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Implementability of a co-designed programme to increase tailored exercise to reduce falls in older people from culturally and linguistically diverse communities: protocol for a pilot randomised controlled trial

Por: Said · C. M. · Ramage · E. R. · Sharma · H. · Batchelor · F. · Bicknell · E. · Bongiovanni · L. · Brijnath · B. · Cahill · P. · Callisaya · M. · Celestino · S. · Chudecka · A. · Engel · L. · Lim · W. K. · McDonald · C. E. · Pinheiro · M. · Sherrington · C. · Vogrin · S. · Zanker · J. · Zhe
Introduction

Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.

Methods and analysis

Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).

Ethics and dissemination

Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.

Trial registration number

ACTRN12624000658516.

Continuous non-invasive electrophysiological monitoring in high-risk pregnancies: study protocol of a cohort intervention random sampling study in a tertiary obstetrical care centre in the Netherlands (NIEM-O study)

Por: de Klerk · N. D. · Berben · P. B. Q. · de Vries · I. R. · Niemarkt · H. · Vullings · R. · van den Heuvel · E. R. · van der Ven · M. · Fransen · A. F. · Oei · S. G. · van Laar · J. O. E. H.
Introduction

Women with high-risk pregnancies (eg, pre-eclampsia, imminent preterm birth) are often hospitalised due to the need for foetal and maternal monitoring. They are monitored for 30–45 min up to three times a day with conventional cardiotocography (CTG). In the meantime, they reside at the hospital, but the foetal status is not monitored. Continuous foetal monitoring is currently not recommended using CTG, due to the potential temperature rise from consistent exposure to ultrasound waves. For safe 24/7 monitoring, newly developed devices using non-invasive electrophysiological cardiotocography (eCTG) instead of conventional CTG offer a promising alternative. Previous research into eCTG has shown favourable results in monitoring foetal heart rate throughout both pregnancy and labour. This study aims to investigate the effect of implementing continuous antepartum eCTG monitoring in hospitalised high-risk pregnancies on perinatal and maternal outcome.

Methods and analysis

In this single centre prospective cohort intervention random sampling study, eligible women will be included on the Obstetric High Care of Máxima MC Veldhoven, the Netherlands. In total, 511 pregnant women with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalisation will be recruited. Eligible women will be prospectively included in the cohort receiving standard treatment: intermittent CTG monitoring. From these women, a random sample of the prospective cohort will be offered a new monitoring method: 24/7 eCTG monitoring. For the eCTG monitoring, a wireless abdominal electrode patch, the Nemo Foetal Monitoring System will be used. Additional data from a historical cohort (2014–2019) of 1400 women receiving standard treatment will be included. Perinatal and maternal outcome, along with satisfaction levels of both patient and caregivers, will be compared between groups.

Ethics and dissemination

The study is registered on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22) via https://www.toetsingonline.nl/to/ccmo_monitor.nsf/conceptabr?OpenForm and approved by the Medical Ethics Committee of Máxima MC (W22.070) on 7 November 2023. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

Trial registration number

NCT06151613.

Lessons learned from the promotion of Essential Emergency and Critical Care in Tanzania - a qualitative study

Por: Kaliza · A. C. · Mlunde · L. B. · Schell · C. O. · Khalid · K. · Sawe · H. · Mkumbo · E. · Kigombola · A. · Mwandalima · I. · Sylvanus · E. · Kilindimo · S. · Lugazia · E. R. · Masuma · J. S. · Baker · T.
Objective

To describe the lessons learnt during the promotion of a new approach to the care of critically ill patients in TanzaniaEssential Emergency and Critical Care (EECC).

Design

A descriptive qualitative study using thematic analysis of structured interviews.

Setting and participants

The study was conducted in Tanzania, involving 11 policymakers, researchers and senior clinicians who participated in the promotion of EECC in the country.

Findings

Five inter-related themes emerged from the promotion of EECC in Tanzania: (1) early and close collaboration with the government and stakeholders; (2) conduct research and use evidence; (3) prioritise advocacy and address misconceptions about EECC; (4) leverage events and embed activities in other health system interventions; and (5) employ a multifaceted implementation strategy. The themes map to the normalisation process theory domains of coherence, cognitive participation, collective action and reflexive monitoring.

