Parallel Assignment Research Articles

A snapshot of the ongoing clinical research on COVID-19.

The pandemic of coronavirus disease 2019 (COVID-19) presents an unprecedented challenge to rapidly develop new diagnostic, preventive and therapeutic strategies. Currently, thousands of new COVID-19 patients are quickly enrolled in clinical studies. We aimed to investigate the characteristics of the COVID-19 studies registered in ClinicalTrials.gov and report the extent to which they have incorporated features that are desirable for generating high-quality evidence. On April 28, 2020, a total of 945 studies on COVID-19 have been registered in ClinicalTrials.gov; 586 studies are interventional (62.0%), the most frequent allocation scheme is the parallel group assignment (437; 74.6%), they are open-label and the most common primary purpose is the research on treatment. Too many of the ongoing interventional studies have a small expected sample size and may not generate credible evidence at completion. This might lead to a delayed recognition of effective therapies that are urgently needed, and a waste of time and resources. In the COVID-19 pandemic era, it is crucial that the adoption of new diagnostic, preventive and therapeutic strategies is based upon evidence coming from well-designed, adequately powered and carefully conducted clinical trials.

Influence of Negative Calorie Foods on Atherogenic Indices in Overweight Women

Objective: The present study aimed to determine the effects of diet of negative calorie foods (NCF) on weight, atherogenic lipids, and atherogenic ratio and compare its efficiency with diet of low calorie foods (LCF). Materials and Methods: In this randomized clinical trial, the participants were randomly selected from inactive overweight females (age 45-75 years) by parallel assignment were distributed randomly into two groups: NCF group that received a highcarbohydrate (75%), and low-fat (10%) diet, and LCF group had a dietary recipe with 55% of carbohydrate and a little fat (30%) content. Both groups had a healthy calorie restriction (15%) from their daily caloric requirements within three months. Evaluation of body weight, atherogenic lipids (total-C, HDL-C and LDL-C), and atherogenic ratio (total-C to HDL-C) were performed pre- and postintervention for all subjects and compared to each other. Results: The results of the within-group comparison of NCF and LCF on weight (respectively, P -value= 0.04; P -value= 0.03), total-C (respectively, P -value= 0.02; P -value= 0.03), HDL-C (respectively, P -value= 0.04; P -value= 0.01) and LDL-C (respectively, P -value= 0.01; P -value= 0.03) revealed significant effects. Also, significant differences were observed between groups in atherogenic lipid profile, total-C ( P -value: 0.03), HDL-C ( P -value: 0.001), and LDL-C ( P -value: 0.03). The result of the between-group comparison was also significant in atherogenic ratio ( P -value: 0.04). Conclusion: Contrary to expectation, dietary regimen demonstrated a similar pattern of weight loss in females. The NCF when compared to the LCF, is not a healthy choice for weight loss in sedentary females with overweight.

Bilateral motor priming for post stroke upper extremity hemiparesis: A randomized pilot study.

Bilateral priming, device assisted bilateral symmetrical wrist flexion/extension, is a noninvasive neuromodulation technique that can be used in the clinic. We examined the additive effect of bilateral motor priming and task specific training in individuals with severe upper limb hemiparesis. This is a parallel assignment, single-masked, randomized exploratory pilot study with three timepoints (pre-/post-intervention and follow up). Participants received either bilateral motor priming or health care education followed by task specific training. Sixteen participants who were at least 6 months post-stroke and had a Fugl Meyer Upper Extremity (FMUE) score between 23 and 38 were randomized. Our primary and secondary measures were Chedoke Arm & Hand Activity Index 9 (CAHAI-9) and the FMUE respectively. We determined changes in interhemispheric inhibition using transcranial magnetic stimulation. We hypothesized that improvement in the priming group would persist at follow up. There was no between-group difference in the CAHAI. The improvement in the FMUE was significantly greater in the experimental group at follow up (t = 2.241, p = 0.045). Both groups improved in the CAHAI. There was a significant between-group difference in the secondary outcome measure (FMUE) where the bilateral priming group had an average increase of 10 points from pre-intervention to follow up.

Acceptability, Feasibility, and Preliminary Efficacy of a Resilience-Oriented Family Intervention to Prevent Adolescent HIV and Depression: A Pilot Randomized Controlled Trial.

