Two-arm Controlled Trial Research Articles

Preliminary trial of a well-being diary with Japanese primary school students

The well-being of Japanese children has been reported to be low, compared with children in other developed countries. However, there has been a lack of social and emotional education specially designed to promote the well-being of this demographic. To address this gap, the authors developed a well-being diary (WE diary) suited for the Japanese school context during the COVID-19 pandemic. This study was a two-arm controlled trial to investigate the efficacy and feasibility of the WE diary using the social and emotional learning approach. The participants comprised Japanese primary school students aged 7–8 (35 females and 34 males) who volunteered for this 8-week program, which was implemented during 10–15-minute extra class periods. The students in the WE diary group and waitlist conditions completed questionnaires at three time points, under the supervision of the teacher. Based on the findings, there were significant positive changes in the scores for well-being and perceived social support, indicating the feasibility of this program in Japanese primary schools. The overall usefulness of the well-being diary among this demographic could motivate researchers, policymakers, and practitioners to promote social and emotional learning in Japanese schools.

Evaluation of the effectiveness and cost-effectiveness of psychological first aid (PFA) system based training for frontline health workers in emergency health services in China a study protocol of a cluster randomized controlled trial.

There is insufficient evidence on the effectiveness and cost-effectiveness of psychological interventions to enhance frontline responders' mental health proficiency and competence in emergency settings. This paper describes the methods for the evaluation of the effectiveness and cost-effectiveness of Psychological First Aid training, to determine whether the intervention is effective and cost-effective as a mental health intervention in public health emergencies. A pilot to evaluate the acceptability of the PFA training found participants were either satisfied (55.6%) or extremely satisfied (44.4%) with the training program. This paper describes the protocol for a cluster randomized two-arm controlled trial. A total of 1,399 non-specialist health care workers will be recruited in 42 hospitals and health care centers across six provinces in China. Participants will be assigned according to hospital or health care center site to one of two groups (n = 699 for intervention group and 709 for control group) to receive system based PFA training or PFA training as usual. Both groups will receive one-day of training, comprising six modules including PFA core concepts, knowledge, skills and practice. Their knowledge, skills, competency, self-efficacy, resilience, and professional quality of life will be assessed immediately after the training; and reassessed after 1 and 2 months. For effectiveness outcomes, repeated measures will be used in a multi-level linear mixed model. The pooled standard deviations will be used to calculate the effect sizes (Cohen's d) within and between groups. Appropriate statistical tests will be used to explore differences between intervention and control groups. For economic outcomes, a health service sector perspective will be adopted, with intervention costs and outcomes collected prospectively. Within-trial cost-effectiveness analysis (CEA) will quantify the incremental costs and PFA proficiency gains of the intervention compared with training as usual at 2 months post training. CEA will present results as cost per unit of mental health proficiency gained. A cost-utility analysis (CUA) model will extend the population to emergency health service users.in order to identify potential for incremental cost offsets attributable to mental health improvement arising from intervention. Intervention costs and effects will be extrapolated to the population of patients who receive the emergency health service in clinical wards and will be modeled over the cohort's lifetime. Modeled CUA results will be calculated as quality-adjusted life-years saved and healthcare cost savings in preventing mental disorders. Ethics approval was obtained from the Second Xiangya Hospital, Central South University Clinical Research Ethics Committee (2021) Ethical Review [Clinical Research] #067). Data about the economic evaluation of the intervention will be stored in the KCL OneDrive at King's College London, UK. The trial protocol was registered with the China Clinical Trials Registry: ChiCTR2200060464. Study findings will be disseminated through peer-reviewed academic papers, and participating hospitals.

The short-term efficacy of electrical pudendal nerve stimulation versus intravesical instillation for the urethral pain syndrome: a randomized clinical trial.

