pregnancy and cardiometabolic outcomes, environmental exposures, questionnaires, banked biospecimens and paediatric data within the ERGO Study.

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert’s consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth.

Systematic review and three-stage modified Delphi expert consensus.

International.

Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance.

Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth.

Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman’s haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman’s haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach.

These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first response management of intraoperative PPH. Determining how best to implement these strategies is a critical next step.

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Systematic review.

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

CRD42022282565.

Delineate the scope of teleconsultation services that can be effectively performed to provide women with comprehensive gynaecological and obstetrical care.

Based on the literature and experts’ insights, we identified a list of gynaecological and obstetrical care practices suitable for teleconsultation. A three-round Delphi consensus survey was then conducted online among a panel of French experts. Experts using a 9-point Likert scale assessed the relevance of each teleconsultation practice in four key domains: prevention, gynaecology and antenatal and postnatal care. Consensus was determined by applying a dual-criteria approach: the median score on a 9-point Likert scale and the percentage of votes either below 5 or 5 and higher.

The study was conducted at a national level in France and involved multiple healthcare centres and professionals from various geographical locations.

The panel comprised 22 French experts with 19 healthcare professionals, including 12 midwives, 3 obstetricians-gynaecologists, 4 general practitioners and 3 healthcare system users. Participants were selected to include diverse practice settings encompassing hospital and private practices in both rural and urban areas.

The study’s primary outcome was the identification of gynaecological and obstetrical care practices suitable for teleconsultation. Secondary outcomes included the level of professional consensus on these practices.

In total, 71 practices were included in the Delphi survey. The practices approved for teleconsultation were distributed as follows: 92% in prevention (n=12/13), 55% in gynaecology (n=18/33), 31% in prenatal care (n=5/16) and 12% in postnatal care (n=1/9). Lastly, 10 practices remained under discussion: 7 in gynaecology, 2 in prenatal care and 1 in postnatal care.

Our consensus survey highlights both the advantages and limitations of teleconsultations for women’s gynaecological and obstetrical care, emphasising the need for careful consideration and tailored implementation.

To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.

Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.

Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.

A total of 74 individuals with cardiovascular diseases.

Risk and time preferences.

The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.

The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

https://doi.org/10.17605/OSF.IO/RWY27.

During the preschool years, children depend on adult caregivers to provide opportunities for physical activity (PA). Research has focused on measuring PA in preschool, as well as barriers and facilitators to children’s PA but caregiver perceptions remain largely unknown especially in light of the COVID-19 pandemic. This study aims to understand the value of PA in preschool following the pandemic from three types of adult caregivers, parents of a young child (n=7), preschool teachers (n=7) and preschool administrators (n=7).

In-depth qualitative interviews were conducted to explore the following research questions: (a) how do caregivers describe the importance of PA in preschool postpandemic? (b) how do caregivers support and prioritise PA in preschool postpandemic and what challenges do they face in doing so? and (c) how do caregivers interact with one another to promote PA? Qualitative answers were coded using a codebook developed to answer the research questions of interest.

Parents, teachers and administrators all described valuing PA for preschoolers, but each caregiver type described a different way of promoting it. All the caregivers listed barriers that inhibit their ability to prioritise and promote PA, some heightened postpandemic. Lastly, there were limited caregiver interactions when it came to promoting PA, with the burden largely falling on teachers.

Our findings indicate that one particularly important area for intervention is supporting parents, teachers and preschool administrators in creating a shared understanding of the importance of PA for young children and ways to collaborate to promote it.

Domestic violence (DV) is a major problem which despite many efforts persists globally. Victims of DV can present with various injuries, whereof musculoskeletal presentation is common.

The DORIS study (Domestic violence in ORthopaedIcS) aimed to establish the annual prevalence of DV at an orthopaedic emergency department (ED) in Sweden.

Female adult patients with orthopaedic injuries seeking treatment at a tertiary orthopaedic centre between September 2021 and 2022 were screened during their ED visit.

This is a single-centre study at a tertiary hospital in Sweden.

Adult female patients seeking care for acute orthopaedic injuries were eligible for the study. During the study period, 4192 female patients were provided with study forms and 1366 responded (32.5%).

The primary outcome measure was to establish the annual prevalence of injuries due to DV and second, to establish the rate of current experience of any type of DV.

One in 14 had experience of current DV (n=100, 7.5%) and 1 in 65 (n=21, 1.5%) had an injury due to DV.