We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression. South African adolescents, 13-15 years of age, with mild depressive symptoms, were randomized to intervention or wait-list using parallel assignment in a single-blind trial. HIV risk behavior and depression were evaluated at baseline, 1, and 3 months. We examined intervention satisfaction, fidelity, trial retention, and preliminary efficacy. One hundred-ninety-six adolescent-parent dyads completed eligibility screening and baseline, and n = 73 dyads were randomized. All families ranked intervention quality as good or excellent. Over 90% were satisfied with content. Facilitators were adherent to intervention protocol. All families were retained in post-intervention assessments. Intervention recipients reported diminished depressive symptoms, inconsistent condom use, and sexual activity, as well as increased HIV testing. Our Family Our Future is highly acceptable and feasible and should be tested in a future efficacy trial.

Ongoing Research Protocols for the Pharmacological Treatment of Neuropsychiatric Symptoms in Dementia.

The implementation of effective interventions for neuropsychiatric symptoms (NPS) is perceived as one of the most pressing research priorities in the field of dementia and one of the main unmet needs from the perspective of affected individuals and their caregivers and relatives. Nevertheless, to date, only a relatively marginal part of dementia research has focused on NPS. This study aimed to describe and discuss the state of the art concerning the identification and development of new pharmacological treatments for NPS in dementia. A review of 320 ongoing phase 1, 2, 3, and 4 protocols registered in the clinicaltrials.gov database was performed. All the trials enrolling patients with dementia were selected. Only studies adopting clinical measures of NPS frequency and/or severity as primary outcome were retained and analyzed. Overall, only a minority of ongoing phase 1, 2, 3 and 4 protocols on dementia (i.e., 9.0%) is primarily targeting NPS. Most of these studies are adopting a placebo-controlled parallel assignment design, testing oral compounds, and targeting specific NPS (mostly agitation and/or aggression). A total of 3,445 subjects with dementia will tentatively be recruited in these trials. The methodologies adopted in these studies, the characteristics of the tested interventions, the eligibility criteria, and the operational definitions of NPS are presented and discussed. The relevance of NPS is not yet matched by an adequate research effort. The current tendency at privileging disease-modifying approaches and other symptoms of dementia and the methodological complexity of studying NPS are still substantially contributing to the gap between research activities and clinical needs.

355 nm Photodissociation of N2O3 Revealed by Velocity-Mapped Ion Imaging.

Dinitrogen trioxide is proposed as a precursor to forming nitrous acid, an important source of hydroxyl radicals in the atmosphere. The spectroscopy and properties of N2O3 have been studied at high pressures or low temperatures, but there are no reports of its gas-phase photodissociation. This study investigates the 355 nm photodissociation of N2O3 in a DC-sliced velocity-mapped ion imaging apparatus using linearly polarized nanosecond pump and probe lasers. The N2O3 sample was generated by expanding NO and NO2 seeded in a He carrier gas. After photodissociation, a high fraction of the available energy ends up in translation of the products. Time-dependent density functional theory calculations confirm the parallel transition dipole assignment if the dissociation occurs from a nonplanar N2O3 conformation. The vector correlations are nearly at the physical limits for a system where μ||v⊥J. The DC-sliced velocity-mapped ion imaging technique is well-suited to investigate N2O3 photodissociation since it resolves product speeds and differentiates among the sources of NO+ in an expansion containing NO, NO2, HONO, and N2O3.

Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial

Background: The innovative treatment model Improving Access to Psychological Therapies (IAPT) and its Norwegian adaptation, Prompt Mental Health Care (PMHC), have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. Objective: To investigate the effectiveness of the PMHC treatment compared to treatment as usual (TAU) at 6-month follow-up. Methods: A randomized controlled trial with parallel assignment was performed in two PMHC sites (Sandnes and Kristiansand) and enrolled clients between November 9, 2015 and August 31, 2017. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression (Patient Health Questionnaire [PHQ-9]/Generalized Anxiety Disorder scale [GAD-7] scores above cutoff). These were randomly assigned (70:30 ratio; n = 463 to PMHC, n = 218 to TAU) with simple randomization within each site with no further constraints. The main outcomes were recovery rates and changes in symptoms of depression (PHQ-9) and anxiety (GAD-7) between baseline and follow-up. Primary outcome data were available for 73/67% in PMHC/TAU. Sensitivity analyses based on observed patterns of missingness were also conducted. Secondary outcomes were work participation, functional status, health-related quality of life, and mental well-being. Results: A reliable recovery rate of 58.5% was observed in the PMHC group and of 31.9% in the TAU group, equaling a between-group effect size of 0.61 (95% CI 0.37 to 0.85, p < 0.001). The differences in degree of improvement between PMHC and TAU yielded an effect size of –0.88 (95% CI –1.23 to –0.43, p < 0.001) for PHQ-9 and –0.60 (95% CI –0.90 to –0.30, p < 0.001) for GAD-7 in favor of PMHC. All sensitivity analyses pointed in the same direction, with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. PMHC was also more effective than TAU in improving all secondary outcomes, except for work participation (z = 0.415, p = 0.69). Conclusions: The PMHC treatment was substantially more effective than TAU in alleviating the burden of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access to effective treatment for adults who suffer from anxiety and mild to moderate depression. A potential effect on work participation needs further examination.

