Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.
PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.
This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.
We evaluated the performance of risk models that incorporate ambulatory ECG data and clinical information for prediction of healthcare expenditures related to heart failure (HF) and stroke events in treated and untreated patients.
A retrospective cohort study of Medicare patients who underwent Zio XT ambulatory monitoring in the USA was conducted between 2014 and 2020.
14-day ambulatory ECG data and claims data were evaluated in the study sample which included 89 923 patients in the HF hospitalisation group, 75 870 in the new-onset HF group and 90 159 in the stroke hospitalisation group. Predictive models for new-onset HF, HF hospitalisation and stroke hospitalisation were generated using LASSO Cox regression with ambulatory ECG variables and components of the CHA2DS2-VASc. For each outcome, we scored patients using standardised linear predictors from three composite risk models, and we evaluated the association between risk score and total Medicare cost.
The following hazard ratios per one SD increase in the new risk score were observed for the model that included all CHA2DS2-VASc components and ECG variables: HF hospitalisation in treated 2.94, 95% CI 2.75 to 3.15; new-onset HF in treated 1.84, 95% CI 1.75 to 1.93; HF hospitalisation in untreated 3.51, 95% CI 3.23 to 3.82; and new-onset HF in untreated 1.92, 95% CI 1.85 to 2.00. Risk scores generated by the model were also predictive of Medicare cost in both treated and untreated patients, with patients in the high-risk category for all outcomes having the greatest Medicare costs during 1 year of follow-up.
Integrating arrhythmia data from ambulatory ECG monitoring into clinical risk models allows for better prediction of healthcare utilisation and cost in both treated and untreated patients at high risk for HF and stroke events.
Women with gestational diabetes mellitus (GDM) are at seven-fold to ten-fold increased risk of type 2 diabetes mellitus (T2DM) when compared with those who experience a normoglycaemic pregnancy, and the cumulative incidence increases with the time of follow-up post birth. This protocol outlines the development and validation of a risk prediction model assessing the 5-year and 10-year risk of T2DM in women with a prior GDM diagnosis.
Data from all birth mothers and registered births in Victoria and South Australia, retrospectively linked to national diabetes data and pathology laboratory data from 2008 to 2021, will be used for model development and validation of GDM to T2DM conversion. Candidate predictors will be selected considering existing literature, clinical significance and statistical association, including age, body mass index, parity, ethnicity, history of recurrent GDM, family history of T2DM and antenatal and postnatal glucose levels. Traditional statistical methods and machine learning algorithms will explore the best-performing and easily applicable prediction models. We will consider bootstrapping or K-fold cross-validation for internal model validation. If computationally difficult due to the expected large sample size, we will consider developing the model using 80% of available data and evaluating using a 20% random subset. We will consider external or temporal validation of the prediction model based on the availability of data. The prediction model’s performance will be assessed by using discrimination (area under the receiver operating characteristic curve, calibration (calibration slope, calibration intercept, calibration-in-the-large and observed-to-expected ratio), model overall fit (Brier score and Cox-Snell R2) and net benefit (decision curve analysis). To examine algorithm equity, the model’s predictive performance across ethnic groups and parity will be analysed. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-Artificial Intelligence (TRIPOD+AI) statements will be followed.
Ethics approvals have been received from Deakin University Human Research Ethics Committee (2021–179); Monash Health Human Research Ethics Committee (RES-22-0000-048A); the Australian Institute of Health and Welfare (EO2022/5/1369); the Aboriginal Health Research Ethics Committee of South Australia (SA) (04-23-1056); in addition to a Site-Specific Assessment to cover the involvement of the Preventative Health SA (formerly Wellbeing SA) (2023/SSA00065). Project findings will be disseminated in peer-reviewed journals and at scientific conferences and provided to relevant stakeholders to enable the translation of research findings into population health programmes and health policy.
The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.
A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.
This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.
CRD42023452537.
As the HIV epidemic stabilises in Sub-Saharan Africa with effective antiretroviral therapy, cardiometabolic disorders (CMDs) remain the next major challenge for people living with HIV. Relationship dynamics and spousal support are important for the medical management of single diseases such as HIV, yet little is known about how couples manage the complexity of multiple competing health conditions and their synergistic effects on health. The Healthy Hearts study aimed to develop a conceptual model of dyadic management of HIV and CMDs, inform interventions for couples in Sub-Saharan Africa, and ultimately improve clinical practice and disease management for HIV and CMD comorbidities.
