bluuebunny/crossref_metadata_2025_split huggingface dataset:
Breaking strength and bone microarchitecture in osteoporosis: a biomechanical approximation based on load tests in 104 human vertebrae from the cervical, thoracic, and lumbar spines of 13 body donors
Authors: Schröder Guido , Reichel Martin , Spiegel Sven , Schulze Marko , Götz Andreas , Bugaichuk Semjon , Andresen Julian Ramin , Kullen Claus Maximilian , Andresen Reimer , Schober Hans-Christof 
Published: April 2022

Abstract
Background
The purpose of the study was to investigate associations between biomechanical resilience (failure load, failure strength) and the microarchitecture of cancellous bone in the vertebrae of human cadavers with low bone density with or without vertebral fractures (VFx).

Methods
Spines were removed from 13 body donors (approval no. A 2017-0072) and analyzed in regard to bone mineral density (BMD), Hounsfield units (HU), and fracture count (Fx) with the aid of high-resolution CT images. This was followed by the puncture of cancellous bone in the vertebral bodies of C2 to L5 using a Jamshidi™ needle. The following parameters were determined on the micro-CT images: bone volume fraction (BVF), trabecular thickness (Tb.Th), trabecular separation (Tb.Sp), degree of anisotropy (DA), trabecular number (Tb.N), trabecular pattern factor (Tb.Pf), and connectivity density (Conn.D). The axial load behavior of 104 vertebral specimens (C5, C6, T7, T8, T9, T12, L1, L3) was investigated with a servohydraulic testing machine.

Results
Individuals with more than 2 fractures had a significantly lower trabecular pattern factor (Tb.Pf), which also proved to be an important factor for a reduced failure load in the regression analysis with differences between the parts of the spine. The failure load (FL) and endplate sizes of normal vertebrae increased with progression in the craniocaudal direction, while the HU was reduced. Failure strength (FS) was significantly greater in the cervical spine than in the thoracic or lumbar spine (p < 0.001), independent of sex. BVF, Tb.Th, Tb.N, and Conn.D were significantly higher in the cervical spine than in the other spinal segments. In contrast, Tb.Sp and Tb.Pf were lowest in the cervical spine. BVF was correlated with FL (r = 0.600, p = 0.030) and FS (r = 0.763, p = 0.002). Microarchitectural changes were also detectable in the cervical spine at lower densities.

Conclusions
Due to the unique microarchitecture of the cervical vertebrae, fractures occur much later in this region than they do in the thoracic or lumbar spine.
Trial registration
Approval no. A 2017-0072.
Designing rare disease care pathways in the Republic of Ireland: a co-operative model
Authors: Ward A. J. , Murphy D. , Marron R. , McGrath V. , Bolz-Johnson M. , Cullen W. , Daly A. , Hardiman O. , Lawlor A. , Lynch S. A. , MacLachlan M. , McBrien J. , Ni Bhriain S. , O’Byrne J. J. , O’Connell S. M. , Turner J. , Treacy E. P. 
Published: April 2022

Abstract
Background
Rare diseases (RDs) are often complex, serious, chronic and multi-systemic conditions, associated with physical, sensory and intellectual disability. Patients require follow-up management from multiple medical specialists and health and social care professionals involving a high level of integrated care, service coordination and specified care pathways.

Methods and objectives
This pilot study aimed to explore the best approach for developing national RD care pathways in the Irish healthcare system in the context of a lack of agreed methodology. Irish clinical specialists and patient/lived experience experts were asked to map existing practice against evidence-based clinical practice guidelines (CPGs) and best practice recommendations from the European Reference Networks (ERNs) to develop optimal care pathways. The study focused on the more prevalent, multisystemic rare conditions that require multidisciplinary care, services, supports and therapeutic interventions.

Results
29 rare conditions were selected across 18 ERNs, for care pathway development. Multidisciplinary input from multiple specialisms was relevant for all pathways. A high level of engagement was experienced from clinical leads and patient organisations. CPGs were identified for 26 of the conditions. Nurse specialist, Psychology, Medical Social Work and Database Manager roles were deemed essential for all care pathways. Access to the therapeutic Health Service Professionals: Physiotherapy, Occupational Therapy, and Speech and Language Therapy were seen as key requirements for holistic care. Genetic counselling was highlighted as a core discipline in 27 pathways demonstrating the importance of access to Clinical Genetics services for many people with RDs.

