Although care for low-risk births in the Netherlands is primarily conducted by midwives, the use of consultant-led care has been increasing for a variety of indications, leading to a high patient burden for consultants. The induction of labour (IOL) of late-term pregnancies has historically been an indication for consultant-led care. This study by Velthuijs et...

As a result of the mass scale of production of plastics since the 1950s, microplastics, defined as particles 1 Microplastics have been linked to reproductive toxicity in both cell culture...

Although the WHO and the Centers for Disease Control and Prevention (CDC) classify preconception health risks (PCHRs) into biomedical, behavioural and social categories, this classification remains theoretical, mainly inconsistent and lacks a scientifically robust framework. Data-driven clustering techniques may help clarify this complexity for policymakers and healthcare providers. This study aimed to assess the status of PCHRs and identify latent classes of these risks among women preparing for pregnancy.

This community-based cross-sectional study was conducted from 31 July to 16 August 2024 in Tigray, Ethiopia, among 865 married women planning to conceive within the next 6 months. Data were gathered through face-to-face interviews using a structured questionnaire. Risk factor indicators covering lifestyle behaviours, substance use, nutritional risks and related factors were developed based on guidelines from the WHO, the CDC and national recommendations. Latent class analysis (LCA) was employed to identify distinct classes of PCHRs, with the optimal number of classes determined using statistical fit indices, adequacy criteria and interpretability. The study also evaluated the overall distribution of PCHRs among participants.

The study took place in Tigray, Ethiopia, among married women intending to become pregnant within 6 months.

Burden of PCHRs and identified distinct latent classes of these risks within the participants.

All participants were exposed to at least four PCHRs, with 84.2% experiencing between 6 and 12 risk factors. The optimal LCA model identified four distinct classes of PCHRs: lifestyle behavioural risks (n=458, 52.9%), reproductive health risks and chronic medical conditions (n=106, 12.25%), nutritional risks and environmental exposure (n=149, 17.23%) and social determinants of health (n=152, 17.57%).

Our study reveals a high baseline level of PCHRs, with all participants exhibiting multiple risk factors for adverse pregnancy outcomes. The identification of four distinct risk profiles underscores the need for tailored risk-specific interventions, particularly in conflict-affected settings. Our findings point out the need for targeted preconception care and risk stratification in national health strategies to improve maternal and child health outcomes.

The Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice was established using data collected as part of a cluster-randomised trial. This aims to support the trial’s follow-up and enable further examination of the interplay between chronic disease, multimorbidity (MM), polypharmacy (PP) and quality of life (QoL) in a Danish general practice setting.

The cohort comprises 35 977 adult patients from 250 general practices participating in a cluster-randomised trial and had a response rate of 22.4%. Participants were either registered as chronic care patients or had attended an annual chronic disease consultation. They completed a comprehensive questionnaire on self-reported chronic conditions, medication use, QoL, treatment burden and patient-centred care. Additionally, 431 general practitioners (GPs) from the participating practices completed a questionnaire about managing patients with complex MM.

Among participants, 51.9% were female, the mean age was 65.6 (SD 12.9) years, 93.1% had education beyond basic schooling, and half were retired. Conditions from more than one organ system-based disease group were reported by 82.2%, and 94.6% used one or more prescription medications. The main challenges reported by the participating GPs in managing patients with complex MM were keeping time and obtaining an overview of the patient’s health status.

Cohort data will be linked with Danish registries to improve the detection and treatment of chronic conditions and PP in general practice.

The cluster randomised trial (MM600) is registered with ClinicalTrials.gov ID: NCT05676541.

Traumatic musculoskeletal injuries are common and often life changing. The 6-month period following injury is a critical phase in recovery, during which engagement with rehabilitation professionals can be key to achieving positive outcomes. However, there is limited understanding of which aspects of recovery matter most to patients, how they define a successful recovery and what this looks like when captured during the lived recovery process. The aim of this study was to explore patients’ views and perceptions of recovery following musculoskeletal trauma and to understand what constitutes successful recovery at 6 months postinjury.

Qualitative study using interpretative phenomenological analysis through semi-structured interviews.

Major trauma centre in the UK.

