Non-randomised prospective clinical trial to improve follow-up adherence, survivorship knowledge and late effects documentation at a childhood cancer clinic in Western Kenya: a study protocol

Introduction
International survivorship guideline consortia have developed strategies to prevent, detect and manage late effects of childhood cancer survivors. However, recommendations do not adequately reflect the everyday reality of paediatric oncology care in low- and middle-income countries. In this study protocol, a survivorship intervention programme, comprising an educational component and a follow-up component, is described. The Educational Programme aims to improve follow-up adherence of childhood cancer survivors through increasing survivorship knowledge of caregivers. The Follow-up Programme aims to map late effects by implementing a follow-up form at the outpatient clinic to be used by trained healthcare providers.

Methods and analysis
This non-randomised prospective clinical trial will be performed at a referral hospital in Western Kenya. 100 caregivers of children diagnosed with cancer, who will complete treatment within 2 months, will be enrolled and followed for 24 months after completion of treatment. A caregiver control group receiving usual care will be recruited, and sequentially, caregivers will be included in an intervention group to attend an educational group session where they receive educational materials (video, booklet and Survivorship Card). Primary study outcome will be survivors’ follow-up adherence. Survivors will be considered lost to follow-up after they miss a scheduled appointment and do not revisit the clinic for more than 6 months. Mixed models regression analyses will be performed to determine intervention effects on follow-up adherence and on caregiver survivorship knowledge uptake. Additionally, healthcare providers will be trained on follow-up care, whereafter a form will be introduced at the outpatient clinic to document late effects in paediatric survivors attending the clinic for the period of a year. Secondary outcomes will be late effects prevalence as documented in the follow-up form and caregiver and healthcare provider survivorship knowledge uptake. Implementation measures (reach, potential effectiveness, adoption, satisfaction and maintenance) will be evaluated for both programmes.

Ethics and dissemination
The Institutional Research and Ethics Committee has approved the study protocol. Findings will also be shared with governmental and non-governmental organisations that support children with cancer in Kenya to inform their target audiences and guide their policy development.
Lessons learnt from this study could inform healthcare providers and policy makers on how to shape survivorship programmes in the Kenyan context and possibly implement similar programmes in other centres in Sub-Saharan Africa.

Trial registration number
NCT06680687.

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ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities – protocol of a pragmatic, individually randomised group treatment trial

Introduction
Chronic low back pain (LBP) imposes significant burden on patients, healthcare systems and society. Physical therapy is a cost-effective method for improving pain and disability; however, only a small number of patients (7–13%) with LBP ever receive physical therapy services. Patients report obstacles to accessing physical therapy, such as transportation, provider availability and missed work. Access is especially limited in rural communities, where approximately 40% fewer physical therapists are available per capita than in metropolitan regions. This lack of access likely contributes to the greater rates of LBP-related disability and opioid consumption in rural communities. Innovative methods for improving access to physical therapy for patients with chronic LBP are urgently needed; these can help address differences in health outcomes and mitigate opioid dependence for patients with chronic LBP living in rural communities. Telerehabilitation increases access to physical therapy, which can potentially improve health outcomes for these patients.

Methods and analysis
This prospective, individually randomised group treatment trial will involve primary care clinics serving rural communities on Maryland’s Eastern Shore. We will enroll 434 individuals with chronic LBP. Eligible patients will be randomised to either standardised education for back pain delivered via website or to a risk-informed telerehabilitation. Standardised education will be delivered via a study website containing information consistent with materials provided by primary care providers. Risk-informed telerehabilitation will be delivered by trained physical therapists using a web-based, video-enabled telehealth platform. The primary outcome is LBP-related disability. Secondary outcomes are opioid use, pain intensity, health-related quality of life and LBP-related healthcare use assessed using standard patient-reported outcome measures, participant self-report and medical chart abstraction. Implementation outcomes are acceptability, adoption, feasibility and fidelity of our treatment approach guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and assessed using surveys, semi-structured interviews and key performance metrics.