This study will enrol 250 couples who have at least one partner living with HIV and CMD (either hypertension or diabetes) for a prospective observational cohort study. Patients will be recruited from HIV and CMD clinics in Zomba and Blantyre, Malawi. Couples will attend four study visits at quarterly intervals over 12 months. Both partners are given interviewer-administered surveys and complete a clinical assessment. Regression techniques will be used to test associations between key constructs in our conceptual model, including communal coping, multimorbidity illness perceptions, relationship quality, psychosocial health, disease management (eg, adherence to lifestyle advice and medications) and disease outcomes (eg, viral suppression and CMD control). Findings will be used to identify elements to target in a couple-based intervention for CMD and HIV.
This study was approved by the University of California, San Francisco (HRPP (Human Research Protection Program); Protocol number 20–32126), and the National Health Sciences Research Committee of Malawi (Protocol number 21/04/2677). The results will be disseminated at local community meetings and conferences focused on relationships, CMDs and HIV and published in scientific journals.
Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.
This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.
We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).
All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.
This study aimed to investigate the association between food insecurity and dietary intake with anxiety and depression among residents of underserved urban settlements in Bangladesh.
This cross-sectional study was used to collect data from participants through face-to-face interviews using structured questionnaires. Food security status was assessed using the Household Food Insecurity Access Scale, while anxiety and depression levels were measured using the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9, respectively. Dietary intake was evaluated through a 24-hour dietary recall and Food Frequency Questionnaire method.
Five districts located within the Khulna Division of Bangladesh.
Residents of underserved urban areas in Bangladesh (n=749), aged ≥18 years old.
Results indicated that 22.1%, 74.6% and 44.5% of participants experienced severe food insecurity, mild to moderate food insecurity and low Household Dietary Diversity Score, with a significant portion also showing symptoms of anxiety (57.1%) and depression (57.9%). Food insecurity and Household Dietary Diversity Score were found to be positively associated with both anxiety (p
These findings highlight that food insecurity not only affects dietary habits but also exacerbates mental health outcomes. Addressing food insecurity and balanced dietary intake could therefore contribute to better mental health outcomes and overall well-being in underserved communities. Policymakers should prioritise comprehensive strategies that ensure access to nutritious foods and provide mental health support to vulnerable groups.
Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.
This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B12). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.
The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.
All data will be made publicly available (deidentified) after the publication of the main impact paper.
The use of natural environments and nature activities as elements in the treatment and rehabilitation of mental health challenges is gaining international attention. The objective of the present review was to summarise the knowledge on the effects of nature-based health interventions (NBHIs) targeting individuals diagnosed with anxiety, depression and/or experiencing stress.
Systematic review and meta-analyses. The quality and certainty of evidence were assessed using the SIGN and GRADE.
Searches were performed in Embase, MEDLINE, PsycINFO, CINAHL, Cochrane and Web of Science.
(1) NBHIs, (2) Individuals with a diagnosis of mild to moderate anxiety, depression and/or experiencing stress, (3) Age of participating individuals: 18–84 years, (4) Study designs: randomised controlled trials, cohort studies, case-control studies and case-series studies and (5) Publication date: 2000–2024.
Screening, quality appraisal and certainty of evidence, assessed using SIGN and GRADE, were performed by two independent reviewers, except title screening. Meta-analyses were performed using random-effect models.
Nineteen articles were included, of which 14 were included in the meta-analyses. The articles showed substantial variation in design, interventions, settings and risk of bias, limiting the certainty of evidence according to GRADE. Participating in NBHIs led to a small to large effect in mental health with standardised mean changes of –0.80 (95% CI= (–1.56; –0.04)), –0.87 (95% CI= (–1.18; –0.56)), –0.32 (95% CI= (–0.74; 0.09)) and 0.58 (95% CI= (0.39; 0.77)) for anxiety, depression and stress scores and overall mental health scores, respectively.
This is the first systematic review examining the effect of NBHIs exclusively on individuals diagnosed with anxiety, depression and/or experiencing stress. Our findings suggest small to large improvements after participating in NBHIs. However, methodological limitations to the included articles necessitate cautious interpretation.
CRD42024516270.