Effectiveness of Prompt Mental Health Care: Preliminary results from a randomized controlled trial

Abstract Background Prompt Mental Health Care (PMHC) service is a Norwegian initiative, adapted from the English ‘Improved Access to Psychological Therapy’ (IAPT), aimed at improving access to primary care treatment for anxiety and depression. Thus far, both PMHC and IAPT have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. This study investigates the effectiveness of PMHC compared to treatment as usual (TAU) at six months follow-up. Methods Randomized controlled trial with parallel assignment in two PMHC sites from November 2015 to March 2018. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression. These were randomly assigned on a 70:30 ratio. Main outcomes were recovery rates and changes in symptoms of depression and anxiety between baseline and follow-up. Primary outcome data were available for 73%/67% in the PMHC/TAU group. Sensitivity analyses based on observed patterns of missingness were conducted. Results A reliable recovery rate of 58.5% was observed in the PMHC group and 31.9% in the TAU group, yielding a between-group effect size (ES) of 0.61 [95% CI 0.37-0.85, p&amp;lt;.001]. The differences in degree of improvement between PMHC and TAU yielded an ES of -0.88 [95% CI -1.23-0.43, p &amp;lt; 0.001] for symptoms of depression and -0.60 [95% CI -0.90-0.30, p &amp;lt; 0.001] for symptoms of anxiety in favour of PMHC. All sensitivity analyses pointed in the same direction with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. Conclusions The PMHC treatment was substantially more effective than TAU in alleviating symptoms of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access of effective treatment for adults who suffer from anxiety and mild to moderate depression. Key messages This study is the first to evaluate the effectiveness of an IAPT-like treatment model in terms of a randomized controlled trial. Prompt Mental Health Care was substantially more effective than TAU in alleviating symptoms of depression and anxiety at 6-months follow-up.

Preventing violence against children in schools (PVACS): protocol for a cluster randomised controlled trial of the EmpaTeach behavioural intervention in Nyarugusu refugee camp

BackgroundWe aim to test the effectiveness of the EmpaTeach intervention to prevent physical violence from teachers to students in Nyarugusu Refugee Camp, Tanzania. EmpaTeach is a 10-week, 14-session, classroom management and cognitive-behavioural therapy-based intervention for groups of teachers for delivery by lay personnel in resource-constrained settings.MethodsWe will conduct a two-arm cluster randomized controlled trial (RCT) with parallel assignment and an approximately 1:1 allocation ratio. All primary and secondary schools in Nyarugusu will be invited to participate. Whole schools will be stratified according to whether they are Congolese or Burundian, and primary or secondary schools, then randomised to active intervention or wait-list control conditions via a public meeting with headteachers. We will collect survey data from n = 500 teachers and at least n = 1500 students before the intervention, soon after, and at least 6 months after the end of the intervention. The primary outcome measure will be students’ self-reports of experience of physical violence from school staff in the past week, measured using a modified version of the International Society for the Prevention of Child Abuse and Neglect Screening Tool-Child Institutional at the first follow-up after the intervention. Secondary outcomes include emotional violence, depressive symptoms and educational test scores. Analysis will be intention to treat, using repeat cross-sectional data from individuals.DiscussionIf successful, the EmpaTeach intervention would represent one of a handful of proven interventions to reduce violence from teachers to students in any setting. IRC provides an immediate platform for scale up of the intervention via its current work in more than 40 conflict-affected countries.Trial registrationNCT03745573, registered November 19, 2018 at clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT03745573.

