Conectar
Rising patient numbers and limited resources are creating a challenging environment for healthcare providers recently. Anaesthesiologists are also increasingly faced with complex situations, requiring high adaptability in the operating room. To enhance team adaptability during emergencies, effective communication methods are essential. This study aimed to compare the impact of mobile phones and intercoms on the response time and effectiveness of anaesthesiologist teams in emergency situations.
Prospective, observational and simulation study.
Anaesthesiology and Critical Care, Yokohama City University Medical Center, Yokohama, Japan.
This study, conducted at Yokohama City University Medical Center (Yokohama, Japan), evaluated how communication methods (intercoms vs mobile phones) impact the efficiency of anaesthesiologists in the simulation setting. Two scenarios were tested: (1) retrieving a video laryngoscope during a difficult intubation and (2) gathering support during cardiac arrest.
Outcomes measured included time to secure equipment, time for assistance to arrive and staff numbers gathered. The Wilcoxon signed-rank test was used to compare the outcomes between the intercom and mobile phone groups.
In scenario 1, the time to secure the video laryngoscope was significantly shorter with intercom use compared with mobile phones (intercom vs mobile phone, median (IQR): 29 (25–33) s vs 50 (39–62) s; p=0.013, effect size 20 (95% CI 7 to 31)). In scenario 2, the time from the request for assistance until the first supporting staff member reached the operating room was significantly shorter in using the intercoms (intercom vs mobile phone, median (IQR): 16 (14–18) s vs 35 (31–38) s; p=0.04, effect size 17 (95% CI 6 to 24)), and more personnel were available in the intercom group (intercom vs mobile phone, median (IQR): 3 (3–3.5) persons vs 2 (1–2) persons; p=0.04, effect size 1.5 (95% CI 1 to 3)).
Real-time information sharing through intercoms improved the ability of the anaesthesiologist team to respond more rapidly and effectively in emergency situations, enhancing overall team adaptability. This approach may improve patients’ outcomes by shortening response times and increasing team coordination.
Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.
This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.
The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals.
jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).
Teenagers widely use digital devices for information sharing and other daily activities. Their heavy reliance on smartphones and tablets may contribute to repetitive-use injuries of the thumb.
This study aimed to investigate the prevalence of texting thumb (TT) among medical students and to identify the potential associations between TT and behavioural patterns during digital device use.
This cross-sectional study employed an online, self-developed questionnaire to assess demographic and behavioural patterns associated with smartphone use. Data on thumb pain and its features were evaluated for diagnostic purposes. This study comprised medical students from six medical schools in Jordan. Data were collected from 482 medical students, excluding those who did not meet the inclusion criteria.
The prevalence of TT was 34%, predominantly on the right side (53%) and at the thumb base (69%). The findings suggest that TT was significantly associated with specific behavioural patterns, including supporting the forearm (p=0.026, adjusted OR: 1.611; 95% CI 1.059 to 2.449), number of texting per day (p=0.005, adjusted OR: 1.319; 95% CI 1.086 to 1.603) and studying hours per day using a digital device (p=0.002, adjusted OR: 1.586; 95% CI 1.193 to 2.109). Also, students’ attitudes toward thumb pain were significantly associated with the TT (p=0.005, adjusted OR: 1.351; 95% CI 1.094 to 1.668).
Students’ attention to behavioural patterns is crucial when using digital devices. Supporting the forearm, limiting text message use, avoiding prolonged use of digital devices, never ignoring hand pain and resting the hand significantly reduce the risk of thumb overuse injury.