To analyse patient profiles, transportation patterns and time delays in ischaemic time and door-to-balloon (DTB) time and evaluate the effect of these delays on in-hospital mortality among patients undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction (STEMI) at a tertiary care hospital in Colombo.
Retrospective observational study.
Tertiary care hospital specialising in STEMI treatment, located in Sri Lanka.
The study included adults aged 16–87 years admitted for P-PCI between January 2018 and September 2023, presenting with STEMI and undergoing emergency P-PCI. Patients with incomplete records or unrealistic values on ischaemic time or DTB time were excluded.
Outcome measures include ischaemic time, DTB time and in-hospital mortality. The associations of demographic factors, transfer methods and DTB time with survival rates were analysed.
A total of 1758 patients underwent P-PCI (mean age, 53.0±11.64), with 85.2% being male. The male risk group was 46–60 years (OR, 1.22), whereas the female risk group was predominantly older than 60 years (OR, 1.87). The median ischaemic time was 4 hours and 36 min, and the median DTB time was 110 min. The in-hospital mortality rate was 3.8% (63/1,664). Prolonged DTB times exceeding 120 min were significantly associated with increased mortality (p=0.046), although alternative thresholds (45, 60 or 90 min) were not significant (p>0.05). Binary logistic regression with multiple variables identified female sex (OR, 2.52; 95% CI, 1.168 to 5.435, p=0.018), increasing age (OR 1.05; 95% CI, 1.016 to 1.085, p=0.004) and DTB times (OR, 1.001; 95% CI, 1.000 to 1.002, p=0.027) as independent predictors of mortality.
Despite improvements in DTB times, this study indicates that prolonged delays exceeding 120 min remain associated with increased mortality. Older age and female sex were identified as independent predictors of higher mortality. These findings underscore the need for efficient patient transfer methods and prompt decision-making at the primary healthcare level to minimise delays and disparities in P-PCI outcomes.
To identify and contextualise evidence-based strategies for implementing deprescribing practices at different levels of healthcare in Brazil, through the development of an evidence brief for policy that includes stakeholder deliberation and considers barriers, facilitators and equity aspects.
This protocol outlines the development of an evidence brief for policy using a mixed-methods design. It involves synthesising evidence for health policies by integrating global research and local evidence through three stages: stakeholder exchange, evidence brief development and external endorsement. The Supporting Policy-Relevant Reviews and Trials tools for evidence-informed health policies will guide both the synthesis of strategies and the facilitation of deliberative dialogues. The synthesis will encompass evidence from systematic reviews and meta-analysis on deprescribing strategies across healthcare levels, focusing on effectiveness, harms, costs, perceptions, barriers, facilitators and equity. Studies proposing strategies not yet implemented will be excluded. Study selection and data extraction will be conducted independently and in duplicate. The methodological quality of included studies will be assessed using the A Measurement Tool for Assessing the Methodological Quality of Systematic Reviews-2 criteria. Synthesised evidence will be used to develop evidence-based strategies, which will then be presented in deliberative dialogues for endorsement by stakeholders and adaptation to the Brazilian context. Endorsement rates will be classified as high, moderate or low based on predefined criteria.
This study was approved by the University of Sorocaba Research Ethics Committee (certificate 82098324.7.0000.5500). Informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations.
CRD42024548845.
Breastfeeding is beneficial to the health of both the mother and infant. Despite recommendations to breastfeed by organisations including the WHO and the American Academy of Pediatrics, rates of breastfeeding remain below public health goals. The Mother and Infant Metabolome and Microbiome (MIMM) study is a prospective cohort study of healthy mother-term infant dyads designed to comprehensively assess the perinatal, maternal, neonatal and infant factors that are associated with breastfeeding outcomes and human milk composition.
MIMM participants were recruited from two medical centres in Boston, Massachusetts, from 2019 to 2023 and are followed for 2 years. Dyads were included if the mother delivered a singleton infant at ≥37 weeks’ gestation, was discharged home 2 and infant gestational age was 39.3 weeks. Approximately 43% of infants were born via caesarean delivery, and 45.5% were female.
