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Evaluation of women's worries in different strategies for the prevention of early onset group B streptococcal disease in neonates

: Early onset group B streptococcal (EOGBS) disease is an important cause of neonatal morbidity and mortality. EOGBS preventive strategies aim to reduce the risk of neonatal complications. Two new strategies to prevent EOGBS were implemented in two regions in the Netherlands: a risk-based and a combination strategy and were compared to the Dutch strategy in a third region. Little is known how women feel about preventive EOGBS strategies, the consequences for management during labour, side effects such as harm caused by over prescribing of antibiotics or anxiety caused by screening.

The characteristics and prevalence of phobias in pregnancy

The primary objective was to estimate the population prevalence of specific phobias (including pregnancy related specific phobias) and associated mental disorders. The secondary objective was to investigate the effectiveness of routinely collected screening tools (depression and anxiety screens, Whooley and GAD-2 respectively) in identifying specific phobias. Specific phobias are the most common anxiety disorder to occur during pregnancy, but studies on prevalence and clinical correlates of specific phobias, including pregnancy related specific phobias are lacking.

The initiation of Dutch newly qualified hospital-based midwives in practice, a qualitative study

In the Netherlands, a percentage of newly qualified midwives start work in maternity care as a hospital-based midwife, although prepared particularly for working autonomously in the community.

The struggle is real—A mixed qualitative methods synthesis of challenges in nursing care in activities of daily living

Abstract

Introduction

Supporting care receivers in Activities of Daily Living (ADL), irrespective of diagnosis, setting, or cultural background, lies at the heart of fundamental nursing care. The pursuit of quality ADL care becomes increasingly challenging with the changing complexity of care needs. ADL care delivery is often undervalued and is considered a low-status task despite its crucial importance to care receivers. This study aims to synthesize challenges in ADL care irrespective of the care setting.

Methods

In the mixed qualitative methods study, we used expert panel consultations, world café sessions, and a rapid literature review. For data analysis, we simultaneously analyzed the three data sets using inductive and deductive inquiry.

Results

We identified four challenges and their corresponding subthemes. They are (1) Undervalued common-sense work versus complex, high-skilled care provision; (2) Limitations in professional reflective clinical decision-making; (3) Missed opportunities for shared ADL decisions; and (4) Meeting ADL care needs in a high-throughput system.

Conclusion

These challenges reveal the complexity of ADL care and how its paradoxical narrative relates to the conditions in which nursing professionals struggle to create opportunities, for reflective clinical reasoning and shared ADL decisions, by facing organizational and environmental barriers.

Clinical Relevance

This study is relevant to nursing professionals, care organizations, policymakers, and researchers aiming to improve ADL care and provide insights into challenges in ADL care. This study forms the starting point for a changing narrative on ADL nursing care and subsequent quality improvements in the form of, for example, guidelines for nursing professionals.

Methodology for Analyzing Qualitative Data in Multiple Languages

imageBackground Translation strategies are commonly used for qualitative interview data to bridge language barriers. Inconsistent translation of interviews can lead to conceptual inequivalence, where meanings of participants' experiences are distorted, threatening scientific rigor. Objectives Our objective is to describe a systematic method developed to analyze multilingual, qualitative interview data while maintaining the original language of the transcripts. Methods A literature review of translation strategies, cross-language, and multilingual qualitative research was conducted. Combined with criteria for qualitative content analysis and trustworthiness, the methodology was developed and used for a qualitative descriptive study. Results The study had interview data in both English and Spanish. The research team consisted of both native Spanish and English speakers, who were grouped based on language. Verbatim transcription of data occurred in the original languages. All codes were kept in English, allowing the research team to view the data set as a whole. Two researchers within each group coded each transcript independently before reaching a consensus. The entire research team discussed all transcripts, and finally, major themes were determined. Participants' quotes remained in the original language for publication, with an English translation included when needed. Discussion Analyzing transcripts in the original language brought forth cultural themes that otherwise may have been overlooked. This methodology promotes conceptual equivalence and trustworthiness that is paramount in cultural, linguistic, and social determinants of health research to advance health equity.

