CONSORT 2010 statement: extension to randomised crossover trials.

Evidence shows the quality of reporting of randomised controlled trials is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings, prevents researchers from extracting information for systematic reviews, and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of randomised controlled trials. The primary focus of the statement was on parallel group trials with two treatment groups. Crossover trials are a particular type of trial for chronic conditions in which participants are randomised to a sequence of interventions. They are a useful and efficient design because participants act as their own control. However, the reporting of crossover trials has been variable and incomplete, which hinders their use in clinical decision making and by future researchers. We present the CONSORT extension to randomised crossover trials, which aims to facilitate better reporting of crossover trials. The CONSORT 2010 checklist is revised for crossover designs, and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence based rationale for CONSORT crossover checklist items are provided

Environmental and behavioural interventions for reducing physical activity limitation and preventing falls in older people with visual impairment

BACKGROUND: Impairment of vision is associated with a decrease in activities of daily living. Avoidance of physical activity in older adults with visual impairment can lead to functional decline and is an important risk factor for falls. The rate of falls and fractures is higher in older people with visual impairment than in age‐matched visually normal older people. Possible interventions to reduce activity restriction and prevent falls include environmental and behavioral interventions. OBJECTIVES: We aimed to assess the effectiveness and safety of environmental and behavioral interventions in reducing physical activity limitation, preventing falls and improving quality of life amongst visually impaired older people. SEARCH METHODS: We searched CENTRAL (including the Cochrane Eyes and Vision Trials Register) (Issue 2, 2020), Ovid MEDLINE, Embase and eight other databases to 4 February 2020, with no language restrictions. SELECTION CRITERIA: Eligible studies were randomized controlled trials (RCTs) and quasi‐randomized controlled trials (Q‐RCTs) that compared environmental interventions, behavioral interventions or both, versus control (usual care or no intervention); or that compared different types of environmental or behavioral interventions. Eligible study populations were older people (aged 60 and over) with irreversible visual impairment, living in their own homes or in residential settings. To be eligible for inclusion, studies must have included a measure of physical activity or falls, the two primary outcomes of interest. Secondary outcomes included fear of falling, and quality of life. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included six RCTs (686 participants) conducted in five countries (Australia, Hungary, New Zealand, UK, US) with follow‐up periods ranging from two to 12 months. Participants in these trials included older adults (mean age 80 years) and were mostly female (69%), with visual impairments of varying severity and underlying causes. Participants mostly lived in their homes and were physically independent. We classified all trials as having high risk of bias for masking of participants, and three trials as having high or unclear risk of bias for all other domains. The included trials evaluated various intervention strategies (e.g. an exercise program versus home safety modifications). Heterogeneity of study characteristics, including interventions and outcomes, (e.g. different fall measures), precluded any meta‐analysis. Two trials compared the home safety modification by occupational therapists versus social/home visits. One trial (28 participants) reported physical activity at six months and showed no evidence of a difference in mean estimates between groups (step counts: mean difference (MD) = 321, 95% confidence interval (CI) ‐1981 to 2623; average walking time (minutes): MD 1.70, 95% CI ‐24.03 to 27.43; telephone questionnaire for self‐reported physical activity: MD ‐3.68 scores, 95% CI ‐20.6 to 13.24; low‐certainty of evidence for each outcome). Two trials reported the proportion of participants who fell at six months (risk ratio (RR) 0.76, 95% CI 0.38 to 1.51; 28 participants) and 12 months (RR 0.59, 95% CI 0.43 to 0.80, 196 participants) with low‐certainty of evidence for each outcome. One trial (28 participants) reported fear of falling at six months, using the Short Falls Efficacy Scale‐International, and found no evidence of a difference in mean estimates between groups (MD 2.55 scores, 95% CI ‐0.51 to 5.61; low‐certainty of evidence). This trial also reported quality of life at six months using 12‐Item Short Form Health Survey, and showed no evidence of a difference in mean estimates between groups (MD ‐3.14 scores, 95% CI ‐10.86 to 4.58; low‐certainty of evidence). Five trials compared a behavioral intervention (exercise) versus usual activity or social/home visits. One trial (59 participants) assessed self‐reported physical activity at six months and showed no evidence of a difference between groups (MD 9.10 scores, 95% CI ‐13.85 to 32.5; low‐certainty of evidence). Three trials investigated different fall measures at six or 12 months, and found no evidence of a difference in effect estimates (RRs for proportion of fallers ranged from 0.54 (95% CI 0.29 to 1.01; 41 participants); to 0.93 (95% CI 0.61 to 1.39; 120 participants); low‐certainty of evidence for each outcome). Three trials assessed the fear of falling using Short Falls Efficacy Scale‐International or the Illinois Fear of Falling Measure from two to 12 months, and found no evidence of a difference in mean estimates between groups (the estimates ranged from ‐0.88 score (95% CI ‐2.72 to 0.96, 114 participants) to 1.00 score (95% CI ‐0.13 to 2.13; 59 participants); low‐certainty of evidence). One trial (59 participants) assessed the European Quality of Life scale at six months (MD ‐0.15 score, 95% CI ‐0.29 to ‐0.01), and found no evidence of a clinical difference between groups (low‐certainty of evidence). AUTHORS' CONCLUSIONS: There is no evidence of effect for most of the environmental or behavioral interventions studied for reducing physical activity limitation and preventing falls in visually impaired older people. The certainty of evidence is generally low due to poor methodological quality and heterogeneous outcome measurements. Researchers should form a consensus to adopt standard ways of measuring physical activity and falls reliably in older people with visual impairments. Fall prevention trials should plan to use objectively measured or self‐reported physical activity as outcome measures of reduced activity limitation. Future research should evaluate the acceptability and applicability of interventions, and use validated questionnaires to assess the adherence to rehabilitative strategies and performance during activities of daily living