13 participants (mean age (SD) 51 (17) years, 69% male) completed the interview. Eligibility criteria: adults >18 years, musculoskeletal injury from a traumatic event and ability to communicate in English. Purposive sampling included age, gender, injury severity and injury type. Interviews were audio recorded and transcribed verbatim.

Three main themes were identified: (1) The recovery journey: participants reflected on their recovery while still processing the accident/injuries. They often drew on other people’s experiences to make sense of their recovery. Recovery was accompanied by a range of negative emotions and personal challenges. (2) The outcome: participants used multiple strategies to work towards recovery, guided by personalised individual goals. A successful recovery was defined as their ‘normal’. (3) Healthcare/clinicians impact recovery: Participants reported confusion and mixed messages from healthcare professionals, leading to uncertainty around injury management. Fragmented care pathway and difficulties accessing healthcare and support were also highlighted.

Recovery at 6 months post injury involves a complex interplay of physical and emotional factors. This period can be particularly challenging to navigate, often with no or limited support. There is a need for a targeted, individualised approach to guide patients through this period of recovery. Participants’ focus was on the outcome following their injury, setting goals for the future, with successful recovery defined as ‘normal’. Further research is needed to support clinicians in developing effective psychologically informed rehabilitation plans.

Adolescent idiopathic scoliosis (AIS) is a common paediatric spinal deformity with large curves surgically managed through spinal fusion. However, postoperative rehabilitation remains inconsistent and varies depending on clinician, hospital or location. Our international e-Delphi consensus established a broad range of statements from preoperative care until 12 months postoperatively. However, rehabilitation and graded return to sport between 3 and 12 months remains vague and further consensus work is needed. This study aims to understand the intermediate and late stages of rehabilitation in order to guide return to sport, exercise and physical activity. The primary objective is to explore content of rehabilitation and milestones between 3 and 12 months postoperatively. This understanding of postoperative care will form the basis for future postoperative guidance.

This protocol for a nominal group technique (NGT) study is written in accordance with the Accurate Consensus Reporting Document guidelines. A national sample of expert surgeons, physiotherapists and nurses in AIS will be recruited. The NGT will take place virtually and will consist of six stages: stage 1: idea generation; stage 2: round robin idea sharing; stage 3: discussion and clarification; stage 4: anonymous voting; stage 5: results feedback; and stage 6: discussion and final voting. This NGT will be preceded by a scoping review which will be disseminated a priori to inform stage 1 idea generation. The population, concept, context framework will be used to explore postoperative rehabilitation towards sports, exercise or physical activities following any kind of spinal surgery. The study steering group and patient and public involvement representative have been involved from conceptualisation and will continue to be involved until final dissemination.

The University of Birmingham has provided ethical approval: ERN_4201-Jun2025. Dissemination will take place through conference presentation and peer-reviewed publications.

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

NCT06156176

This study compared the effectiveness of first-time use of faster aspart with rapid-acting insulin analogues in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D).

This retrospective cohort study used data from 1 January 2017 to 8 May 2021 captured in the Clinical Practice Research Datalink Aurum database in the UK.

Patients with T1D or T2D either initiating faster aspart or another rapid-acting insulin analogue (‘new users’) or switching from a rapid-acting insulin analogue to faster aspart or to another rapid-acting insulin analogue (‘switchers’) were included. The index date was the date of first prescription of faster aspart or a rapid-acting insulin analogue, or of switching to a different rapid-acting analogue or to faster aspart.

A total of 9695 and 2170 patients were included in the new users (T1D, 1737; T2D, 7958) and switchers cohorts (T1D, 1764; T2D, 406), respectively.

Glycated haemoglobin (HbA1c) change at 6 months, occurrence of hypoglycaemia from index to 12 months post-index and treatment persistency from index to discontinuation or censoring.

Numerically greater reductions were observed with faster aspart than rapid-acting insulins in T1D switchers and new users in change in HbA1c at 6 months. Patients with T1D who switched to faster aspart experienced a significant reduction in rate of hypoglycaemia (p=0.0021). Treatment persistency was higher with faster aspart than with rapid-acting insulins among T1D switchers. No distinction in treatment persistency was observed between the treatment groups for T1D new users or T2D switchers.