MIMM study procedures include longitudinal (1) collections of maternal blood, vaginal swab, stool and milk and infant blood and stool samples and (2) assessments of breastfeeding status, child neurodevelopment and growth and maternal health at birth, 6 weeks and 6, 12, 18 and 24 months. Data collection through 18 months is complete. The overall objective of the MIMM study is to identify potential targets to improve breastfeeding outcomes, human milk composition and ultimately, maternal and child health. Preliminary analyses, reported in conference presentations (with ongoing analyses and results manuscripts pending), have found that (1) mothers with higher levels of stress were less likely to be exclusively breastfeeding their infants at 6 weeks; (2) higher breastfeeding intensity was associated with greater postpartum weight loss at 6 weeks; (3) feeding type was a more relevant predictor of feeding frequency and volume compared with feeding mode; (4) infants who received exclusive human milk had higher food enjoyment compared with those who received any formula; and (5) infants of mothers with obesity had higher average feeding volume per feed.
Data collection for the final 24-month visit is expected to be completed by August 2025. We expect that all sample assays will be completed by December 2025. Findings will continue to be submitted for presentation at scientific conferences, and we expect to publish the first findings from this cohort in manuscript format in 2025.
Uterine serous carcinoma (USC) accounts for 40% of endometrial cancer-related deaths. The standard of care for stages III and IV USC yields a 20%–30% survival at 2 years and a 10%–20% survival at 3–5 years. Recent advances in the second-line treatment of advanced or recurrent USC are rapidly evolving. Targeted therapeutic approaches with the use of lenvatinib plus pembrolizumab, as well as the use of trastuzumab deruxtecan, offer new hope for successful second-line therapies for patients. However, further investigation into novel targeted therapeutic approaches is warranted, given the high burden of disease associated with this aggressive histological subtype. USC shares clinical and genomic similarities with epithelial ovarian cancer, suggesting a correlation with ‘BRCAness’. Niraparib, a potent PARP1 and PARP2 inhibitor, was shown to have a positive impact on platinum-sensitive recurrent ovarian cancer, regardless of the presence or absence of BRCA status. Our hypothesis is that patients with stage III, stage IV and platinum-sensitive recurrent USC receiving niraparib maintenance in addition to standard therapy for USC may have an improved progression-free survival.
Participating sites include the primary site, Northwell Health Zucker Cancer Centre, and secondary site, Rutgers Cancer Institute of NJ. Females over the age of 18 with stage III, stage IV or platinum-sensitive recurrent USC will be recruited and enrolled based on inclusion/exclusion criteria. 24 subjects will be enrolled during phase 1 and 21 subjects will be enrolled during phase 2, over a total of 3 years. Patients will receive an individualised dose of niraparib daily every 28 days per cycle for 1 year or until progression of disease. Follow-up of disease status will continue for 5 years poststudy treatment. This phase II clinical trial will employ a Simon two-stage minimax design to test the null hypothesis that the 1 year response rate is
Ethical approval was granted by Northwell Health Cancer Institute institutional review board (reference number: 19–0380) and PRMS. Alongside journal publications, results will be available publicly on completion of the study as approved by the sponsor investigator.
NCTN04080284
Chest pain is a major cause of emergency ambulance calls, often linked to acute myocardial infarction (AMI), a critical condition requiring immediate hospitalisation. Current diagnostic methods, such as history taking and ECG, have limitations, especially for non-ST-elevation myocardial infarction. High-sensitivity cardiac troponin (cTn) assays are more diagnostically sensitive, but the downside is that it needs hospital-based testing, which can delay diagnosis and the necessary treatment protocol. Point-of-care cTn testing, on the other hand, is much faster and done nearer to the patient; hence, it may fundamentally change the prehospital care pathway in terms of diagnostic accuracy, clinical utility and related safety.
To present a protocol for a systematic review and meta-analysis that will assess the diagnostic accuracy, clinical utility and safety of point of care (POC) troponin tests, with or without clinical decision aids, for ruling out AMI in adults presenting with cardiac chest pain to emergency ambulance services in prehospital settings.