Cochrane Eyes and Vision: a perspective introducing Cochrane Corner in Eye.

In 1972, Archie Cochrane wrote "It is surely a great criticism of our profession that we have not organised a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomised controlled trials". The Cochrane Collaboration arose in response to Archie Cochrane's challenge. Cochrane Eyes and Vision aims to prepare and promote access to systematic reviews of interventions for preventing or treating eye conditions and/or visual impairment, and helping people adjust to visual impairment or blindness. To identify all relevant randomised controlled trials, Cochrane Eyes and Vision has a team of information specialists who develop search strategies to identify studies for inclusion in Cochrane reviews. Since 1997 we have published 266 protocols, 193 new reviews and 158 updated reviews. The majority of these are reviews of intervention effectiveness; three reviews are diagnostic test accuracy reviews. Overall 18% of reviews contain no trials, highlighting a potential evidence gap. We provide training, education and guidance to systematic review authors and work with clinical and patient partners to prioritise and disseminate reviews. In addition, Cochrane Eyes and Vision US satellite carries out critical methodologic research addressing topics relevant to producing high-quality reviews. We are partnering with the journal Eye to publish commentaries on selected Cochrane systematic review findings. This partnership will allow us to make high-quality evidence available to ophthalmologists and other practitioners, researchers, policy makers and patients

Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices.

BackgroundMany therapeutic options are available to glaucoma patients. One recent therapeutic option is minimally invasive glaucoma surgical (MIGS) devices. It is unclear how patients view different treatments and which patient-reported outcomes would be most relevant in patients with mild to moderate glaucoma. We developed a questionnaire for patients eligible for MIGS devices and a patient preference study to examine the value patients place on certain outcomes associated with glaucoma and its therapies.ObjectivesTo summarize the progress to date.MethodsQuestionnaire development: We drafted the questionnaire items based on input from one physician and four patient focus groups, and a review of the literature. We tested item clarity with six cognitive interviews. These items were further refined. Patient preference study: We identified important benefit and risk outcomes qualitatively using semi-structured, one-on-one interviews with patients who were eligible for MIGS devices. We then prioritized these outcomes quantitatively using best-worst scaling methods.ResultsQuestionnaire testing: Three concepts were deemed relevant for the questionnaire: functional limitations, symptoms, and psychosocial factors. We will evaluate the reliability and validity of the 52-item draft questionnaire in an upcoming field test. Patient preference study: We identified 13 outcomes that participants perceived as important. Outcomes with the largest relative importance weights were "adequate IOP control" and "drive a car during the day."ConclusionsPatients have the potential to steer clinical research towards outcomes that are important to them. Incorporating patients' perspectives into the MIGS device development and evaluation process may expedite innovation and availability of these devices

