Universal Trial Number Research Articles

Cosmetic camouflage improves health-related quality of life in women with systemic lupus erythematosus and permanent skin damage: A controlled intervention study.

To investigate the effect of cosmetic camouflage in health-related quality of life (HRQoL) in women with systemic lupus erythematosus (SLE) and permanent facial skin damage. This is a randomized controlled clinical trial (Universal Trial Number: U1111-1210-2554e) with SLE women from outpatients using ACR/1997 and/or SLICC/2012 criteria, aged over 18 years old, with modified SLEDAI 2k < 4 and permanent facial skin damage, recruited in two tertiary centers to use cosmetic camouflage (n = 36) or no intervention (n = 20). Endpoints were score variations in SLE Quality of Life (SLEQoL) (total and each domain), Dermatology Life Quality Index (DLQI), Rosenberg self-esteem scale and Hospital Anxiety and Depression Scale (HADS), after daily use of cosmetic camouflage for 12 +/-2 weeks (Phase I), "as needed" use of cosmetic camouflage for another 12 +/-2 weeks (Phase II), and during total follow up (24 +/-2 weeks). Univariate and multivariate linear regressions were conducted by protocol analysis. Both groups were similar at baseline regarding age, disease duration, socio-demographic, clinical, laboratory and treatment characteristics. The comparison of score variations between intervention and control groups showed an independent HRQoL improvement in total SLEQoL score after using cosmetic camouflage in Phase I [β -27.56 (CI 95% -47.86 to -7.27) p = 0.009] and total follow up [β -28.04 (CI 95% -48.65 to -7.44) p = 0.09], specifically in mood, self-image and physical functioning domains. Also, there was an improvement in DLQI scores during Phase I [β -7.65 (CI 95% -12.31 to -3.00) p = 0.002] and total follow up [β -8.97(CI95% -12.99 to -4.94) p < 0.001). Scores for depression [β -1.92 (CI 95% -3.67 to -0.16) p = 0.033], anxiety [β -2.87 (CI 95% -5.67 to -0.07] p = 0.045] and self-esteem [β 2.79 (CI 95% 0.13 to 5.46) p = 0.041] improved considering the total follow up. No significant changes occurred in the control group scores. The use of cosmetic camouflage improved the HRQoL in female SLE patients with permanent facial skin damage.

Study protocol: older people in retirement villages. A survey and randomised trial of a multi-disciplinary invention designed to avoid adverse outcomes

BackgroundThere is increasing interest among older people in moving into retirement villages (RVs), an attractive option for those seeking a supportive community as they age, while still maintaining independence. Currently in New Zealand there is limited knowledge of the medical, service supports, social status and needs of RV residents. The objective of this study is to explore RV facilities and services, the health and functional status of RV residents, prospectively study their healthcare trajectories and to implement a multidisciplinary team intervention to potentially decrease dependency and impact healthcare utilization.MethodsAll RVs located in two large district health boards in Auckland, New Zealand were eligible to participate. This three-year project comprised three phases: The survey phase provided a description of RVs, residents’ characteristics and health and functional status. RV managers completed a survey of size, facilities and recreational and healthcare services provided in the village. Residents were surveyed to establish reasons for entry to the village and underwent a Gerontology Nurse Specialist (GNS) assessment providing details of demographics, social engagement, health and functional status. The cohort study phase examines residents’ healthcare trajectories and adverse outcomes, over three years. The final phase is a randomised controlled trial of a multidisciplinary team intervention aimed to improve health outcomes for more vulnerable residents.Residents who triggered potential unmet health needs during the assessment in the survey phase were randomised to intervention or usual care groups. Multidisciplinary team meetings included the resident and support person, a geriatrician or gerontology nurse practitioner, GNS, pharmacist and General Practitioner. The primary outcome of the randomised controlled trial will be first acute hospitalization. Secondary outcomes include all acute hospitalizations, long-term care admissions, and all-cause mortality.DiscussionThis paper describes the study protocol of this complex study. The study aims to inform policies and practices around health care services for residents in retirement villages. The results of this trial are expected early 2020 with publication subsequently.Trial registrationAustralia and New Zealand Clinical Trials Registry: ACTRN12616000685415. Registered 25.5.2016.Universal Trial Number (UTN): U111–1173-6083.

Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (the SEcReT study): protocol for a randomised controlled pilot study

IntroductionMild cognitive impairment is considered a precursor to dementia and significantly impacts upon quality of life. The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than in the general population, with older age and comorbidities further increasing the risk of cognitive decline. Exercise improves neurogenesis, synaptic plasticity and inflammatory and neurotrophic factor pathways, which may help to augment the effects of cognitive decline. However, the effects of resistance training on cognitive, functional and overall patient-reported recovery have not been investigated in the surgical cardiac population. This study aims to determine the effect of early moderate-intensity resistance training, compared to standard care, on cognitive recovery following cardiac surgery via a median sternotomy. The safety, feasibility and effect on functional recovery will also be examined.MethodsThis study will be a prospective, pragmatic, pilot randomised controlled trial comparing a standard care group (low-intensity aerobic exercise) and a moderate-intensity resistance training group. Participants aged 18 years and older with coronary artery and/or valve disease requiring surgical intervention will be recruited pre-operatively and randomised 1:1 to either the resistance training or standard care group post-operatively. The primary outcome, cognitive function, will be assessed using the Alzheimer’s Disease Assessment Scale and cognitive subscale. Secondary measures include safety, feasibility, muscular strength, physical function, multiple-domain quality of recovery, dynamic balance and patient satisfaction. Assessments will be conducted at baseline (pre-operatively) and post-operatively at 2 weeks, 8 weeks, 14 weeks and 6 months.DiscussionThe results of this pilot study will be used to determine the feasibility of a future large-scale randomised controlled trial that promotes the integration of early resistance training into existing aerobic-based cardiac rehabilitation programs in Australia.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001430325p. Registered on 9 October 2017. Universal Trial Number (UTN): U1111-1203-2131.

Where is an emotion? Using targeted visceroception as a method of improving emotion regulation in healthy participants to inform suicide prevention initiatives: a randomised controlled trial

BackgroundWilliam James’ 1884 paper “What is an emotion?” has generated much recent interest in affective science regarding somatic contributions to emotion. Studies of interoception (“sensing the physiological condition of the body”) suggest that sensing specific parts of the body contributes to the production of emotion, namely when sensing the viscera (i.e. “visceroception” of the heart, gut or lungs). Improved visceroception has, for instance, been linked to increased emotional intensity, suggesting a role for interoception in emotion regulation that may pertain specifically to visceral bodily locations. Thus, in addition to asking James’ question, “What is an emotion?”, we ask, “Where is an emotion?”. Further, there is an evidence base pointing to the connections between emotion regulation and suicide, and between interoception and suicide. This is a preliminary trial investigating whether targeted interoception/visceroception improves emotion regulation. Ultimately, the overall project aims to inform suicide prevention efforts.MethodsThe trial utilises a pre-test/post-test control group design, with two experimental groups undergoing visceroceptive interventions (focussing on areas pertaining to the gut or heart) and a control group. The interventions will run for 8 weeks. A spatial cueing task will measure reaction times to bodily changes relating to lower abdomen or chest focus. A stop/signal task will measure emotional inhibition, which is hypothesised to obscure awareness of active bodily locations. Visceroceptive ability will be tracked using a heartbeat estimation task, a water load test, and by self-report questionnaire. The sample will consist of healthcare professionals and healthcare students. Despite these being groups that represent a relatively high suicide risk among professional and student groups, all participants will be healthy, given the preliminary nature of this trial.DiscussionTo our knowledge, this will be the first project to address whether emotional feeling presents as a localised bodily phenomenon and whether trained awareness of emotional localisation can improve emotion regulation. It will also be the first to investigate relationships between interoception and emotional inhibition (i.e. whether a sustained interoceptive practice leads to the disinhibition of bodily emotional sensations, which can positively contribute to emotion regulation). These empirical findings on emotion regulation from a healthy sample will be used to inform a desk-based enquiry into the role of embodied emotion in suicide prevention, which may make a significant contribution to a growing evidence base on interoception and suicide.Trial registrationACTRN12619000324112. Registered on 4 March 2019. Universal Trial Number (UTN): U1111-1221-0201.

Brazilian translation, cross-cultural adaptation and validation of the MG Composite scale and Quantitative Myasthenia gravis testing form: a multicentric study protocol.