Urethral pain syndrome is a chronic condition characterized by disturbing feeling or server pain sensed at the urethra without specific treatment. This double-center, two-arm controlled trial aimed to explore the efficacy of electrical pudendal nerve stimulation (EPNS) versus intravesical instillation (II) of heparin and alkalinized lidocaine for urethral pain syndrome (UPS). Eighty eligible patients took three sessions of EPNS, or 1 session of II per week, for 6consecutive weeks. The primary end point was the change of pelvic pain and urgency/frequency symptom (PUF) score from baseline to week 6. Secondary outcome measures included changes of visual analogue scale (VAS) score and three sub-score extracted from PUF score. The enrolled participants were all included in the intention-to-treat analyses, and baseline characteristics between the two groups were well balanced. The post-treatment PUF score decreased by 10.0 (7.00, 16.50) in the EPNS group, and by 7.0 (3.00, 10.00) in the II group. At the closure of treatment, the medians of changes in symptom score, bother score, pain-related score and VAS score were 6.50 (4.25, 10.00), 4.00 (2.00, 6.00), 6.00 (5.00, 8.00),4.50 (2.25, 6.00), respectively, in the EPNS group, and 4.00 (2.00, 7.00), 3.00 (1.00, 3.00), 3.00 (2.00, 6.00), 2.00 (1.00, 4.00), respectively, in the II group. All the between-group differences were statistically significant. Compared with the II, the EPNS results in superior pain control and better relief of lower urinary tract symptoms, and deserves further attention. ClinicalTrials.gov (NCT03671993).

Direct pulp capping (DPC) in primary molars using (3Mix-MP) and the characteristics of the carious lesion as predictor factors for its success: a randomized controlled trial.

This study aimed at the following: (a) To evaluate the effectiveness of direct pulp capping (DPC) in children's primary molars using a combination of three antibiotics (3Mix-MP) as direct pulp capping materials compared with Calcium Hydroxide and (b) to assess the impact of pulp exposure diameter, its location and restoration extent on the success rate of the technique. This was a randomized double-blind, parallel, two-arm controlled trial. Forty-four primary molars with deep active caries, whose removal resulted in pulp exposures, were treated with direct pulp capping and were allocated randomly into two groups: Group A, DPC with 3Mix-MP; and group B, DPC with Calcium Hydroxide (CH). All teeth were restored with composite resin restorations. The exposures were classified according to their diameter, location and number of the filling surfaces. Clinical follow-ups were performed at intervals of 3months for 1year, and radiographical follow-ups were done after 6-12months. Data were assessed using Chi-squared test (χ2) at a 0.05 level of significance and binary logistic regression was performed to determine the effect of the characteristics of the carious lesion on success rates. The success rate of the technique was 54.5% in group A and 77.3% in group B, but the difference was not statistically significant. The pulp exposure diameter, its location and the number of the filling surfaces did not affect the success rate significantly. (a) Direct pulp capping in primary teeth achieved comparable success rates with no significant difference between 3Mix-MP and Calcium hydroxide. (b) The exposure location, its diameter and the extent of the restoration had no significant impact on the success rates of direct pulp capping in primary teeth. ISRCTN, ISRCTN13525994. Registered 31 October 2018 - Retrospectively registered, ( http:// www.isrctn.com/ISRCTN13525994 ).

Multicentre randomised controlled trial about the effect of individual reminiscence therapy in older adults with neurocognitive disorders.

To evaluate the effectiveness of a 13-week individual reminiscence therapy (RT) intervention to improve the overall cognitive function, memory, executive function, mood and quality of life (QoL) of people with neurocognitive disorders. A single-blind, multicentre, randomised parallel two-arm controlled trial recruited 251 people with neurocognitive disorders attending 24 institutions providing care and support services for older adults in Portugal. The primary outcome measure was cognitive function (Mini-Mental State Examination [MMSE]). Secondary outcomes were memory (Memory Alteration Test [MAT]), executive function (Frontal Assessment Battery [FAB]), mood (Geriatric Depression Scale-15 [GDS-15]) and self-reported QoL-Alzheimer's disease AD). Participants in the intervention group (n = 131) received 26 individual RT sessions, twice a week, over the course of 13 weeks. Participants in the control group (n = 120) maintained their treatment as usual. Intention-to-treat analysis showed that, at endpoint assessment, the intervention group had significantly improved in relation to the control group in MMSE (mean difference 1.84, 95% CI [0.80, 2.89], p = .001, d = .44), MAT (mean difference 2.82, 95% CI [0.72, 4.91], p = .009, d = .34) and QoL-AD (mean difference 1.78, 95% CI [0.17, 3.39], p = .031, d = .28). Non-significant improvements were found on FAB (mean difference 0.74, 95% CI [-0.04, 1.52], p = .062, d = .24) and GDS-15 (mean difference -0.63, 95% CI [-1.45, 0.19], p = .130, d = .19). For people with neurocognitive disorders attending social care and support services, the individual RT designed for this trial should be considered an intervention with the potential to improve cognition, memory and QoL.

Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.

Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes. To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty. An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study. The trial took place in 14 NHS physiotherapy departments. People identified as being at high risk of a poor outcome after knee arthroplasty. A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy. The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries. In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points; p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold. The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded. This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it. Current Controlled Trials ISRCTN13517704. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.

Peer support to maintain psychological wellbeing in people with advanced cancer: findings from a feasibility study for a randomised controlled trial

BackgroundAdvanced cancer affects people’s lives, often causing stress, anxiety and depression. Peer mentor interventions are used to address psychosocial concerns, but their outcomes and effect are not known. Our objective was to determine the feasibility of delivering and investigating a novel peer mentor intervention to promote and maintain psychological wellbeing in people with advanced cancer.MethodsA mixed methods design incorporating a two-armed controlled trial (random allocation ratio 1:1) of a proactive peer mentor intervention plus usual care, vs. usual care alone, and a qualitative process evaluation. Peer mentors were recruited, trained, and matched with people with advanced cancer. Quantitative data assessed quality of life, coping styles, depression, social support and use of healthcare and other supports. Qualitative interviews probed experiences of the study and intervention.ResultsPeer mentor training and numbers (n = 12) met feasibility targets. Patient participants (n = 12, from 181 eligible who received an information pack) were not recruited to feasibility targets. Those who entered the study demonstrated that intervention delivery and data collection were feasible. Outcome data must be treated with extreme caution due to small numbers, but indicate that the intervention may have a positive effect on quality of life.ConclusionsPeer mentor interventions are worthy of further study and researchers can learn from these feasibility data in planning participant recruitment and data collection strategies. Pragmatic trials, where the effectiveness of an intervention is tested in real-world routine practice, may be most appropriate. Peer mentor interventions may have merit in enabling survivors with advanced cancer cope with their disease.Trial RegistrationThe trial was prospectively registered 13.6.2016: ISRCTN10276684.

Improving well-being after traumatic brain injury through volunteering: a randomized controlled trial

ABSTRACT Objective To evaluate the efficacy of a novel intervention facilitating volunteer activity to improve well-being in individuals with traumatic brain injury (TBI). Design Randomized two-arm controlled trial, with a wait-list control condition (ClinicalTrials.gov NCT#01728350). Setting Community-based setting. Participants Seventy-four community-dwelling individuals at least 1-year post TBI, who had completed inpatient or outpatient TBI rehabilitation. Interventions A novel intervention, HOPE – Helping Others through Purpose and Engagement, involving orientation/training and a 3-month volunteer placement for the participant, along with training for community agencies regarding TBI. Main outcome measure(s ): Satisfaction With Life Scale (SWLS); Flourishing Scale (FS); Brief Symptom Inventory-18 (BSI-18); Scale of Positive and Negative Experience (SPANE); Purpose in Life subscale (one of six in the Ryff Scale of Psychological Well-Being – 54 item version). Results There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group. There were no significant treatment effects on the additional secondary measures of well-being, although they trended in a positive direction. Conclusions This study supports our primary hypothesis that individuals who take part in a volunteer intervention will demonstrate greater psychological well-being in comparison to a control group.

