Genitourinary syndrome of menopause (GSM) is a chronic, oestrogen-deficient condition that is frequently underdiagnosed and undertreated. Although low-dose vaginal estriol improves epithelial trophism and microbial balance, a substantial proportion of women report persistent symptoms. High-quality randomised evidence evaluating combined therapeutic strategies remains scarce. Energy-based modalities, including the erbium:YAG (Er:YAG) laser (=2940 nm), have been proposed as adjunctive treatments. This trial aims to assess the efficacy of Er:YAG laser therapy combined with vaginal estriol compared with estriol alone in postmenopausal women with GSM.
This is a single-centre, randomised, double-blind, controlled clinical trial. Postmenopausal women aged 45–70 years with vaginal pH ≥5.0 and at least one moderate GSM symptom (Visual Analogue Scale ≥4) will be eligible. Exclusion criteria include current systemic or local hormone therapy, previous vaginal energy-based treatment, abnormal cervical cytology and body mass index ≥35 kg/m2. All participants will receive vaginal estriol cream (0.5 mg per dose) daily for 14 days, followed by twice-weekly administration for 16 weeks. Participants will be randomised (1:1) to receive either estriol plus sham Er:YAG laser or estriol plus active Er:YAG laser. Three laser sessions will be delivered at approximately 4-week intervals. Assessments will occur at baseline, monthly during treatment and 4 months after the final session. The primary outcome is the Vulvovaginal Health Index, with the primary endpoint defined as the change from baseline to 4 months post-treatment, reflecting sustained effect. Secondary outcomes include GSM symptom severity, vaginal microbiome composition (16S rRNA sequencing), quality of life (Menopause Rating Scale) and sexual function (Female Sexual Function Index). Data will be analysed using repeated-measures analysis of variance or appropriate non-parametric tests, with significance set at p
Ethical approval has been obtained from the Human Research Ethics Committee of UNINOVE. Written informed consent will be obtained. Findings will be disseminated via peer-reviewed journals and scientific meetings.
To summarise the evidence on long-term and infrequent harms following selected spinal and paraspinal injections and denervation procedures for chronic non-cancer spine pain.
Systematic review and meta-analysis.
MEDLINE, EMBASE and Cumulative Index to Nursing and Allied Health Literature from inception to October 2023.
Non-randomised studies reporting on harms of selected interventional procedures administered to adults living with chronic axial or radicular non-cancer spine pain with ≥4 weeks of follow-up.
A parallel guideline panel provided input on the scope, design and interpretation of this systematic review, including selection of adverse events for consideration. Systematic literature screening, data abstraction and risk of bias appraisal were conducted independently and in duplicate by pairs of reviewers. We used random-effects models for all meta-analyses and the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the certainty of evidence.
We included 60 longitudinal studies (56 non-comparative, 4 comparative) that enrolled 4966 patients with chronic non-cancer spine-related pain. 31 studies investigated radiofrequency ablation or denervation, 22 epidural injections and 11 joint injections or nerve blocks. Low certainty evidence suggests that joint targeted steroid injection and epidural steroid injection for chronic spine pain may result in temporary altered level of consciousness (incidence: 2.1%; 95% CI 1.1% to 4.0%), joint radiofrequency nerve ablation, joint targeted steroid injection and epidural injection of local anaesthetic and steroids may result in deep infection (incidence: 0.7%; 95% CI 0.3% to 2.0%), epidural steroid injection, joint radiofrequency nerve ablation and joint targeted injection of local anaesthetic and steroids may result in dural puncture (incidence: 1.4%; 95% CI 0.5% to 4.3%), and dorsal root ganglion radiofrequency and joint radiofrequency nerve ablation with or without joint-targeted injection of steroids may result in prolonged pain or stiffness (incidence: 8.6%; 95% CI 6.3% to 11.6%). Several interventional procedures may result in metabolic complications and prolonged sensory deficits, but the supporting evidence was only very low certainty. Most complications resolved spontaneously or with conservative management.
Low certainty evidence suggests that several common interventional procedures for chronic spine pain show risk of deep infection, dural puncture, temporary altered level of consciousness and prolonged pain or stiffness. Other harms are uncertain due to very low certainty evidence, and catastrophic outcomes were not reported in the small studies that contributed to our analyses.
The BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) study is a multicentre prospective observational cohort designed to identify biomarkers associated with prostate cancer (PCa) risk that may be modifiable through lifestyle factors. This paper describes the cohort, along with the data and bio-samples available for future studies in PCa risk assessment.
Canadian men at risk of PCa were enrolled based on one of two criteria (1) negative first prostate biopsy within 6 months from enrolment (Group 1); or (2) a prostate-specific antigen (PSA) blood level between 2.5 and 10 ng/mL without prior prostate biopsy (Group 2). At baseline, blood samples and comprehensive data were collected. PCa incidence and lifestyle factors were updated for all participants over 2 years, with extended follow-up for those who provided additional consent.
Recruitment was conducted across four health centres in Quebec, Canada. A total of 2053 men were enrolled—1499 in Group 1 and 554 in Group 2. All participants completed the initial visit, which included collection of medical and family history, anthropometric measurements, demographic information, dietary and alcohol intake, physical activity, tobacco use, medication use, and quality of life assessments, and candidate biomarker measurements. At the 2-year mark, 7.2% of participants had developed PCa; this figure has since increased to 15.3% (median follow-up: 6.1 years). Additionally, 84% (n=1718) consented to ongoing annual follow-up.
This large, prospective cohort of men at risk of PCa offers valuable resources for risk stratification and primary prevention. The BioCaPPE biosamples and data are available to support the identification of lifestyle-related biomarkers associated with PCa risk in this population.
ClinicalTrials.gov Identifier: NCT03383016.
Post-COVID-19 condition (PCC) has emerged as a major public health concern. We aimed to estimate the 1-year incidence of PCC in adults with confirmed SARS-CoV-2 infection in Lombardy, Italy, comparing community-managed and hospitalised patients and to assess the prognostic value of the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) score to support estimation of long-term PCC prevalence.
Retrospective-prospective observational cohort study enrolling patients infected between 1 March 2020 and 31 December 2022. The study visit was conducted between 16 January and 23 December 2024.
Multicentre study involving seven public hospitals and general practitioners across Lombardy.
Randomly sampled adults aged 18–70 years with confirmed SARS-CoV-2 infection. Hospitalised patients (HP) were admitted for COVID-19; general practitioner patients (GPP) were managed in the community. The total sample comprised: 1162 (546 HP, 616 GPP).
This is an observational study with no active intervention.
Primary outcome: 1-year incidence of PCC retrospectively assessed at the study visit.
Secondary outcomes: symptom profiles, long-term PCC prevalence at the study visit and predictive value of the NIH RECOVER score.
Median age was 57.1 years in HP and 42.9 years in GPP; 66.1% of HP and 47.7% of GPP were male. PCC developed in 280 patients (223 HP, 57 GPP). The 1-year cumulative incidence was 39.9% in HP (95% CI 35.9% to 44.1%) and 9.1% in GPP (95% CI 7.1% to 11.7%). The NIH RECOVER score was associated with PCC at 1 year (OR 1.18, 95% CI 1.14 to 1.21). Model-based long-term PCC prevalence was 31.8% in HP and 6.3% in GPP.
PCC remained frequent and heterogeneous, particularly among previously HP. In this cohort, the NIH RECOVER score showed prognostic value for estimating longer-term PCC burden. These findings underscore the need for structured long-term follow-up across both hospital and primary care settings.
Over 50% of patients participating in cardiac rehabilitation (CR) experience poor sleep and/or, closely related, psychological stress. Although stress management interventions are generally available, they are typically underutilised in CR, and sleep remains an underaddressed component within CR. This is concerning, as poor sleep and stress not only reinforce each other but are also associated with poorer cardiovascular health and lower quality of life. Therefore, the primary aim of the OPtimising CArdiac REhabilitation by REfining Sleep and STress (RESST) study is to investigate the (cost-)effectiveness of adding a behavioural intervention targeted at improving sleep and managing stress during CR (RESST intervention) on sleep and psychological stress. Furthermore, the study aims to explore the (bidirectional) associations between sleep, stress and lifestyle behaviours.