Effect of hyperbaric oxygen treatment on diabetic foot ulcers: A meta‐analysis

Abstract

The meta-analysis aimed to assess the effect of hyperbaric oxygen treatment on diabetic foot ulcers. Using dichotomous or contentious random or fixed effect models, the outcomes of this meta-analysis were examined and the odds ratio (OR) and the mean difference (MD) with 95% confidence intervals (CIs) were computed. 17 examinations from 1992 to 2022 were enrolled for the present meta-analysis, including 7219 people with diabetic foot ulcers. Hyperbaric oxygen treatment had a significantly higher healed ulcer (OR, 14.39; 95% CI, 4.02–51.52, p < 0.001), higher adverse event (OR, 2.14; 95% CI, 1.11–4.11, p = 0.02), lower mortality (OR, 0.22; 95% CI, 0.07–0.71, p = 0.01) and higher ulcer area reduction (MD, 23.39; 95% CI, 11.79–34.99, p < 0.001) compared to standard treatment in patients with diabetic foot ulcers. However, hyperbaric oxygen treatment and standard treatment had no significant difference in amputation (OR, 0.62; 95% CI, 0.22–1.75, p = 0.37), major amputation (OR, 0.59; 95% CI, 0.18–1.92, p = 0.38), minor amputation (OR, 0.64; 95% CI, 0.15–2.66, p = 0.54) and healing time (MD, −0.001; 95% CI, −0.76 to 0.75, p = 0.99) in patients with diabetic foot ulcers. The examined data revealed that hyperbaric oxygen treatment had a significantly higher healed ulcer, adverse event, and ulcer area reduction and lower mortality, however, there was no significant difference in amputation and healing time compared to standard treatment in patients with diabetic foot ulcers. Yet, attention should be paid to its values since most of the selected examinations had a low sample size and some of the comparisons had a low number of selected studies.

Software‐based interventions for low back pain management: A systematic review and meta‐analysis

Abstract

Introduction

Using software for self-management interventions can improve health outcomes for individuals with low back pain, but there is a dearth of research to confirm its effectiveness. Additionally, no known research has evaluated the effective elements of software-based interventions for low back pain self-management components. This study aimed to synthesize the effectiveness of software-based interventions to promote self-management health outcomes among individuals with low back pain.

Design

A systematic review and meta-analysis was conducted.

Methods

Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement, relevant studies up to July 2022 were searched via four electronic databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Web of Science.

Results

4908 adults with low back pain who participated in 23 studies were included. Software-based interventions were effective in reducing fear avoidance (mean difference [MD] = −0.95, 95% CI: −1.45 to −0.44), pain catastrophizing (MD = −1.31, 95% CI: −1.84 to −0.78), disability (MD = −8.21, 95% CI: −13.02 to −3.39), and pain intensity (MD = −0.86, 95% CI: −1.17 to −0.55). Specifically, interventions that included an exercise component were more effective in reducing pain and disability. Additionally, cognitive behavioral therapy (CBT) intervention significantly reduced fear avoidance and pain catastrophizing but had no noticeable impact on disability and pain compared to standard treatment. The certainty of the evidence in this review varied from very low to high across outcomes. The heterogeneity of the study results was significant, suggesting that future studies in this area could optimize the design, time points, measures, and outcomes to strengthen the evidence.

Conclusions

Low back pain self-management interventions delivered through software-based programs effectively reduce pain intensity, disability, fear avoidance, and pain catastrophizing.

Clinical Relevance

Low back pain is among the most common reasons for seeking healthcare visits. Combining exercise and counseling through soft-based programs may effectively address this issue and its associated suffering and disability.

Commentary on a Turkish kangaroo care study

Por: Clarkson · G.

Commentary on: Toprak FÜ, Erenel AS. The effect of kangaroo care practice after caesarean section on paternal-newborn interaction: A mixed-methods study in Turkey. Midwifery. 2022 Dec; 115:103489. doi: 10.1016/j.midw.2022.103489. Epub 2022 Sep 15.

Implications for practice and research

  • Turkish fathers should be encouraged to hold their infants by kangaroo care (KC) after maternal caesarean section.

  • Future research in Turkey could focus on the facilitators and barriers to paternal skin-to-skin holding.

  • Context

    Newborns, when consoled with skin-to-skin holding, or KC, are better able to adapt physiologically after caesarean delivery. KC in Turkey is a desired practice, but when the mother has caesarean section, this delays the practice. In Turkey, fathers are not routinely offered KC. Since there is a high rate of caesarean sections in Turkey, the nursing staff do not offer KC to many infants. There are two hypotheses in this study: (1) newborns...