Conclusions
This study proposes a methodology for Irish RD care pathway development, in collaboration with patient/service user advocates. Common RD patient needs and health care professional interventions across all pathways were identified. Key RD stakeholders have endorsed this national care pathway initiative. Future research focused on the implementation of such care pathways is a priority.
Characteristics of patients who received helicopter emergency medical services in Japan from 2012 to 2019: a retrospective analysis of data from Tochigi Prefecture
Authors: Wake Koji , Noguchi Takafumi , Hishinuma Hidekazu , Zaitsu Masayoshi , Kikuchi Jin , Uchida Masatoshi , Hayashi Kentaro , Machida Masanari , Houzumi Hajime , Hoshiyama Eisei , Takahashi Kyo , Kobashi Gen , Ono Kazuyuki 
Published: April 2022

Abstract
Background
Helicopter Emergency Medical Services (HEMS) has been in operation in Japan since 2001, allowing patients almost anywhere in the nation to receive on-scene emergency treatment from physicians. However, there is insufficient literature on the characteristics of the patients who use Japanese HEMS. Thus, this study aimed to investigate the overall characteristics of patients receiving HEMS care within a single prefecture in Japan.

Methods
We retrospectively analyzed the data of 5163 patients—in Tochigi Prefecture—who received HEMS care from 2012 to 2019. Descriptive statistics were used to analyze the following aspects of care: diagnosis, severity, background characteristics, geographical and environmental variables, immediate pre-hospital intervention, transportation type, and short-term clinical outcomes.

Results
Among 7370 HEMS requests received during the study period, treatment was provided to 5163 patients (1.8 cases per day; 3489 men [67.6%]). Nearly 55% (n = 2856) of patients were aged above 60 years. Age peaks were observed at 0–9 years and 60–69 years. The median distance from the base hospital to the site was 26.7 km. The age-standardized rate of HEMS treatment was 30.3 patients per 100,000 people. Cases of trauma and cardiovascular diseases were the most common (65.3%). Most individuals aged 0–9 years and 60–69 years had neurological disease (seizures accounted for 80.5% of this group) and cardiovascular disease, respectively. The number of patients was similar across all four seasons. After immediate pre-hospital intervention, 81.6% of patients receiving HEMS care were transferred by the helicopter ambulance (53.4% and 28.2% to the base hospital and to other hospitals, respectively). Overall, 56.6% of patients receiving HEMS care were transferred to the base hospital, and the short-term recovery rate was above 75%. Intravenous drip and oxygen administration were the most common pre-hospital interventions (93.1% and 72.7%, respectively).

Conclusions
This study is the first to describe the overall characteristics of HEMS patients using comprehensive data of all HEMS patients in one prefecture in Japan. Further research using both local- and national-level data is needed to accelerate the understanding of the benefits of HEMS.
Collaborative community mental health and aged care services with peer support to prevent late-life depression: study protocol for a non-randomised controlled trial
Authors: Liu Tianyin , Leung Dara Kiu Yi , Lu Shiyu , Kwok Wai-Wai , Sze Lesley Cai Yin , Tse Samson Shu Ki , Ng Siu Man , Wong Paul Wai Ching , Lou Vivian Wei Qun , Tang Jennifer Yee Man , Wong Daniel Fu Keung , Chan Wai Chi , Kwok Ricky Yu Kwong , Lum Terry Yat Sang , Wong Gloria Hoi Yan 
Published: April 2022

Abstract
Background
Late-life depression is common, modifiable, yet under-treated. Service silos and human resources shortage contribute to insufficient prevention and intervention. We describe an implementation research protocol of collaborative stepped care and peer support model that integrates community mental health and aged care services to address service fragmentation, using productive ageing and recovery principles to involve older people as peer supporters to address human resource issue.

