Background: Reducing unintended teenage pregnancy and promoting adolescent sexual health remains a priority in England. Both whole-school and social-marketing interventions are promising approaches to addressing these aims. However, such interventions have not been rigorously trialled in the UK and it is unclear if they are appropriate for delivery in English secondary schools. We developed and pilot trialled Positive Choices, a new whole-school social marketing intervention to address unintended teenage pregnancy and promote sexual health. Our aim was to assess the feasibility and acceptability of the intervention and trial methods in English secondary schools against pre-defined progression criteria (relating to randomisation, survey follow-up, intervention fidelity and acceptability and linkage to birth/abortion records) prior to carrying out a phase III trial of effectiveness and cost-effectiveness.
Methods: Pilot RCT with integral process evaluation involving four intervention and two control schools in south-east England. The intervention comprised a student needs survey; a student/staff-led school health promotion council; a classroom curriculum for year-9 students (aged 13-14); whole-school student-led social-marketing activities; parent information; and a review of local and school-based sexual health services. Baseline surveys were conducted with year 8 (aged 12-13) in June 2018. Follow-up surveys were completed 12 months later. Process evaluation data included audio recording of staff training, surveys of trained staff, staff log books and researcher observations of intervention activities. Survey data from female students were linked to records of births and abortions to assess the feasibility of these constituting a phase III primary outcome.
Results: All six schools were successfully randomised and retained in the trial. Response rates to the survey were above 80% in both arms at both baseline and follow-up. With the exception of the parent materials, the fidelity target for implementation of essential elements in three out of four schools was achieved. Student surveys indicated 80% acceptability among those who reported awareness of the programme and interviews with staff suggested strong acceptability. Linkage to birth/abortion records was feasible although none occurred among participants.
Conclusions: The criteria for progression to a phase III trial were met. Our data suggest that a whole-school social-marketing approach may be appropriate for topics that are clearly prioritised by schools. A phase III trial of this intervention is now warranted to establish effectiveness and cost-effectiveness. Births and terminations are not an appropriate primary outcome measure for such a trial.
Trial Registration: ISRCTN65324176.
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http://dx.doi.org/10.1186/s40814-022-00971-y | DOI Listing |
JAMA
January 2025
Institut Jules Bordet, l'Université Libre de Bruxelles and Hôpital Universitaire de Bruxelles, Brussels, Belgium.
Importance: Triple-negative breast cancer is an aggressive subtype with a high incidence in young patients, a high incidence in non-Hispanic Black women, and a high risk of progression to metastatic cancer, a devastating sequela with a 12- to 18-month life expectancy. Until recently, one strategy for treating early-stage triple-negative breast cancer was chemotherapy after surgery. However, it was not known whether the addition of immune therapy to postsurgery chemotherapy would be beneficial.
View Article and Find Full Text PDFInfect Dis Ther
January 2025
Vaccine Research and Development, Pfizer R&D UK Ltd, Marlow, UK.
Introduction: Infants and young children typically have the highest age-related risk of invasive meningococcal disease. The immunogenicity and safety of a single primary dose and a booster of a meningococcal A/C/W/Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix) in infants were evaluated.
Methods: In this phase 3b, open-label, single-arm study, healthy 3-month-old infants received a single Nimenrix dose followed by a booster at age 12 months (1 + 1 series).
J Multidiscip Healthc
January 2025
Department of Health and Nursing Sciences, Faculty of Social and Health Sciences, University of Inland Norway, Elverum, Norway.
Purpose: The palliative phase of a patient's life is often characterized by disease complexity, increasing the need for holistic care, support for the patient's relatives, and the up-to-date knowledge of a multidisciplinary healthcare team. Physicians in nursing homes have the main responsibility for providing palliative care to vulnerable and fragile patients. There is limited research uncovering physicians' experience and perceptions of what is important in this phase of patients' lives.
View Article and Find Full Text PDFFront Psychol
January 2025
Radboud University Medical Center Health Academy, Nijmegen, Netherlands.
Background: Recent research in the field of "Arts and Health" has demonstrated the beneficial impact of arts-based interventions on health and well-being across diverse populations. Recognizing their potential, especially in cases where conventional healthcare cannot address the multifaceted impact of conditions such as in Parkinson's disease (PD), our study advocates for an integrative approach in medical practice and neuroscience. We recommend incorporating learning environments from the design phase through long-term care.
View Article and Find Full Text PDFTrials
January 2025
Department of Electrical and Computer Engineering, Princeton University, Princeton, 08544, NJ, USA.
Background: Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30-40% of these trials fail mainly because such studies have inadequate sample sizes, stemming from the inability to obtain accurate initial estimates of average treatment effect parameters.
Methods: To remove this obstacle from the drug development cycle, we present a new algorithm called Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator (TAD-SIE) that powers a parallel-group trial, a standard RCT design, by leveraging a state-of-the-art hypothesis testing strategy and a novel trend-adaptive design (TAD).
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