Spironolactone is a useful and effective acne treatment option for adult female patients. We aim to establish whether spironolactone could be a safe treatment for the management of acne in the female adolescent population as well. The objective of this scoping review is to provide an evidence map of the safety profile of spironolactone in the paediatric population aged 0–17 across all clinical indications.

This scoping review will be conducted according to the Joanna Briggs Institute scoping review protocol. Relevant publications will be searched on the MEDLINE, Embase and Web of Science databases from inception until July 2025. The authors of included studies will be contacted using contact details provided in the manuscript to check for any further published or unpublished data on the review question. An initial search will be conducted using keywords to identify relevant articles. After identifying the research strategy, articles will be extracted into a reference management tool, and a two-part study selection process will be systematically applied by two reviewers. The first part consists of screening titles and abstracts to define the eligibility of each article. In the second part, the full texts will be screened and only relevant articles will be kept. All articles related to the safety of spironolactone in children and adolescents across all clinical indications will be included. Data will be extracted using a scoping review management software such as Covidence, collated and charted to summarise all the relevant methods, outcomes and key findings in the articles.

This scoping review will provide an extensive overview of the available safety evidence for the use of spironolactone in children and teenagers. Since the scoping review methodology consists of reviewing and collecting data from publicly available materials, this study does not require ethics approval. The results will be disseminated in a peer-reviewed publication.

To assess the quality of amoxicillin products in Indonesia’s private market by surveying the range of products available across different areas, followed by product sampling and laboratory testing.

A cross-sectional survey employing mystery shoppers to purposively sample the widest possible range of amoxicillin products available to patients across different areas in Indonesia.

Licensed and unlicensed medicine outlets in remote, rural and urban areas and online.

Amoxicillin products that are sold to patients as oral solid and dry liquid formulations.

Quality of amoxicillin products, assessed using compendial testing of active pharmaceutical ingredient content and dissolution. Samples that failed any quality test were classified as substandard or out-of-specification (OOS). The raw prevalence of substandard amoxicillin was adjusted based on the national market volume of each product variant.

We surveyed 476 outlets, mostly pharmacies (68.5%), websites (19.7%) and drug stores (10.9%). Among the 120 collected samples, there were 59 distinct products, collectively representing 95% of the estimated market volume for oral solid products and 65% for dry syrups. 12 out of 110 oral solid samples tested OOS (10.9%), as did 3 out of 10 dry syrups (30%). The samples that failed originated from various areas and types of outlets. We found no relation between the price and quality of amoxicillin.

The oral solid amoxicillin products that tested OOS represent an estimated 12.7% of the national market volume. We found no relation between the price and quality of amoxicillin. Combining product-variety sampling with data on market volume presents a promising approach to gain insight into the prevalence of poor-quality medical products using a relatively small sample size.

Patient-centred care (PCC) is associated with better experiences for chronic care encounters and better outcomes. However, its assessment and resultant management outcomes have not been well documented in Malawi. As Malawi strives to institutionalise PCC in its quality-of-care initiatives, documenting its correlates and outcomes is a good starting point in the implementation and advocacy of PCC among chronic care patients, particularly those living with diabetes mellitus (DM).

We sought to assess the level of diabetic patients’ perception of PCC and its relationship to self-efficacy, adherence and glycaemic control among patients with DM.

This study was done in DM clinics of two district and two central hospitals in southern Malawi.

This was a cross-sectional analytical study. We studied 607 subsequent consenting adult patients with DM. We assessed the level of perception of using a locally generated and validated tool and its correlation with self-efficacy, adherence and long-term glycaemic control after a medical encounter. We used K-means clustering, linear and logistic regression, and path analysis in the analysis.

The study’s outcome measures included adherence, self-efficacy, long-term glycaemic control. Adherence included aspects related to medication, diet, lifestyle and appointment keeping and was assessed using the Hill-Bone tool. Self-efficacy was assessed using a Stanford self-efficacy tool while long-term glycaemic control was determined through haemoglobin A1c (HbA1c) point-of-care testing.