Unified protocol for anxiety disorders in two cities of Mexico measuring gamma activity: Study protocol for a randomized controlled trial

BackgroundThe Unified Protocol for Emotional Disorders (UP) for emotional regulation manifests effective results in a broad range of mental disorders. The UP efficacy was tested in several countries, but it has not been tested within Mexican population. It is crucial to do more research and implement effective protocols to intervene Mexican population with Anxiety Disorders (AD). ObjectiveThis study aims to examine and describe the research procedures and treatment interventions of the UP in a Randomized Controlled Trial (RCT), to approach and treat AD in patients in 2 Mexican borderland cities, by applying the UP and an Electroencephalogram (EGG) neuro screening. MethodsThe enrolled patients will be randomized in a two-arm control trial with repeated measures, comprising between 18 and 60 years, that were diagnosed with an AD, and low scored in depression symptoms and suicidal ideation. The study will comprise of two conditions: an intervention group clinical trial with the UP or a waiting list control. The primary outcome measures will be applied on AD quantitative self-reports and a gamma activity by EGG before and after the intervention and in follow-ups of 3 and 6 months. The participants in the waiting list group, will receive the treatment after the trial first group completes the treatment. ConclusionsProcesses and outcomes of this project, will provide evidence in order to apply the UP in a broader population with AD and other mental disorders also covered by this protocol, such as depression and borderline personality disorder in a broader Mexican population, a country that suffers with a major health issue with an increasing rate of mental disorders and scarce psychological and health coverage.

Feasibility and Effectiveness of a Workplace-Adapted Mindfulness-Based Programme to Reduce Stress in Workers at a Private Sector Logistics Company: An Exploratory Mixed Methods Study.

There is a high prevalence of stress in the logistics sector owing to very demanding, fast-paced and unpredictable tasks. Mindfulness-based programmes may reduce stress but require considerable practice. Our aim was to evaluate the feasibility and effectiveness of a shortened, workplace-adapted mindfulness-based programme for the logistics sector (WA-MBP-LS) for the purpose of reducing stress. A nonblinded, nonrandomised, two-arm controlled trial was conducted. The WA-MBP-LS (n = 32) consisted of six weekly 90-min mindfulness sessions. The control group (n = 36) attended a psycho-educational seminar. The Perceived Stress Scale (PSS) and Five Facets of Mindfulness Questionnaire (FFMQ) were measured at pretest, posttest and 6-month follow-up. Differences between groups were evaluated using mixed-effects models. Qualitative methods were used to analyse implementation issues. A 64.2% reduction was observed between initial volunteers and actual participants. Attrition at six-month follow-up was 45.6%. Participants attended a median of five sessions. Decreases in PSS favoured the WA-MBP-LS group at posttest and follow-up. FFMQ played a mediating role in PSS reductions. Barriers were disinterest, lack of programming, work overload and absences from work. Facilitators were curiosity, timing, company facilities and audio recordings. The WA-MBP-LS was feasible and effective in reducing stress, but more efforts to improve the practicalities of implementation are desirable.

Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Results From a Pilot Randomized Controlled Trial

Be a Mom is a self-guided web-based intervention, grounded in cognitive behavioral therapy, delivered to postpartum women to prevent persistent postpartum depression [PPD] symptoms. We aimed to evaluate Be a Mom in terms of its preliminary efficacy, feasibility, and acceptability. A pilot randomized, two-arm controlled trial was conducted. Eligible women (presenting PPD risk-factors and/or early-onset PPD symptoms) were enrolled in the study and were randomly assigned to the intervention (Be a Mom) or to the waiting-list control group. Participants in both groups completed baseline (T1) and postintervention (T2) assessments. The 194 women presenting risk factors/early-onset PPD symptoms were allocated to the intervention (n = 98) or to the control (n = 96) group. A significant Time × Group interaction effect was found for both depressive and anxiety symptoms, with women in the intervention group presenting a larger decrease in symptoms from T1 to T2 (p < .05). Less than half of the women (41.8%) completed Be a Mom. Most women (71.4%) would use Be a Mom again if needed. Results provide preliminary evidence of the Be a Mom’s efficacy, acceptability and feasibility, although further research is needed to establish Be a Mom as a selective/indicative preventive intervention for persistent PPD.

