CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

Radiographic analysis of femoroacetabular impingement with Hip2Norm-reliable and validated

The purpose of this study was to validate the accuracy, consistency, and reproducibility/reliability of a new method for correction of pelvic tilt and rotation of radiographic hip parameters for pincer type of femoroacetabular impingement on an anteroposterior pelvic radiograph. Thirty cadaver hips and 100 randomized, blinded AP pelvic radiographs were used for investigation. To detect the software accuracy, the calculated femoral head coverage and classic hip parameters determined with our software were compared to reference measurements based on CT scans or conventional radiographs in a neutral orientation as gold standard. To investigate software consistency, differences among the different parameters for each cadaver pelvis were calculated when reckoned back from a random to the neutral orientation. Intra- and interobserver comparisons were used to analyze the reliability and reproducibility of all parameters. All but two parameters showed a good-to-very good accuracy with the reference measurements. No relevant systematic errors were detected in the Bland-Altman analysis. Software consistency was good-to-very good for all parameters. A good-to-very good reliability and reproducibility was found for a substantial number of the evaluated radiographic acetabular parameters. The software appears to be an accurate, consistent, reliable, and reproducible method for analysis of acetabular pathomorphologies.

Index of Complexity, Outcome and Need scored on plaster and digital models

The aim of this study was to compare standard plaster models with their digital counterparts for the applicability of the Index of Complexity, Outcome, and Need (ICON). Generated study models of 30 randomly selected patients: 30 pre- (T(0)) and 30 post- (T(1)) treatment. Two examiners, calibrated in the ICON, scored the digital and plaster models. The overall ICON scores were evaluated for reliability and reproducibility using kappa statistics and reliability coefficients. The values for reliability of the total and weighted ICON scores were generally high for the T(0) sample (range 0.83-0.95) but less high for the T(1) sample (range 0.55-0.85). Differences in total ICON score between plaster and digital models resulted in mostly statistically insignificant values (P values ranging from 0.07 to 0.19), except for observer 1 in the T(1) sample. No statistically different values were found for the total ICON score on either plaster or digital models. ICON scores performed on computer-based models appear to be as accurate and reliable as ICON scores on plaster models.

A Routing Protocol Based on Energy and Link Quality for Internet of Things Applications

The Internet of Things (IoT) is attracting considerable attention from the universities, industries, citizens and governments for applications, such as healthcare, environmental monitoring and smart buildings. IoT enables network connectivity between smart devices at all times, everywhere, and about everything. In this context, Wireless Sensor Networks (WSNs) play an important role in increasing the ubiquity of networks with smart devices that are low-cost and easy to deploy. However, sensor nodes are restricted in terms of energy, processing and memory. Additionally, low-power radios are very sensitive to noise, interference and multipath distortions. In this context, this article proposes a routing protocol based on Routing by Energy and Link quality (REL) for IoT applications. To increase reliability and energy-efficiency, REL selects routes on the basis of a proposed end-to-end link quality estimator mechanism, residual energy and hop count. Furthermore, REL proposes an event-driven mechanism to provide load balancing and avoid the premature energy depletion of nodes/networks. Performance evaluations were carried out using simulation and testbed experiments to show the impact and benefits of REL in small and large-scale networks. The results show that REL increases the network lifetime and services availability, as well as the quality of service of IoT applications. It also provides an even distribution of scarce network resources and reduces the packet loss rate, compared with the performance of well-known protocols.

Privacy Panel: Usable and Quantifiable Mobile Privacy

The ever increasing popularity of apps stems from their ability to provide highly customized services to the user. The flip side is that in order to provide such services, apps need access to very sensitive private information about the user. This leads to malicious apps that collect personal user information in the background and exploit it in various ways. Studies have shown that current app vetting processes which are mainly restricted to install time verification mechanisms are incapable of detecting and preventing such attacks. We argue that the missing fundamental aspect here is a comprehensive and usable mobile privacy solution, one that not only protects the user's location information, but also other equally sensitive user data such as the user's contacts and documents. A solution that is usable by the average user who does not understand or care about the low level technical details. To bridge this gap, we propose privacy metrics that quantify low-level app accesses in terms of privacy impact and transforms them to high-level user understandable ratings. We also provide the design and architecture of our Privacy Panel app that represents the computed ratings in a graphical user-friendly format and allows the user to define policies based on them. Finally, experimental results are given to validate the scalability of the proposed solution.