Introduction: Myasthenia gravis (MG) is a chronic and inflammatory disease characterized by progressive weakness of the skeletal muscles due to changes in the synaptic junctions between nerves and muscle fibres. Typically, patients have a history of progressive weakness and fatigue in skeletal muscles, which occurs during sustained or repeated activities and improves after rest. Scoring systems to assess the degree of disease severity are commonly used in clinical drug trials. Further, specific instruments to assess health-related quality of life (HRQOL) have been designed to measure self-perception of symptoms and wellness during the disease or after disease treatment. HRQOL is an important component of patient evaluation, as some individuals can tolerate severe impairment and disability, while others may be very unhappy even with less severe symptom profiles. The objective of the proposed study is to translate and perform a cultural adaptation and validation of two specific instruments for assessing the clinical course of patients with MG. These instruments include the Quantitative Test for Myasthenia gravis (QMG) and Myasthenia gravis Composite Scale (MGC). Methods and analyses: The study design will follow a multi-method approach, and will be conducted in three stages consisting of translation, cultural adaptation, and validation of the QMG and MGC for Brazilian Portuguese patients. This multi-step process will consider aspects of construct and predictive validity as well as reliability and structure of the instrument. The entire process will follow the procedures proposed and developed in other linguistic and social-cultural contexts based on previous studies. Ethics: This study has received approval from the Human Research Ethics Committee of Nove de Julho University (Brazil) under process no. 360.488 based on the Helsinki declaration and is registered with the World Health Organization (WHO) under Universal Trial Number (UTN) U1111-1147-7853 and the Brazilian Registry of Clinical Trials (REBEC) RBR -7ckpdd.

Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose\u2014the randomized controlled HOMe aFers study

BackgroundIn patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively.MethodsIn the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias.ResultsHypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants.ConclusionsWhile both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI.Trial registrationClinical Trials.gov NCT02905539. Registered on 8 September 2016.2015-004808-36 (EudraCT Number)U1111-1176-4563 (WHO Universal Trial Number)DRKS00010766 (Deutsches Register Klinischer Studien)

Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial

IntroductionSepsis is defined as detrimental immune response to an infection. This overwhelming reaction often abolishes a normal reconstitution of the immune cell homeostasis that in turn increases the risk for...

Using mind control to modify cue-reactivity in AUD: the impact of mindfulness-based relapse prevention on real-time fMRI neurofeedback to modify cue-reactivity in alcohol use disorder: a randomized controlled trial

BackgroundAlcohol Use Disorder is a severe mental disorder affecting the individuals concerned, their family and friends and society as a whole. Despite its high prevalence, novel treatment options remain rather limited. Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments. In the context of the TRR SFB 265 C04 “Mindfulness-based relapse prevention as an addition to rtfMRI NFB intervention for patients with Alcohol Use Disorder (MiND)” study, both interventions will be combined to a state-of-the art intervention that will use mindfulness-based relapse prevention to improve the efficacy of a real-time neurofeedback intervention targeting the ventral striatum, which is a brain region centrally involved in cue-reactivity to alcohol-related stimuli.Methods/designAfter inclusion, N = 88 patients will be randomly assigned to one of four groups. Two of those groups will receive mindfulness-based relapse prevention. All groups will receive two fMRI sessions and three real-time neurofeedback sessions in a double-blind manner and will regulate either the ventral striatum or the auditory cortex as a control region. Two groups will additionally receive five sessions of mindfulness-based relapse prevention prior to the neurofeedback intervention. After the last fMRI session, the participants will be followed-up monthly for a period of 3 months for an assessment of the relapse rate and clinical effects of the intervention.DiscussionThe results of this study will give further insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback interventions for the treatment of Alcohol Use Disorder. Additionally, the study will provide further insight on neurobiological changes in the brain caused by the neurofeedback intervention as well as by the mindfulness-based relapse prevention. The outcome might be useful to develop new treatment approaches targeting mechanisms of Alcohol Use Disorder with the goal to reduce relapse rates after discharge from the hospital.Trial registrationThis trial is pre-registered at clinicaltrials.gov (trial identifier: NCT04366505; WHO Universal Trial Number (UTN): U1111–1250-2964). Registered 30 March 2020, published 29 April 2020.

The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan.