by Tanaporn Anosri, Soraya Kaewngam, Ram Prajit, Kornrawee Suwannakot, Nataya Sritawan, Anusara Aranarochana, Wanassanan Pannangrong, Jariya Umka Welbat, Peter Wigmore, Apiwat Sirichoat
Methotrexate (MTX) is used in treating several malignancies. However, MTX neurotoxicity remains a significant clinical side effect, leading to cell division malformation, and neurogenesis impairment. Chrysin, a flavonoid compound found in natural products, demonstrates various biological characteristics, including neuroprotective and antioxidant properties. The purpose of this study was to investigate the ameliorative effect of chrysin on oxidative damage and neurogenesis impairment caused by MTX. Male Sprague-Dawley rats were randomly divided into four groups, including the vehicle, MTX (75 mg/kg), chrysin (10 mg/kg), and chrysin+MTX groups. Chrysin was orally administered for 15 days. MTX was administered intravenously on days 8 and 15. The hippocampal neural stem cells were evaluated using sex determining region Y-box 2 (sox2) and nestin immunofluorescence staining. Antioxidant enzyme expression and the levels of oxidative stress marker were assessed. Additionally, the expressions of nuclear factor erythroid 2-related factor 2 (Nrf2), brain-derived neurotrophic factor (BDNF), cAMP-response element binding (CREB), and phosphorylated CREB (pCREB) were evaluated using Western blotting. Results showed that MTX significantly decreased the activity of antioxidant enzymes and produced oxidative stress. MTX also impaired neurogenesis, evidenced by decreased sox2 and nestin-positive cells and decreased expression of Nrf2, BDNF, CREB, and pCREB in the hippocampus and prefrontal cortex. However, chrysin significantly reversed the effects of MTX on these parameters. In conclusion, chrysin exhibits neuroprotective effects against MTX-induced neurogenesis impairment by upregulating antioxidant enzyme activity, reducing oxidative stress, and improving protein expression related to neurogenesis.Labour companionship is a recommendation by WHO that health authorities enable women to choose a companion during labour to ensure a safe and dignified labour experience for the birthing woman. However, most healthcare facilities in low- and middle-income countries do not necessarily consider this maternal need, which hampers a positive maternal experience during labour.
This study aims to examine midwives' perception towards the involvement of male partners in labour companionship.
An exploratory phenomenological approach was chosen and semi-structured interviews were used for this study.
The four main themes identified in this study include ‘Understanding of male partners' involvement in labour companionship’, ‘Involvement of midwives in decision-making’, ‘Barriers to male partners' involvement in labour companionship’ and ‘Facilitators of male partners' involvement in labour companionship’.
This study found a lack of understanding among midwives of the significance of male partners' involvement in labour companionship; and the identification of hierarchical and authoritarian leadership as a barrier to midwives' participation in decision-making highlights the need for transformational leadership styles to empower midwives. Overall, the findings of this study can inform maternity care policy as well as resource development, education and professional training in the field of midwifery.
To elucidate the essential strategies used by home-visit nurses to support the independence of individuals with dementia who live alone.
Qualitative interview study employing the Interpretive Description methodology.
Purposive sampling was conducted across three home-visit nursing offices in Tokyo. Individual semi-structured interviews were conducted with 14 home-visit nurses between June and August 2022. The interviews explored the strategies the participants employed while caring for individuals with dementia living alone. The transcribed data were analysed using reflexive thematic analysis.
Four strategies were identified: Strategy 1. Cultivating a relationship of trust to manage client refusal, Strategy 2. Fostering a balance between client and practical realities, Strategy 3. Optimising limited support resources and Strategy 4. Educating and advocating for a lack of understanding among supporters.
Home-visit nurses incorporate their standard practices into four strategies at both the direct care and support network levels to support independent living of individuals with dementia living alone. These strategies address the challenge of balancing autonomy with safety and health protection, which is a key consideration in supporting this population.
The findings provide guidance for home-visit nursing practice and inform the development of educational programmes to enhance their training.
This study advances understanding of how home-visit nurses navigate the challenges of autonomy, safety and health for people with dementia living alone, offering insights to inform future research and educational initiatives.
This study adhered to the Consolidated Criteria for Reporting Qualitative Research.
This study did not include patient or public involvement in its design, conduct, or reporting.
This study assessed the associations between asthma, gastro-oesophageal reflux disease (GORD) and health-related quality-of-life (HRQoL) among adolescents.
A cross-sectional survey.
Six randomly selected schools across all five educational zones of the Anuradhapura district in Sri Lanka.
A total of 1127 adolescents aged 13–14 years were included from six randomly selected schools representing all five educational zones in the Anuradhapura district, Sri Lanka.
Prevalence of asthma and GORD, the associations between asthma, GORD and HRQoL among adolescents in Sri Lanka.