The International ADHD in Substance Use Disorders Prevalence (IASP) study: background, methods and study population

Attention deficit/hyperactivity disorder (ADHD) is an increasingly recognized comorbid condition in subjects with substance use disorders (SUDs). This paper describes the methods and study population of the International ADHD in Substance Use Disorders Prevalence (IASP) study. Objectives of the IASP are to determine the prevalence of ADHD in adult treatment seeking patients with SUD in different countries and SUD populations, determine the reliability and validity of the Adult ADHD Self-report Scale V 1.1 (ASRS) as ADHD screening instrument in SUD populations, investigate the comorbidity profile of SUD patients with and without ADHD, compare risk factors and protective factors in SUD patients with and without a comorbid diagnosis of ADHD, and increase our knowledge about the relationship between ADHD and the onset and course of SUD. In this cross-sectional, multi-centre two stage study, subjects were screened for ADHD with the ASRS, diagnosed with the Conner's Adult ADHD Diagnostic Interview for DSM-IV (CAADID), and evaluated for SUD, major depression, bipolar disorder, anti social personality disorder and borderline personality disorder. Three thousand five hundred and fifty-eight subjects from 10 countries were included. Of these 40.9% screened positive for ADHD. This is the largest international study on this population evaluating ADHD and comorbid disorders.

Survey estimation and marginal effects in Stata

Stata is a general purpose software package that has become popular among various disciplines such as epidemiology, economics, or social sciences. Users like Stata for its scientific approach, its robustness and reliability, and the ease with which its functionality can be extended by user written programs. In this talk I will first give a brief overview of the functionality of Stata and then discuss two specific features: survey estimation and predictive margins/marginal effects. Most surveys are based on complex samples that contain multiple sampling stages, are stratified or clustered, and feature unequal selection probabilities. Standard estimators can produce misleading results in such samples unless the peculiarities of the sampling plan are taken into account. Stata offers survey statistics for complex samples for a wide variety of estimators and supports several variance estimation procedures such as linearization, jackknife, and balanced repeated replication (see Kreuter and Valliant, 2007, Stata Journal 7: 1-21). In the talk I will illustrate these features using applied examples and I will also show how user written commands can be adapted to support complex samples. Complex can also be the models we fit to our data, making it difficult to interpret them, especially in case of nonlinear or non-additive models (Mood, 2010, European Sociological Review 26: 67-82). Stata provides a number of highly useful commands to make results of such models accessible by computing and displaying predictive margins and marginal effects. In my talk I will discuss these commands provide various examples demonstrating their use.

The Swiss Neonatal Quality Cycle, a monitor for clinical performance and tool for quality improvement

BACKGROUND We describe the setup of a neonatal quality improvement tool and list which peer-reviewed requirements it fulfils and which it does not. We report on the so-far observed effects, how the units can identify quality improvement potential, and how they can measure the effect of changes made to improve quality. METHODS Application of a prospective longitudinal national cohort data collection that uses algorithms to ensure high data quality (i.e. checks for completeness, plausibility and reliability), and to perform data imaging (Plsek's p-charts and standardized mortality or morbidity ratio SMR charts). The collected data allows monitoring a study collective of very low birth-weight infants born from 2009 to 2011 by applying a quality cycle following the steps 'guideline - perform - falsify - reform'. RESULTS 2025 VLBW live-births from 2009 to 2011 representing 96.1% of all VLBW live-births in Switzerland display a similar mortality rate but better morbidity rates when compared to other networks. Data quality in general is high but subject to improvement in some units. Seven measurements display quality improvement potential in individual units. The methods used fulfil several international recommendations. CONCLUSIONS The Quality Cycle of the Swiss Neonatal Network is a helpful instrument to monitor and gradually help improve the quality of care in a region with high quality standards and low statistical discrimination capacity.