Background: The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3 months on child development, growth, morbidity, laboratory indices of anaemia, iron deficiency, and inflammation at end of intervention and after a further 9 months post intervention in children aged 8 months living in rural Bangladesh. This paper describes the statistical analysis plan. Methods: BRISC is a multi-site, three-arm, double-dummy blinded, parallel group, randomised control superiority trial in 3300 children. The statistical analysis plan was developed by the trial statistician in consultation with the trial steering committee and trial management committee based on the protocol, data collection forms, and study outcomes available in the blinded study database. Conclusion: This detailed statistical analysis plan published prior to unblinding the allocated treatments will support the statistical analyses and reporting of the BRISC trial to be undertaken after unblinding. It allows for transparency as well as reproducibility of statistical analyses and reporting. Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125.

Hypopharyngeal packing during adenotonsillectomy by cold dissection in children: a randomized controlled trial.

Nausea and vomiting occur in up to 70% of children after adenotonsillectomy, ingested blood during procedure being one of the reasons for emesis. Hypopharyngeal packing (HP) is a common practice among otolaryngologists to prevent blood from being swallowed, but studies in nasal surgeries in adults failed to show efficacy of this technique in reducing postoperative nausea and vomiting (PONV). There are no studies evaluating the effect of HP in adenotonsillectomy in children. The aim of this study is to evaluate the efficacy HP during adenotonsillectomy in children in the prevention of PONV. This is a randomized, double-blinded, controlled trial. Children aged 4-16years, scheduled for adenotonsillectomy due to sleep-disordered breathing were enrolled in Hospital da Criança Santo Antônio (Brazil). 192 participants were screened, while 129 were enrolled and completed follow-up for primary outcome. Patients were randomized in a consecutive manner to receive HP or not during adenotonsillectomy. PONV occurrence was assessed in the first 24h after surgery in HP and control group and relative risk with 95% confidence interval was calculated. There were 129 patients randomized, 64 in the HP and 65 in the control group. Female were 40.3% and mean ± SD age was 7.3 ± 2.9. Baseline characteristics and surgery variables were distributed similarly between the groups. Incidence of PONV was 20.3% in the HP and 23.1% in the control group. The relative risk for PONV was 0.88 (95% CI 0.46-1.70). Our results suggest that there is no benefit of HP during adenotonsillectomy in children for the prevention of PONV. Brazilian Register of Randomized Trials (REBEC) identifier: RBR-3zjn27; Universal Trial Number U1111-1197-7461.

Peripheral Electrical Stimulation Paired With Movement-Related Cortical Potentials Improves Isometric Muscle Strength and Voluntary Activation Following Stroke.

BackgroundEndogenous paired associative stimulation (ePAS) is a neuromodulatory intervention that has potential to aid stroke recovery. ePAS involves pairing endogenous electroencephalography (EEG) signals known as movement-related cortical potentials (MRCPs), with peripheral electrical stimulation. Previous studies have used transcranial magnetic stimulation (TMS) to demonstrate changes in corticomotor excitability following ePAS. However, the use of TMS as a measure in stroke research is limited by safety precautions, intolerance, and difficulty generating a measurable response in more severely affected individuals. We were interested in evaluating the effect of ePAS using more feasible measures in people with stroke. This study asks whether ePAS produces immediate improvements in the primary outcomes of maximal voluntary isometric contraction (MVIC) and total neuromuscular fatigue of the dorsiflexor muscles, and in the secondary outcomes of muscle power, voluntary activation (VA), central fatigue, peripheral fatigue, and electromyography activity.MethodIn this repeated-measures cross-over study, 15 participants with chronic stroke completed two interventions, ePAS and sham, in a randomized order. During ePAS, 50 repetitions of visually cued dorsiflexion were completed, while single pulses of electrical stimulation were delivered to the deep branch of the common peroneal nerve. Each somatosensory volley was timed to arrive in the primary motor cortex at the peak negativity of the MRCP. Univariate and multivariate linear mixed models were used to analyze the primary and secondary data, respectively.ResultsThere was a statistically significant increase in dorsiflexor MVIC immediately following the ePAS intervention (mean increase 7 N), compared to the sham intervention (mean change 0 N) (univariate between-condition analysis p = 0.047). The multivariate analysis revealed a statistically significant effect of ePAS on VA of the tibialis anterior muscle, such that ePAS increased VA by 7 percentage units (95% confidence interval 1.3–12.7%). There was no statistically significant effect on total neuromuscular fatigue, muscle power, or other secondary measures.ConclusionA single session of ePAS can significantly increase isometric muscle strength and VA in people with chronic stroke. The findings confirm that ePAS has a central neuromodulatory mechanism and support further exploration of its potential as an adjunct to stroke rehabilitation. In addition, the findings offer alternative, feasible outcome measures for future research.Clinical trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12617000838314 (www.anzctr.org.au), Universal Trial Number U111111953714.