This study of 1127 adolescents (44.8% male, mean age 13.66±0.56 years) found that 16.1% (n=181) had current asthma and 17.9% (n=202) exhibited symptoms of GORD. A significant association was observed between current asthma and GORD (OR 2.30, 95% CI 1.59 to 3.31, p=0.0005). Comorbidity of asthma and GORD was observed in 4.8% of participants (n=54). The total HRQoL score was not associated with asthma, GORD or those having both asthma and GORD. However, the presence of GORD was associated with poor emotional functioning (unstandardized regression coefficient ± standard error = -4.7±1.7, p=0.008).
Asthma and GORD were significantly associated among early adolescents in Sri Lanka. While overall HRQoL did not differ by disease status, the presence of GORD was associated with poorer emotional functioning.
To examine the relationship between weight loss and problems with oral intake in institutionalised older adults.
A 1-year longitudinal observational study.
Data were obtained from a prospective study conducted in three nursing homes and two long-term care facilities in Japan. Participants' problems with oral intake were assessed using items published in 2021 by the Japanese Ministry of Health, Labour and Welfare. Baseline and follow-up factors were compared between individuals who experienced a weight loss of 5% or more and those who did not. Separate multivariable logistic regression models were constructed for each oral intake assessment item to examine its independent association with weight loss of 5% or more, accounting for transitions in each item between baseline and the 1-year follow-up.
In total, 172 institutionalised older adults were included in the analysis. Among them, 57 (33.1%) participants experienced a weight decrease of 5% or more. The emergence of somnolence or clouding of consciousness during meals at the 1-year follow-up in participants without these signs at baseline was independently associated with a weight loss of 5% or more, after adjustment for baseline characteristics.
Recognising signs of somnolence or clouding of consciousness during meals may be useful for the early detection and prevention of weight loss in institutionalised older adults.
Early detection of individuals at risk is essential to prevent significant weight loss and its associated adverse outcomes. Recognising somnolence or clouding of consciousness during meals may enable earlier detection and intervention to prevent weight loss and improve the quality of care for older adults.
Strengthening the Reporting of Observational Studies in Epidemiology.
No patient or public contribution.
Breast screening uptake remains low in parts of the UK, partly due to barriers including limited transport access. Offering free transport to screening appointments may help address this and improve uptake. This general practitioner (GP) cluster-randomised feasibility trial will assess whether offering free door-to-door transport alongside routine screening invitations increases attendance.
Eight general practices in Yorkshire will be randomised to either the intervention (routine invitation plus information about booking free door-to-door transport) or control (routine invitation only) group. Around 8000 women due for routine breast screening will be included. Primary feasibility outcomes include GP recruitment and randomisation, intervention fidelity, proportion of women from the 10% most deprived areas, acceptability and data transfer processes. Secondary outcomes include understanding travel behaviour, cost-effectiveness and screening uptake. Data will be collected from routine National Health Service (NHS) screening records, data linkage with NHS England, travel surveys and qualitative interviews exploring experiences and acceptability. Patient and public involvement is embedded throughout with members contributing to advisory and oversight roles.
The trial has received ethical approval from the London–Harrow Research Ethics Committee, Section 251 approval from the Confidentiality Advisory Group and other relevant regulatory bodies. The University of Hull is the study sponsor. Results will be disseminated through peer-reviewed journal publications, conference presentations and plain English summaries for participants and the public. Findings will inform the feasibility and design of a potential larger trial to improve breast screening uptake via transport support.