Ethics and dissemination
Ethics approval was obtained from the Johns Hopkins Medicine Institutional Review Boards (IRB), which serves as the single IRB for this trial. Upon completion, study data will be shared in compliance with National Institutes of Health guidelines.

Trial registration number
NCT06471920.

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Physician experiences of electronic health record interoperability and its practical impact on care delivery in the English NHS: a cross-sectional survey study

Background
The lack of interoperability has been a well-recognised limitation associated with the use of electronic health records (EHR). However, less is known about how it manifests for frontline NHS staff when delivering care, how it impacts patient care and what its implications are on care efficiency.

Objectives
(1) To capture the perceptions of NHS physicians regarding the current state of EHR interoperability, (2) to investigate how poor interoperability affects patient care and safety and (3) to explore the effects it has had on care efficiency in the NHS.

Methods
An online Qualtrics survey was conducted between June and October 2021 to explore how NHS physicians perceived the present state of interoperability among EHR in service, its effects on patient safety and its impact on care efficiency in NHS healthcare facilities. Recruitment was performed via convenience sampling and snowballing in collaboration with contacts at Health Education England deaneries and the Royal College of General Practitioners. Descriptive statistics were used to report any notable findings observed.

Results
A total of 636 NHS physicians participated, of which 218 (34.3%) completed the survey fully. Participants reported that EHR interoperability is rudimentary across much of the NHS, with limited ability to read but not edit data from within their organisation. Negative perceptions were most pronounced among specialties in secondary care settings and those with less than 1 year of EHR experience or lower self-reported EHR skills. Limited interoperability prolonged hospital stays, lengthened consultation times and frequently necessitated repeat investigations to be performed. Limited EHR interoperability impaired physician access to clinical data, hampered communication between providers and was perceived to threaten patient safety.

Conclusion
As healthcare data continues to increase in complexity and volume, EHR interoperability must evolve to accommodate these growing changes and ensure the continued delivery of safe care. The experiences of physicians provide valuable insight into the practical challenges limited interoperability poses and can contribute to future policy solutions to better integrate EHR in the clinical environment.

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Role of health information technology in enhancing chronic disease management: a scoping review protocol

Introduction
Chronic diseases, such as diabetes, hypertension and cardiovascular diseases, represent a significant burden on global health systems. Health information technology (HIT) offers innovative solutions to improve disease management, patient outcomes and healthcare efficiency. However, the diverse applications and impacts of HIT in chronic disease management are not well understood. The objective of this scoping review is to assess the extent and type of evidence on the role of HIT in enhancing chronic disease management.

Methods and analysis
This protocol outlines a scoping review to assess the extent and nature of the evidence on the role of HIT in managing chronic diseases. The review will be conducted in accordance with the JBI methodology for scoping reviews. This review will include studies involving adult patients with chronic diseases. The focus will be on various HIT interventions, including electronic health records (EHRs), telehealth services, mobile health (mHealth) applications, remote monitoring devices and health information exchanges (HIEs). Studies conducted in primary care, hospital and community health settings will be considered. Exclusions will include studies focused on paediatric populations or non-digital health interventions. We will include quantitative, qualitative and mixed-methods studies published from January 2013 to December 2024. A comprehensive search will be conducted across PubMed, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Scopus and Google Scholar. Reference lists of included studies will be screened for additional sources. Two independent reviewers will screen titles, abstracts and full texts, extract data and resolve discrepancies through discussion or consultation with a third reviewer. The study is scheduled to begin in May 2025 and conclude by November 2025, and the process will be documented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. The data will be presented as tables, charts and a narrative summary.

Ethics and dissemination
As this review involves the analysis of publicly available literature, ethical approval is not required. The results will be disseminated via peer-reviewed publications, conference presentations and engagements with stakeholders involved in chronic disease care and digital health policy. The authors will also explore opportunities to share supplementary materials in open-access repositories to promote transparency and reproducibility.