This parallel-arm multicentre randomised controlled trial will include 200 CR patients across 3 major CR centres in the Netherlands who experience poor sleep and/or stress. Patients will be randomised in a 1:1 ratio to standard CR or standard CR with the RESST intervention. Standard CR is a structured programme combining exercise, lifestyle guidance and risk management. On top of standard CR, the RESST intervention consists of 5 in-person group sessions targeting sleep and stress and is based on Acceptance and Commitment Therapy and Cognitive Behavioural Therapy. Primary outcomes are accelerometer-assessed and self-reported sleep and perceived stress. Secondary outcomes include quality of life, psychosocial well-being, chronic stress biomarkers (hair cortisol and cortisone), momentary fatigue, momentary stress and physical activity. Linear mixed models will be used to assess changes in outcomes at 3-month (after intervention and/or CR completed) and 6-month follow-up. The momentary data collected with ecological momentary assessment and accelerometry will be analysed using multilevel linear mixed models to explore the (bidirectional) relationship between sleep, stress and other lifestyle components such as physical activity.
This study was approved by the ethics committee of Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2024-0238). The findings will be disseminated through publications in peer-reviewed journals, presentations at academic conferences and professional and patient publications.
Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.
RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.
This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.
Health inequalities remain resistant to interventions that primarily target individual behaviour. Although systems approaches are increasingly promoted, their application in practice is often not well grounded in real-world settings. In this protocol paper, we present the approach we will take in an overarching project that synthesises the combined insights of four ongoing systems-based research projects on system-based approaches for reducing health inequalities in the Netherlands. By bringing together and comparing findings across diverse contexts, populations and interventions, we aim to generate an empirically grounded understanding of what works, for whom, in what contexts and why, and to derive actionable strategies for systemic change to reduce health inequalities.
We use a realist approach to synthesise insights from the four ongoing projects. The design involves four iterative steps: (1) Identifying cross-cutting themes from project proposals and literature, (2) Developing and refining context–mechanism–outcome (CMO) configurations through literature review and Slow Science meetings, (3) Engaging Critical Friends to co-develop actionable strategies and (4) Assessing and validating these strategies across diverse contexts. Iterative feedback loops ensure continuous refinement, integration of stakeholder perspectives and exploration of emergent challenges. This design enables theory-informed, practice-based strategies to support sustainable system change in reducing health inequalities.
Ethical approval for the four underlying projects has been obtained from the relevant institutional review boards, and the way their data is used for this overarching project falls within their approved scope. Dissemination will be ongoing and co-created with stakeholders, including policy briefs, factsheets, educational tools and academic publications, to support uptake of strategies for systems change.
To determine the proportion of postpartum depression (PPD), explore associated risk factors with PPD, and examine changes in PPD, social support and quality of life (QOL) among adolescent and adult mothers in the first 6 months postpartum during the COVID-19 pandemic.
A longitudinal comparative study was conducted using an online questionnaire from January to August 2021.
The study recruited 65 adolescent and 65 adult mothers who attended postpartum checkups at 6 weeks postpartum in primary hospitals across Ayutthaya, Chachoengsao and Phetchaburi provinces in Thailand. Data were collected by the Edinburgh Postnatal Depression Scale, Postpartum Support Questionnaire, and the World Health Organisation Quality of Life Brief at 6 weeks, 4 months and 6 months postpartum.
Finally, 60 adolescent and 60 adult mothers were included for analysis. Adolescent mothers experienced lower social support and QOL compared to adult mothers over the 6-month postpartum period. Notably, both adolescent and adult mothers had significantly increased PPD proportions from 6 weeks to 6 months postpartum (31.7%–48.3% and 23.3%–43.3%, respectively). However, there was no significant difference in the PPD proportions between groups. In adjusted models, significant risk factors for PPD during the first 6 months postpartum included educational level, unintended pregnancy, mode of delivery and social support.
Significant changes in PPD, social support and QOL were observed in both adolescent and adult mothers during the first 6 months postpartum. Adolescent mothers consistently demonstrated lower levels of social support and QOL at 6 weeks, 4 months and 6 months postpartum compared to adult mothers. Additionally, mothers with lower educational attainment, unintended pregnancies, caesarean deliveries and low social support were more likely to experience PPD.
Midwives/nurses should provide routine PPD screenings throughout the first six months postpartum for all mothers, particularly for at-risk mothers such as adolescent mothers or those with lower education, unintended pregnancies, caesarean deliveries and limited social support.
