Dental caries is the most common oral disease worldwide, affecting up to 90% of children globally. It can lead to pain, infection and impaired quality of life. Early prevention is a key strategy for reducing the prevalence of dental caries in young children. Valid and reliable diagnostic or prognostic tools that enable accurate individualised prediction of current or future dental caries are essential for facilitating personalised caries prevention and early intervention. However, no efficacious tools currently exist in early childhood—the optimal period for disease prevention. We aim to develop and validate diagnostic and prognostic prediction tools for dental caries in young children, using a combination of environmental, physical, behavioural and biological early life data.

Data sources include two prospective studies, with a total sample size of approximately 600 children. These cohorts have collected detailed demographic, antenatal, perinatal and postnatal data from medical records and parent-completed questionnaires and biological samples including a dental plaque swab. Candidate predictor variables will include sociodemographic characteristics, health history, behavioural and microbiological characteristics. The outcome variable will be the presence, incidence or severity of dental caries diagnosed using the International Caries Detection and Assessment System. Statistical and machine learning approaches will be used for selection of predictor variables and model development. Internal validation will be conducted using resampling methods (i.e., bootstrapping) and nested cross-validation. Model performance will be evaluated using standard performance metrics such as accuracy, discrimination and calibration. Where feasible, external validation will be performed in an independent cohort. Model development and reporting will be guided by the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) statement and the Prediction model Risk Of Bias Assessment Tool (PROBAST) guidelines.

This study has ethical and governance approval from The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC/111803/RCHM-2024). Results of this study will be published in peer-reviewed journals and presented at scientific conferences.

Infant2Child: ACTRN12622000205730—pre-results; MisBair: NCT01906853—post results.

This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.

A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.

Data were sourced from the published literature and input from international stakeholders.

pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.

A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as ‘no consensus’. 13 individuals (six pwMS, one pwMS’s friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as ‘no consensus’. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.

We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.

https://osf.io/ys7xt/.