by Masanori Nishi, Yasushi Yoshikawa, Yuki Usui, Hajime Nishida, Shota Nakamura, Koichiro Tashiro, Yoshifumi Kudo
The purpose of this study was to investigate the correlation between femoral morphological indices from anteroposterior hip radiographs and dual-energy X-ray absorptiometry-assessed bone mineral density in postmenopausal female patients undergoing primary total hip arthroplasty for hip osteoarthritis. We also evaluated the impact of hip deformity on these correlations and the diagnostic cut-off values for osteoporosis. This retrospective study, conducted at a single institute (February 2018 to July 2024), reviewed the data of postmenopausal patients (>50 years old) with hip osteoarthritis who underwent total hip arthroplasty. Patients with a history of hip surgical procedures, infection, metabolic bone disease, or inadequate imaging findings were excluded. Dual-energy X-ray absorptiometry was used to assess bone mineral density at the femoral neck, total hip, lumbar spine, and distal radius. Five femoral indices were measured: the canal-to-calcar ratio, canal flare index, cortical thickness index, canal diaphysis ratio, and canal bone area ratio. Analyses included Pearson’s correlation and receiver operating characteristic curve analysis. Moderate correlations were observed between total hip bone mineral density and indices in 95 hip osteoarthritic joints (all Tönnis grade 3) and 86 normal joints. The canal bone area ratio had the strongest correlation (hip osteoarthritis: r = −0.61; normal: r = −0.62; pEl presente estudio fundamenta la construcción de un modelo de cuidado holístico e intercultural de las mujeres indígenas del Pueblo de los Pasto en el ciclo del embarazo, parto y puerperio; consta de cuatro elementos claves, la relación-tensión entre el conocimiento en salud y saber indígena, los actores que diversifican las formas de cuidado institucional y cultural, los escenarios de cuidado más allá de las instituciones de salud con implicación del saber étnico, la reivindicación de las percepciones, vivencias y experiencias de las mujeres y de las parteras reclamando un cuidado integral bajo la sinergia entre el saber científico y el étnico. La fundamentación fue resultado de un proceso hermenéutico en cuádruple vía- encuentro con ideas fuerza resultado de la revisión bibliográfica, priorización de marcos normativos exigentes de una atención humanizada y diferencial, el diálogo con mujeres gestantes y el reconocimiento invaluable de las parteras del pueblo de los Pastos. En ese sentido, la investigación se guio por el análisis e interpretación en doble vía, primero, interpretación bibliográfica de textos científicos, académicos y marcos normativos afines al estudio, y segundo, relatos y argumentos culturales obtenidos a través de entrevista, grupos focales y diálogos de saberes con mujeres y parteras.
Older adults with cancer have ageing-related vulnerabilities that influence their treatment tolerance and decision-making. In our previous randomised controlled trial (MAPLE), integrating geriatric assessment (GA) with communication support using a question prompt list (QPL), delivered by trained intervention providers, facilitated patient–oncologist communication, increased implementation of GA-guided management (GAM) and improved patient outcomes. However, its widespread adoption has been limited by the need for trained personnel and dedicated time. To enhance scalability and sustainability, we developed a mobile application-based intervention to deliver GAM and communication support. This MAPLE2 study aims to evaluate the feasibility of the intervention using this mobile application-based GA and QPL among older adults with cancer.
This multicentre, open-label, pilot randomised controlled trial will be conducted at two academic hospitals in Japan. Patients aged≥70 years with solid cancer or lymphoma initiating or changing systemic therapy will undergo baseline GA. Patients with any GA impairment will be randomised to receive either (1) a mobile application-based intervention providing feedback of GA summary with tailored GAM recommendations and QPL or (2) usual care. The primary endpoint is the proportion of participants who complete all of the following interventions using the mobile application: (1) self-administered GA, (2) receipt of the tailored GAM recommendations and QPL and (3) confirmation that their oncologists review the tailored GAM recommendations and QPL at subsequent visits. Forty participants are planned to be enrolled.
The study has been approved by the Institutional Review Board of the National Cancer Center, Japan (approval number: 2025-089). Written informed consent will be obtained from all participants. Results will be presented at academic conferences and published in peer-reviewed journals.
Recruitment has been initiated from 8 September 2025 and is planned to be completed by 31 August 2026, with a follow-up period by 31 August 2027.
UMIN000058887
To examine the associations between food-related behaviours and nutrient intake on nutritional status among clients undergoing Community-Based Treatment and Rehabilitation (CBTaR) in Kelantan, Malaysia.
Cross-sectional analytical study.
Seven CBTaR centres (n=7) across the state of Kelantan, Malaysia.
A total of 393 adult clients (aged 18 years and above) enrolled in CBTaR programmes between June and December 2022 were selected through stratified random sampling.
The primary outcome was nutritional status, assessed using body mass index. Secondary outcomes included nutrient intake (macronutrients and micronutrients) and food-related behaviours (emotional eating, external eating, restrained eating and food addiction), measured through Bahasa Malaysia validated questionnaires and 24-hour dietary recalls. All variables were introduced into the structural equation modelling to examine the associations among these variables and their association with nutritional status.