We have followed the STROBE guidelines.
No patient or public contribution.
Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.
A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p
The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.
Patients with chronic somatic diseases such as obesity often develop comorbid depressive symptoms. E-mental health interventions are an innovative and effective treatment option within a stepped care approach. Studies have shown that acceptance and adherence are higher when they are tailored to the specific needs of the target group. This study protocol describes a randomised controlled trial (RCT) of an internet-based self-help intervention, Fit4Mood, to improve mental health in the high-risk group of adults with obesity. The objective of the @ktivPLUS research project is to evaluate the effectiveness, acceptability and cost-effectiveness of the intervention in comparison to an online bibliotherapy.
Eligible individuals will be randomly allocated to an intervention group (access to an internet-based intervention) or to an active control group (access to an online bibliotherapy). Assessments will be conducted before the start of the intervention (baseline (BL)) and 4 months after BL (follow-up (FU)). The primary outcome is the reduction in depressive symptoms (Beck Depression Inventory-II) in n=190 participants. Secondary outcomes are anxiety, quality of life, activity, self-efficacy, resilience, mental and digital health literacy, stress, sleep quality, weight loss, weight management activities and readiness to lose weight, weight self-stigma, uptake, adherence and satisfaction with the intervention, workability and cost-effectiveness at follow-up. Additionally, sociodemographics, health, comorbidities and disabilities, as well as internet-specific information, will be assessed at BL. Intention-to-treat analysis using generalised linear mixed models will be applied.
Approval for this study has been granted by the ethics committee of the University of Leipzig (ID: 140/25-ek). All participants will provide informed consent prior to participation in the study. Results will be disseminated in peer-reviewed journals and presented at national and international conferences. In the case of a successful evaluation, the internet-based self-help intervention Fit4Mood will be provided as freeware, which will be easily accessible and free of charge.
The current RCT study has been registered at the German Clinical Trials Register (Identifier: DRKS00036178, Registered 24 June 2025; https://www.drks.de/search/de/trial/DRKS00036178).
Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.
This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.
This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.
This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).
Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).
We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.
The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).
In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.
Former COVID-19 patients and controls participated in this cohort study.
Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p
Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.
The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).
Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.
We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.
Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.
There are structural and functional modifications that occur to the neonatal heart immediately after birth. While a number of studies recently have assessed cardiac function in the newborn, there is a dearth of data on diastolic function in the neonatal period during transition and into infancy. The objective of this study is to assess diastolic function in a large cohort of infants to provide normative reference values and to assess the influence of predefined maternal and infant characteristics.
This is a single-centre observational study of babies born at 35 weeks of gestation and above, involving echocardiography in the first 2 DOL and longitudinal follow-up of these infants up to 18 months of age. The echocardiographic measurements to assess diastolic function used in this study include conventional echo measures, novel echo measures using tissue Doppler imaging and deformation measures using 2D speckle tracking echocardiography.
The protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. The findings from this study will be disseminated in peer-reviewed journals and during scientific conferences.
Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.
Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;
Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.
NCT06542315, registered on 6 August 2024.
In Germany, influenza vaccination rates in at-risk groups are well below the 75% coverage recommended by the WHO. Although it has been shown that general practitioners (GPs) can play a key role in increasing their patients’ willingness to be vaccinated, this potential does not seem to have been fully used. This study aims to uncover factors that motivate GPs to vaccinate their patients against influenza, investigate the role of financial incentives in achieving higher vaccination rates and determine how the daily practice of GPs can be made more vaccination friendly.
A mixed-methods approach is employed to reach the research aims. Literature reviews will be conducted to identify factors that motivate GPs to vaccinate against influenza and to identify studies in which preferences are elicited. This is followed by semistructured interviews with GPs (n=6–10). The scoping reviews and interviews serve as a basis for the development of a quantitative survey directed at GPs which includes a discrete choice experiment. The quantitative survey will be sent to a total of 3760 GPs.
The study will be conducted in accordance with the Declaration of Helsinki. A positive vote has been received from the Ethics Committee of the Medical Association North Rhine (2024259). Study participants will only be included in the study after being given informed consent. Manuscripts will be prepared for the scoping review on motivating factors and after completion of the quantitative survey, which will be submitted to peer-reviewed journals. Interim results and final results of the project will be presented at conferences.