Learning How to Ask - Does a one-day training increase trauma inquiry in routine substance use disorder practice? Results of a cluster-randomized controlled trial

AimsTo examine the effectiveness of a one-day skills training program for increasing trauma inquiry in routine substance use disorder treatment. DesignCluster-randomized two-armed controlled trial, with 12 substance use disorder (SUD) organizations operating 25 counseling centers, randomly assigned to training in trauma inquiry (13 counseling centers of 8 SUD organizations) or no training (12 counseling centers of 4 SUD organizations). SettingSUD counseling centers in Northern Germany. CasesN = 5204 SUD counseling services. InterventionThe professionals assigned to the intervention group received a one-day training in trauma inquiry plus a 1.5-hour refresher session 3 months later. Professionals in the control group received no training. MeasuresOver a 12-month period, professionals documented for each counseling service whether they asked the client about four traumatic events: physical abuse, emotional abuse, sexual abuse and neglect. AnalysisPrimary outcomes were rates of asking about physical abuse, sexual abuse, emotional abuse and neglect in the 6 months after training. These were compared across conditions, while adjusting for baseline probabilities in the 6 months before training, using mixed-effects logistic regression. FindingsIn the 6 months after training, the rate of asking about physical abuse was 18% higher in the SUD counseling services of trained professionals, relative to services of untrained professionals (OR = 1.18, 95% CI = [1.01–1.37, p = .035]). No effect was found for asking about sexual abuse, emotional abuse and neglect. ConclusionA one-day training program in trauma inquiry, combined with a brief refresher session, was effective in increasing inquiries about physical abuse in routine counseling practice. The training was ineffective in increasing inquiries about sexual abuse, emotional abuse and neglect. The effectiveness of a one-day training of trauma inquiry might be increased by a longer training, or by combining it with additional elements, such as ongoing supervision.

Cognitive training for children and adolescents with fragile X syndrome: a randomized controlled trial of Cogmed

BackgroundIndividuals with fragile X syndrome (FXS) typically demonstrate profound executive function (EF) deficits that interfere with learning, socialization, and emotion regulation. We completed the first large, non-pharmacological controlled trial for FXS, designed to evaluate the efficacy of Cogmed, a computer/tablet-based working memory (WM) training program.MethodsThe study was a randomized, blinded, parallel two-arm controlled trial in 100 children and adolescents with FXS (63 male, 37 female; 15.28 ± 3.36 yrs.). Participants were randomized equally to adaptive (difficulty level adjusted to performance) or non-adaptive (control) Cogmed training. Participants were assessed at home using objective measures of WM (primary outcome) and EF at baseline, following 20–25 caregiver-supported sessions over 5–6 weeks, and at follow-up 3 months after cessation of training. Parents and teachers provided ratings of WM, attention, and EF.ResultsThe WM composite and selective domains of EF (distractibility, cognitive flexibility), as well as parent- and teacher-reported attention and EF, significantly improved across the full study sample, with many changes maintained at follow-up. However, comparisons of improvement between adaptive and non-adaptive control conditions did not differ, showing that progressively challenging the WM system by expanding span length did not provide added benefit overall.ConclusionsFurther experimental comparisons are needed before Cogmed working memory training can be considered empirically validated for children with FXS, forming the basis of treatment recommendation. However, given that prior studies show no significant changes on these measures in FXS without treatment, that improvements were maintained for 3 months, and that blinded teachers reported improvements in the classroom, the modest benefits seen in both adaptive and non-adaptive groups overall are unlikely to be attributable to placebo or practice effects alone. Future analyses examining inter-individual differences (e.g., baseline capacity, training efficiency, co-morbidity, training environment, characteristics of training aide) may help to link this intervention to outcomes and potential transfer effects.Trial registrationUS National Institutes of Health (ClinicalTrials.gov), NCT02747394.

Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: The Enhancement of Self-Regulatory Skills and Its Association With Postpartum Depressive Symptoms.