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What is the Zanzibari craftswomens experience on eyeglass use, business challenges and solutions? Participatory action research using solicited diaries and listening workshop narratives

Objective
To present older presbyopic Zanzibari craftswomen’s firsthand experiences with the eyeglasses, the challenges they face in advancing their businesses and proposed solutions to these challenges.

Design
This participatory action research used solicited diaries, where 10 craftswomen documented their experiences with presbyopia correction for 6 months. The diaries were translated into English for qualitative content analysis. Researchers then held a 2-day listening workshop with 20 craftswomen to discuss the diary findings and gather their perspectives on challenges and solutions. These workshops included group discussions and debates to encourage open communication. Narrative analysis was conducted to identify the key narratives.

Setting
Zanzibar, Unguja and Pemba Islands.

Participants
Zanzibari craftswomen entrepreneurs with corrected presbyopia, 40 years and older.

Intervention
Presbyopia near vision eyeglasses for 6 months.

Results
The study found that improved vision with eyeglasses significantly benefits craftswomen in Zanzibar. They experience increased work efficiency, quality and income. Craftswomen also reported greater independence, confidence and participation in daily activities. However, limited market access and competition restrict their income growth. Business skills training in areas like marketing and finance is seen as a solution for sustainable success.

Conclusions
Improved near vision was associated with enhanced productivity, financial confidence and well-being among craftswomen. However, persistent barriers—including limited market access, competition and lack of business skills—highlight that a vision-only approach may not address the intersectional challenges faced by older women entrepreneurs in Zanzibar. These findings suggest that integrated strategies combining vision care with business mentoring may offer more sustainable support.

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Progress and determinants of household access to improved drinking water in India using a Water Access Index: insights from the National Family Health Survey towards achieving SDG 6.1

Background and objective
Access to clean drinking water is essential for health and development. Despite global and national initiatives, many regions in India continue to face inadequate water access. This study assesses progress, sociodemographic determinants and geographic disparities in access to drinking water in India, aligning with Sustainable Development Goal (SDG) 6.1.

Design
This study used secondary data from five rounds of the National Family Health Survey (NFHS-1 to NFHS-5; 1992–2021), nationally representative surveys conducted across India. Logistic regression was employed to examine the association between household sociodemographic characteristics and access to improved drinking water. A Water Access Index (WAI) was constructed using Principal Component Analysis (PCA) based on four indicators: access to improved sources, on-premises availability, 5-minute round-trip access and household water treatment. The scores were normalised to a 0–100 scale.

Setting and participants
The study used household data from NFHS-1 (88 562 households), NFHS-2 (92 477), NFHS-3 (109 041), NFHS-4 (601 506) and NFHS-5 (636 699), covering all 36 states/union territories in India.

Results
There has been a notable improvement in access to improved sources, on-premises water and timely availability. Factors such as higher educational attainment, pucca housing and the absence of a below poverty line card were positively associated with better access. Based on WAI scores, 343 districts (49%) were categorised as front runners (65–99%), 142 districts (20%) as performers (50–64%) and 221 districts (31%) as aspirants (0–49%). Only one district (0.1%) achieved universal access. Many districts in West Bengal, Bihar, Odisha, Jharkhand and other states still exhibit low-to-moderate water access.

Conclusion
While access to improved drinking water has advanced, regional and socioeconomic disparities remain stark. Targeted, multisectoral policies are essential to ensure equitable progress towards SDG 6.1 across all districts and population groups in India.

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Maternal Screening for Congenital Syphilis

Often dismissed as a deadly and dreaded disease of the past, syphilis has made a forceful and frightening comeback in the US. In particular, the recent dramatic increase in syphilis among pregnant women is an urgent public health concern. Between 2016 and 2022, according to a report by the Centers for Disease Control and Prevention, the rate of maternal syphilis more than tripled in the US. In addition, this population-level data source revealed that 47 states have reported recent increases in their maternal syphilis rates. This finding underscores the breadth of this unfolding public health crisis. Predictably and worryingly, the rate of increase was steepest among mothers lacking access to prenatal care.