Predictability of Nonremitting Depression After First 2Weeks of Antidepressant Treatment: A VAST-D Trial Report.

Objective:In this secondary analysis of data from the Veterans Affairs Augmentation and Switching Treatments for Improving Depression Outcomes (VAST‐D) study, the authors sought to determine the effectiveness of early improvement (or lack thereof) for predicting remission from depression with antidepressant therapy.Methods:This study used data from the VAST‐D study, a multisite, randomized, single‐blind trial with parallel assignment to one of three medication interventions for 1,522 veterans whose major depressive disorder was unresponsive to at least one course of antidepressant treatment meeting minimal standards for dosage and duration. The authors calculated the positive predictive value (PPV) and negative predictive value (NPV) of early improvement on remission, response, or greater than minimal improvement from depression for various degrees of improvement (10%–50%) on the Quick Inventory of Depressive Symptomatology–Clinician Rated (QIDS‐C) at 1, 2, 4, and 6 weeks.Results:The end of week 2 of treatment was identified as the best time to evaluate early improvement. The presence of a ≥20% drop from the baseline QIDS‐C score by the end of week 2 resulted in a PPV for remission of 38% and an NPV of 93% by week 12. Extending the observational window to week 6 minimally improved NPV (97%). This association did not differ across treatment groups.Conclusions:A lack of early improvement at the end of week 2 of antidepressant therapy can be used to inform clinical decisions on the likelihood of nonremission of depression during the subsequent 10 weeks, even when dosage optimization is incomplete.

Resistance training in patients with schizophrenia: Concept and proof of principle trial

Resistance training has been shown to contribute to the prevention and management of cardiovascular diseases, which is why it can help reducing morbidity and mortality in schizophrenia patients. Moreover, positive effects on different schizophrenia symptom domains have been proposed.However, a specific resistance training tailored to the needs of schizophrenia patients and its evaluation is still lacking. The objective in this proof of principle trial was to evaluate the feasibility and efficacy of a newly developed 12-week resistance program according to current recommendations of the WHO and the American College of Sports Medicine. We employed a single blind, parallel assignment clinical trial design with participants randomized to attend either a resistance training including three 50min units per week or a balance and tone program as control condition.The primary outcome was the impact on health-related difficulties assessed with the World Health Organization Disability Assessment Schedule (WHO-DAS). Secondary outcome parameters included the level of functioning, schizophrenia symptoms, selected cognitive parameters as well as risk factors for cardiovascular diseases.In our proof of principle trial, we could not find significant time or group effects of resistance training on the WHO-DAS. However, we could observe significant positive effects on the level of functioning assessed with the Global Assessment of Functioning Scale (GAF) over the course of time, which were more pronounced in the intervention group. Our findings indicated that patients with schizophrenia could safely participate in resistance training with relevant improvements in their level of functioning. Well-powered replication trials are needed to provide more efficacy data.

Making it work in free agent work: The coping practices of Swedish freelance journalists

Studies of post-industrial work have shown how workers are increasingly shouldering the risk of and the responsibility for social protection, work shortages, professional training, and securing a stream of continuous incoming work. This study of Swedish freelance journalists examines how these free agents cope with a situation whereby the need exists to actively bear the full responsibility for attracting and contracting, producing, and billing their work as journalists. The empirical material shows how freelancers engage in various coping practices to secure both sufficient amounts of work and the accompanying economic compensation. Freelancers who “make it work” are often those managing to embed themselves in long-standing relationships with clients and colleagues, thus ensuring a long-term work horizon and a steady income. Even so, the inherent “responsibilization” of contemporary work is amplified and intensified by the freelance work mode. This study makes two contributions: Firstly, it provides knowledge of free agent work in a Swedish context, a national setting that is often presumed to be a “role model” for good working conditions. Secondly, it highlights the specifics of managing work that entails a continuous stream of sequential and parallel assignments of limited duration and the ongoing “employment management work” this entails as regards making sure assignments keep “coming in”.

Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF)

BackgroundThe diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing “minor” amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care.MethodsIn this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain.ResultsAt 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p = 0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups.ConclusionThe results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded.Trial registrationClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).