Overall, the mean score for PCC was 62.86 (SD 14.78). The study highlighted two groups of patients with statistically distinct mean scores of 51.6 (7.8) vs 77.1 (7.2) out of a possible 92 (p

Although this study did not find a direct correlation between PCC and glycaemic control, it has demonstrated that PCC medical encounters could potentially improve glycaemic control by enhancing patients’ adherence to their diabetes management plans. Even though PCC is not an end in itself, medical encounters that prioritise good relational ambience, patient involvement and capacitation are promising interventions in DM care, especially for patients with or at risk of DM complications. The general lack of patient individualisation and involvement elements found in the medical encounters in our study could explain why PCC hardly has an impact on self-efficacy. The study highlights the importance of PCC in DM patient management and outlines important innovative adaptations towards transforming medical education to equip and appraise interpersonal skills that have an impact on patient-reported experiences and outcomes.

To determine associations between arm and ankle systolic blood pressures (SBPs), develop and validate a multivariable model predicting arm SBP from ankle SBP, and investigate associations between ankle SBP, cardiovascular disease and mortality.

Ankle-arm SBP differences were examined in two-stage individual participant data (IPD) meta-analyses using multivariable hierarchical linear regression models. Models were used to derive and validate a prediction model for arm SBP based on ankle SBP. Model performance was assessed using area under the receiver operating characteristic (AUROC) curve analyses. Prognostic associations of ankle SBP with outcomes were examined using Cox proportional hazards models.

Searches identified cohorts for the Inter-arm Blood Pressure Difference IPD (INTERPRESS-IPD) Collaboration from Medline, Old Medline, Medline in process, Embase and CINAHL databases from inception until January 2017; unpublished data were also sought. Required primary outcomes were all-cause mortality, cardiovascular mortality, and/or fatal and non-fatal cardiovascular events.

Prospective studies from community, primary care or general clinic settings, without language restriction, that recorded SBP in both arms were eligible. Adults aged ≥18 years with SBP measured in all four limbs, in a supine position, were included in the current analyses. People with peripheral artery disease were excluded.

Anonymised datasets were individually cleaned and then combined into a single dataset for the INTERPRESS-IPD Collaboration.

The current dataset included 33 710 participants from 14 studies; mean age 58 years, 45% female, mean baseline arm blood pressure 138/80 (SD: 20/12) mm Hg. Mean ankle SBP was 12.0 mm Hg (95% CI 8.8 to 15.2) higher than arm SBP. The multivariable model predicting arm SBP from ankle SBP demonstrated excellent performance (AUROC curves, sensitivities and specificities were >0.82, 0.80 and 0.82, respectively, at all BP thresholds from 130 to 160 mm Hg). Model performance was superior to existing arithmetic formulae.

Ankle SBP was neither associated with all-cause nor cardiovascular mortality (HR 1.000 (0.997 to 1.002; p=0.682) and 1.001 (0.996 to 1.005; p=0.840), respectively). However, lower-reading ankle SBP was associated with fatal or non-fatal cardiovascular events (HR 1.005 (1.002 to 1.007; p

On average, ankle SBP is 12 mm Hg higher than arm SBP. Estimating individual arm SBP from ankle SBP measurements with a multivariable model is more accurate than existing fixed arithmetic formulae. This model, operationalised in an online calculator (https://ablebp.research.exeter.ac.uk/), could facilitate hypertension management and cardiovascular care for people unable to have arm SBP measured.

CRD42015031227.

Molar incisor hypomineralisation (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. The secondary objective is to assess whether dentin hypersensitivity and the severity of MIH lesions are associated with alterations in orofacial functions.