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Coping with a chronic condition that requires lifelong medication: a qualitative study with people living with atrial fibrillation in Sao Paulo, Brazil

Objective
To provide insight into how people cope with living with atrial fibrillation (AF) and taking oral anticoagulants (OACs), informing how services and healthcare delivery could be improved to offer the appropriate support patients require, thereby optimising their quality of life and well-being.

Design
A qualitative study employing focus group discussions (FGDs).

Setting
11 primary care units in a socioeconomically deprived area of the Butantan district in São Paulo, Brazil.

Participants
Adults (≥18 years) with AF purposively recruited based on sex, age and socioeconomic status.

Results
Saturation was met with three FGDs comprising seven, five and five participants, respectively. Theme one focused on self-management, where many participants discussed their methods for adhering to dietary restrictions and alternative medications, including plant-based options and specific foods, and how they modified their daily activities to reduce AF complications and symptoms. Theme two was rationality, where participants described three main ways that they cope with taking long-term medication (often warfarin): thinking that it controls their AF symptoms; it is an obligation; it prevents morbidity and premature death. Theme three was attitude and emotions, where participants described their initial reactions of shock and fear after diagnosis and ongoing emotions of sadness and frustration due to required self-management activities and regular blood tests. Theme four was medication regimen, where participants discussed difficulties with polypharmacy, changes to AF medication (particularly from non-vitamin K antagonist OACs (NOACs) to warfarin), side effects from taking warfarin and various methods of medication management.

Conclusions
This study presents three key findings with implications for patient care and support. First, the shock and fear experienced during diagnosis due to a lack of knowledge about AF suggests that improvements in public knowledge about AF are needed. Second, people with additional chronic conditions may need improved care and support, given the concern participants had regarding when and how to take their medications safely. Third, improved access to NOACs may reduce the difficulties, frustrations and concerns participants had regarding warfarin use (eg, diet, dose adjustments, self-management and monthly international normalised ratio tests).

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Correction: Concordance and determinants of mothers and childrens diets in Nigeria: an in-depth study of the 2018 Demographic and Health Survey

Akseer N, Tasic H, Adeyemi O, et al. Concordance and determinants of mothers’ and children’s diets in Nigeria: an in-depth study of the 2018 Demographic and Health Survey. BMJ Open 2023;13:e070876. doi: 10.1136/bmjopen-2022-070876
This article was previously published with an error.
Figure 2 contains an error. Rather than presenting different findings for three age groups, the results were duplicated three times for a single age group. The corrected figure is displayed below for your reference.
Figure 2 (A) Percentage concordance and discordance between maternal and child consumption of specific food groups in past 24 hours. (B) Percentage concordance between maternal and child consumption of specific food groups in past 24 hours (child age 6–11 months). (C) Percentage concordance between maternal and child consumption of food groups (child age 12–23 months).

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Prevalence and types of errors in the electronic health record: protocol for a mixed systematic review

Introduction
In countries with access to the electronic health record (EHR), both patients and healthcare professionals have reported finding errors in the EHR, so-called EHRrors. These can range from simple typos to more serious cases of missing or incorrect health information. Despite their potential detrimental effect, the evidence on EHRrors has not been systematically analysed. It is unknown how common EHRrors are or how they impact patients and healthcare professionals.

Methods and analysis
A mixed systematic review will be carried out to address the research gap. We will search PubMed, Web of Science and CINAHL for studies published since 2000, which report original research data on patient-identified and healthcare professional-identified EHRrors. We will analyse (1) the prevalence of EHRrors, (2) the types of EHRrors and (3) their impact on care. Quantitative and qualitative findings will be synthesised following the Joanna Briggs Institute Framework for Mixed Systematic Reviews. Identified studies will be critically appraised for meta-biases and risk of bias in individual studies. The confidence in the emerging evidence will be further assessed through the Grading of Recommendations Assessment, Development and Evaluation approach. Findings will be contextualised and interpreted involving an international team of patient representatives and practising healthcare professionals.

