scholarly journals The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet

2022 ◽  
pp. 105566562110597
Author(s):  
Steven John Lo ◽  
Paul Chapman ◽  
David Young ◽  
David Drake ◽  
Mark Devlin ◽  
...  
Keyword(s):  
Patient Education ◽  
Augmented Reality ◽  
Trial Design ◽  
Cleft Lip ◽  
Primary Outcome ◽  
Rating Scale ◽  
Mental Effort ◽  
Phase 2 ◽  
Secondary Outcomes ◽  
Effort Rating

Background The Cleft Lip Education with Augmented Reality (CLEAR) project centers around the use of augmented reality (AR) in patient leaflets, as a visual means to overcome the “health literacy” gap. This trial followed Virtual Reality (VR CORE) guidelines for VR Phase 2 (Pilot) trials. Methods Participants included families of children treated for Cleft Lip and Palate at the Royal Hospital for Children, Glasgow. Interventions were AR leaflet or Traditional Leaflet. Objectives were to calculate sample sizes, assess outcome instruments, trial design, and acceptability to patients. Primary outcome measure was Mental Effort Rating Scale, and secondary outcomes were Patient Satisfaction (Visual Analogue Scale), Usefulness Scale for Patient Information Material (USE) scale, and Instructional Materials Motivation Survey (IMMS). Randomization was by block randomization. The trial was single blinded with assessors blinded to group assignment. Results 12 Participants were randomized, with crossover design permitting analysis of 12 per group. Primary outcome with Mental Effort Rating Scale indicated higher mental effort with Traditional compared to AR Leaflet (4.75 vs 2.00, P = .0003). Secondary outcomes for Satisfaction were Traditional 54.50 versus AR 93.50 ( P = .0001); USE scale 49.42 versus 74.08 ( P = .0011); and IMMS 112.50 versus 161.75 ( P = .0003). Subjective interviews noted overwhelmingly positive patient comments regarding the AR leaflet. Outcome instruments and trial design were acceptable to participants. No harms were recorded. Conclusions The CLEAR pilot trial provides early evidence of clinical efficacy of AR leaflets in patient education. It is hoped that this will provide a future paradigm shift in the way patient education is delivered.

scholarly journals Emotion regulation group therapy for deliberate self-harm: a multi-site evaluation in routine care using an uncontrolled open trial design

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016220 ◽  
Author(s):  
Hanna Sahlin ◽  
Johan Bjureberg ◽  
Kim L Gratz ◽  
Matthew T Tull ◽  
Erik Hedman ◽  
...  
Keyword(s):  
Emotion Dysregulation ◽  
Trial Design ◽  
Primary Outcome ◽  
Borderline Personality ◽  
Post Treatment ◽  
Deliberate Self Harm ◽  
Site Evaluation ◽  
Self Harm ◽  
Secondary Outcomes

ObjectiveEmotion regulation group therapy (ERGT) has shown promising results in several efficacy trials. However, it has not been evaluated outside a research setting. In order to increase the availability of empirically supported treatments for individuals with borderline personality disorder and deliberate self-harm, an evaluation of ERGT in routine clinical care was conducted with therapists of different professional backgrounds who had received brief intensive training in ERGT prior to trial onset.DesignMulti-site evaluation, using an uncontrolled open trial design with assessments at pretreatment, post-treatment and 6-month follow-up.Setting14 adult outpatient psychiatric clinics across Sweden.ParticipantsNinety-five women (mean age=25.1 years) with borderline personality disorder (both threshold and subthreshold) and repeated self-harm were enrolled in the study. Ninety-three per cent of participants completed the post-treatment assessment and 88% completed the follow-up assessment.Primary and secondary outcome measuresPrimary outcome was self-harm frequency as measured with the Deliberate Self-Harm Inventory. Secondary outcomes included self-harm versatility, emotion dysregulation, other self-destructive behaviours, depression, anxiety, stress symptoms and interpersonal and vocational difficulties.InterventionERGT is an adjunctive, 14-week, acceptance-based behavioural group treatment that directly targets both self-harm and its proposed underlying mechanism of emotion dysregulation.ResultsAt post-treatment, intent-to-treat analyses revealed a significant improvement associated with a moderate effect size on the primary outcome of self-harm frequency (51%, reduction; Cohen’s d=0.52, p<0.001) as well as significant improvements in the secondary outcomes of self-harm versatility, emotion dysregulation, other self-destructive behaviours and general psychiatric symptomatology. These results were either maintained or further improved on at 6-month follow-up.ConclusionsERGT appears to be a feasible, transportable and useful treatment for deliberate self-harm and other self-destructive behaviours, emotion dysregulation and psychiatric symptoms when delivered by clinicians in the community.Trial registration numberNCT01986257; results.