Reductions in HbA1c were numerically larger with faster aspart in three of four subgroups. There was higher treatment persistency with faster aspart vs rapid-acting insulin analogues among T1D switchers.

NN1218-4967.

Gestational trophoblastic disease, characterised by abnormal proliferation of trophoblastic tissue in the placenta during pregnancy, contributes to maternal morbidity and mortality. This study aimed to estimate the pooled prevalence and histopathological patterns of gestational trophoblastic disease in Africa, where previous studies have reported inconsistent findings.

Systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines.

We searched PubMed, ScienceDirect, Hinari and Google Scholar for studies published between January 2000 and January 2024.

Institution-based observational studies from African countries reporting the prevalence and/or histopathological patterns of gestational trophoblastic disease, using total deliveries as the denominator.

Data were extracted into Excel and analysed using Stata V.17. Pooled estimates were calculated using a random-effects model with Knapp-Hartung adjustment. Heterogeneity was assessed with Cochran’s Q test and the I² statistic, and study quality was evaluated using the Joanna Briggs Institute tool.

Of the 2252 studies identified, 33 were included, comprising 2885 gestational trophoblastic disease cases from eight countries. The pooled prevalence of gestational trophoblastic disease in Africa was 4.35 per 1000 deliveries (95% CI 3.26 to 5.45, I²=99.8%). The pooled prevalence of hydatidiform mole, invasive mole and choriocarcinoma in Africa was 3.49 per 1000 deliveries (95% CI 2.45 to 4.52, I²=99.7%), 0.47 per 1000 deliveries (95% CI 0.14 to 0.79, I²=72.2%) and 0.97 per 1000 deliveries (95% CI 0.54 to 1.40, I²=99.1%), respectively.

This review indicated the prevalence of gestational trophoblastic disease was high. Hydatidiform mole was the predominant histopathological pattern observed. Routine antenatal screening is needed for early detection. Further research should be conducted to identify risk factors and evaluate strategies for the prevention and management of the disease.

CRD42024504268.

Effective community-based disease management is essential for public health. In low- and middle-income countries, sustainable strategies for timely diagnosis and treatment are a research priority. This study aims to assess the feasibility of a non-invasive saliva self-sampling method, paired with digitally linked molecular point-of-care diagnostics, for detecting respiratory infections among paediatric patients in the Tshwane District, South Africa.

A field study will be conducted at Steve Biko Academic Hospital to compare saliva collection using the CandyCollect lollipop device and standard mouth swabs. The spiral groove of the lollipop device captures pathogens, which are stored in DNA/RNA preservation media and later analysed using quantitative PCR and commercially available rapid antigen tests. The multiplex respiratory pathogen panel, based on TaqMan real-time PCR technology, targets key paediatric pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, respiratory syncytial virus (RSV) and influenza A/B. Nucleic acids will be extracted using standard viral extraction kits and analysed following manufacturer protocols. Internal controls will be included in each qPCR run, and samples with CT values below defined thresholds will be considered positive. Rapid antigen tests will detect common pathogens such as influenza A/B, RSV and SARS-CoV-2 for comparative analysis. User experience and acceptability will be assessed via child-friendly and caregiver surveys following sample collection. The study will be implemented in two phases: diagnostic performance evaluation and user feedback assessment. The protocol is aligned with the Standard Protocol Items: Recommendations for Interventional Trials 2013 checklist.

Ethical approval has been granted by the University of Pretoria (509/2023) and the Gauteng Department of Health (GP_202406_032). The study is registered in the Pan African Clinical Trial Registry (PACTR202411743094783). Findings will be disseminated through peer-reviewed journals, conferences and stakeholder briefings. The study complies with South Africa’s Protection of Personal Information Act. Data collection is scheduled from November 2024 to February 2025, with project completion expected within 1 year.

Pan African Clinical Trial Registry (PACTR202411743094783).