Methods/design
This is a non-randomised controlled trial examining the effectiveness and cost-effectiveness of the “Jockey Club Holistic Support Project for Elderly Mental Wellness” (JC JoyAge) model versus care as usual (CAU) in community aged care and community mental health service units in 12 months. Older people aged 60 years and over with mild to moderate depressive symptoms or risk factors for developing depression will be included. JoyAge service users will receive group-based activities and psychoeducation, low-intensity psychotherapy, or high-intensity psychotherapy according to the stepped care protocol in addition to usual community mental health or aged care, with support from an older peer supporter. The primary clinical outcome, depressive symptoms, and secondary outcomes, self-harm risk, anxiety symptoms, and loneliness, will be measured with the Patient Health Questionnaire-9 (PHQ-9), Self-Harm Inventory, Generalized Anxiety Disorder 7-item scale (GAD-7), and UCLA Loneliness 3-item scale (UCLA-3) respectively. Cost-effectiveness analysis will assess health-related quality of life using the EQ-5D-5L and service utilisation using the Client Service Receipt Inventory (CSRI). We use multilevel linear mixed models to compare outcomes change between groups and calculate the incremental cost-effectiveness ratio in terms of quality-adjusted life years.

Discussion
This study will provide evidence about outcomes for older persons with mental health needs receiving collaborative stepped care service without silos and with trained young-old volunteers to support engagement, treatment, and transitions. Cost-effectiveness findings from this study will inform resource allocation in this under-treated population.

Trial registration
ClinicalTrials.gov NCT03593889. Registered on 20 July 2018.
The effectiveness of a media-based intervention promoting help-seeking for mental health difficulties by Australian men: study protocol for a randomised controlled trial
Authors: Nicholas Angela , Requena Simone Scotti , Ftanou Maria , Rice Simon , Fletcher Justine , Mackinnon Andrew , Seidler Zac , Le Long Khanh-Dao , Mihalopoulos Cathrine , Pirkis Jane 
Published: April 2022

Abstract
Background
Approximately one fifth of Australian males aged 16+ experience mood, anxiety or substance use disorders in a given year, and suicide by males accounts for three quarters of all suicides annually. However, males with mental health problems are less likely to seek and receive help than their female counterparts. Media campaigns with videos at their core are gaining popularity as a means of promoting help-seeking for mental health difficulties, but few studies have rigorously tested the impact of such videos. This randomised controlled trial tests the effectiveness of a short video promoting help-seeking by Australian men.

Methods
This study is an online randomised controlled trial (RCT). Participants will attend an online group orientation session, where they will provide consent to participate and complete a baseline questionnaire (T1). After completion of the T1 questionnaire, participants will be randomised to watch either the intervention or control video on a 1:1 basis. After randomisation, participants will be able to access their allocated video for 1 week. Seven days after T1, participants will again be sent links to the video and to the post-exposure questionnaire (T2). One month after T2, participants will be emailed the follow-up questionnaire (T3). The primary outcome will be change in help-seeking intentions from T1 to T2. Secondary outcomes will be changes in help-seeking intentions from T1 to T3, changes in intentions to encourage other males to seek help, self-reliance, and male depression symptoms from T1 to T2 and from T1 to T3. The cost-effectiveness of the intervention will be evaluated. Participants will also complete questions about their opinions of the video and its effects at T2 and T3.

Discussion
Our video-based intervention is designed to promote help-seeking for mental health difficulties among Australian men. If a lack of net harm is shown to be associated with viewing the intervention video, the video will be publicly released and could have broad impacts on individual and community attitudes towards help-seeking for mental health difficulties, and ultimately enhance men’s mental health and wellbeing. An evaluation of the effectiveness of the intervention is essential to ensure the intervention is achieving its objectives.