Feasibility and Acceptability of a Student-Led Lifestyle (Diet and Exercise) Intervention Within a Residential Rehabilitation Setting for People With Severe Mental Illness, GO HEART (Group Occupation, Health, Exercise And Rehabilitation Treatment).

PurposePeople with severe mental illness (SMI) experience poor physical health and premature mortality, contributed significantly by modifiable lifestyle risk factors such as poor nutrition, low cardiorespiratory fitness, and physical inactivity. Lifestyle interventions can reduce cardiometabolic risk and confer a range of other positive mental and physical health benefits. We assessed the feasibility, acceptability, safety, and preliminary effectiveness of a lifestyle (combined dietary and exercise) intervention lead by senior exercise and dietetics students in a residential mental health rehabilitation setting.DesignSingle arm, prospective study evaluating outcomes pre and post a 10-week dietary and exercise intervention.MethodPeople with SMI from three residential rehabilitation units participated in a mixed aerobic and resistance training exercise intervention three times per week that was combined with a dietary intervention (six individual and group sessions). Primary outcome considerations were feasibility (recruitment, retention, and participation rates), acceptability, and adverse events. Secondary outcomes were preliminary effectiveness; (functional exercise capacity, volume of exercise, and metabolic markers), psychiatric symptoms, quality of life, and attitudes to exercise.ResultsForty-two participants were recruited (92% primary diagnosis of schizophrenia). Intervention feasibility was supported by high levels of recruitment (68%), retention (77%), and participation (70% exercise, 65% diet sessions); and the absence of serious adverse events. Significant improvements in functional exercise capacity, volume of exercise, general psychiatric symptoms, and negative psychotic symptoms occurred. Anthropometric and metabolic blood markers did not change. While the intervention was acceptable to participants, motivation for and perceived value of exercise reduced over 10 weeks.ConclusionsA brief pragmatic student-led lifestyle intervention integrated into usual mental health care was feasible, acceptable, safe, and scalable across two additional mental health residential rehabilitation sites, and resulted in physical and mental health improvements. Increased frequency of dietary sessions and length of dietary intervention may improve metabolic outcomes in the future. People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors. While this brief intervention was feasible and acceptable, this study highlights some of the challenges associated with maintaining motivation for healthy lifestyles for people with SMI. Longer term investigation of real-world lifestyle interventions is warranted, together with additional interventions that may support people with SMI to sustain motivation to address lifestyle factors.Clinical Trial RegistrationThe trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), Unique Identifier: ACTRN 12618000478213, http://www.anzctr.org.au Universal trial number (UTN)—U1111-1211-4009.

Australian Indigenous model of mental healthcare based on transdiagnostic cognitive–behavioural therapy co-designed with the Indigenous community: protocol for a randomised controlled trial – CORRIGENDUM

Background A four- to seven-fold increase in the prevalence of current mood, anxiety, substance use and any mental disorders in Indigenous adults compared with non-Indigenous Australians has been reported. A lifetime prevalence of major depressive disorder was 23.9%. High rates of comorbid mental disorders indicated a transdiagnostic approach to treatment might be most appropri- ate. The effectiveness of psychological treatment for Indigenous Australians and adjunct Indigenous spiritual and cultural healing has not previously been evaluated in controlled clinical trials. Aims This project aims to develop, deliver and evaluate the effectiveness of an Indigenous model of mental healthcare (IMMHC). Trial registration: ANZCTR Registration Number: ACTRN12618001746224 and World Health Organization Universal Trial Number: U1111-1222-5849. Method The IMMHC will be based on transdiagnostic cognitive–behav- iour therapy co-designed with the Indigenous community to ensure it is socially and culturally appropriate for Indigenous Australians. The IMMHC will be evaluated in a randomised con- trolled trial with 110 Indigenous adults diagnosed with a current diagnosis of depression. The primary outcome will be the severity of depression symptoms as determined by changes in Beck Depression Inventory-II score at 6 months post-interven- tion. Secondary outcomes include anxiety, substance use disorder and quality of life. Outcomes will be assessed at base- line, 6 months post-intervention and 12 months post- intervention. Results The study design adheres to the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations and CONSORT extensions for pilot trials. We followed the Standard Protocol Items for Randomised Trials statement recommenda- tions in writing the trial protocol. Conclusions This study will likely benefit participants, as well as collaborating Aboriginal Medical Services and health organisations. The transdiagnostic IMMHC has the potential to have a substantial impact on health services delivery in the Indigenous health sector.