Aim: Be a Mom is a self-guided, web-based intervention to prevent persistent postpartum depression symptoms [PPD], targeting both at-risk postpartum women and/or women presenting early-onset postpartum depressive symptoms (selective/indicated preventive intervention). Be a Mom is grounded on the principles of Cognitive-Behavior Therapy and incorporates the recent contributions of acceptance and compassion-based approaches (third-wave approaches) applied to the perinatal context. This study aimed to explore the processes underlying therapeutic change in the Be a Mom intervention, by: (1) exploring whether participation in the Be a Mom promotes the enhancement of self-regulatory skills (emotion regulation abilities, psychological flexibility and self-compassion) in comparison with women who did not participate in the program; and (2) exploring whether changes in self-regulatory skills are associated with changes in depressive symptoms, among women who participated in the Be a Mom program.Methods: A pilot randomized, two-arm controlled trial was conducted. Eligible women (presenting PPD risk-factors and/or early-onset PPD symptoms) were enrolled in the study and were randomly assigned to the intervention group (Be a Mom, n = 98) or to the waiting-list control group (n = 96). Participants in both groups completed baseline (T1) and post-intervention assessments (T2), including measures of depressive symptoms, emotion regulation abilities, psychological flexibility and self-compassion.Results: From baseline to post-intervention assessment, women in the intervention group showed a significantly greater decrease in the levels of emotion regulation difficulties (p < 0.001) and a significant greater increase in the levels of self-compassion (p < 0.001) compared to the control group. No significant differences were found concerning psychological flexibility. Moreover, a greater decrease in difficulties in emotion regulation and greater increase in self-compassion levels were significantly associated with a greater decrease in depressive symptoms, among women in the intervention group.Discussion: Be a Mom promotes the enhancement of women’s emotion regulation abilities and self-compassion, and this seems to exert a protective effect in the presence of PPD risk factors (or early-onset symptoms) because it led to a reduction of depressive symptoms. By providing some insights into the processes that underlie treatment response to Be a Mom, this study highlights the important role of the targeted third-wave processes applied to the perinatal context.

Effect of induced chronic atrial fibrillation on exercise performance in Standardbred trotters.

BackgroundAtrial fibrillation (AF) is the most common arrhythmia affecting performance in horses. However, no previous studies have quantified the performance reduction in horses suffering from AF.ObjectivesTo quantify the effect of AF on maximum velocity (V max), maximum heart rate (HRmax), heart rate recovery (T 100), hematologic parameters and development of abnormal QRS complexes.AnimalsNine Standardbred trotters.MethodsTwo‐arm controlled trial. Six horses had AF induced by means of a pacemaker and 3 served as sham‐operated controls. All horses were subjected to an exercise test to fatigue before (SET1) and after (SET2) 2 months of AF or sham. The V max and HRmax were assessed using a linear mixed normal model. Abnormal QRS complexes were counted manually on surface ECGs.ResultsAtrial fibrillation resulted in a 1.56 m/sec decrease in V max (P < .0001). In the AF group, HRmax ± SD increased from 226 ± 11 bpm at SET1 to 311 ± 27 bpm at SET 2. The AF group had higher HRmax at SET2 compared with controls (P < .0001), whereas no difference between the control and AF groups was observed at SET1 (P = .96). Several episodes of wide complex tachycardia were observed during exercise in 3 of the AF horses during SET2.Conclusions and Clinical ImportanceAtrial fibrillation resulted in a significant reduction in performance, an increase in HR and development of abnormal QRS complexes during exercise, which may be a risk factor for collapse or sudden cardiac death.

Effectiveness of a Group Physiotherapy Intervention in Nontraumatic, Inoperable Painful Shoulder: A Randomized Clinical Trial.

The aim of the study was to assess the effectiveness of a group intervention in painful shoulder. This was a two-arm controlled clinical trial with a 5-wk follow-up and 1:1 allocation ratio with pretreatment and posttreatment assessments in a Spanish hospital in 2015-2016. This study comprised 74 patients with nontraumatic, inoperable painful shoulder. Patients were randomized into two groups: (1) in intervention, patients underwent group rehabilitation exercises supervised by a physical therapist and (2) in control, patients performed the same exercises as the intervention group but in their own home. The main variables were the differences preintervention and postintervention between scores on the visual analog scale, Constant-Murley scale, and Disabilities of the Arm, Shoulder and Hand scale. The mean differences in the main variables were compared between the two interventions (t test). Registration code is NCT02541279 (clinicaltrials.gov). Differences were found in favor of the intervention group: (1) visual analog scale = -0.1 (P = 0.723), (2) Constant-Murley = 4.1 (P = 0.085), and (3) Disabilities of the Arm, Shoulder and Hand = 14.7 (P < 0.001). Relevant improvements were obtained with our intervention in the Disabilities of the Arm, Shoulder and Hand scale.