Coloured Letters and Numbers (CLaN): A reliable factor-analysis based synaesthesia questionnaire

Synaesthesia is a heterogeneous phenomenon, even when considering one particular sub-type. The purpose of this study was to design a reliable and valid questionnaire for grapheme-colour synaesthesia that captures this heterogeneity. By the means of a large sample of 628 synaesthetes and a factor analysis, we created the Coloured Letters and Numbers (CLaN) questionnaire with 16 items loading on 4 different factors (i.e., localisation, automaticity/attention, deliberate use, and longitudinal changes). These factors were externally validated with tests which are widely used in the field of synaesthesia research. The questionnaire showed good test–retest reliability and construct validity (i.e., internally and externally). Our findings are discussed in the light of current theories and new ideas in synaesthesia research. More generally, the questionnaire is a useful tool which can be widely used in synaesthesia research to reveal the influence of individual differences on various performance measures and will be useful in generating new hypotheses.

Context-Aware Adaptive Opportunistic Routing in Mobile Ad-hoc and Sensor Networks

Mobile ad-hoc networks (MANETs) and wireless sensor networks (WSNs) have been attracting increasing attention for decades due to their broad civilian and military applications. Basically, a MANET or WSN is a network of nodes connected by wireless communication links. Due to the limited transmission range of the radio, many pairs of nodes in MANETs or WSNs may not be able to communicate directly, hence they need other intermediate nodes to forward packets for them. Routing in such types of networks is an important issue and it poses great challenges due to the dynamic nature of MANETs or WSNs. On the one hand, the open-air nature of wireless environments brings many difficulties when an efficient routing solution is required. The wireless channel is unreliable due to fading and interferences, which makes it impossible to maintain a quality path from a source node to a destination node. Additionally, node mobility aggravates network dynamics, which causes frequent topology changes and brings significant overheads for maintaining and recalculating paths. Furthermore, mobile devices and sensors are usually constrained by battery capacity, computing and communication resources, which impose limitations on the functionalities of routing protocols. On the other hand, the wireless medium possesses inherent unique characteristics, which can be exploited to enhance transmission reliability and routing performance. Opportunistic routing (OR) is one promising technique that takes advantage of the spatial diversity and broadcast nature of the wireless medium to improve packet forwarding reliability in multihop wireless communication. OR combats the unreliable wireless links by involving multiple neighboring nodes (forwarding candidates) to choose packet forwarders. In opportunistic routing, a source node does not require an end-to-end path to transmit packets. The packet forwarding decision is made hop-by-hop in a fully distributed fashion. Motivated by the deficiencies of existing opportunistic routing protocols in dynamic environments such as mobile ad-hoc networks or wireless sensor networks, this thesis proposes a novel context-aware adaptive opportunistic routing scheme. Our proposal selects packet forwarders by simultaneously exploiting multiple types of cross-layer context information of nodes and environments. Our approach significantly outperforms other routing protocols that rely solely on a single metric. The adaptivity feature of our proposal enables network nodes to adjust their behaviors at run-time according to network conditions. To accommodate the strict energy constraints in WSNs, this thesis integrates adaptive duty-cycling mechanism to opportunistic routing for wireless sensor nodes. Our approach dynamically adjusts the sleeping intervals of sensor nodes according to the monitored traffic load and the estimated energy consumption rate. Through the integration of duty cycling of sensor nodes and opportunistic routing, our protocol is able to provide a satisfactory balance between good routing performance and energy efficiency for WSNs.