    Reliability and validity of the revised Rushton Moral Resilience Scale for healthcare workers

    Abstract

    Aim

    To refine the Rushton Moral Resilience Scale (RMRS) by creating a more concise scale, improving the reliability, particularly of the personal integrity subscale and providing further evidence of validity.

    Background

    Healthcare workers are exposed to moral adversity in practice. When unable to preserve/restore their integrity, moral suffering ensues. Moral resilience is a resource that may mitigate negative consequences. To better understand mechanisms for doing so, a valid and reliable measurement tool is necessary.

    Design

    Cross-sectional survey.

    Methods

    Participants (N = 1297) had completed ≥1 items on the RMRS as part of the baseline survey of a larger longitudinal study. Item analysis, confirmatory factor analyses, reliability analyses (Cronbach's alpha), and correlations were used to establish reliability and validity of the revised RMRS.

    Results

    Item and confirmatory factor analysis were used to refine the RMRS from 21 to 16 items. The four-factor structure (responses to moral adversity, personal integrity, relational integrity and moral efficacy) demonstrated adequate fit in follow-up confirmatory analyses in the initial and hold-out sub-samples. All subscales and the total scale had adequate reliabilities (α ≥ 0.70). A higher-order factor analysis supports the computation of either subscale scores or a total scale score. Correlations of scores with stress, anxiety, depression and moral distress provide evidence of the scale's validity. Reliability of the personal integrity subscale improved.

    Conclusion and Implications

    The RMRS-16 demonstrates adequate reliability and validity, particularly the personal integrity subscale. Moral resilience is an important lever for reducing consequences when confronted with ethical challenges in practice. Improved reliability of the four subscales and having a shorter overall scale allow for targeted application and will facilitate further research and intervention development.

    Patient/Public Contribution

    Data came from a larger study of Canadian healthcare workers from multiple healthcare organizations who completed a survey about their experiences during COVID-19.

    Sex differences among children, adolescents and young adults for mental health service use within inpatient and outpatient settings, before and during the COVID-19 pandemic: a population-based study in Ontario, Canada

    Por: Moin · J. S. · Vigod · S. N. · Plumptre · L. · Troke · N. · Asaria · M. · Papanicolas · I. · Wodchis · W. P. · Brail · S. · Anderson · G.
    Objectives

    The pandemic and public health response to contain the virus had impacts on many aspects of young people’s lives including disruptions to daily routines, opportunities for social, academic, recreational engagement and early employment. Consequently, children, adolescents and young adults may have experienced mental health challenges that required use of mental health services. This study compared rates of use for inpatient and outpatient mental health services during the pandemic to pre-pandemic rates.

    Design

    Population-based repeated cross-sectional study.

    Setting

    Publicly delivered mental healthcare in primary and secondary settings within the province of Ontario, Canada.

    Participants

    All children 6–12 years of age (n=2 043 977), adolescents 13–17 years (n=1 708 754) and young adults 18–24 years (n=2 286 544), living in Ontario and eligible for provincial health insurance between March 2016 and November 2021.

    Primary outcome measures

    Outpatient mental health visits to family physicians and psychiatrists for: mood and anxiety disorders, alcohol and substance abuse disorders, other non-psychotic mental health disorders and social problems. Inpatient mental health visits to emergency departments and hospitalisations for: substance-related and addictive disorders, anxiety disorders, assault-related injuries, deliberate self-harm and eating disorders. All outcomes were analysed by cohort and sex.

    Results

    During the pandemic, observed outpatient visit rates were higher among young adults by 19.01% (95% CI: 15.56% to 22.37%; 209 vs 175 per 1000) and adolescent women 24.17% (95% CI: 18.93% to 29.15%; 131 vs 105 per 1000) for mood and anxiety disorders and remained higher than expected. Female adolescents had higher than expected usage of inpatient care for deliberate self-harm, eating disorders and assault-related injuries.

    Conclusions

    Study results raise concerns over prolonged high rates of mental health use during the pandemic, particularly in female adolescents and young women, and highlights the need to better monitor and identify mental health outcomes associated with COVID-19 containment measures and to develop policies to address these concerns.