Assessments will be performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive analyses will characterise the sample. The Shapiro-Wilk test will assess normality. For normally distributed data, analysis of variance and Tukey’s post hoc test will be used. For non-normal data, the Mann-Whitney U test will be applied. The 2 test will analyse categorical variables and compare NOT-S domains between groups. Potential confounders (eg, age, sex, socioeconomic status) will be controlled through stratification or as covariates. Logistic and Poisson regressions will model associations for categorical and count-based outcomes, respectively. Statistical significance will be set at p

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 83969924.2.0000.5511; approval date: 22 November 2024). Participants will agree to take part in the study by signing an informed consent form. The findings will be published in a peer-reviewed journal. The collected data will be available on request.

NCT06692257.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality globally. Early diagnosis and intervention are crucial for preventing disease progression. The concept of early COPD is considered to represent the initial phase of the disease course. However, different terms are used, and a standardised definition is lacking. This has hindered research and clinical utility. This systematic review aims first to examine current early COPD research and outline the definitions and terms used to help reach consensus and direct future clinical research. Second, it will identify currently proposed markers and tools for predicting the progression of early COPD and the quality of evidence to help direct future research and facilitate the development of novel management strategies.

This study will search for all clinical studies on early COPD, using a standardised search strategy, searching CENTRAL (the Cochrane Library), MEDLINE (Ovid), PubMed, Scopus, Web of Science and Google Scholar. Titles and abstracts will be reviewed and compared against inclusion and exclusion criteria. Stage 1 of this review will assess the terms and definitions used for early COPD. Stage 2 will assess studies presenting additional markers or tools for predicting the progression of early COPD. Study quality will be assessed using a modified Downs and Black checklist for observational studies and the risk of bias (RoB) 2 tool for randomised controlled trials. This protocol has been registered in PROSPERO (CRD42025645320).

This systematic review will use freely available data within the literature and will not directly involve human participants; therefore, ethical approval is not required. The results of this systematic review will be prepared and submitted for presentation as conference presentation(s) and for publication as a peer-reviewed article.

CRD42025645320.

Adverse events during paediatric anaesthesia are common, with hypoxaemia during the induction period being a leading cause, as infants and children are particularly vulnerable to hypoxaemia during periods of apnoea. The administration of supplementary oxygen, referred to as apnoeic oxygenation, has been shown to prolong safe apnoea times and increase first-pass intubation success rates. Despite these benefits, apnoeic oxygenation is not routinely used in paediatric anaesthesia. Low-flow apnoeic oxygenation, delivered via a standard nasal cannula, is a simple approach to provide supplementary oxygen during paediatric airway management without requiring additional equipment. However, its efficacy in airway management during elective surgeries has not been adequately studied.

The ApOx-Pedi-Trial is a single-centre, cluster randomised, controlled clinical trial comparing the use of low-flow apnoeic oxygenation during the induction of general anaesthesia in infants and children up to 6 years of age undergoing elective surgery at the Department of Pediatric Surgery at Heidelberg University Hospital to standard of care (no apnoeic oxygenation). Randomisation is conducted using a weekly cluster randomisation method, where all patients presenting for surgery in a given week either receive apnoeic oxygenation or standard of care during the induction of general anaesthesia, based on the week’s group allocation.

The study population will consist of two independent, age-stratified cohorts (24 months to 6 years), each including 100 patients. Statistical analysis of study endpoints will be conducted separately for each cohort to allow for age-specific assessment of outcomes.

The primary objective of this trial is to evaluate whether apnoeic oxygenation can prevent a decrease in transcutaneous haemoglobin saturation (SpO₂) during the induction of general anaesthesia in infants and children. The primary outcome measure will be the lowest recorded SpO₂ value throughout the apnoeic period.

The ApOx-Pedi-Trial received permission from the local ethics committee (Ethics Committee of the medical faculty at Heidelberg University, Heidelberg, Germany) under the registration number S-074–2024. The study is following institutional Guidelines and the Declaration of Helsinki of 1975 in its most recent version. Trial results will be submitted to peer-reviewed journals and presented at national and international conferences.

The trial is prospectively registered on ClinicalTrials.gov with the number NCT06576596.