Ethics and dissemination
The study will not involve collection or analysis of individual patient data; thus, ethical approval is not required. Results will be published in a peer-reviewed publication and further disseminated through scientific events and educational materials.

PROSPERO registration number
CRD42024622849.

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Access to mental healthcare for refugees, asylum seekers and migrants: an umbrella review of barriers

Objective
To identify the factors that prevent or hinder access to mental healthcare services for refugees, asylum seekers and migrants.

Design
An umbrella review was conducted on scoping reviews, systematic reviews, meta-analyses and meta-syntheses published between January 2013 and December 2023.

Data sources
The databases searched (on 11 December 2023) included PubMed (via NCBI, including MEDLINE), Embase (via Embase.com), Web of Science Core Collection, Scopus and the Cochrane Database of Systematic Reviews (via Cochrane Library). Search strings were categorised as concepts, wherein concept one was population (refugees, asylum seekers and migrants), concept two was mental health services and concept three was the type of review (systematic review, meta-analysis, scoping review or literature review).

Eligibility criteria for selecting studies
Reviews were included if study participants were refugees, asylum seekers and migrants. Additionally, mental health-providing services or organisations and mental health providers were included. Excluded study participants were people with a migration background and second- or third-generation migrants.

Data extraction and synthesis
Two independent reviewers screened the identified articles on title and abstract. The 48 full-text articles were assessed in detail against inclusion and exclusion criteria by the two researchers and one person from the Belgian Superior Health Council.

Results
18 reviews were included. The extensive literature review identified various factors that prevent and restrict access to mental healthcare services for individuals with a recent migration background. Among the eight concepts of barriers, the most frequently mentioned were stigma and stigmatisation, language and communication challenges, financial obstacles, cultural barriers (including religious beliefs and faith) and issues with service delivery. Additionally, differences in culture, education and gender were recognised as factors limiting access to mental health services. Recommendations for policy and practice included implementing a multidisciplinary and multi-agency approach to facilitate access for newly arriving migrants and refugees, increasing financial allocations for translation and interpretation services, enabling policies to promote mental health utilisation and introducing educational programmes at the grassroot level among migrants and refugees.

Conclusion
Policy implementation should address the identified barriers and be routinely assessed for efficacy in service delivery and uptake. Future research should focus on enabling the utilisation of mental healthcare services among migrants, asylum seekers, and refugees.

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Peer support enhanced behavioural crisis response teams in the emergency department: protocol for a stepped-wedge cluster-randomised controlled trial

Introduction
Despite expert recommendations to prioritise non-invasive and patient-centred approaches for behavioural crisis management, physical restraints are commonly used in the emergency department (ED). Patients describe the restraint process as coercive and dehumanising. The use of peer support workers, who are individuals with lived experience of mental illness and behavioural conditions, has shown positive patient outcomes when assisting individuals experiencing behavioural crises. However, there is limited evidence of the implementation of such an approach in the ED setting. The goal of this study is to evaluate if the implementation of a Peer support enhanced Agitation Crisis response Team (PACT) for behavioural crisis management in the ED is more effective than usual care to reduce restraint use and improve outcomes among patients presenting to the ED with behavioural crises.

Methods and analysis
We will first conduct a stakeholder-informed needs assessment to codesign the protocol and then train staff and peers in PACT intervention readiness. Next, a stepped-wedge, cluster-randomised controlled trial will be conducted over 3 years at five ED sites across a healthcare system in the Northeast USA. The PACT intervention will integrate peer delivery of trauma-informed care within a structured, interprofessional, team-based response protocol for behavioural crisis management. The primary outcome is the rate of physical restraint and/or sedation use. The secondary outcome is the level of patient agitation during the ED visit. Analyses of primary and secondary outcomes will be conducted using generalised linear mixed models.

Ethics and dissemination
This protocol has been approved by the Yale University Human Investigation Committee (protocol number 2000037554). The study is deemed minimal risk and has been granted a waiver of consent for trial participants. However, verbal consent will be obtained for a subset of patients receiving follow-up data collection. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations, or through direct mail notifications.