Trial registration
anzctr.org.au 12621001008819
PRObiotics and SYNbiotics to improve gut health and growth in infants in western Kenya (PROSYNK Trial): study protocol for a 4-arm, open-label, randomised, controlled trial
Authors: Otiti Mary Iwaret , Kariuki Simon , Wang Duolao , Hall Lindsay J. , Ter Kuile Feiko O. , Allen Stephen 
Published: April 2022

AbstractBackgroundMalnutrition amongst under-fives remains common in resource-poor countries and is resistant to current interventions. New opportunities have emerged to target “environmental enteric dysfunction” (EED) that refers to the abnormal gut structure and function that results from colonisation of the gut with pathogenic microbes and compromises nutrition and growth in early life. Although the gut microbiome may provide a defence against ingested gut pathogens through colonisation resistance, its development is adversely affected by multiple environmental factors. Dietary supplements of pro- or synbiotics may build the resilience of the gut microbiome against these environmental factors and boost colonisation resistance. We aim to assess whether dietary supplementation of newborns in rural Kenya with pro/synbiotics prevents or ameliorates EED and improves growth.MethodsSix hundred newborns less than 4 days old will be recruited from Homa Bay County Teaching and Referral Hospital, western Kenya. Newborns will be randomly allocated, stratified by HIV exposure, in a 1:1:1:1 ratio to one of 4 study arms to receive either of two synbiotics, a probiotic or no supplement. Supplements will be given daily for 10 days and then weekly until 6 months of age. Participants will be followed until the age of 2 years. The primary outcome is systemic inflammation at 6 months assessed by plasma alpha-1-acid glycoprotein. Secondary outcomes include biomarkers of gut health and growth, anthropometric indices, morbidity and mortality.DiscussionAs dietary supplements with pro- or synbiotics may improve gut health and can be administered in early life, our findings may inform the package of interventions to prevent malnutrition and improve growth in Africa and similar low-resource settings.Trial registrationPan African Clinical Trials Registry, Trial number: PACTR202003893276712. Date: 02/03/2020https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9798
The impact of session-introducing mindfulness and relaxation interventions in individual psychotherapy for children and adolescents: a randomized controlled trial (MARS-CA)
Authors: Kalmar Julia , Baumann Ines , Gruber Elena , Vonderlin Eva , Bents Hinrich , Neubauer Andreas B. , Heidenreich Thomas , Mander Johannes 
Published: April 2022

AbstractBackgroundThe investigation of mindfulness-based interventions (MBIs) in cognitive-behavioral therapy has greatly increased over the past years. However, most MBI research with youth focuses on structured, manualized group programs, conducted in school settings. Knowledge about the implementation and effects of MBIs in individual psychotherapy with children and adolescents is scarce. To fill this research gap, the “Mindfulness and Relaxation Study – Children and Adolescents” (MARS-CA) is designed. It aims to assess the effects of short session-introducing interventions with mindfulness elements on juvenile patients’ symptomatic outcome and therapeutic alliance in individual child and adolescent psychotherapy.MethodsMARS-CA is conducted at a university outpatient training center for cognitive-behavior therapy. Short session-introducing interventions with mindfulness elements will be compared to short session-introducing relaxation interventions and no session-introducing intervention to explore their effects on symptomatic outcome and therapeutic alliance. The session-introducing interventions will take place at the beginning of 24 subsequent therapy sessions. We hypothesize that patients’ symptomatic outcome and therapeutic alliance improve more strongly in the mindfulness condition than in the other two conditions and that the mindfulness condition moderates the relationship between therapeutic alliance and symptomatic outcome. Patients and their trainee therapists will be randomized to one of the three treatment arms. Participants aged between 11 and 19 years and having a primary diagnosis of either a depressive disorder, an anxiety disorder, or a hyperkinetic disorder will be included. Therapeutic alliance will be assessed after every therapy session (therapy session 1 to therapy session 24), symptomatic outcome will be assessed before the start of treatment (pre), after the 3rd, the 10th, and the 17th therapy sessions, at the end of treatment (24th therapy session, post), and at a 6-month follow-up. Additionally, mindfulness and mindfulness-related measures as well as demographic data, adherence, allegiance, and therapeutic techniques will be assessed. It is our aim to assess a sample of 135 patients. We will conduct multilevel modeling to address the nested data structure.DiscussionThe study can provide information about how add-on MBIs, conducted by trainee therapists, influence therapeutic alliance and symptomatic outcome in individual psychotherapy in children and adolescents.Trial registrationClinicalTrials.govNCT04034576. Registered on July 17, 2019
Effect of listening to music on anxiety, pain, and cardiorespiratory parameters in cardiac surgery: study protocol for a randomized clinical trial
Authors: de Andrade Érica Vieira , Haas Vanderlei José , de Faria Maíla Fidalgo , dos Santos Felix Márcia Marques , Ferreira Maria Beatriz Guimarães , Barichello Elizabeth , da Silva Pires Patricia , Barbosa Maria Helena 
Published: April 2022