scholarly journals Effectiveness of physical therapy treatment in addition to usual podiatry management of plantar heel pain: a randomized clinical trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Shane M. McClinton ◽  
Bryan C. Heiderscheit ◽  
Thomas G. McPoil ◽  
Timothy W. Flynn
Keyword(s):  
Physical Therapy ◽  
Primary Outcome ◽  
Rating Scale ◽  
Heel Pain ◽  
Global Rating ◽  
Plantar Heel Pain ◽  
Patient Reported ◽  
Physical Therapy Treatment ◽  
Secondary Outcomes ◽  
Therapy Treatment

Abstract Background Many patients will seek care from a podiatrist for plantar heel pain (PHP), while few of these patients will also be seen by a physical therapist. Physical therapists can provide treatment that is not a part of routine podiatric care for PHP and may provide additional improvement. Therefore, the purpose of this study was to examine the effects of interdisciplinary care for PHP that incorporated physical therapy treatment after initiating podiatric treatment. Methods Eligible individuals with PHP that presented to a podiatrist were randomized to receive usual podiatric care (uPOD) or usual podiatric care plus physical therapy treatment (uPOD+PT). The primary outcome was change in foot and ankle ability measure (FAAM) at 6-months. Secondary outcomes included change in numeric pain rating scale (NPRS), patient-reported success, and 6-week and 1-year endpoints. Patient-reported success was defined as the top two global rating of change scale rankings. Primary analysis was intention-to-treat (ITT) using analysis by covariance adjusted to baseline scores, and a secondary per-protocol (PP) analysis was performed analyzing only those who completed treatment. Results Ninety-five individuals participated and were included in the ITT analysis, and 79 were included in the PP analysis. For the primary outcome of FAAM change from baseline to 6-months, both groups improved significantly (uPOD+PT: 26.8 [95% CI 21.6, 31.9]; uPOD: (20 [15.6, 24.4]), but there was no between-group difference (4.3 [− 1, 9.6]). For secondary outcomes, the uPOD+PT group demonstrated greater improvement in NPRS at 6 weeks (0.9 [0.3, 1.4]) and 1 year (1.5 [0.6, 2.5]) in the ITT analysis. In the PP analysis, the uPOD+PT group demonstrated greater improvement in FAAM at 6 months (7.7 [2.1, 13.3]) and 1 year (5.5 [0.1, 10.8]), NPRS at 6 weeks (0.9 [0.2, 1.6]), 6 months (1.3 [0.6, 2.1]) and 1 year (1.3 [0.6, 2.1]), and in patient-reported success (relative risk [95% CI]) at 6 weeks (2.8 [1.1, 7.1]), 6 months (1.5 [1.1, 2.1]), and 1 year (1.5 [1.1, 1.9]). Conclusions There was no significant benefit of uPOD+PT in the primary outcome of FAAM change at 6 months. Secondary outcomes and PP analysis indicated additional benefit of uPOD+PT, mostly observed in individuals who completed treatment. Trial registration Prospectively registered May 24, 2013 at www.clinicaltrials.gov (NCT01865734).

scholarly journals Randomised controlled trial of Antiglucocorticoid augmentation (metyrapone) of antiDepressants in Depression (ADD Study)