    Quantifying the potential epidemiological impact of a 2-year active case finding for tuberculosis in rural Nepal: a model-based analysis

    Por: Shrestha · S. · Mishra · G. · Hamal · M. · Dhital · R. · Shrestha · S. · Shrestha · A. · Shah · N. P. · Khanal · M. · Gurung · S. · Caws · M.
    Objectives

    Active case finding (ACF) is an important tuberculosis (TB) intervention in high-burden settings. However, empirical evidence garnered from field data has been equivocal about the long-term community-level impact, and more data at a finer geographic scale and data-informed methods to quantify their impact are necessary.

    Methods

    Using village development committee (VDC)-level data on TB notification and demography between 2016 and 2017 in four southern districts of Nepal, where ACF activities were implemented as a part of the IMPACT-TB study between 2017 and 2019, we developed VDC-level transmission models of TB and ACF. Using these models and ACF yield data collected in the study, we estimated the potential epidemiological impact of IMPACT-TB ACF and compared its efficiency across VDCs in each district.

    Results

    Cases were found in the majority of VDCs during IMPACT-TB ACF, but the number of cases detected within VDCs correlated weakly with historic case notification rates. We projected that this ACF intervention would reduce the TB incidence rate by 14% (12–16) in Chitwan, 8.6% (7.3–9.7) in Dhanusha, 8.3% (7.3–9.2) in Mahottari and 3% (2.5–3.2) in Makwanpur. Over the next 10 years, we projected that this intervention would avert 987 (746–1282), 422 (304–571), 598 (450–782) and 197 (172–240) cases in Chitwan, Dhanusha, Mahottari and Makwanpur, respectively. There was substantial variation in the efficiency of ACF across VDCs: there was up to twofold difference in the number of cases averted in the 10 years per case detected.

    Conclusion

    ACF data confirm that TB is widely prevalent, including in VDCs with relatively low reporting rates. Although ACF is a highly efficient component of TB control, its impact can vary substantially at local levels and must be combined with other interventions to alter TB epidemiology significantly.

    Behavioural outcomes of children born with intrauterine growth restriction: protocol for a systematic review and meta-analysis

    Por: Yakoub · N. · Reinelt · T. · Natalucci · G.
    Introduction

    Intrauterine growth restriction (IUGR) is a pregnancy condition, which is associated with poor perinatal outcomes and long-term neurodevelopmental impairment. Several studies also investigated the impact of IUGR on child behaviour (eg, internalising and externalising behaviour, social competencies). However, so far, no systematic review or meta-analysis has been conducted that summarises these effects while considering relevant third variables such as type of IUGR diagnosis and control group, or concurrent cognitive abilities. The objective of this study is to summarise the current evidence regarding the relationship between IUGR and behavioural outcomes from early childhood to young adulthood. Additionally, to explore how third variables such as type of control group, or cognitive abilities, relate to this association.

    Methods

    Search strategy: The following electronic databases will be searched—Web of Science, Medline Ovid, PsycInfo, Cochrane Library, Scopus and Embase. Inclusion criteria: observational (eg, cohort studies and case–control studies) and intervention studies (if standard care is used and norm values are reported for the control group) will be included if they quantitatively compare children with and without IUGR from the age of 2 to 18 years. The main outcomes are internalising and externalising behaviour, and social competencies.

    Ethics and dissemination

    No ethics approval was necessary for this protocol. Dissemination of findings will be done by publishing the results in peer-reviewed journals. The results of this systematic review will provide guidance for practice and counselling for clinicians and therapists facing patients affected by IUGR and their families.

    PROSPERO registration number

    CRD42022347467.

    Examining the health and functioning status of medical laboratory professionals in Ontario, Canada: an exploratory study during the COVID-19 pandemic

    Por: Joncic · G. · Jain · M. · Chattu · V. K. · Gohar · B. · Nowrouzi-Kia · B.
    Objectives

    This study aims to explore the overall and specific aspects of the functioning of medical laboratory professionals (MLPs) in Ontario, Canada during the COVID-19 pandemic.

    Design

    A cross-sectional analysis where a questionnaire was used to assess the mental status of MLPs.

    Setting

    An online questionnaire administered in Ontario, Canada.