In addition to hypertension, the constellation of metabolic abnormalities (diabetes mellitus, dyslipidaemia and/or obesity) independently increases the incidence and severity of cardiovascular diseases, and this is compounded by the modern lifestyle and ageing society. The prevalence of metabolic syndrome is high and non-hypertensive heart failure is common in Asians. Adverse cardiac remodelling is an important substrate for cardiac dysfunction in the onset and progression of heart failure and its amelioration improves outcomes and prognosis. A better understanding of metabolic-driven cardiac remodelling is warranted due to the rising prevalence and complexity of metabolic syndrome and strong interests in targeted therapy.

Response of the myocardium to hypertrophic conditions in the adult population is a prospective observational cohort study with an aim to establish the significance of cardiac remodelling by cardiovascular magnetic resonance (CMR). The current recruitment target is 2000 participants. Expanding from the initial population with hypertension, the study examines adults with cardiometabolic conditions, including diabetes, dyslipidaemia, obesity and fatty liver disease. Eligible patients are identified at National Heart Centre Singapore, primary care clinics and through public outreach. Physical, clinical, imaging and biochemical data are collected. Cardiac remodelling features pertaining to hypertrophy, fibrosis and functional changes are assessed on CMR. Body adiposity is mapped by MRI across the heart, liver and abdomen. Outcome data are adjudicated and follow-up assessment will be available in a subset of participants. Blood biomarkers will be investigated in relation to imaging findings. Cross-sectional analysis will establish the implication of cardiometabolic disease towards cardiac remodelling, while follow-up and outcome analysis will infer on disease progression and prognosis.

The study was approved by the SingHealth Centralised Institutional Review Board (2015/2603). Written informed consent is obtained from all participants. Study findings will be reported in peer-reviewed journals and at scientific conferences.

ClinicalTrials.gov, NCT02670031.

Recent literature has demonstrated benefits of the upright position and mobility during labour, including a reduction in caesarean birth incidence and the promotion of positive childbirth experiences. However, mobilisation during labour is still not a common practice worldwide. This study by Borer and Dubovi investigates the use of interactive-constructive forms of childbirth instruction to improve maternal education of the benefits of mobility and foster positive attitudes towards this style of labouring. Chi...

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

Persistent epithelial defect (PED) management can be challenging. First line of treatment includes lubrication, bandage contact lenses and punctal plugs. The second line of treatment includes autologous serum (AS). Topical insulin has been shown to be safe for topical use and improve corneal epithelial healing. Therefore, a controlled clinical trial (control group with current standard treatment, ie, AS) multicentre, randomised and with a blind third observer will be conducted to evaluate the efficacy and safety of the use of insulin eye-drops in the treatment of PED.

A preselection of patients with epithelial defect after 1 week of treatment will be made and blood tests will be obtained in order to dispense AS if necessary. After 2 weeks of standard treatment, if the PED persists and the patient meets criteria, patients will be enrolled after signing an informed consent form. Patients will be randomly allocated to receive either insulin (1 UI/mL, 4 times a day) or AS (20%, 5–6 times a day) eye-drops for 3 months. 234 patients will be included, 117 in each treatment group. The main variable (PED size) will be obtained from slit-lamp photographs, an objective and easily quantifiable variable which will be evaluated by a blinded investigator (third observer). Patients will be examined every 3–5 days until week 4 of study treatment and once a week until 6 weeks, to continue with a visit every 2 weeks until reaching 3 months of follow-up. Primary endpoints are: complete epithelialisation, epithelialisation rate (initial defect area/days until epithelialisation) and time until complete closure.

Ethical approval has been obtained from Hospital Clinico San Carlos in Madrid and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The findings will be disseminated in peer-reviewed publications and presentations at meetings.

EudraCT 2022-003589-19.

People identified as higher risk by a machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation [FIND-AF]) are at increased risk of cardio-renal-metabolic-pulmonary disease and cardiovascular death. The OPTIMISE-1 randomised controlled trial aims to test the effect of community-based specialist-led identification and management of cardio-renal-metabolic-pulmonary (CRMP) disease and risk factors compared with usual care on the use of therapeutic interventions over a follow-up of 6 months among high FIND-AF risk community-dwelling individuals.