2015 ◽  
Vol 2 (4) ◽  
pp. 1-98 ◽  
Author(s):  
I Nicol Ferrier ◽  
Ian M Anderson ◽  
Jane Barnes ◽  
Peter Gallagher ◽  
Heinz CR Grunze ◽  
...  
Keyword(s):  
Adverse Events ◽  
Hpa Axis ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Primary Outcome ◽  
Rating Scale ◽  
Controlled Trial ◽  
Cochrane Review ◽  
Analysis Of Covariance ◽  
Refractory Depression ◽  
Secondary Outcomes

BackgroundDepressed patients who do not respond to second-line antidepressant drugs are characterised as suffering from treatment-refractory depression (TRD). Chronic psychosocial stress hypothalamic–pituitary–adrenal (HPA) axis dysfunction is associated with attenuated responses to antidepressants. Corticosteroid co-administration reduces the increase in forebrain 5-hydroxytryptamine with selective serotonin reuptake inhibitors, whereas antiglucocorticoids have the opposite effect. A Cochrane review suggesting that antiglucocorticoid augmentation of antidepressants may be effective in treating TRD included a pilot study of the cortisol synthesis inhibitor, metyrapone. TheAntiglucocorticoid augmentation of antiDepressants inDepression (ADD Study) was a multicentre randomised placebo-controlled trial of metyrapone augmentation of serotonergic antidepressants in patients with TRD.ObjectiveTo determine the efficacy and safety of augmentation of standard serotonergic antidepressants with metyrapone 500 mg twice a day for 3 weeks in patients with TRD.MethodsA total of 165 patients with moderate to severe TRD aged 18–65 years were randomised to metyrapone 500 mg twice daily or placebo for 3 weeks, in addition to ongoing serotonergic antidepressants. The primary outcome was improvement in Montgomery–Åsberg Depression Rating Scale (MADRS) score 5 weeks after randomisation estimated using analysis of covariance. Secondary outcomes included the degree of persistence of treatment effect for up to 6 months, and also safety and tolerability of metyrapone. ADD included substudies investigating the potential mechanism of action of metyrapone, and utilised a comparator group of healthy participants.ResultsThe estimated mean difference for each of our study outcomes between randomised groups, 5 weeks post randomisation (allowing for variation between centres and whether or not patients originate from primary or secondary care) was MADRS –0.51 [95% confidence interval (CI) –3.48 to 2.46]; Beck Depression Inventory (BDI) –2.65 (95% CI –6.41 to 1.10); Clinical Anxiety Scale 0.46 (95% CI –1.20 to 2.12); State–Trait Anxiety Inventory 1.2 (95% CI –0.6 to 3.0); European Quality of Life-5 Dimensions 0.015 (95% CI –0.069 to 0.099); EuroQol visual analogue scale 5.6 (95% CI –0.7 to 12.0); and Young Mania Rating Scale –0.04 (95% CI –0.52 to 0.45). The differences were not statistically significant and were small in relation to the change from baseline in both groups that was observed immediately after completion of therapy. Endocrinological data required for compliance assessment are not yet available. HPA function, similar in patients and control subjects, was not associated with differing clinical responses. Neuropsychological impairments were found, along with changes in brain structure and function, but no effect of metyrapone was seen on these measures.DiscussionThe inclusion criteria led to the sample being broadly representative of patients with TRD, within the UK NHS, with high anxiety and BDI scores. Metyrapone augmentation of antidepressants is not efficacious for outpatients with TRD who are moderately depressed. There was no obvious benefit associated with the use of metyrapone, either on the primary outcome or over the period of follow-up, and this negative result extended to other secondary outcomes. Metyrapone was well tolerated. There were no serious adverse events attributable to it and adverse events were as common with the placebo. HPA axis function was not associated with differing clinical or neuropsychological outcomes.ConclusionsThe results of the study suggest that although metyrapone augmentation was well tolerated, it is ineffective in the treatment of refractory depression. This finding is contrary to a previous proof of principle study in more acutely unwell patients. Future research should consider whether or not antiglucocorticoid treatments, such as metyrapone, should be targeted at patients with confirmed hypercortisolaemia.Trial registrationCurrent Controlled Trials ISRCTN45338259.Funding detailsThis study was funded by the National Institute for Health Research Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.