Clinical Trial Registration and Reporting: Drug Therapy and Prevention of Cardiac-Related Infections

Objective: Clinical trials are the source of evidence. ClinicalTrials.gov is valuable for analyzing current conditions. Until now, the state of drug interventions for heart infections is unknown. The purpose of this study was to comprehensively assess the characteristics of trials on cardiac-related infections and the status of drug interventions. Methods: The website ClinicalTrials.gov was used to obtain all registered clinical trials on drug interventions for cardiac-related infections as of February 16, 2019. All registration studies were collected, regardless of their recruitment status, research results, and research type. Registration information, results, and weblink-publications of those trials were analyzed. Results: A total of 45 eligible trials were evaluated and 86.7% of them began from or after 2008 while 91.1% of them adopted interventional study design. Of all trials, 35.6% were completed and 15.6% terminated. Besides, 62.2% of interventional clinical trials recruited more than 100 subjects. Meanwhile, 86.7% of the eligible trials included adult subjects only. Of intervention trials, 65.8% were in the third or fourth phase; 78.1% adopted randomized parallel assignment, containing two groups; 53.6% were masking, and 61.0% described treatment. Moreover, 41.5% of the trials were conducted in North America while 29.3% in Europe. Sponsors for 40.0% of the studies were from the industry. Furthermore, 48.9% of the trials mentioned information on monitoring committees, 24.4% have been published online, and 13.3% have uploaded their results. Drugs for treatments mainly contained antibiotics, among which glycopeptides, β-lactams, and lipopeptides were the most commonly studied ones in experimental group, with the former ones more common. Additionally, 16.2% of the trials evaluated new antimicrobials. Conclusions: Most clinical trials on cardiac-related infections registered at ClinicalTrials.gov were interventional randomized controlled trials (RCTs) for treatment. Most drugs focused in trials were old antibiotics, and few trials reported valid results. It is necessary to strengthen supervision over improvements in results, and to combine antibacterial activity with drug delivery regimens to achieve optimal clinical outcomes.

Midazolam Sedation Induces Upper Limb Coordination Deficits That Are Reversed by Flumazenil in Patients with Eloquent Area Gliomas.

Midazolam has been found to exacerbate or unmask limb motor dysfunction in patients with brain tumors. This study aimed to determine whether the exacerbated upper limb motor-sensory deficits are mediated through benzodiazepine sites by demonstrating reversibility by flumazenil in patients with gliomas in eloquent areas. This was an interventional, parallel assignment, nonrandomized trial. Study subjects were admitted in the operating room. Patients with supratentorial eloquent area gliomas and volunteers of similar age without neurologic disease were sedated with midazolam, but still responsive and cooperative. Motor and sensory functions for upper extremities were evaluated by the Nine-Hole Peg Test before and after midazolam, as well as after flumazenil reversal. Thirty-two cases were included: 15 in the glioma group and 17 in the control group. The total dose of midazolam and flumazenil were comparable between the groups. In the glioma group, the times to task completion after midazolam in the contralateral hand (P = 0.001) and ipsilateral hand (P = 0.002) were 26.5 (95% CI, 11.3 to 41.7) and 13.7 (95% CI, 5.0 to 22.4) seconds slower than baseline, respectively. After flumazenil reversal, the contralateral hand (P = 0.99) and ipsilateral hand (P = 0.187) performed 1.2 (95% CI, -3.3 to 5.8) and 1.5 (95% CI, -0.5 to 3.5) seconds slower than baseline, respectively. In the control group, the dominant (P < 0.001) and nondominant hand (P = 0.006) were 2.9 (95% CI, 1.4 to 4.3) and 1.7 (95% CI, 0.5 to 2.9) seconds slower than baseline, respectively. After flumazenil, the dominant hand (P = 0.99) and nondominant hand (P = 0.019) performed 0.2 (95% CI, -0.7 to 1.0) and 1.3 (95% CI, -0.2 to 2.4) seconds faster than baseline, respectively. In patients with eloquent area gliomas, mild sedation with midazolam induced motor coordination deficits in upper limbs. This deficit was almost completely reversed by the benzodiazepine antagonist flumazenil, suggesting that this is a reversible abnormality linked to occupation of the receptor by midazolam.