This protocol follows BMJ guidelines and adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 reporting standards. It is registered with PROSPERO (ID: CRD42024533117). A comprehensive search strategy will identify relevant studies in MEDLINE, EMBASE and CINAHL, focusing on literature from 2000 onwards. Eligibility criteria include adults with chest pain suspected of AMI, excluding those with ST-elevation myocardial infarction. The primary target is type 1 AMI, with secondary outcomes including major adverse cardiac events at 30 days. Risk of bias assessment will be performed using tools such as Quality Assessment of Diagnostic Accuracy Studies version 2, Risk of Bias 2, and Risk of Bias in Non-randomised Studies of Interventions, while the quality of the economic evaluations will be appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Data items extracted will include patient demographics, test characteristics and outcomes. Where possible, meta-analyses will be conducted by fitting hierarchical models for diagnostic accuracy and random effects models for clinical and cost-effectiveness estimates. Subgroup analyses are proposed to quantify the effect of variables such as gender, ethnicity and type of troponin assay on the estimated parameters.
Ethical approval is not required. The results will be published in a peer-reviewed journal and presented at international conferences.
This protocol is registered with PROSPERO, the International Prospective Register of Systematic Reviews, under the ID CRD42024533117. Any future amendments will be updated in the PROSPERO record.
High-speed boat operations expose personnel to slamming-induced impacts, which can lead to musculoskeletal injuries and cognitive impairments. Despite existing safety measures, regulations and protocols, the risk of injuries remains significant. The MultiAgency, prospective, exploratory, non-intervention, cohort Study on Human Impact Exposure oNboard high-speed boats study aims to investigate the nature and magnitude of these impacts, their acute and long-term health effects, and potential injury prevention strategies to improve operational safety and performance.
This is an ongoing multicentre, prospective, non-intervention, observational cohort study. The first participant was enrolled on 23 August 2024. High-speed boat operators log self-reported pain data via a smartphone app, using a Visual Analogue Scale and pain drawings. Triaxial accelerometers are installed on boat hulls and worn by participants to measure impact exposure. Data analysis assesses correlations between exposure and reported pain, enabling the identification of risk factors and the development of safety guidelines for high-speed boat operations.
The study has received ethical approval from the relevant ethics committees, including the Swedish Ethics Review Authority (no. 2022-04931-01). All participants will provide informed consent before enrolment. The findings will be disseminated through technical reports, articles in peer-reviewed journals, conference presentations and direct engagement with military and maritime stakeholders to enhance training protocols and safety measures.
To provide evidence of the cost savings of a quality improvement (QI) initiative preventing healthcare-associated infections (HAIs) in critical care settings.
A micro-costing study focused on financial data related to a nationwide multicentric project preventing central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).
Brazilian public healthcare system.
Adult, paediatric and neonatal intensive care units (ICUs) participating in the QI initiative.
This collaborative QI project implemented a multifaceted strategy to enhance infection-control measures. Participating ICUs reported the number of patients with and without HAIs and information on each HAI’s aggregate average cost (AC), which was analysed following the Brazilian Ministry of Health’s micro-costing guidelines. The 1-year preintervention period evidenced an aggregated AC in adult, paediatric and neonatal ICUs, respectively, of Intl$21 763.5 (95% CI 20 683.6 to 22 843.0), Intl$34 062.4 (95% CI 25 819.6 to 42 304.9) and Intl$32 903.2 (95% CI 29 203.6 to 36 602.4) for CLABSI; Intl$25 202.5 (95% CI 24 276.6 to 26 127.8), Intl$44 753.6 and Intl$17 238.4 for VAP and Intl$19 166.3 (95% CI 17 676.2 to 20 656.1) and Intl$55 873.3 (95% CI 43 563.1 to 68 183.1) for CAUTI (not included neonatal ICUs).
The cost savings were estimated using the HAIs prevented—expenses avoided—during the QI intervention period from September 2021 to December 2023. The HAIs prevented were estimated using the difference between observed and predicted infections based on the aggregated preintervention baseline.
Of the 188 participating ICUs, 31 voluntarily completed and provided the requested financial data with 100% accuracy. Considering the prevented 7342 HAIs for adult, paediatric and neonatal ICUs, respectively: 1647, 86 and 205 CLABSI; 3775, 114 and 118 VAP; and 1377 and 20 CAUTI, we estimated a saving of Intl$175.3 million (95% CI 153.2 to 180.9 million) to the Brazilian unified health system and a resultant estimated return on investment (ROI) of 890%.
This QI collaborative is a value-based initiative preventing HAIs in adult, paediatric and neonatal ICUs in South American settings. The substantial cost savings and a remarkable ROI underscore the economic viability of investing in comprehensive QI infection prevention strategies.