scholarly journals Methoxyflurane in Non-Life-Threatening Traumatic Pain—A Retrospective Observational Study

Healthcare ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1360
Author(s):  
Florian Ozainne ◽  
Philippe Cottet ◽  
Carlos Lojo Rial ◽  
Stephan von Düring ◽  
Christophe A. Fehlmann
Keyword(s):  
Primary Outcome ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Self Assessment ◽  
Large Panel ◽  
Emergency Ambulance ◽  
Numerical Rating ◽  
Life Threatening ◽  
Secondary Outcomes ◽  
Median Pain

Pain management is a key issue in prehospital trauma. In Switzerland, paramedics have a large panel of analgesic options. Methoxyflurane was recently introduced into Switzerland, and the goal of this study was to describe both the effect of this medication and the satisfaction of its use. This was a retrospective cohort study, performed in one emergency ambulance service. It included adult patients with traumatic pain and a self-assessment of 3 or more on the visual analogue scale or verbal numerical rating scale. The primary outcome was the reduction in pain between the start of the care and the arrival at the hospital. Secondary outcomes included successful analgesia and staff satisfaction. From December 2018 to 4 June to October 2020, 263 patients were included in the study. Most patients had a low prehospital severity score. The median pain at arrival on site was 8 and the overall decrease in pain observed was 4.2 (95% CI 3.9–4.5). Regarding secondary outcomes, almost 60% had a successful analgesia, and over 70% of paramedics felt satisfied. This study shows a reduction in pain, following methoxyflurane, similar to outcomes in other countries, as well as the attainment of a satisfactory level of pain reduction, according to paramedics, with the advantage of including patients in their own care.

Comparison of Anterior Suprascapular, Supraclavicular, and Interscalene Nerve Block Approaches for Major Outpatient Arthroscopic Shoulder Surgery

2018 ◽  
Vol 129 (1) ◽  
pp. 47-57 ◽  
Author(s):  
David B. Auyong ◽  
Neil A. Hanson ◽  
Raymond S. Joseph ◽  
Brian E. Schmidt ◽  
April E. Slee ◽  
...  
Keyword(s):  
Nerve Block ◽  
Primary Outcome ◽  
Rating Scale ◽  
Shoulder Surgery ◽  
Opioid Consumption ◽  
Outcome Analysis ◽  
Double Blind ◽  
Arthroscopic Shoulder Surgery ◽  
Secondary Outcomes ◽  
Interscalene Nerve Block

Abstract Background The interscalene nerve block provides analgesia for shoulder surgery, but is associated with diaphragm paralysis. One solution may be performing brachial plexus blocks more distally. This noninferiority study evaluated analgesia for blocks at the supraclavicular and anterior suprascapular levels, comparing them individually to the interscalene approach. Methods One hundred-eighty-nine subjects undergoing arthroscopic shoulder surgery were recruited to this double-blind trial and randomized to interscalene, supraclavicular, or anterior suprascapular block using 15 ml, 0.5% ropivacaine. The primary outcome was numeric rating scale pain scores analyzed using noninferiority testing. The predefined noninferiority margin was one point on the 11-point pain scale. Secondary outcomes included opioid consumption and pulmonary assessments. Results All subjects completed the study through the primary outcome analysis. Mean pain after surgery was: interscalene = 1.9 (95% CI, 1.3 to 2.5), supraclavicular = 2.3 (1.7 to 2.9), suprascapular = 2.0 (1.4 to 2.6). The primary outcome, mean pain score difference of supraclavicular–interscalene was 0.4 (–0.4 to 1.2; P = 0.088 for noninferiority) and of suprascapular–interscalene was 0.1 (–0.7 to 0.9; P = 0.012 for noninferiority). Secondary outcomes showed similar opioid consumption with better preservation of vital capacity in the anterior suprascapular group (90% baseline [P &lt; 0.001]) and the supraclavicular group (76% [P = 0.002]) when compared to the interscalene group (67%). Conclusions The anterior suprascapular block, but not the supraclavicular, provides noninferior analgesia compared to the interscalene approach for major arthroscopic shoulder surgery. Pulmonary function is best preserved with the anterior suprascapular nerve block.