Abstract
Background
Preoperative anxiety and postoperative pain are frequent in cardiac surgeries and constitute important stressors for patients, which can cause several complications. One strategy that aims to alleviate these phenomena is listening to music as a non-pharmacological intervention. The aim of this study is to evaluate the effect of listening to music on preoperative state-anxiety, postoperative pain, at rest and when instructed to cough, and cardiorespiratory parameters in patients undergoing cardiac surgery.

Methods
A randomized, parallel, simple masking clinical trial will be conducted with patients 18 years of age or older who have undergone elective cardiac surgery by sternotomy, who agree to participate in the research and sign a free and informed consent form. Study participants will be randomly divided, in a 1:1 ratio, to one of the two groups: experimental (subjected to listening to music for 20 min in the pre- and postoperative period) or control (standard care in the pre- and postoperative period), using a randomization scheme generated by the Randomization.com website. The sample size calculation was obtained after conducting a pilot study.

Discussion
The results of the study may contribute to the implementation of non-pharmacological interventions in health services, highlighting the protocols for listening to music, to minimize anxiety and pain in cardiac surgery.

Trial registration
ReBEC RBR-8mdyhd. Posted on December 10, 2019
Remote, real-time expert elicitation to determine the prior probability distribution for Bayesian sample size determination in international randomised controlled trials: Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone (BIPED) study
Authors: Lan Jingxian , Plint Amy C. , Dalziel Stuart R. , Klassen Terry P. , Offringa Martin , Heath Anna ,   on behalf of the Pediatric Emergency Research Canada (PERC) KIDSCAN/PREDICT BIPED Study Group
Published: April 2022

AbstractBackgroundBayesian methods are increasing in popularity in clinical research. The design of Bayesian clinical trials requires a prior distribution, which can be elicited from experts. In diseases with international differences in management, the elicitation exercise should recruit internationally, making a face-to-face elicitation session expensive and more logistically challenging. Thus, we used a remote, real-time elicitation exercise to construct prior distributions. These elicited distributions were then used to determine the sample size of the Bronchiolitis in Infants with Placebo Versus Epinephrine and Dexamethasone (BIPED) study, an international randomised controlled trial in the Pediatric Emergency Research Network (PERN). The BIPED study aims to determine whether the combination of epinephrine and dexamethasone, compared to placebo, is effective in reducing hospital admission for infants presenting with bronchiolitis to the emergency department.MethodsWe developed a Web-based tool to support the elicitation of the probability of hospitalisation for infants with bronchiolitis. Experts participated in online workshops to specify their individual prior distributions, which were aggregated using the equal-weighted linear pooling method. Experts were then invited to provide their comments on the aggregated distribution. The average length criterion determined the BIPED sample size.ResultsFifteen paediatric emergency medicine clinicians from Canada, the USA, Australia and New Zealand participated in three workshops to provide their elicited prior distributions. The mean elicited probability of admission for infants with bronchiolitis was slightly lower for those receiving epinephrine and dexamethasone compared to supportive care in the aggregate distribution. There were substantial differences in the individual beliefs but limited differences between North America and Australasia. From this aggregate distribution, a sample size of 410 patients per arm results in an average 95% credible interval length of less than 9% and a relative predictive power of 90%.ConclusionRemote, real-time expert elicitation is a feasible, useful and practical tool to determine a prior distribution for international randomised controlled trials. Bayesian methods can then determine the trial sample size using these elicited prior distributions. The ease and low cost of remote expert elicitation mean that this approach is suitable for future international randomised controlled trials.Trial registrationClinicalTrials.govNCT03567473