39-LB: Individualised Screening for Diabetic Retinopathy: The ISDR Study—A Randomised Controlled Trial of Safety, Efficacy, and Cost-Effectiveness

Background: Varying the intervals in retinopathy screening informed by personal risk offers reallocation of resources to better target high risk groups and address the increasing prevalence of diabetes. However, safety data especially on extended intervals is minimal. Aim: To evaluate the safety, efficacy and cost effectiveness (CE) of individualized variable-interval risk-based screening in a population setting compared to usual care. Methods: Masked 2 arm, parallel assignment, equivalence RCT (largest to date in screening) with independent trials unit monitoring in people with diabetes aged ≥12 years attending screening in a single English program. Randomization was 1:1 to individualized screening (active group; 6, 12 or 24 months for high, medium and low risk) determined by a risk calculation engine using real-time local demographic, retinal and clinical data, compared with annual screening (control). CE analysis measuring NHS and societal costs took a 2-year time horizon. Findings: 4534 participants entered the study - after withdrawals/loss to follow-up: active 2097; control 2224. Attendance rates at first follow-up visit (primary outcome, safety) were equivalent (per protocol analysis, 5% margin): active 83.6% control 84.7% (difference 1.0, 90% CI -0.8, 2.9). STDR detection rates were non-inferior (1.5% margin): active 1.43% control 1.71% (difference -0.28, CI -0.93, 0.36). Quality of life (EQ5D5L, HUI3) was not significantly different between the groups. Incremental cost saving per person was £18.75 (NHS cost) rising to £49.96 with societal costs. A 39.3% reduction in number of appointments was seen. Conclusions: All parties involved in diabetes care can be reassured that extended and personalized screening intervals can safely be introduced in established screening program. Scale-up with further validation outside a research setting is recommended. Views expressed are solely those of the authors. Disclosure D.M. Broadbent: None. A. Wang: None. C.P. Cheyne: None. J.G. Lathe: None. I.M. Stratton: Consultant; Self; Novo Nordisk A/S. Research Support; Self; Bayer AG, Boehringer Ingelheim International GmbH. J. Vora: None. M. Garcia-Finana: None. M. James: None. S.P. Harding: None. Funding UK National Institute for Health Research

Monitor link assignment for reentry users based on BeiDou inter-satellite links

The BeiDou Navigation Satellite System (BDS) has equipped its new-generation satellites with inter-satellite link (ISL) payloads to improve navigation services and system operation. When the inter-satellite ranging and communication are satisfied, we analyze the exploitation of the spare ISL capability for serving atmospheric reentry users. These users can be monitored over the atmospheric reentry segment with ISL transmission, even in the absence of visibility to ground stations and escaping the blackout. We modeled the problem and proposed a link assignment method combining parallel assignment of ISLs and dynamic access of monitor links. First, ISLs were assigned for inter-satellite ranging and communication, which were quantified with the number of different links and timeslot delays respectively. Corresponding assignment algorithm operated in the stations and the computing resource was abundant. Therefore, the heuristic algorithm was used to search the shortest route and the fitness function was determined with a shortest path algorithm. Based on the ISL assignment, extended users were accessed to the ISL network dynamically without influencing performances of the constellation. Because of the uncertainty of users’ states, the monitor link assignment was implemented onboard with short-term predicted states and therefore the computing resource was scarce. Short-term predicted states conquered the deviation of satellite-user visibility. And a simple smallest delay strategy was used to determine the access nodes for users. To evaluate performances of the algorithm, link assignments were implemented for the BeiDou global constellation with 3 users. Each satellite was linked with at least 10 satellites and communicated with stations within 3 timeslots on the basis of ISL assignments. The assignment of monitor links demonstrated the user access did not influence the ranging and communication index of the ISL network and 1-, 2-, and 3-timeslot route delays of users occupy the main parts and the total ratio is larger than 95%.

Safety, Efficacy and Cost Effectiveness of Individualised Screening for Diabetic Retinopathy: The ISDR Randomised Controlled Trial