scholarly journals Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Scott H. Kollins ◽  
Ann Childress ◽  
Andrew C. Heusser ◽  
Jacqueline Lutz
Keyword(s):  
Video Game ◽  
Primary Outcome ◽  
Rating Scale ◽  
Stimulant Medication ◽  
Additional Treatment ◽  
Adhd Medication ◽  
Open Label ◽  
Serious Adverse Events ◽  
Treatment Benefit ◽  
Hyperactivity Disorder

AbstractSTARS-Adjunct was a multicenter, open-label effectiveness study of AKL-T01, an app and video-game-based treatment for inattention, as an adjunct to pharmacotherapy in 8–14-year-old children with attention-deficit/hyperactivity disorder (ADHD) on stimulant medication (n = 130) or not on any ADHD medication (n = 76). Children used AKL-T01 for 4 weeks, followed by a 4-week pause and another 4-week treatment. The primary outcome was change in ADHD-related impairment (Impairment Rating Scale (IRS)) after 4 weeks. Secondary outcomes included changes in IRS, ADHD Rating Scale (ADHD-RS). and Clinical Global Impressions Scale—Improvement (CGI-I) on days 28, 56, and 84. IRS significantly improved in both cohorts (On Stimulants: −0.7, p < 0.001; No Stimulants: −0.5, p < 0.001) after 4 weeks. IRS, ADHD-RS, and CGI-I remained stable during the pause and improved with a second treatment period. The treatment was well-tolerated with no serious adverse events. STARS-Adjunct extends AKL-T01’s body of evidence to a medication-treated pediatric ADHD population, and suggests additional treatment benefit.

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

scholarly journals A113 ANNUAL COLONOSCOPY VOLUME IS NOT PREDICTIVE OF COLONOSCOPY QUALITY - FINDINGS FROM THE SOUTHWEST ONTARIO COLONOSCOPY COHORT

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 92-93
Author(s):  
M Sey ◽  
O Siddiqi ◽  
C McDonald ◽  
S cocco ◽  
Z Hindi ◽  
...  
Keyword(s):  
Predictive Value ◽  
Detection Rate ◽  
Primary Outcome ◽  
Case Mix ◽  
Operating Characteristics ◽  
Polyp Detection ◽  
Cecal Intubation ◽  
Polyp Detection Rate ◽  
Secondary Outcomes ◽  
Colonoscopy Quality

Abstract Background Performing a minimum number of colonoscopies annually has been proposed by some jurisdictions as a requirement for maintaining privileges. However, this practice is supported by limited evidence. Aims The objective of this study was to determine if annual colonoscopy volume was associated with colonoscopy quality metrics. Methods A population-based study was performed using the Southwest Ontario Colonoscopy cohort, which consists of all adult patients who underwent colonoscopy between April 2017 and Oct 2018 at 21 academic and community hospitals within the health region. Data were collected through a mandatory quality assurance form completed after each procedure and pathology reports were manually reviewed. Physician annualized colonoscopy volumes were compared by correlation analysis to each quality-related outcome, by means of the area under the receiver operating characteristics curve (AUROC), and logistic regression. The prognostic value of colonoscopy volume was also adjusted for case-mix and potential confounders in separate regression analyses for each outcome. The primary outcome was ADR. Secondary outcomes were polyp detection rate (PDR), sessile serrated polyp detection rate (SSPDR), and cecal intubation. Results A total of 47,195 colonoscopies were performed by 75 physicians (37.5% by gastroenterologists, 60% by general surgeons, 2.5% others). There were no clear relationships between annual colonoscopy volumes and study outcomes. Colonoscopy volume was not associated with ADR (OR 1.03, 95% CI 0.96–1.10, p=0.48) and corresponded to an AUROC not significantly different from the null (AUROC 0.52, 95% CI 0.43–0.61, p=0.65). Multi-variable regression adjusting for case-mix also demonstrated no predictive value of annual colonoscopy volume for the primary outcome (OR 1.03, 95% CI 0.94–1.12, p=0.55). Similarly, analyses of secondary outcomes failed to find an association between colonoscopy volume and PDR, SSPDR, or cecal intubation (Table 1). Conclusions Annual colonoscopy volumes do not predict ADR, PDR, SSPDR, or cecal intubation rate. Results of unconditional and conditional approaches for examining the predictive value of annual colonoscopy volume for quality related outcomes. Funding Agencies None

scholarly journals Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson’s disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The ‘Exenatide-PD3’ study