OPTIMISE-1 is a multicentre, pragmatic, prospective, randomised, open-label, blinded-endpoint strategy trial that will recruit 138 participants aged 30 years or older, with a high FIND-AF risk score and previously enrolled in the FIND-AF pilot study (NCT05898165), to be randomised 1:1 to a specialist-led care intervention or usual care. The primary endpoint is a composite of initiation or increase of guideline-directed CRMP therapies. The secondary endpoints are the components of the primary endpoint, time to primary endpoint, diagnosis of new CRMP diseases or risk factors, time to diagnosis of new CRMP diseases or risk factors, initiation or increase of guideline-directed CRMP therapies for participants with recorded CRMP disease, initiation or increase of guideline-directed CRMP therapies for participants with newly diagnosed CRMP disease and change in participant-reported quality of life.

The study has ethical approval (the North East & North Tyneside 2 Research Ethics Committee reference 24/NE/0188). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder’s open access policy.

Clinicaltrials.gov NCT06444711.

To assess atrial fibrillation (AF) burden, symptoms and quality of life (QoL) in endurance athletes with paroxysmal AF.

Prospective cohort study.

Otherwise healthy endurance athletes with paroxysmal AF in Norway, Australia and Belgium. The current study presents baseline measurements collected before the intervention of a randomised controlled trial on effects of individually tailored training adaptation.

AF burden (percentage time in AF) was measured by insertable cardiac monitors (Confirm Rx, Abbott). AF-related symptoms and QoL were assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) with any score

43 athletes (age 57±10 (mean±SD), range 33–75 years, 3 women) were included. The athletes were monitored for 50±18 days. Median AF burden was 0.18% (IQR 0%–2.6%). Out of 29 athletes with at least one AF episode, 21 (72%) had AF episodes >60 min. 13 athletes (30%) had AFEQT overall score 60 min were associated with reduced QoL (mean AFEQT score 78 vs 90, p=0.001 and 78 vs 90, p=0.001, respectively). There were large individual variations between the athletes concerning AF burden, symptoms and QoL.

Although most athletes were still competing, more than half had troublesome symptoms. One-third had reduced QoL, which was associated with higher AF burden and longer duration of AF episodes. Variations between the athletes highlight the need for individually tailored AF management in athletes with paroxysmal AF.

NCT04991337.

To gain insight into patients’ views, perceptions, experiences and expectations postlumbar discectomy.

A qualitative study using interpretative phenomenological analysis (IPA) purposively recruited patients undergoing lumbar discectomy at one UK spinal centre. Purposive criteria included age, sex, ethnicity, symptom duration, work/sick leave, education level and co-existing psychological issues. Semi-structured interviews were conducted using a patient co-constructed topic guide. Interview transcriptions were analysed in accordance with IPA. Strategies enhancing trustworthiness included suspension of judgements and presuppositions, reflexivity, iterative coding process and critique from co-investigators.

Data from 14 participants (eight elective, 6 emergency surgery) informed four themes. The theme ready to move forwards was characterised by high satisfaction with post-operative improvement, positivity and optimism, with readiness to work towards personal goals. The theme post-operative fear and uncertainty was characterised by reflections on pre-operative difficulties fuelling fear about potential recurrence and long-term impacts. The theme of advice and guidance considered important was characterised by the expectation and value of support provided (verbal, written); instances of negative influences from healthcare interactions and access to unregulated patient information sources suggest scope for future improvement. The final theme, heterogeneity in peri-operative needs, was characterised by variation in depth/access to patient information, perceived post-operative support and wide-ranging preoperative activity/fitness.

Surgery offers physical and psychosocial changes which could be better harnessed to positively influence recovery through high quality verbal/written communication. Peri-operative advice and guidance was valued; while this was sufficient for some, personalised rehabilitation should be available owing to the identified heterogeneity.

To identify the patterns of tuberculosis (TB) notification rates and examine their relationship with social and economic determinants in Nepal between 2020 and 2023.

Cross-sectional study.

Nepal.

All TB cases across all ages.

Prevalence of TB cases.

This cross-sectional spatial analysis used the data set of the National Tuberculosis Control Centre, Nepal, covering the Fiscal Year (FY) 2020–2021 to 2022–2023. Moran’s I and Local Indicators of Spatial Association were employed to detect the spatial autocorrelation between the prevalence of TB and associated social and demographic factors.