Dynamic Transformation of Nano-MoS2 in a Soil-Plant System Empowers Its Multifunctionality on Soybean Growth

Molybdenum disulfide (nano-MoS2) nanomaterials have shown great potential for biomedical and catalytic applications due to their unique enzyme-mimicking properties. However, their potential agricultural applications have been largely unexplored. A key factor prior to the application of nano-MoS2 in agriculture is understanding its behavior in a complex soil-plant system, particularly in terms of its transformation. Here, we investigate the distribution and transformation of two types of nano-MoS2 (MoS2 nanoparticles and MoS2 nanosheets) in a soil-soybean system through a combination of synchrotron radiation-based X-ray absorption near-edge spectroscopy (XANES) and single-particle inductively coupled plasma mass spectrometry (SP-ICP-MS). We found that MoS2 nanoparticles (NPs) transform dynamically in soil and plant tissues, releasing molybdenum (Mo) and sulfur (S) that can be incorporated gradually into the key enzymes involved in nitrogen metabolism and the antioxidant system, while the rest remain intact and act as nanozymes. Notably, there is 247.9 mg/kg of organic Mo in the nodule, while there is only 49.9 mg/kg of MoS2 NPs. This study demonstrates that it is the transformation that leads to the multifunctionality of MoS2, which can improve the biological nitrogen fixation (BNF) and growth. Therefore, MoS2 NPs enable a 30% increase in yield compared to the traditional molybdenum fertilizer (Na2MoO4). Excessive transformation of MoS2 nanosheets (NS) leads to the overaccumulation of Mo and sulfate in the plant, which damages the nodule function and yield. The study highlights the importance of understanding the transformation of nanomaterials for agricultural applications in future studies.</p

COVID-19 randomised trial protocols : Rapid publication without barriers

Peer reviewedPublisher PD

Интеграционные процессы на постсоветском пространстве

Основываясь на теоретических и эмпирических методах исследованиях, был изучен процесс становления и развития интеграционных процессов на постсоветском пространстве. В результате изученного материала был разработан проект дальнейшего развития отношений, включающего три потенциальных сценария

Multi-contrast atherosclerosis characterization (MATCH) of carotid plaque with a single 5-min scan: technical development and clinical feasibility

BACKGROUND: Multi-contrast weighted imaging is a commonly used cardiovascular magnetic resonance (CMR) protocol for characterization of carotid plaque composition. However, this approach is limited in several aspects including low slice resolution, long scan time, image mis-registration, and complex image interpretation. In this work, a 3D CMR technique, named Multi-contrast Atherosclerosis Characterization (MATCH), was developed to mitigate the above limitations. METHODS: MATCH employs a 3D spoiled segmented fast low angle shot readout to acquire data with three different contrast weightings in an interleaved fashion. The inherently co-registered image sets, hyper T1-weighting, gray blood, and T2-weighting, are used to detect intra-plaque hemorrhage (IPH), calcification (CA), lipid-rich necrotic core (LRNC), and loose-matrix (LM). The MATCH sequence was optimized by computer simulations and testing on four healthy volunteers and then evaluated in a pilot study of six patients with carotid plaque, using the conventional multi-contrast protocol as a reference. RESULTS: On MATCH images, the major plaque components were easy to identify. Spatial co-registration between the three image sets with MATCH was particularly helpful for the reviewer to discern co-existent components in an image and appreciate their spatial relation. Based on Cohen’s kappa tests, moderate to excellent agreement in the image-based or artery-based component detection between the two protocols was obtained for LRNC, IPH, CA, and LM, respectively. Compared with the conventional multi-contrast protocol, the MATCH protocol yield significantly higher signal contrast ratio for IPH (3.1 ± 1.3 vs. 0.4 ± 0.3, p < 0.001) and CA (1.6 ± 1.5 vs. 0.7 ± 0.6, p = 0.012) with respect to the vessel wall. CONCLUSIONS: To the best of our knowledge, the proposed MATCH sequence is the first 3D CMR technique that acquires spatially co-registered multi-contrast image sets in a single scan for characterization of carotid plaque composition. Our pilot clinical study suggests that the MATCH-based protocol may outperform the conventional multi-contrast protocol in several respects. With further technical improvements and large-scale clinical validation, MATCH has the potential to become a CMR method for assessing the risk of plaque disruption in a clinical workup