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047993
Author(s):  
Nirosen Vijiaratnam ◽  
Christine Girges ◽  
Grace Auld ◽  
Marisa Chau ◽  
Kate Maclagan ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Primary Outcome ◽  
Phase 3 ◽  
Double Blind ◽  
Treatment Groups ◽  
Link Type ◽  
South Central ◽  
Disease Modifying ◽  
Secondary Outcomes

IntroductionParkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. The aim of this multicentre UK trial is to confirm whether these previous positive results are maintained in a larger number of participants over 2 years and if effects accumulate with prolonged drug exposure.Methods and analysisThis is a phase 3, multicentre, double-blind, randomised, placebo-controlled trial of exenatide at a dose of 2 mg weekly in 200 participants with mild to moderate PD. Treatment duration is 96 weeks. Randomisation is 1:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson’s Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores. Secondary outcomes will be summarised between treatment groups using summary statistics and appropriate statistical tests to assess for significant differences.Ethics and disseminationThis trial has been approved by the South Central-Berkshire Research Ethics Committee and the Health Research Authority. Results will be disseminated in peer-reviewed journals, presented at scientific meetings and to patients in lay-summary format.Trial registration numbersNCT04232969, ISRCTN14552789.

Galectin-3 predicts cardiovascular events in patients with type-2 diabetes

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Lorenzo-Almoros ◽  
A Pello ◽  
A Acena ◽  
J Martinez-Milla ◽  
N Tarin ◽  
...  
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Plasma Levels ◽  
Cardiovascular Events ◽  
Primary Outcome ◽  
Funding Source ◽  
Increased Risk ◽  
Galectin 3 ◽  
Secondary Outcomes

Abstract Introduction Type-2 diabetes mellitus (T2DM) is associated with early and severe atherosclerosis. However, few biomarkers can predict cardiovascular events in this population. Methods We followed 964 patients with coronary artery disease (CAD), assessing at baseline galectin-3, monocyte chemoattractant protein-1 (MCP-1) and N-terminal fragment of brain natriuretic peptide (NT-proBNP) plasma levels. Secondary outcomes were acute ischemia and heart failure or death. Primary outcome was the combination of the secondary outcomes. Results Male patients were 75.0% in T2DM and 76.6% in the non-T2DM subgroup (p=0.609). Age was 61.0 (54–72) and 60.0 (51–71) years, respectively (p=0.092). 232 patients had T2DM. Patients with T2DM showed higher MCP-1 [144 (113–195) vs. 133 (105–173) pg/ml, p=0.006] and galectin-3 [8.3 (6.5–10.5) vs. 7.8 (5.9–9.8) ng/ml, p=0.049] levels. Median follow-up was 5.39 years (2.81- 6.92). Galectin-3 levels were associated with increased risk of the primary outcome in T2DM patients [HR 1.57 (1.07–2.30); p=0.022], along with a history of cerebrovascular events. Treatment with clopidogrel was associated with lower risk. In contrast, NT-proBNP and MCP-1, but not galectin-3, were related to increased risk of the event in non-diabetic patients [HR 1.21 (1.04–1.42); p=0.017 and HR 1.23 (1.05–1.44); p=0.012, respectively], along with male sex and age. Galectin-3 was also the only biomarker that predicted the development of acute ischemic events and heart failure or death in T2DM patients, while in non-diabetics MCP-1 and NT-proBNP, respectively, predicted these events. Conclusion In CAD patients, cardiovascular events are predicted by galectin-3 plasma levels in patients with T2DM, and by MCP-1 and NT-proBNP in those without T2DM. Effect of Gal-3 on the primary endpoint Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Insituto de Salud Carlos III

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