Trial registration number
Clinicaltrials.gov: NCT06556069.

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Exploring perspectives regarding death cafes for people experiencing homelessness: a qualitative study

Background
People experiencing homelessness (PEH) often die at a younger age than the general population. Advanced ill-health often occurs late in its trajectory (if at all), leaving many PEH to die without adequate support from hospital-based, hospice-based or community-based palliative care services. Despite the high rate of bereavement and exposure to death among PEH, there are rarely opportunities for them to reflect on their experiences, thoughts and preferences around death or receive bereavement support. Death cafés are a global social franchise, providing a space for people to participate in an open group discussion about death, dying and bereavement. They are free to attend and unstructured but facilitated.

Objectives
To explore the perspectives of PEH and the professionals that support them with regards to the potential acceptability, benefits and challenges of death cafes.

Methods
A qualitative study comprising of interviews with nine homelessness and/or palliative care professionals with experience of running death cafés for, or supporting PEH in other ways, and two focus groups with nine people with lived experience of homelessness. The research was co-produced with a lived experience co-researcher forming a core part of the research team. Reflexive thematic analysis was utilised to develop themes.

Results
Five themes were developed to highlight the perspectives and experiences of death cafés for PEH: choice; expertise in facilitation: recognising risk and the unstructured nature; promoting safety against potential risk; potential benefits and potential practical considerations. Themes highlight the need for a trauma-informed approach. Death cafés could be impactful, where done well, but they are not without risk.

Conclusions
Death cafés for PEH pose risks that require comprehensive consideration and trauma-informed, expert facilitation. However, this research highlighted that a low-pressure space to explore thoughts around death, dying and bereavement is currently an unmet need within this population.

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Impact of Venous CONgestion on Organ Function and Outcomes in Sepsis (ICON-Sepsis): a prospective observational cohort study protocol

Introduction
Sepsis is a common condition with significant morbidity, mortality and annual costs of care in the billions of dollars. Despite innumerable studies on the causes of, and therapies for, sepsis, the mortality rate has not changed substantially in the last 20 years. Treatments remain generic, with current guidelines recommending the same approach for all patients, regardless of the litany of differences that exist at baseline. Moreover, the blanket administration of 30 cc/kg of intravenous fluid (IVF) to all patients is recognised as being directly harmful to some. Patient-level heterogeneity in prior sepsis trials is recognised as a substantial contributor to all these problems, yet no prior investigation has attempted to identify volume-informed septic phenotypes, a necessary first step towards precision care.

Methods and analysis
Predicated on prior studies demonstrating detectability of organ-level congestion, we hypothesise that central venous hypertension (1) is deleterious to the function of the lungs, liver, kidneys and vascular endothelium; (2) is worsened by cardiac dysfunction and IVF administration; and (3) contributes to adverse organ-specific and overall outcomes. Beginning in the emergency department, cardiac function will be assessed with echocardiography while congestion in the lungs and kidneys will be assessed using previously validated sonographic markers of congestion. Biomarkers for each organ will be collected concurrently, thereby increasing the fidelity of our phenotypic profiles by pairing indicators of macroscopic and microscopic stress and dysfunction. Data will also be collected at 24 hours and 7 days (or discharge, whichever comes first) after presentation. Classical and machine learning approaches will be used to analyse our large data stream and develop a rule-based system to identify distinct subpopulations of patients with sepsis who have greater risk/likelihood of both organ-specific and overall adverse outcomes.

Ethics and dissemination
This project has been approved by the Wayne State University Institutional Review Board, with patient enrolment beginning in April 2024. Findings will be reported and disseminated via conference presentations and open-access publications.

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[Corrigendum] Corrigendum to effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk: a randomised controlled trial

We acknowledge that the description of the eligibility and inclusion criteria in our article “Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk: a randomised controlled trial” published in this journal1 may have been open to misinterpretation. There has been a question regarding the inclusion of infants before 3 days of age. We therefore appreciate the opportunity to clarify this.

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