    Participants

    632 MLPs (medical laboratory technologists, technicians and assistants) were included.

    Main outcome measures

    We employed the WHO Disability Assessment Schedule V.2.0 (WHODAS V.2.0) Questionnaire to assess functioning/disability and Copenhagen Psychosocial Questionnaire, third edition for psychosocial workplace factors. Multiple regression analysis examined the relationship between overall and specific domain functioning scores and psychosocial workplace factors.

    Results

    Of the total 632 participants, the majority were female gender and Caucasian. It was found that health (β=2.25, p

    Conclusion

    This study provides preliminary evidence of the overall and specific aspects of functioning among the MLPs during the COVID-19 pandemic. Besides, these findings can support and guide the improvement of workplace practices and policies among MLPs in the future.

    Supporting adolescents participation in muscle-strengthening physical activity: protocol for the 'Resistance Training for Teens (RT4T) hybrid type III implementation-effectiveness trial

    Por: Kelly · H. T. · Smith · J. J. · Verdonschot · A. · Kennedy · S. G. · Scott · J. J. · McKay · H. · Nathan · N. · Sutherland · R. · Morgan · P. J. · Salmon · J. · Penney · D. · Boyer · J. · Lloyd · R. S. · Oldmeadow · C. · Reeves · P. · Pursey · K. · Hua · M. · Longmore · S. · Norman · J. · Vo
    Introduction

    In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the ‘Resistance Training for Teens’ (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear.

    Objective

    To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T.

    Methods and analysis

    We will conduct a hybrid type III implementation–effectiveness trial involving grade 9 and 10 (aged 14–16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) ‘low’ (training and resources), (2) ‘moderate’ (training and resources+external support) or ‘high’ (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p

    Ethics and dissemination

    Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers.

    Trial registration number

    ACTRN12622000861752.

    (Cost-)effectiveness of an individualised risk prediction tool (PERSARC) on patients knowledge and decisional conflict among soft-tissue sarcomas patients: protocol for a parallel cluster randomised trial (the VALUE-PERSARC study)

    Introduction

    Current treatment decision-making in high-grade soft-tissue sarcoma (STS) care is not informed by individualised risks for different treatment options and patients’ preferences. Risk prediction tools may provide patients and professionals insight in personalised risks and benefits for different treatment options and thereby potentially increase patients’ knowledge and reduce decisional conflict. The VALUE-PERSARC study aims to assess the (cost-)effectiveness of a personalised risk assessment tool (PERSARC) to increase patients’ knowledge about risks and benefits of treatment options and to reduce decisional conflict in comparison with usual care in high-grade extremity STS patients.

    Methods

    The VALUE-PERSARC study is a parallel cluster randomised control trial that aims to include at least 120 primarily diagnosed high-grade extremity STS patients in 6 Dutch hospitals. Eligible patients (≥18 years) are those without a treatment plan and treated with curative intent. Patients with sarcoma subtypes or treatment options not mentioned in PERSARC are unable to participate. Hospitals will be randomised between usual care (control) or care with the use of PERSARC (intervention). In the intervention condition, PERSARC will be used by STS professionals in multidisciplinary tumour boards to guide treatment advice and in patient consultations, where the oncological/orthopaedic surgeon informs the patient about his/her diagnosis and discusses benefits and harms of all relevant treatment options. The primary outcomes are patients’ knowledge about risks and benefits of treatment options and decisional conflict (Decisional Conflict Scale) 1 week after the treatment decision has been made. Secondary outcomes will be evaluated using questionnaires, 1 week and 3, 6 and 12 months after the treatment decision. Data will be analysed following an intention-to-treat approach using a linear mixed model and taking into account clustering of patients within hospitals.

    Ethics and dissemination

    The Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) approved this protocol (NL76563.058.21). The results of this study will be reported in a peer-review journal.

    Trial registration number

    NL9160, NCT05741944.

    Understanding the dynamics of chemsex among men who have sex with men, male sex workers and transgender women in Dhaka, Bangladesh: a multiphase sequential mixed-method research protocol

    Por: Sarwar · G. · Irfan · S. D. · Reza · M. · Khan · M. N. M. · Khan · S. I.
    Introduction

    Chemsex is defined as drug use to enhance sexual pleasure. Global literature illustrated the pervasiveness of chemsex among men who have sex with men (MSM) and transgender women (hijra) for prolonging anal intercourse, reducing pain and intensifying pleasure, oftentimes without condoms. Global literature highlighted the association between chemsex and unsafe sexual behaviours. These circumstances warrant targeted chemsex research to explore the chemsex situation. The study aims to explore the overall dynamics of chemsex among MSM, male sex workers (MSW) and hijra in Dhaka, Bangladesh and formulate culturally relevant, context-specific, gender-sensitive and evidence-based recommendations for chemsex interventions.

