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Decide TB is a pragmatic, hybrid effectiveness-implementation type 2 cluster-randomised trial with a stepped wedge design. The comprehensive TDA-based approach (intervention) will be implemented under programmatic conditions in four districts in each country (each comprising one DH and six PHCs), randomly selected to switch sequentially from the standard of care to the intervention. Evaluations will assess epidemiological, clinical, economic, social sciences, implementation and health policy endpoints. Aggregated and individual data from children with presumptive TB will be extracted from facility registers and individual data will be collected using an electronic medical record (EMR), both data sources will be entered in national Demographic Health Information System 2 databases. Questionnaires and individual/group interviews (among healthcare workers (HCWs), parents/caregivers and key informants), supervision and mentoring reports and quantitative cost tools will be used.
Ethics approval was obtained from national ethics committees in Mozambique (Instituto Nacional de Saúde review board and National Committee for Bioethics in Health) and Zambia (University of Zambia ethical review board and National Health Research Authority); this includes a waiver for analysing data collected by NTPs (no identifiable information reported, intervention with minimal risk) without individual consent from children’s parents/caregivers. Informed consent will be obtained from HCWs, parents/caregivers and key informants. Results will be openly shared with the scientific community, WHO and national and international stakeholders for translation into policy and practice. Procedures for requesting further use of Decide TB data will be publicly available.
NCT06593080; PACTR202407866544155.
To design and develop a novel co-produced intervention tool aimed at facilitating discussions that lung cancer nurses have with lung cancer patients about clinical trial opportunities; and promote trial recruitment.
A multi-phase qualitative focus group (phase 1) and co-production (phase 2) study.
The rigorous design and content of the intervention tool was informed by qualitative data from seven focus groups with lung cancer healthcare professionals (n = 38) and patients and their carers (n = 22) to establish barriers and facilitators to clinical trial participation. Data collection took place across England and Scotland between October and December 2023. Findings from a previously published systematic review were also incorporated to inform intervention tool design. The tool was developed through an extended co-production workshop comprising lung cancer nurses (n = 7), lung cancer patients (n = 2) and health researchers (n = 4). The COM-B model of behavioural change underpinned both phases of the project to guide tool development.
Phase 1 focus groups identified the need for a tool to provide basic trial information to patients, and to support lung cancer nurses in discussing trials with patients, thus improving nurses' knowledge, confidence, and awareness of trials. The phase 2 coproduction workshop identified that the tool should consist of two elements: a patient-facing information pamphlet and a large poster for nurses to assist them in discussing trial opportunities.
The study results demonstrate how nurses can be supported to discuss clinical trial opportunities with patients, with the potential to increase long-term recruitment to clinical trials.
Lung cancer nurses often lack confidence to support patients to make informed choices about trial enrolment. By addressing this issue, participation in lung cancer clinical trials can be significantly improved to benefit patient outcomes and trial participation rates.
The tool has the potential to be used across a range of different cancer settings and sites to increase recruitment to clinical trials.
The COREQ checklist was utilised to ensure that robust processes were followed and reported on.
Patients and members of the public were involved in all study processes and contributed to the study design, interpretation of the data, and intervention design. Their contributions included reviewing focus group topic guides, reviewing data analysis, the co-production of the intervention tool, and co-authoring this paper, ensuring the research addressed the needs and priorities of lung cancer patients when making an informed choice about clinical trial participation.
To investigate associations between adventurous play, outdoor play and screen time and mental health (MH) in British preschool-aged children.
Cross-sectional.
A nationally representative sample of caregivers of 2–4 years old (n=1066) in England, Scotland and Wales (Britain), recruited through an online research data and analytics group (YouGov UK).
Caregivers of 1018 children provided valid complete-case data (age 2: n=298 (29%), age 3: n=365 (36%), age 4: n=355 (35%); female n=481 (47%); white: n=878 (81%)).
Four outcomes, derived from parent-report questionnaires: internalising and externalising scores (using the Strengths and Difficulties Questionnaire) and positive and negative affect scores (using the Positive and Negative Affect Schedule for Children-P). Linear regression was used to explore associations between the three exposures (time (in hours per week) a child spent: (1) playing adventurously; and engaging in (2) educational screen time and (3) recreational screen time) and the four outcomes; interactions between play and screen time variables were also tested. Models were adjusted for child and parental demographic variables.