The results revealed that food-related behaviour was significantly associated with the nutrient intake (β=–0.524, p≤0.001). Additionally, the drug use profile significantly determined the food-related behaviour (β=–0.129, p=0.006) and nutritional status (β=–0.134, p=0.007). Nutrient intake was found to be a significant predictor of nutritional status (β=–0.213, p≤0.001). Sociodemographic and drug use profiles were significantly correlated with nutritional outcomes through behavioural and dietary associations. Importance-performance map analysis identified nutrient intake as the most impactful variable, highlighting the need for urgent intervention (R2=0.272).
This study highlights that nutrient intake is a significant predictor associated with food-related behaviours on nutritional status among individuals with substance use disorder. Integrating nutrition counselling and behavioural interventions into CBTaR services may improve recovery and long-term health outcomes.
The work of receptionists in general practice is evolving rapidly and becoming more complex due to a number of changes within primary and community care services, such as increased digitalisation. In under-served areas, these changes have been further complicated by under-resourcing and workforce challenges around staff recruitment and retention. The National Health Service (NHS) 10-year health plan is set to accelerate further significant changes. There is limited understanding about how and why these changes and workforce challenges are impacting and will impact the future work of receptionists in general practice in under-served areas.
This realist review will build on an existing programme theory related to general practitioner workforce sustainability. The review will examine what works, for whom, how and under what circumstances for receptionist work in general practice, in under-served areas. For example, how influences such as the expectations of patients (in under-served communities), poor staffing or limited career progression. Key stakeholders, including public contributors and individuals from general practice settings, will inform the realist review.
The review will be conducted using existing secondary and grey literature sources. The search strategy comprises five electronic databases: Medline, Embase, PsycINFO, CINAHL and Web of Science Core Collection (SCIE, SSCI, AHCI) with a date limit of 2015 applied to the search. The review will follow Pawson’s five steps: (1) shaping the scope of the review; (2) searching for evidence; (3) document selection and appraisal; (4) data extraction and (5) data synthesis. The findings will be reported in accordance with the Realist and Meta-narrative Evidence Synthesis Evolving Standards.
Ethical approval is not needed for secondary analysis. The findings of this review will contribute to ongoing work as part of our ‘Workforce Voices’ programme of research. They will be disseminated to policymakers, commissioners, providers of health and social care and primary care and community healthcare teams through peer-reviewed publications, members of the public, conference presentations, social media and recommendations.
This paper discusses data errors and offers guidance on data cleaning techniques, with a particular focus on handling missing values and outliers in quantitative datasets.
Methodological discussion.
This paper provides an overview of various techniques for identifying and addressing data anomalies, which can arise from incomplete, noisy, and inconsistent data. These anomalies can significantly affect data quality, leading to biased model parameter estimates and evidence-based decisions. Data cleaning, particularly the appropriate handling of missing values and outliers, is essential to improving data quality before analysis. Data cleaning includes screening for anomalies, diagnosing errors, and applying appropriate corrective measures.
Proper handling of missing values and the identification and correction of outliers are crucial aspects of data cleaning in ensuring data quality and the reliability of statistical analyses. Effective data cleaning enhances the validity and accuracy of research findings for evidence-based decision making that leads to optimal patient outcomes.
The quality of study results depends on how a dataset and its complexities are processed or handled before the analysis. Nursing researchers must use a framework to identify and address important data anomalies and produce reliable results.
This paper describes data cleaning, often overlooked during the data mining process, as a crucial step before conducting data analysis. By addressing missing values and outliers, identifying and fixing data anomalies, and enhancing data quality prior to analysis, data cleaning techniques can produce precise research findings for evidence-based decision making.
In this methodological paper, no new data were generated.
No patient or public contribution.
This study aims to identify distinct profiles of work engagement among oncology nurses through Latent Profile Analysis and explore how these profiles influence nurse safety behaviour.
A cross-sectional design with latent profile analysis.
A total of 957 oncology nurses from tertiary hospitals across five provinces and municipalities in China participated in this questionnaire-based study. Data were collected on demographic information, the Work Engagement Scale, the General Self-Efficacy Scale and the Nurse Safety Behaviour Scale. The analysis was conducted using SPSS 24.0 and Mplus 8.3, with Latent Profile Analysis, R3STEP and BCH methods employed to uncover underlying patterns and relationships.
