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Non-inferiority (NI) trial designs, which assess whether an experimental intervention is no worse than the standard of care, have become increasingly prevalent in recent years. Current thinking suggests that the intention-to-treat (ITT) analysis is considered anti-conservative in the presence of protocol violations when compared with the per-protocol (PP) analysis.
We aim to conduct a methodological review of NI trials to compare the results from ITT and PP analysis in NI trials. A comprehensive electronic search strategy will be used to identify studies indexed in MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases. We will include 390 NI trials published prior to 31 December 2024. The primary outcomes are the treatment effect estimates from ITT and PP analyses. Secondary outcomes are the CI widths and the bounds of the CIs from the ITT and PP analyses. Analysis will calculate the relative difference in the point estimates, CI widths and CI bounds between the two approaches. Linear models will be used to investigate the relationship between the outcomes and the proportion of patients excluded from the PP analysis.
This is a methodological review that has been registered on the International Prospective Register for Systematic Reviews (PROSPERO, CRD420251125360). Research ethics is not required as the project is a methodological review of previously published trials. Study findings will be shared via peer-reviewed publications and presentations at academic conferences.
There is a pressing need for effective interventions that can support healthcare workers and caregivers in the challenging yet crucial task of disclosing the HIV status to infected children and adolescents. Previously, we developed and tested a successful disclosure intervention called Sankofa in Ghana. In an ongoing 5-year follow-up study, Sankofa 2, we aim to build on the successful Sankofa trial by testing the intervention on a larger scale.
This study is a pragmatic, stepped-wedge cluster randomised trial.
It is being conducted in 12 HIV paediatric clinics in Ghana to examine the effectiveness, health benefits, cost and implementation of the Sankofa intervention. Caregiver–child dyads (n=700) will be enrolled. Evaluation of effectiveness, health benefits, cost and implementation of the Paediatric HIV disclosure intervention, Sankofa 2, is posed to offer valuable insights for scale-up and sustainability.
Ethical clearance has been obtained from the Ghana Health Service Ethics Review Committee, the University of Ghana Ethical and Protocol Review Committee, the Committee on Human Research Publication and Ethics of the Kwame Nkrumah University of Science and Technology, the Johns Hopkins Medicine Institutional Review Board and the Yale School of Medicine Human Investigation Committee. The clinical trial was registered on ClinicalTrials.gov on 5 March 2021. All caregiver participants are required to provide written informed consent and the children assent before enrolment. If either the child or caregiver says no to the study, the dyad is not eligible for the study. No study-related procedures are performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.
Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The Breast cancer Reasoning and Activity INtervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.
This Hybrid Type I effectiveness–implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I–IIIa breast cancer and within 3–36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.
This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.
To explore the impact of medical complexity, defined by the number of chronic conditions, on the complexity of care, as described by the frequency of nursing diagnoses (NDs) and nursing actions (NAs), in paediatric patients.
Retrospective observational study.
This study was conducted in an Italian university hospital and involved the analysis of electronic health records for neonatal and paediatric patients who were consecutively admitted from January to December 2022. The sample was classified into three categories—non-chronic, single chronic and multimorbid patients—according to their clinical profiles. NDs recorded within the first 24 h from patient hospital admission and NAs performed throughout the hospital stay were counted for each group.
Distinct variations in the prevalence and patterns of NDs and NAs were observed across different levels of medical complexity. A significant moderate positive correlation between the number of NDs and NAs was found. However, the frequency of NDs did not directly correlate with the number of chronic conditions. Conversely, a weak but significant negative correlation was identified between the quantity of NAs and the number of chronic conditions. While the frequency of NDs showed a stable but decreasing trend as the number of chronic conditions increased, a higher number of chronic conditions were associated with a lower quantity of NAs.
We discovered a notable variation in the complexity of care across varying levels of medical complexity in paediatric patients. Our findings suggest that the complexity of care does not necessarily correspond to the degree of medical complexity. The observed negative relationship between the number of chronic conditions and the quantity of NAs underscores the need for further research to explore this unexpected finding and its implications for clinical practice.
Without the adoption of standardised nursing terminologies, such as nursing diagnoses (NDs) and nursing actions (NAs), assessing the complexity of care in paediatric settings can be challenging. Integrating clinical nursing information systems that incorporate standardised NDs and NAs into electronic health records is crucial for accurately documenting and analysing the complexity of care and its relationship with medical complexity.
In paediatric patients, the frequency of nursing diagnoses (NDs) at hospital admission is significantly associated with the quantity of nursing actions (NAs) delivered during hospitalisation. However, there is no correlation between the frequency of NDs and medical complexity, as defined by the number of chronic disorders. Specifically, the frequency of NDs decreases with increasing medical complexity, while the quantity of NAs is negatively associated with the number of chronic disorders. This indicates that the complexity of care cannot be inferred solely from medical complexity, and additional factors need to be explored. These findings enhance understanding of how complexity of care relates to medical complexity in paediatric patients. Insights into the prevalence and patterns of NDs and NAs can benefit nurses, managers, researchers and policymakers by informing clinical and organisational decision-making to ensure high-quality care.
The study adhered to the RECORD Statement.
Patients, service users, caregivers or public members were not directly involved in the design, conduct, analysis and interpretation of data or in writing this paper. Patients contributed only to data collection.
To describe the health literacy (HL) levels of hospitalised patients and their relationship with nursing diagnoses (NDs), nursing interventions and nursing measures for clinical risks.
Retrospective study.
The study was conducted from December 2020 to December 2021 in an Italian university hospital. From 146 wards, 1067 electronic nursing records were randomly selected. The Single-Item Literacy Screener was used to measure HL. Measures for clinical risks were systematically assessed by nurses using Conley Index score, the Blaylock Risk Assessment Screening Score, Braden score, and the Barthel Index. A univariable linear regression model was used to assess the associations of HL with NDs.
Patients with low HL reported a higher number of NDs, interventions and higher clinical risks. HL can be considered a predictor of complexity of care.
The inclusion of standardised terms in nursing records can describe the complexity of care and facilitate the predictive ability on hospital outcomes.
HL evaluation during the first 24 h. From hospital admission could help to intercept patients at risk of higher complexity of care. These results can guide the development of interventions to minimise needs after discharge.
No patient or public contribution was required to design or undertake this research. Patients contributed only to the data collection.
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