The overall prevalence rate for TB in FY 2020–2021 was 98.08 per 100 000 population. This increased to 129.82 per 100 000 population in FY 2021–2022, followed by a slight decrease to 128.39 per 100 000 population in FY 2022–2023. The highest TB prevalence was observed in Kathmandu, with 146 cases per 100 000 population in 2020–2021, and in Dang district, the rate decreased from 215–191 per 100 000 population. We investigated the spatial patterns of TB prevalence and highlighted the geographic areas in each district in Nepal from 2021 to 2023 with Moran’s I of 0.558, 0.614 and 0.596, respectively. The consistent identification of High-High clusters in specific districts like Banke, Kapilbastu and Parsa across all 3 years periods highlighted persistent high-risk areas for TB transmission in Nepal.

This study emphasised the strong spatial associations and the complex, diverse aspects of TB transmission shaped by demographic and socioeconomic factors. Our results highlighted the need for tailored public health approaches that account for specific social determinants to address TB effectively.

Body contouring surgery (BCS) can be applied to reduce the physical and mental burden of excess skin after massive weight loss. Self-reported outcomes of patients are used to assess this burden and to evaluate the effectiveness of BCS. The aim of this study is to clarify what is reflected in self-reports of excess skin after bariatric surgery. We hypothesise that the self-reported burden of excess skin is associated with both objectively assessed excess skin and the disposition to experience negative emotions.

This cross-sectional study will include 68 outpatients presenting at a plastic surgery clinic with a request for BCS. Patients fill out two questionnaires (the BODY-Q and the Sahlgrenska Excess Skin Questionnaire (SESQ)) to measure the size and burden of excess skin as well as the Big Five Inventory (BFI) to measure the disposition towards negative emotionality. Anonymised photographs of excess skin will be rated independently by four plastic surgeons using the Pittsburgh Rating Scale (PRS) Rainbow Classification to establish the objective amount of excess skin. Multiple linear regression analyses will be performed to identify the association of BODY-Q and SESQ scores with objective appraisals of excess skin by plastic surgeons, negative emotionality and demographics. Interobserver agreement for PRS Rainbow Classification will be established by Fleiss’ kappa.

Ethical approval was obtained from the regional medical ethics committee (METC; W20.258) and the institutional review board (Lokale Toetsing, St. Antonius Hospital in Nieuwegein, no. Z23.035). Informed consent of participants will be obtained. The results of this study will be submitted for publication in a peer-reviewed journal.

The prevalence of women with primary dysmenorrhoea is high and negatively impacts physical and mental health. The intense cyclic episodes of pain generate central nervous system dysfunctional processing. In this sense, strategies focused on the central nervous system are important to re-establish normal functioning. Home-based self-administered transcranial direct current stimulation (tDCS) emerges as a strategy to modulate dysfunctional brain areas and improve the symptoms. This protocol aims to evaluate the effects of home-based self-administered tDCS for pain, premenstrual symptoms, physical performance, quality of life, electroencephalography and patient global impression in women affected by primary dysmenorrhoea.

This is a single-centre, parallel, randomised, double-blinded clinical trial protocol. 40 women affected by primary dysmenorrhoea will be randomised into two groups (active-tDCS or sham-tDCS). Then, 20 consecutive sessions of home-based self-administered tDCS will be performed. The assessments will occur at five time points: baseline, after the 20th sessions, at the first, second and third cycles after tDCS interventions (follow-ups). Primary outcome will be pain according to visual analogue scale. Quality of life, premenstrual symptoms screening, depression, anxiety, physical performance, electroencephalography and participants’ satisfaction will be the secondary outcomes. A mixed analysis of variance will calculate the effect of stimulation.

The study was approved by the ethics committee of the Federal University of Rio Grande do Norte (No. 6.037.756) and registered in the Brazilian Clinical Trials Registry (n° RBR-747k8vb). Participants may withdraw at any time without penalty. Free support will be available from the lead researcher if needed. All procedures will follow Good Clinical Practice and international ethical standards.

https://ensaiosclinicos.gov.br/rg/RBR-747k8vb