Australian Indigenous model of mental healthcare based on transdiagnostic cognitive-behavioural therapy co-designed with the Indigenous community: protocol for a randomised controlled trial.

A four- to seven-fold increase in the prevalence of current mood, anxiety, substance use and any mental disorders in Indigenous adults compared with non-Indigenous Australians has been reported. A lifetime prevalence of major depressive disorder was 23.9%. High rates of comorbid mental disorders indicated a transdiagnostic approach to treatment might be most appropriate. The effectiveness of psychological treatment for Indigenous Australians and adjunct Indigenous spiritual and cultural healing has not previously been evaluated in controlled clinical trials. This project aims to develop, deliver and evaluate the effectiveness of an Indigenous model of mental healthcare (IMMHC). Trial registration: ANZCTR Registration Number: ACTRN12618001746224 and World Health Organization Universal Trial Number: U1111-1222-5849. The IMMHC will be based on transdiagnostic cognitive-behaviour therapy co-designed with the Indigenous community to ensure it is socially and culturally appropriate for Indigenous Australians. The IMMHC will be evaluated in a randomised controlled trial with 110 Indigenous adults diagnosed with a current diagnosis of depression. The primary outcome will be the severity of depression symptoms as determined by changes in Beck Depression Inventory-II score at 6 months post-intervention. Secondary outcomes include anxiety, substance use disorder and quality of life. Outcomes will be assessed at baseline, 6 months post-intervention and 12 months post-intervention. The study design adheres to the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations and CONSORT extensions for pilot trials. We followed the Standard Protocol Items for Randomised Trials statement recommendations in writing the trial protocol. This study will likely benefit participants, as well as collaborating Aboriginal Medical Services and health organisations. The transdiagnostic IMMHC has the potential to have a substantial impact on health services delivery in the Indigenous health sector.

Efficacy of web-assisted self-help for parents of children with ADHD (WASH) \u2013 a three-arm randomized trial under field/routine care conditions in Germany

BackgroundCurrent clinical guidelines recommend parent management training (PMT) in the treatment of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD). However, (a) a lack of supply and (b) structural barriers to attending and continuing face-to-face PMT restrict the access to this training. The main purpose of this study is to investigate the efficacy of online PMT in decreasing ADHD symptoms and oppositional behavior problems and to evaluate the effects of additional telephone-based support of the parents.MethodsThe target sample size is n = 495 children with suspected or even clinical diagnosis of ADHD and current symptoms of ADHD or ODD. The study is based on a randomized three-arm parallel group design, in which the effects of treatment as usual (TAU) are compared to TAU plus web-assisted self-help (TAU+WASH) and to TAU plus web-assisted self-help and telephone-based support (TAU+WASH+SUPPORT).DiscussionThe results will provide important insights into the efficacy of web-assisted self-help for parents of children with ADHD and the additional effects of telephone-based support.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00013456. January 3rd 2018.World Health Organization Trial Registration Data Set: Universal Trial number (UTN) U1111–1205-6181. November 23rd 2017.

A multi-vendor, multi-center study on reproducibility and comparability of fast strain-encoded cardiovascular magnetic resonance imaging