For each additional hour per week a child engaged in adventurous play, they had lower internalising scores (–0.02 (–0.03 to –0.01)) and higher positive affect scores (0.04 (0.02 to 0.05)). More hours per day (vs
In British preschoolers, adventurous play is associated with better MH outcomes, whereas higher educational screen time was associated with poorer MH, indicating that adventurous play may benefit preschoolers’ MH or that preschoolers with better mental health are more likely to engage in adventurous play. Adventurous play may also offset possible negative associations with screen time.
Overweight and obesity impacts approximately 50% of pregnant women. Professional medical colleges worldwide recommend women with a higher body mass index (BMI) lose weight before conception. While diet and lifestyle interventions before pregnancy are associated with improvements in diet and modest weight loss, subsequent clinical pregnancy outcomes are poorly reported.
Our aim is to conduct a randomised controlled trial of a comprehensive lifestyle intervention for women with overweight or obesity who are planning pregnancy. We will evaluate the impact of this intervention on maternal health and well-being prior to conception; and pregnancy, birth and newborn health outcomes in a subsequent pregnancy.
Women with a BMI ≥25.0 kg/m2 who plan to conceive within 2 years will be recruited.
Women randomised to the ‘Educational Control Group’ will attend a pre-conception health consultation with a research midwife, providing limited information about obesity and associated risks in pregnancy, nutrition, exercise and weight management.
Women randomised to the ‘Pre-pregnancy Lifestyle Intervention Group’ will attend a pre-conception health consultation with a research midwife, as above, and additionally consult with a research dietitian and trained health coaches throughout the 6-month intervention period. Women will also have access to a specifically designed mHealth application providing tailored content and interactive tasks delivered bi-weekly during this time.
Secondary outcomes will include a range of maternal pre-conception health outcomes; maternal and infant pregnancy and birth outcomes; diet and physical activity changes; and quality of life.
We estimate a mean birth weight z-score of 0.43 (SD 1.09) and will recruit 800 women to detect 0.4 SD difference (alpha 0.05 (two-tailed); power 80%). Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.
The study protocol was approved by the Human Research and Ethics Committee of the Women’s and Children’s Hospital, Adelaide, South Australia (HREC/17/WCHN/177; 2020/HRE01445) on 17 August 2018. The first participant was recruited in June 2021, with recruitment anticipated through 2025. The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.
ACTRN 12621000128897. This study has been registered at (https://www.anzctr.org.au/).
In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children
Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.
This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.
If clinical trials measure and report the outcomes included in core outcome sets (COS) for a given condition/disease as a minimum, this has the potential to improve comparability between trials and prevent research waste. Until now, the uptake of the Bronchiectasis and Hidradenitis Suppurativa (HS) COS has not been assessed.
This study assessed the uptake of Bronchiectasis and HS COS using a review of trial registries, with entries taken from ClinicalTrials.gov and the WHO International Clinical Trial Registry Platform. This uptake assessment provides valuable information to inform COS refinement and uncover areas lacking uptake to inform further dissemination requirements.
For each trial, the outcomes included in the trial registry entry were extracted and compared with those included in the corresponding Bronchiectasis or HS COS. The Bronchiectasis COS consists of 18 outcomes, and the HS COS, 6.
Of the trials registered after both COS were developed in 2018, 63% (12/19) of HS trials planned to measure the full COS, whereas for Bronchiectasis, 0% (0/24) of trials planned to measure the full COS. However, of the five priority outcomes to be measured for Bronchiectasis, 4% (1/24) of trials planned to measure all five outcomes.
Both COS publications’ focus was to reach consensus on what outcomes should be measured. Despite both publications referring to the Core outcome Measures for Effectiveness Trials (COMET) Handbook, which discusses the importance of COS dissemination, implementation plans were not included in either publication.
The results suggest that uptake of the HS COS is relatively good, despite yearly fluctuations, whereas for Bronchiectasis, COS uptake is limited. Further research into standardised measurement tools for HS is expected to increase uptake. The focus for Bronchiectasis, however, will be to refine the COS for feasible application in clinical trials. Future COS development publications should use all resources from the COMET initiative to ensure feasible dissemination of the COS.
FreshRSS 