Conclusion

The integration of EECC into Tanzania’s health policy is a result of a multidisciplinary collaboration including government and partners that has used evidence, advocacy and context and included multifaceted implementation strategies. The lessons from Tanzania’s experience provide guidance for adoption in similar settings to improve critical care systems, foster access to care and optimal outcomes for all critically ill patients.

Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART): a prospective cohort study

Por: Kjaer · A. S. L. · Vestager · M. L. · Blixenkrone-Moller · E. · Asserhoj · L. L. · Kloppenborg · J. T. · Lossl · K. · Ekelund · C. K. · Rode · L. · Hjort · L. · Hoffmann · E. R. · Lyng Forman · J. · Beck Jensen · R. · Pinborg · A.
Introduction

The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.

Methods and analysis

The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).

Ethics and dissemination

The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).

Trial registration number

NCT06334003

Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study

Por: Nemati · K. · Michael · Y. Z. · Hhando · B. P. · Jatosh · S. · Houpt · E. R. · Mduma · E. · DeBoer · M. D.
Background

Poor linear growth over time can lead to stunting, a significant public health problem in low-resource settings. Catch-up growth, the process of accelerated growth following growth faltering, is important for mitigating the long-term impacts of early stunting. This study aimed to identify key predictors of growth over time, stunting and catch-up growth among children in rural Tanzania.

Methods

We evaluated 182 children from the Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development cohort, whose anthropometric measurements were collected at six points from birth to 11.5 years. We assessed outcomes of height-for-age z-score (HAZ), stunting and catch-up growth using mixed-model linear and logistic regression to assess associations of maternal education, household income, socioeconomic status, insulin-like growth factor 1 (IGF-1) and thyroid function tests. We defined stunting as HAZ ≤–2 and catch-up growth both as stunting resolved from age 2 years to 11.5 years and a HAZ increase of >0.5 from 2 years to 11.5 years.

Results

Cohort participants exhibited a moderate amount of catch-up growth, with per cent stunting decreasing from 72.6% at 2 years to 39.0% at 11.5 years. Maternal education, household income, socioeconomic status and IGF-1 were positively associated with HAZ (eg, IGF-1 point estimate 0.141±0.067, p=0.036) and negatively associated with odds of stunting across time points, while thyroid-stimulating hormone was negatively associated with HAZ and positively associated with odds of stunting (all p

Conclusions

These findings highlight the need for comprehensive interventions that address socioeconomic, hormonal and biological factors to promote catch-up growth and reduce stunting in resource-limited settings. The results offer valuable insights towards improving child health outcomes in similar contexts.

Trial registration number

NCT02441426 (post-results) and NCT05121935.

Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study)

Introduction

Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.

Methods and analysis

This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.

Ethics and dissemination

This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

Trial registration number

NCT06135961.

Efficacy of non-surgical treatments for acute non-specific low back pain: protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Trager · R. J. · Baumann · A. N. · Bejarano · G. · Burton · W. · Blackwood · E. R. · Holmes · B. D. · Goertz · C. M.
Introduction

Acute low back pain (LBP) is a prevalent condition with various non-surgical treatment options, yet no comprehensive network meta-analysis has systematically compared their relative efficacy for pain and disability. This study aims to fill that gap by synthesising available evidence on the efficacy of different types of non-surgical interventions for acute LBP, such as various medications, manual therapies and education-based therapies. Our coprimary objectives are to (1) compare each active treatment to an inert reference for measures of LBP and related disability and (2) rank the efficacy of treatments.

Methods and analysis

We will conduct a systematic search across multiple databases, including grey literature, to identify randomised controlled trials evaluating non-surgical treatments for acute LBP. Eligible studies must report on pain and/or disability outcomes in adults. The risk of bias will be assessed using the Risk of Bias tool, and the certainty of evidence will be graded using CINeMA (Confidence in Network Meta-Analysis). We will use a frequentist network meta-analysis to pool standardised mean differences in pain and disability, employing random-effects models to account for heterogeneity. A qualitative analysis will assess study characteristics and transitivity, while a quantitative analysis will evaluate efficacy and inconsistency. Results will be presented using network geometry, p-scores, forest plots, funnel plots, Egger’s test, Q-statistics and league tables to visualise both direct and indirect evidence and to identify potential biases.

Ethics and dissemination

This review protocol does not involve any primary research with human participants, animal subjects or medical record review. Consequently, this work did not require approval from an institutional review board or ethics committee. Results will be submitted to a peer-reviewed journal and presented at conference(s). De-identified data will be made available in a public repository.

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