The prevalence of DV found in the current study is comparable to international findings and adds to the growing body of evidence that it needs to be considered in clinical practice. It is important to raise awareness of DV, and frame strategies, as healthcare staff have a unique position to identify and offer intervention to DV victims.

Decisions about nurse staffing models are a concern for health systems globally due to workforce retention and well-being challenges. Nurse staffing models range from all Registered Nurse workforce to a mix of differentially educated nurses and aides (regulated and unregulated), such as Licensed Practical or Vocational Nurses and Health Care Aides. Systematic reviews have examined relationships between specific nurse staffing models and client, staff and health system outcomes (eg, mortality, adverse events, retention, healthcare costs), with inconclusive or contradictory results. No evidence has been synthesised and consolidated on how, why and under what contexts certain staffing models produce different outcomes. We aim to describe how we will (1) conduct a realist review to determine how nurse staffing models produce different client, staff and health system outcomes, in which contexts and through what mechanisms and (2) coproduce recommendations with decision-makers to guide future research and implementation of nurse staffing models.

Using an integrated knowledge translation approach with researchers and decision-makers as partners, we are conducting a three-phase realist review. In this protocol, we report on the final two phases of this realist review. We will use Citation tracking, tracing Lead authors, identifying Unpublished materials, Google Scholar searching, Theory tracking, ancestry searching for Early examples, and follow-up of Related projects (CLUSTER) searching, specifically designed for realist searches as the review progresses. We will search empirical evidence to test identified programme theories and engage stakeholders to contextualise findings, finalise programme theories document our search processes as per established realist review methods.

Ethical approval for this study was provided by the Health Research Ethics Board of the University of Alberta (Study ID Pro00100425). We will disseminate the findings through peer-reviewed publications, national and international conference presentations, regional briefing sessions, webinars and lay summary.

Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.

This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.

The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.

NCT03406624.

Kenya still faces the challenge of mothers and neonates dying from preventable pregnancy-related complications. The free maternity policy (FMP), implemented in 2013 and expanded in 2017 (Linda Mama Policy (LMP)), sought to address this challenge. This study examines the quality of care (QoC) across the continuum of maternal care under the LMP in Kenya.

We conducted a convergent parallel mixed-methods study across multiple levels of the Kenyan health system, involving key informant interviews with national stakeholders (n=15), in-depth interviews with county officials and healthcare workers (HCWs) (n=21), exit interview survey with mothers (n=553) who utilised the LMP delivery services, and focus group discussions (n=9) with mothers who returned for postnatal visits (at 6, 10 and 14 weeks). Quantitative data were analysed descriptively, while qualitative data were analysed thematically. All the data were triangulated at the analysis and discussion stage using a framework approach guided by the QoC for maternal and newborns.

The results showed that the expanded FMP enhanced maternal care access: geographical, financial and service utilisation. However, the facilities and HCWs bore the brunt of the increased workload and burnout. There was a longer waiting time for the initial visit by the pregnant women because of the enhanced antenatal care package of the LMP. The availability and standards of equipment, supplies and infrastructure still posed challenges. Nurses were multitasking and motivated despite the human resources challenge. Mothers were happy to have received care information; however, there were challenges regarding respect and dignity they received (inadequate food, over-crowding, bed-sharing and lack of privacy), and they experienced physical, verbal and emotional abuse and a lack of attention/care.

Addressing the negative aspects of QoC while strengthening the positives is necessary to achieve the Universal Health Coverage goals through better quality service for every woman.

Non-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted life years attributed to NCDs has doubled over the past 30 years, from 18% to 36%. To mitigate the escalating burden of severe NCDs, the Tanzanian government, in collaboration with local and international partners, seeks to extend the integrated package of essential interventions for severe NCDs (PEN-Plus) to district-level facilities, thereby improving accessibility. This study aims to estimate the cost of initiating PEN-Plus for rheumatic heart disease, sickle cell disease and type 1 diabetes at Kondoa district hospital in Tanzania.

We will employ time-driven activity-based costing (TDABC) to quantify the capacity cost rates (CCR), and capital and recurrent costs associated with the implementation of PEN-Plus. Data on resource consumption will be collected through direct observations and interviews with nurses, the medical officer in charge and the heads of laboratory and pharmacy units/departments. Data on contact times for targeted NCDs will be collected by observing a sample of patients as they move through the care delivery pathway. Data cleaning and analysis will be done using Microsoft Excel.