The results revealed three distinct profiles of work engagement: ‘Highly Efficient and Focused Type’ (43.7%), ‘Moderately Balanced Type’ (37.4%) and ‘Low Effort and Coping Type’ (18.9%). The distribution of these profiles was closely related to factors such as weekly working hours, adverse event experiences, safety training experiences and self-efficacy. Moreover, these work engagement profiles positively impacted nurse safety behaviour.
The study demonstrates that different work engagement profiles significantly influence the safety behaviour of oncology nurses. Key factors such as weekly working hours, adverse event experiences, safety training experiences and self-efficacy play a crucial role in shaping these work engagement profiles.
The findings provide a new perspective and intervention approach for enhancing work engagement and nurse safety behaviour. It is recommended that hospital management develop personalised training and incentive measures tailored to nurses with different characteristics to improve overall nursing quality and patient safety.
No patient or public involvement.
Osteogenesis imperfecta (OI) is the most common inherited cause of bone fragility (approximately 1 in 16 000). People with OI suffer bone fragility causing fractures, pain and deformity; sarcopenia causing fatigue and poor endurance; aortic root dilatation and hearing loss. No drug currently has market authorisation to treat OI in Europe. Current standard-of-care is multidisciplinary, with pharmacological interventions—primarily bisphosphonates—directed at increasing bone mass; however, such interventions are of equivocal efficacy. The structural damage that can accumulate as a result of repeated fractures over time may not be reversible. The lack of a treatment with clearly defined efficacy in terms of reducing fracture frequency or the sarcopenia, that is increasingly recognised in this condition, leads to the consideration of alternatives based on what is known about the molecular pathophysiology of the condition. For reasons that are currently unclear, transforming growth factor beta (TGFβ) pathway signalling is increased in OI, and both studies in mouse models and more recently also in humans suggest that reducing TGFβ pathway signalling could be of benefit in OI. This demonstrator project tests the hypothesis that losartan, an antihypertensive agent known to reduce circulating TGFβ, will reduce bone turnover and bone loss and have a positive effect on muscle function and quality of life in adults and older adolescents with OI.
This is a phase 2/pilot, open-label, dose-escalating study. This study aims to identify the effective dose for losartan in this population to inform the design of a pivotal phase III study. The study aims to recruit 30 adolescents and adults aged 16 years and above with OI across secondary care study sites in the UK and Italy. Participants will be recruited from the patient populations attending for treatment of OI at the participating hospital sites or referred by clinicians at the Participant Identification Centres (PIC sites). Participants will be randomised to one of three ‘final doses’—25, 50 or 75 mg losartan once daily. All participants will start on 25 mg once daily. Those assigned to higher ‘final doses’ will increase in 25 mg once daily increments on day 8 and day 15 following safety assessments. The primary outcome measures are to establish the effective dose of losartan in OI patients, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX) over the 24-week period of the study.
Secondary outcome measures are to determine the changes in proxy efficacy outcomes for bone (turnover, mass, architecture and strength) using blood tests, high-resolution peripheral quantitative CT (HRpQCT), dual-energy X-ray absorptiometry (DXA) and muscle (strength) using the ‘Timed Up and Go’ test. In addition, the changes in quality of life, including pain and fatigue, will be evaluated by using a disease-specific tool (OI-QOL) and a validated generic tool (EQ-5D-5L-VAS).
In the UK, the study protocol and amendments have been approved by the London Bridge Research Ethics Committee (REC reference: 23/LO/015) and by the Medicines and Healthcare products Regulatory Agency (MHRA). In Italy, the study protocol and amendments have been approved by the Italian and European ethics and regulatory authorities (Clinical Trials Information System European Union (CTIS EU) portal according to EU Regulation 536/2014). Final version of study protocol: Version 3.2, 05.03.2025. Final results will be disseminated in peer-reviewed journals through local OI, orthopaedic and other relevant clinical networks and at national and international meetings. Sheffield Children’s National Health Service Foundation Trust (UK) and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli (Italy) are the joint study sponsors.
ISRCTN (ISRCTN13317811).
FreshRSS 