Decreasing Inappropriate Use of Antibiotics in Primary Care in Four Countries in South America-Cluster Randomized Controlled Trial.

High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America. Very few interventions targeting general practitioners (GPs) to decrease inappropriate antibiotic prescribing have been investigated in this region. This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections (RTIs) attending primary care. The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media. Both are RTIs for which antibiotics have a very limited effect. A cluster randomized two-arm control trial was implemented. Healthcare centres from Bolivia, Argentina, Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were randomly allocated to either intervention or control group. During ten consecutive weeks, GPs in the intervention group received evidence-based online feedback on the management of suspected RTIs. In patients with acute bronchitis, the intervention reduced the antibiotic prescribing rate from 71.6% to 56% (control group from 61.2% to 52%). In patients with acute otitis media, the intervention reduced the antibiotic prescribing from 94.8% to 86.2% (no change in the control group). In all RTIs, the intervention reduced antibiotic prescribing rate from 37.4% to 28.1% (control group from 29% to 27.2%). Online evidence-based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America.

Healing effects of prolotherapy in treatment of knee osteoarthritis healing effects of prolotherapy in treatment of knee osteoarthritis

Pelotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a two-arm controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis (OA). A total of 104 adults with at least 6 months of painful primary knee OA were treated with dextrose prolotherapy (group I). They were divided into two subgroups: Ia and Ib. Subgroup Ia was treated with both techniques of prolotherapy (Hackett technique – classic, traditional prolotherapy – and Lyftgot technique – neural prolotherapy), whereas subgroup Ib was treated with the Hackett technique only. Extra-articular and intra-articular injections were administered at 1, 2, and 3 months, with as needed additional treatments at months 4 and 5. A total of 24 adults with at least 6 months of painful primary knee OA were treated with physiotherapy (group II). Outcome measures included the following: clinical assessment; visual analogue scale (VAS), 10; Western Ontario McMaster University Osteoarthritis Index (WOMAC), 96 points; plain radiographs; and musculoskeletal ultrasound. Postprocedure hot packs were applied, and at-home massage and exercises were taught. 128 Patients enrolled in the study were matched with each other for sex, age, disease durations, and BMI. Subgroups Ia and Ib reported a significant improvement as regards the clinical assessment, VAS, WOMAC, and radiological assessment at 12 months, compared with their baseline at month 0 and compared with group II (P ≤ 0.001). At 12 months, the mean ± SD of VAS was 0.32 ± 0.27 for subgroup Ia, 0.44 ± 0.5 for subgroup Ib, and 9.9 ± 1.65 for group II, and the mean ± SD of WOMAC was 11.32 ± 10.3 for subgroup Ia, 18.5 ± 10.25 for subgroup Ib, and 79.5 ± 22.63 for group II. Postprocedure application of hot packs, massage, and paracetamol resulted in diminution of injection-related pain. There were no adverse events. Prolotherapy resulted in clinically sustained improvement of pain, function, and radiological assessment, which means that the healing effects of prolotherapy is better than that of physiotherapy. The combination of the two prolotherapy techniques results in quicker and better improvement for patients in terms of the clinical assessment, VAS, and WOMAC.

715 Robotic kidney transplantation with regional hypothermia: Results from a prospective two-arm non-randomized controlled trial (Ideal phase 2b)

715 Robotic kidney transplantation with regional hypothermia: Results from a prospective two-arm non-randomized controlled trial (Ideal phase 2b)

The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults

IntroductionA theory within the social epidemiology field is that financial stress related to having inadequate financial savings may contribute to psychological stress, poor mental health and poor health-related behaviours among...