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Tiny Bites, a digital health intervention delivered in early childhood education and care centres to support educators and caregivers to prevent childhood obesity: study protocol for a cluster randomised controlled trial

Por: Yoong · S. L. · Lum · M. · Leung · G. K. W. · Pearson · N. · Truby · H. · Dix · C. · Moumin · N. A. · Wolfenden · L. · Ananthapavan · J. · Grady · A. · Wiggers · J. · Delaney · T. · Rychetnik · L. · Romiti · M. · Lamont · H. · Stanley · S. · Lim · M. · Oldmeadow · C. · Mastersson · N. · Suth
Introduction

Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.

Aim

To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.

Methods and analysis

This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.

Ethics and dissemination

Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.

Trial registration number

ACTRN12624000576527.

Nurse‐Led Models of Service Delivery for Skin Cancer Detection: A Systematic Review

ABSTRACT

Aim

To consolidate evidence on nurse-led models for skin cancer detection by focusing on their roles, comparing their effectiveness to physician-led care and highlighting any value-added benefits.

Design

Systematic review methodology with narrative synthesis.

Data Sources

MEDLINE Complete, PubMed, Embase, CINAHL Complete, ScienceDirect, Scopus, BNI, LILACS, PsycINFO, Trip Medical Database, ERIC, EThOS, CDSR, WoS, Google Scholar, ClinicalTrials.gov, ICTRP, CENTRAL and the website ‘Getting It Right First Time’.

Methods

This review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Studies between January 1992 and September 2024 were evaluated using the Joanna Briggs Institute Critical Appraisal Checklists. The search encompassed both peer-reviewed and grey literature; however, no grey literature met the inclusion criteria.

Results

Of the 6680 records screened, six studies met the inclusion criteria, involving 3325 patients across England, New Zealand and the United States. These studies focused on nurse-led models of care for skin cancer, assessing outcomes such as diagnostic accuracy, treatment effectiveness, cost savings, waiting times, access to care and patient satisfaction. While none directly compared nurse-led to dermatologist-led models, one study demonstrated comparable diagnostic accuracy between nurses and ophthalmologists. Nurse-led models were shown to effectively substitute for or complement physician-led care, though only one study was authored by a nurse consultant, highlighting a gap in nursing-led research. Service users favoured community-based, nurse-led care for its accessibility, convenience and cost-effectiveness, with health education noted as an added benefit in one study.

Conclusion

Nurse-led models demonstrate potential for high diagnostic accuracy in skin cancer, effective treatment delivery and enhanced patient education on skin self-examination. While role delineation remains a challenge, nurses play a critical role in supporting dermatologists in addressing the increasing referral demands associated with skin cancer care.

Trial Registration: The systematic review protocol (registration number: CRD42023448950) was developed in collaboration with a patient representative with lived experience of melanoma, alongside academic experts in dermatology nursing and specialist; dermatology clinicians.

Patient Contribution

A patient representative with lived experience of melanoma contributed to the review protocol.

Policy and Practice Implications

Training and Competency Development: Completing nationally recognised dermatology nursing qualifications beyond the Advanced Clinical Practice pathway and practical training to extend assessment, diagnostic and treatment skills are essential for autonomous practice in dermatology. Specific skills in nurse-led skin cancer care are vital to ensure clinical competency. Dermatology Nurse Consultant Training Programme: Policies should prioritise nationally recognised Advanced Nurse Practitioner to Dermatology Nurse Consultant Training Programmes focusing on assessment, diagnostic and treatment skills. A structured, portfolio-based approach to training is crucial for achieving competency and enabling autonomous practice in dermatology, supporting the delivery of high-quality care. Support for Community-Based Care: Policy-level support for community-based care is critical, particularly in rural or underserved regions. These models reduce patient travel, improve timely care access and provide training opportunities for rural clinicians, offering a viable alternative to hospital-based services. Standardising Nurse-Led Models: Developing national or international guidelines is essential for scaling nurse-led models. Standardisation allows these models to adapt to the specific needs of local services while maintaining high standards of care. Delivering Comprehensive Care: Nurse-led models show promise in delivering standard care comparable to physician-led services for specific components of the skin cancer care pathway. They also provide value-added care benefits, such as tailored patient education, enhancing outcomes and satisfaction.