Myocardial strain is a convenient parameter to quantify left ventricular (LV) function. Fast strain-encoding (fSENC) enables the acquisition of cardiovascular magnetic resonance images for strain-measurement within a few heartbeats during free-breathing. It is necessary to analyze inter-vendor agreement of techniques to determine strain, such as fSENC, in order to compare existing studies and plan multi-center studies. Therefore, the aim of this study was to investigate inter-vendor agreement and test-retest reproducibility of fSENC for three major MRI-vendors. fSENC-images were acquired three times in the same group of 15 healthy volunteers using 3 Tesla scanners from three different vendors: at the German Heart Institute Berlin, the Charité University Medicine Berlin-Campus Buch and the Theresien-Hospital Mannheim. Volunteers were scanned using the same imaging protocol composed of two fSENC-acquisitions, a 15-min break and another two fSENC-acquisitions. LV global longitudinal and circumferential strain (GLS, GCS) were analyzed by a trained observer (Myostrain 5.0, Myocardial Solutions) and for nine volunteers repeatedly by another observer. Inter-vendor agreement was determined using Bland-Altman analysis. Test-retest reproducibility and intra- and inter-observer reproducibility were analyzed using intraclass correlation coefficient (ICC) and coefficients of variation (CoV). Inter-vendor agreement between all three sites was good for GLS and GCS, with biases of 0.01–1.88%. Test-retest reproducibility of scans before and after the break was high, shown by ICC- and CoV values of 0.63–0.97 and 3–9% for GLS and 0.69–0.82 and 4–7% for GCS, respectively. Intra- and inter-observer reproducibility were excellent for both parameters (ICC of 0.77–0.99, CoV of 2–5%). This trial demonstrates good inter-vendor agreement and test–retest reproducibility of GLS and GCS measurements, acquired at three different scanners from three different vendors using fSENC. The results indicate that it is necessary to account for a possible bias (< 2%) when comparing strain measurements of different scanners. Technical differences between scanners, which impact inter-vendor agreement, should be further analyzed and minimized.DRKS Registration Number: 00013253.Universal Trial Number (UTN): U1111-1207-5874.

Can We Play Together? A Closer Look at the Peers of a Peer-Mediated Intervention to Improve Play in Children with Autism Spectrum Disorder.

Peer-mediated interventions (PMIs) are often used to support children with autism spectrum disorder (ASD) to develop social skills. However, more investigation is needed to better understand the role of peers as both intervention recipients and models. Sixty-five typically developing peers who participated in a PMI for children with ASD were investigated using a randomised control trial. Play sessions of the dyads were scored using the Test of Playfulness. Results showed a significant moderate intervention effect for the peers from pre- to post-intervention; outcomes for children with ASD were not influenced by peer characteristics; and, the children demonstrated a similar pattern of play interaction. Implications for practice are discussed.Clinical Trials Registry Australian New Zealand Clinical Trials Registry, https://www.anzctr.org.au/ (ACTRN12615000008527; Universal Trial Number: U1111-1165-2708).

Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand

BackgroundA healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Māori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training (FFIT), a weight management and healthy lifestyle program for overweight and obese men aged 35–65 years , delivered by community coaching staff at professional football clubs, has been shown to be beneficial and cost-effective. A pilot program inspired by FFIT but delivered by professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, improved physiological outcomes, and adherence to healthy lifestyle behaviors in overweight and obese men. The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) program.MethodsA pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30–65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs. Participants in the intervention group undergo physical training sessions, in addition to workshop-based sessions to learn about nutrition, physical activity, sleep, sedentary behavior, and a range of behavior-change strategies for sustaining a healthier lifestyle. The control group receives the program after 52 weeks. The primary outcome is change in body weight from baseline to 52 weeks. Secondary outcomes include change in body weight at 12 weeks; waist circumference, blood pressure, fitness, and lifestyle behaviors at 12 and 52 weeks; and cost-effectiveness. A process evaluation informed by the RE-AIM framework will evaluate potential implementation of RUFIT-NZ as an ongoing program in NZ after the trial.DiscussionThis trial will investigate the effectiveness and cost-effectiveness of the RUFIT-NZ program in overweight and obese NZ men.Trial registrationAustralia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered on 18 January 2019, according to the World Health Organization Trial Registration Data Set. Universal Trial Number, U1111-1245-0645.

A double-blind randomised placebo-controlled trial of melatonin as an adjuvant agent in induction of labour (MILO): a study protocol

IntroductionInduction of labour (IOL) is a common practice. In Australia, up to 40% of women undergoing labour induction will ultimately have a caesarean section. As a biological role for melatonin...

Evaluation of the effect of multidisciplinary simulation-based team training on patients, staff and organisations: protocol for a stepped-wedge cluster-mixed methods study of a national, insurer-funded initiative for surgical teams in New Zealand public hospitals

IntroductionNetworkZ is a national, insurer-funded multidisciplinary simulation-based team-training programme for all New Zealand surgical teams. NetworkZ is delivered in situ, using full-body commercial simulators integrated with bespoke surgical models. Rolled...