    Methods and analysis

    This will be a sequential, exploratory, mixed-methods study. Data will be collected at four drop-in centres in Dhaka in three phases. To explore issues related to chemsex, the formative phase (phase 1) will generate evidence on the overall dynamics of chemsex through a literature review and qualitative interviews. Qualitative data will be manually analysed using thematic analysis. In phase 2, a cross-sectional survey will be conducted among 458 MSM, male sex workers and hijra to measure the prevalence, reasons and sexual risk behaviour associated with chemsex. In phase 3, qualitative interviews will be conducted with the participants involved in chemsex, service providers and relevant stakeholders to add qualitative depth to survey responses. In this phase, service provision will also be investigated for people engaging in chemsex. Moreover, based on the findings of phases 1 and 2, and qualitative interviews of phase 3, a preliminary chemsex intervention model will be developed through a series of intervention design workshops.

    Ethics and dissemination

    Ethical approval has been attained from the Ethical Review Committee of icddr,b. Informed consent will be obtained from the participants, and confidentiality will be maintained during data collection and storage. Findings will be disseminated via several platforms including dissemination seminars, scientific articles and study report.

    Barriers to and facilitators of effective management of fever episodes in hospitalised Kenyan children with cancer: protocol for convergent mixed methods study

    Por: Nessle · C. N. · Njuguna · F. · Dettinger · J. · Koima · R. · Nyamusi · L. · Kisembe · E. · Kinja · S. · Ndungu · M. · Njenga · D. · Langat · S. · Olbara · G. · Moyer · C. · Vik · T.
    Introduction

    Febrile neutropenia is an oncological emergency in children with cancer, associated with serious infections and complications. In low-resourced settings, death from infections in children with cancer is 20 times higher than in high-resourced treatment settings, thought to be related to delays in antibiotic administration and management. The barriers to effective management of fever episodes in children with cancer have not previously been described. This convergent mixed-methods study will provide the evidence to develop fever treatment guidelines and to inform their effective implementation in children with cancer at Moi Teaching and Referral Hospital (MTRH), a level 6 referral hospital in western Kenya.

    Methods and analysis

    Prospective data collection of paediatric patients with cancer with new fever episodes admitted to MTRH will be performed during routine treatment. Clinical variables will be collected from 50 fever episodes, including cancer diagnosis and infectious characteristics of the fever episode, and elapsed time from fever onset to various milestones in the management workflow. Semistructured qualitative interviews with healthcare providers (estimated 20 to reach saturation) will explore the barriers to and facilitators of appropriate management of fever episodes in children with cancer. The interview guide was informed by a theoretical framework and Consolidated Framework for Implementation Research. A mixed-methods analysis use of joint display tables and process mapping will link and integrate the two types of data with meta-inferences.

    Ethics and dissemination

    Institutional review board approval was obtained from the MTRH (0004273) and the University of Michigan (HUM0225674), and the study was registered with National Commission for Science Technology and Innovation (P/23/22885). Written consent will be obtained from all participants. Results will be formally shared with local and national policy leadership and local end users, presented at relevant national academic conferences and submitted for publication in a peer-reviewed journal.

    Study protocol to investigate the efficacy of confocal laser endomicroscopy-based selective single-elimination diet over standard fivefold elimination diet in patients with endomicroscopically proven food intolerance: app-assisted, monocentric, double-bli

    Por: Hessler · N. · Kordowski · A. · Sasse · J. · Ahlemann · G. · Schulz · F. · Schröder · T. · Exner · A. · Jablonski · L. · Jappe · U. · Bischoff · S. C. · Grzegorzek · M. · König · I. R. · Sina · C.
    Introduction

    Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL.

    Methods and analysis

    The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events.

    Ethics and dissemination

    The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.

    Trial registration number

    German Clinical Trials Register (DRKS00029323).

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