Impact Statement

Nurse-led models demonstrate diagnostic accuracy in identifying skin lesions, including skin cancer, while contributing to treatment, patient education and follow-up care. Despite their growing role in skin cancer management, greater dissemination and publication of their outcomes are needed to inform clinical practice. This review highlights the importance of standardising nurse-led approaches into scalable frameworks to support dermatologists, enhance patient outcomes and ensure consistent care standards in skin cancer. Further evaluation is required to assess their efficiency, cost-effectiveness and implementation across diverse healthcare settings.

Morphine for chronic breathlessness (MABEL) in the UK: a health economic evaluation of a multisite, parallel-group, dose titration, double-blind, randomised, placebo-controlled trial

Por: Atter · M. J. · Hall · P. · Evans · R. A. · Norrie · J. · Cohen · J. · Williams · B. · Chaudhuri · N. · Bajwah · S. · Higginson · I. · Pearson · M. · Currow · D. · Stewart · G. · Fallon · M. · Johnson · M.
Objectives

To compare costs and health consequences and to assess the cost-effectiveness of using low-dose oral long-acting morphine in people with chronic breathlessness.

Design

Within-trial planned cost-consequences and cost-effectiveness analysis of data from a multisite, parallel-group, double-blind, randomised, placebo-controlled trial of low-dose, long-acting morphine.

Setting

11 hospital outpatients across the UK.

Participants

Consenting adults with chronic breathlessness due to long-term cardiorespiratory conditions.

Intervention

5–10 mg two times a day oral long-acting morphine with a blinded laxative for 56 days.

Primary outcome measures

Mean and SD of healthcare resource use (HRU) by trial arm; mean differences and 95% CI of costs between trial arms.

Secondary outcome measures

Mean differences in 28- and 56-day quality-adjusted life years (QALYs based on EuroQol five-dimension five-level score), Short Form-six dimensional scores and ICEpop CAPability-Supportive Care Measure scores; cost-utility of long-acting morphine for chronic breathlessness.

Results

143 participants (75 morphine and 67 placebo) were randomised; 140 (90% power, males 66%, mean age 70.5 (SD 9.4)) formed the modified intention-to-treat population (participants receiving at least one dose of study medication). There were more inpatient and fewer outpatient services used by the morphine group versus the placebo. In the base-case analysis at 56 days, long-acting morphine was associated with similar mean per-patient costs and QALYs. There was an increase of £24 (95% CI –£395 to £552) and 0.002 (95% CI –0.004 to 0.008) QALYs. Hospitalisations were the main driver of cost differences. The corresponding incremental cost-effectiveness ratio was £12 000/QALY, with a probability of cost-effectiveness of 54% at a £20 000 willingness-to-pay threshold. In the scenario analysis that excluded costs of adverse events considered unrelated to long-acting morphine by site investigators and researchers, the probability of cost-effectiveness increased to 73%.

Conclusion

Oral morphine for chronic breathlessness is likely to be a cost-effective intervention provided adverse events are minimised, but the effect on outcome is small and cautious interpretation is warranted.

Trial registration number

ISRCTN87329095.

Time-varying predictors of e-cigarette and cigarette use trajectories from adolescence to emerging adulthood: a longitudinal analysis of US youth in the PATH Study, 2013-2020

Por: Stanton · C. A. · Tang · Z. · Sharma · E. · Anesetti-Rothermel · A. · Marshall · D. · Park-Lee · E. · Silveira · M. L. · Xiao · H. · Deng · L. · Lagasse · L. · Rass · O. · Lee · R. · Valverde · R. · Blanco · C. · Kimmel · H. L. · Compton · W. M. · Hyland · A. J. · Pearson · J. L.
Objective

To examine the longitudinal impact of time-varying factors on US youth’s trajectories of initiation and use of e-cigarettes and cigarettes during the transition from adolescence to young adulthood.

Design

Longitudinal.

Setting

Nationally representative US survey, the Population Assessment of Tobacco and Health (PATH) Study.

Participants

2682 US youth (aged 16–17) at wave (W)1 of the PATH Study across six waves (2013–2020) into young adulthood (aged 22–23).

Primary and secondary outcome measures

Unweighted longitudinal latent class analyses identified trajectory classes of e-cigarette and cigarette use, separately. Nationally representative weighted multinomial logistic regression analyses examined time-varying harm perceptions, substance use problems and tobacco product first tried as predictors of these trajectory classes.