Cross-Layer Optimizations for Multimedia Distribution over Wireless Multimedia Sensor Networks and Flying Ad-Hoc Networks with Quality of Experience Support

The proliferation of multimedia content and the demand for new audio or video services have fostered the development of a new era based on multimedia information, which allowed the evolution of Wireless Multimedia Sensor Networks (WMSNs) and also Flying Ad-Hoc Networks (FANETs). In this way, live multimedia services require real-time video transmissions with a low frame loss rate, tolerable end-to-end delay, and jitter to support video dissemination with Quality of Experience (QoE) support. Hence, a key principle in a QoE-aware approach is the transmission of high priority frames (protect them) with a minimum packet loss ratio, as well as network overhead. Moreover, multimedia content must be transmitted from a given source to the destination via intermediate nodes with high reliability in a large scale scenario. The routing service must cope with dynamic topologies caused by node failure or mobility, as well as wireless channel changes, in order to continue to operate despite dynamic topologies during multimedia transmission. Finally, understanding user satisfaction on watching a video sequence is becoming a key requirement for delivery of multimedia content with QoE support. With this goal in mind, solutions involving multimedia transmissions must take into account the video characteristics to improve video quality delivery. The main research contributions of this thesis are driven by the research question how to provide multimedia distribution with high energy-efficiency, reliability, robustness, scalability, and QoE support over wireless ad hoc networks. The thesis addresses several problem domains with contributions on different layers of the communication stack. At the application layer, we introduce a QoE-aware packet redundancy mechanism to reduce the impact of the unreliable and lossy nature of wireless environment to disseminate live multimedia content. At the network layer, we introduce two routing protocols, namely video-aware Multi-hop and multi-path hierarchical routing protocol for Efficient VIdeo transmission for static WMSN scenarios (MEVI), and cross-layer link quality and geographical-aware beaconless OR protocol for multimedia FANET scenarios (XLinGO). Both protocols enable multimedia dissemination with energy-efficiency, reliability and QoE support. This is achieved by combining multiple cross-layer metrics for routing decision in order to establish reliable routes.

A web-based non-intrusive ambient system to measure and classify activities of daily living.

BACKGROUND The number of older adults in the global population is increasing. This demographic shift leads to an increasing prevalence of age-associated disorders, such as Alzheimer's disease and other types of dementia. With the progression of the disease, the risk for institutional care increases, which contrasts with the desire of most patients to stay in their home environment. Despite doctors' and caregivers' awareness of the patient's cognitive status, they are often uncertain about its consequences on activities of daily living (ADL). To provide effective care, they need to know how patients cope with ADL, in particular, the estimation of risks associated with the cognitive decline. The occurrence, performance, and duration of different ADL are important indicators of functional ability. The patient's ability to cope with these activities is traditionally assessed with questionnaires, which has disadvantages (eg, lack of reliability and sensitivity). Several groups have proposed sensor-based systems to recognize and quantify these activities in the patient's home. Combined with Web technology, these systems can inform caregivers about their patients in real-time (e.g., via smartphone). OBJECTIVE We hypothesize that a non-intrusive system, which does not use body-mounted sensors, video-based imaging, and microphone recordings would be better suited for use in dementia patients. Since it does not require patient's attention and compliance, such a system might be well accepted by patients. We present a passive, Web-based, non-intrusive, assistive technology system that recognizes and classifies ADL. METHODS The components of this novel assistive technology system were wireless sensors distributed in every room of the participant's home and a central computer unit (CCU). The environmental data were acquired for 20 days (per participant) and then stored and processed on the CCU. In consultation with medical experts, eight ADL were classified. RESULTS In this study, 10 healthy participants (6 women, 4 men; mean age 48.8 years; SD 20.0 years; age range 28-79 years) were included. For explorative purposes, one female Alzheimer patient (Montreal Cognitive Assessment score=23, Timed Up and Go=19.8 seconds, Trail Making Test A=84.3 seconds, Trail Making Test B=146 seconds) was measured in parallel with the healthy subjects. In total, 1317 ADL were performed by the participants, 1211 ADL were classified correctly, and 106 ADL were missed. This led to an overall sensitivity of 91.27% and a specificity of 92.52%. Each subject performed an average of 134.8 ADL (SD 75). CONCLUSIONS The non-intrusive wireless sensor system can acquire environmental data essential for the classification of activities of daily living. By analyzing retrieved data, it is possible to distinguish and assign data patterns to subjects' specific activities and to identify eight different activities in daily living. The Web-based technology allows the system to improve care and provides valuable information about the patient in real-time.