Ethical approval to conduct the study has been waived by the Norwegian Regional Ethics Committee and was granted by the Tanzanian National Health Research Ethics Committee NIMR/HQ/R.8a/Vol.IX/4475. A written informed consent will be provided to the study participants. This protocol has been disseminated in the Bergen Centre for Ethics and Priority Setting International Symposium, Norway and the 11th Muhimbili University of Health and Allied Sciences Scientific Conference, Tanzania in 2023. The findings will be published in peer-reviewed journals for use by the academic community, researchers and health practitioners.

Supervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD.

This study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HR_peak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5–7 (progressing to 10–15x60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HR_peak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters.

The Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media.

NCT05612945.

Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

NCT04273360.

Anaemia in the elderly is often difficult to treat with iron supplementation alone as prevalence of anaemia of chronic disease (ACD) alone or mixed with iron-deficiency anaemia (IDA) is high in this age group. Hepcidin remains high in ACD, preventing utilisation of iron for heme synthesis. Vitamin D₃ has shown hepcidin suppression activity in both in vitro and in vivo studies. As there is no study assessing the effect of iron–folic acid (IFA) with vitamin D₃ on haemoglobin levels in the elderly in India, we want to conduct this study to estimate the impact of supplementation of a therapeutic package of IFA and vitamin D₃ on haemoglobin levels in the elderly with mild-to-moderate anaemia in comparison with IFA only. The study will also assess the impact of the proposed intervention on ferritin, hepcidin, 25-hydroxyvitamin D, C reactive protein (CRP) and parathyroid hormone (PTH) levels.

This study is a community-based, double-blind, placebo-controlled, randomised trial. The study will be done in the Kalyani municipality area. Individuals aged ≥60 years with mild-to-moderate anaemia and normal vitamin D₃ levels will be randomised into the intervention (IFA and vitamin D₃ supplementation) group or the control group (IFA and olive oil as placebo). All medications will be self-administered. Follow-up will be done on a weekly basis for 12 weeks. The calculated sample size is 150 in each arm. Block randomisation will be done. The primary outcome is change in haemoglobin levels from baseline to 12 weeks. Secondary outcome is change in serum ferritin, 25-hydroxyvitamin D, hepcidin, CRP and PTH levels from baseline to 12 weeks.

Ethical approval from the Institutional Ethics Committee of All India Institute of Medical Sciences Kalyani has been obtained (IEC/AIIMS/Kalyani/Meeting/2022/03). Written informed consent will be obtained from each study participant. The trial results will be reported through publication in a reputable journal and disseminated through health talks within the communities.

CTRI/2022/05/042775.

Version 1.0.

Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms.

We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients’ hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions.

The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings.

NCT05913700.

Building on Existing Tools To improvE chronic disease pRevention and screening in primary care Wellness of cancer survIvorS and patiEnts (BETTER WISE) was designed to assess the effectiveness of a cancer and chronic disease prevention and screening (CCDPS) programme. Here, we compare outcomes in participants living with and without financial difficulty.

Secondary analysis of a cluster-randomised controlled trial.

Patients of 59 physicians from 13 clinics enrolled between September 2018 and August 2019.

596 of 1005 trial participants who responded to a financial difficulty screening question at enrolment.

1-hour CCDPS visit versus usual care.

Eligibility for a possible 24 CCDPS actions was assessed at baseline and the primary outcome was the percentage of eligible items that were completed at 12-month follow-up. We also compared the change in response to the financial difficulty screening question between baseline and follow-up.

55 of 265 participants (20.7%) in the control group and 69 of 331 participants (20.8%) in the intervention group reported living with financial difficulty. The primary outcome was 29% (95% CI 26% to 33%) for intervention and 23% (95% CI 21% to 26%) for control participants without financial difficulty (p=0.01). Intervention and control participants with financial difficulty scored 28% (95% CI 24% to 32%) and 32% (95% CI 27% to 38%), respectively (p=0.14). In participants who responded to the financial difficulty question at both time points (n=302), there was a net decrease in the percentage of participants who reported financial difficulty between baseline (21%) and follow-up (12%, p

The BETTER intervention improved uptake of CCDPS manoeuvres in participants without financial difficulty, but not in those living with financial difficulty. Improving CCDPS for people living with financial difficulty may require a different clinical approach or that social determinants be addressed concurrently with clinical and lifestyle needs or both.

ISRCTN21333761.