Results

Five e-cigarette classes (2013–2020; 41.5% Persistent Never Use, 12.6% W5 Initiation, 19.9% W3 Initiation, 15.2% Prior Initiation, 10.8% High Frequency Past 30-Day (P30D) Use) and five cigarette classes (2013–2019; 58.6% Persistent Never Use, 11.5% W4 Initiation, 10.9% W2 Initiation, 9.6% Prior Initiation, 9.5% High Frequency P30D Use) were identified. Time-varying harm perceptions and substance use problems were associated with trajectories of initiation and use for both products. Cigarettes, cigarillos, other combustibles and any smokeless tobacco as first product tried were associated with e-cigarette initiation and/or progression to high frequency use. E-cigarettes and hookah as first product tried were associated with later cigarette initiation. High Frequency P30D Cigarette Use was less likely if the first product tried was e-cigarettes, cigarillos, hookah or any smokeless tobacco product.

Conclusions

Results reinforce the need for identification and intervention of early substance use among younger adolescents and targeted public health messaging to address changing harm perceptions and prevent initiation among older adolescents.

Patterns of follow-up testing of abnormal eGFR and UACR for the detection of chronic kidney disease in Australian primary care: analysis of a national general practice dataset

Por: Li · A. K. · Kotwal · S. · Wallace · H. · Ketema · D. B. · Wick · J. · Neuen · B. L. · Falster · M. O. · Lin · J. · Pearson · S.-A. · Peiris · D. · Jardine · M. J. · Woodward · M. · Chalmers · J. · Ronksley · P. E. · Jun · M.
Objective

To evaluate the patterns of abnormal estimated glomerular filtration rate (eGFR) and urine albumin–creatinine ratio (UACR) follow-up testing for the detection of chronic kidney disease (CKD) in Australian general practices.

Design

Retrospective, population-based observational study.

Setting and participants

2 717 966 adults who visited a MedicineInsight participating general practice between 1 January 2012 and 31 December 2020, had ≥1 serum creatinine measurement (with or without a UACR measurement) and did not have CKD at baseline.

Main outcome measure

‘Guideline-concordant follow-up’ was defined as having a record of a repeat eGFR or UACR testing (assessed separately) within 6 months following the abnormal (eGFR2; UACR≥2.5 mg/mmol in males, ≥3.5 mg/mmol in females) incident result. Multivariable logistic regression was used to identify patient factors associated with receiving appropriate follow-up testing.

Results

A total of 220 841 and 114 889 patients with an abnormal incident eGFR and UACR result, respectively, were identified. Nearly half (45.0%) of the patients with an abnormal eGFR result and over two-thirds (69.7%) of the patients with an abnormal UACR result did not have a follow-up test within 6 months. Patient factors associated with a higher likelihood of follow-up eGFR testing included indicators of poorer baseline health and greater CKD risk, such as comorbid diabetes (adjusted OR 1.36, 95% CI 1.32 to 1.40) or more severe incident eGFR (adjusted ORs for eGFR categories 30–44, 15–29 and

Conclusions

In this large, population-based study, we observed substantial gaps in the follow-up of abnormal eGFR and UACR for the detection of CKD in primary care settings. Effective strategies to optimise follow-up testing for CKD detection are needed.

Study protocol for an open-label, single-arm, mixed methods feasibility study of the MWIQ AI-powered decision support tool for diabetes management in GP practices

Por: Dickson · J. · Cunningham · S. G. · Sainsbury · C. · Rutter · M. K. · Kanumilli · N. · Pearson · E. · Brodie · D. · Stevens · M. · Wake · D. J. · Conway · N.
Introduction

Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.

Methods and analysis

The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.

Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.

Ethics and dissemination

This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.

Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.

Trial registration number

ISRCTN17422256.

Phase II randomised controlled basket feasibility trial of a personalised, remotely delivered exercise programme on disease-free survival among early-stage, high-risk cancers: CANFit study protocol

Por: Bullock · A. F. · Cohen · J. · Huang · C. · Jackson · G. · Lind · M. · Pearson · M. · Richardson · G. · Saxton · J. · Twiddy · M. · Wilson · C. · Forbes · C.
Introduction

Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.

Methods and analysis

This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.

Ethics and dissemination

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.

Trial registration number

ISRCTN97662203.

“Are you doing your pelvic floor?” An ethnographic exploration of the interaction between women and midwives about pelvic floor muscle exercises (PFME) during pregnancy

Many women experience urinary incontinence (UI) during and after pregnancy. Pelvic floor muscle exercises (PFME) can prevent and reduce the symptoms of UI. The objective of the study was to explore challenges, opportunities and concerns for women and health care professionals (HCPs), related to the implementation of PFME training for women in current antenatal care.
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