Background: Varying diabetic retinopathy (DR) screening intervals, informed by personal risk-levels, empowers people with diabetes (PWD), and offers reallocation of resources to high risk groups, while addressing the increasing prevalence of diabetes. Safety data on extending intervals is minimal. We evaluated the safety, efficacy and cost effectiveness of individualised risk-based variable-interval population screening compared to usual care, with design input from PWD. Methods: Two-arm, parallel assignment, equivalence randomised controlled trial (minimum 2 year follow-up) in PWD aged ≥12 years registered with one English screening programme. Randomisation was 1:1 to individualised screening (6, 12 or 24 months for high, medium and low risk) determined by a risk calculation engine, using local demographic, screening and clinical data, or to annual screening (control). Primary outcome was attendance (safety). A secondary safety outcome was the development of sight threatening DR (STDR). Cost effectiveness was evaluated within a 2 year time horizon from NHS and societal perspectives. Findings: 4534 participants were randomised, 2265 to the individualised and 2269 to the control arm. Attendance rates at first follow-up were equivalent between individualised (1754/2097, 83·6%) and control (1883/2224, 84·7%) arms (difference -1·0, 95% CI -3·2 to 1·2). STDR detection rates were non-inferior: individualised 1·4%, control 1·7% (- 0·3, -1·1 to 0·5). Sensitivity analyses confirmed findings. Incremental QALYs/person were non-significant: EQ-5D-5L 0·035 (CI -0·04, 0·13), HUI3 0·009 (CI -0·09, 0·10). Incremental cost savings were £21·31 (CI 15·24, 26·79)/person for the NHS and £28·87 (CI 21·08, 35·78) including societal costs. 43·2% fewer screening appointments were required in the individualised arm. Interpretation: Stakeholders involved in diabetes care can be reassured by this largest ophthalmic RCT in DR screening to date that extended and individualised risk-based intervals can be safely and cost effectively introduced in established screening programmes. Trial Registration Number: ISRCTN 87561257. Funding Statement: This study was funded by the UK National Institute for Health Research (NIHR) (Programme Grants for Applied Research, RP-PG-1210-12016). Declaration of Interests: We declare no competing interests. Professor Mark Gabbay is part-funded by the NIHR Collaboration for Leadership in Applied Health Research and Care North West Coast. Ethics Approval Statement: A UK NHS Research Ethics Committee approved the trial (14/NW/0034).

Effects of Dance/Movement Training vs. Aerobic Exercise Training on cognition, physical fitness and quality of life in older adults: A randomized controlled trial

IntroductionIt is generally accepted that physical activity promotes healthy aging. Recent studies suggest dance could also benefit cognition and physical health in seniors, but many styles and approaches of dance exist and rigorous designs for intervention studies are still scarce. The aim of this study was to compare the effects of Dance/Movement Training (DMT) to Aerobic Exercise Training (AET) on cognition, physical fitness and health-related quality of life in healthy inactive elderly. MethodsA single-center, randomized, parallel assignment, open label trial was conducted with 62 older adults (mean age = 67.48 ± 5.37 years) recruited from the community. Participants were randomly assigned to a 12-week (3x/week, 1hr/session) DMT program, AET program or control group. Cognitive functioning, physical fitness and health-related quality of life were assessed at baseline (T-0), and post-training (T-12 weeks). Results41 participants completed the study. Executive and non-executive composite scores showed a significant increase post-training (F(1,37) = 4.35, p = .04; F(1,37) = 7.01, p = .01). Cardiovascular fitness improvements were specific to the AET group (F(2,38) = 16.40, p < .001) while mobility improvements were not group-dependent (10 m walk: F(1,38) = 11.67, p = .002; Timed up and go: F(1,38) = 22.07, p < .001). ConclusionsResults suggest that DMT may have a positive impact on cognition and physical functioning in older adults however further research is needed. This study could serve as a model for designing future RCTs with dance-related interventions. Registrationclinicaltrials. gov Identifier NCT02455258.

Perineal massage and training reduce perineal trauma in pregnant women older than 35years: a randomized controlled trial.

The aim of this study was to evaluate the effectiveness of perineal massage, pelvic floor muscle training (PFMT) and a pelvic floor dysfunction (PFD) prevention educational program in pregnant women above the age of 35 years to prevent perineal tear and episiotomy. A randomized parallel assignment study involved two groups of pregnant women at the obstetrics outpatient clinic 4weeks prior to their due date. The first group (n = 200) was educated to do digital perineal massage and pelvic floor muscle training and received an educational PFD prevention program. The second group (n = 200) received only the prevention education program. Occurrence of perineal laceration was reported at time of delivery as a primary outcome. Statistical analysis was done using the IBM SPSS computer program (Statistical Package for the Social Sciences; IBM Corp, Armonk, NY, USA), release 22 for Microsoft Windows. Delivery was significantly less complicated by perineal tear, episiotomy and postnatal pain in the first than in the second group (p < 0.05). Grades of perineal tear were mostly of first and second degree in the first group compared with the second group. We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively). Performing antenatal digital perineal massage and PFMT in addition to health education is recommended to reduce perineal complications.