Construction and first validation of the comprehensive inventory of mindfulness (CHIME)

Introduction: Measuring trait mindfulness and change in mindfulness may be a crucial prerequisite for the evaluation and further development of mindfulness based interventions for the treatment of mental disorders. This endeavour is nontrivial as current measures cover varying aspects and mindfulness and may have problems regarding validity. This presentation describes the development and validation of a questionnaire for the comprehensive assessment of mindfulness: the Comprehensive Inventory of Mindfulness Experiences (CHIME). Method: The factor structure, reliability, and validity of the CHIME were established in a community sample (N = 298) and a sample of MBSR group participants (N = 161). Results: Factor-analytical procedures supported an eight-factor structure. The structure was tested in a further confirmatory sample (N = 202). The questionnaire and its subscales exhibited good reliability (internal consistency and retest-reliability). Analysis of the measurement invariance of the single items over groups differing in age, gender, meditation experience, and symptom load pointed to the absence of systematic differences in the items' semantic understanding. Parameters reflecting construct validity, criterion validity, and incremental validity as well as change sensitivity were all at least satisfactory. Conclusions: The CHIME is a self-report measure with favorable psychometric properties based on all aspects of mindfulness that are included in current mindfulness scales. This scale may be helpful in the evaluation and further development of mindfulness based interventions.

Comparison of the critical shoulder angle in radiographs and computed tomography.

OBJECTIVE The critical shoulder angle (CSA) is an indicator of degenerative shoulder pathologies. CSAs above 35° are associated with degenerative rotator cuff disease, whereas values below 30° are common in osteoarthritis of the glenohumeral joint. Measurements are usually performed on radiographs; however, no data have been reported regarding the reliability of CT scan measurements between different readers or the reproducibility of measurements from radiographs to CT scans. The purpose of our study was to clarify whether CSA measurements on radiographs and CT scans of the same patients show similar values. MATERIALS AND METHODS CSA measurements of 60 shoulders (59 patients) were performed on radiographs and multiplanar reconstructions of corresponding CT scans. Inter-reader reliability and inter-method correlation were calculated. RESULTS The mean discrepancy between readers was only 0.2° (SD ±1.0°) on radiographs. CT scan measurements showed a mean discrepancy of 0.3° (SD ±1.2°). The inter-reader reliability was 0.993 for radiographs and 0.989 for CT scans. There was a very strong inter-method correlation between the CSA measured on radiographs and CT scans (Spearman's rho = 0.974). The mean differences between angles on radiographs and CT measurements were -0.05° (SD ±1.2°) and 0.1° (SD ±1.2°), respectively. CONCLUSION Measurements of the CSA on anterior-posterior radiographs and CT scans are highly correlated, and inter-modality differences are negligible.

Patient and Informant Views on Visual Hallucinations in Parkinson Disease.

OBJECTIVE Visual hallucinations (VHs) are a very personal experience, and it is not clear whether information about them is best provided by informants or patients. Some patients may not share their hallucinatory experiences with caregivers to avoid distress or for fear of being labeled insane, and others do not have informants at all, which limits the use of informant-based questionnaires. The aim of this study was to compare patient and caregiver views about VHs in Parkinson disease (PD), using the North-East Visual Hallucinations Interview (NEVHI). METHODS Fifty-nine PD patient-informant pairs were included. PD patients and informants were interviewed separately about VHs using the NEVHI. Informants were additionally interviewed using the four-item version of the Neuropsychiatric Inventory. Inter-reliability and concurrent validity of the different measures were compared. RESULTS VHs were more commonly reported by patients than informants. The inter-rater agreement between NEVHI-patient and NEVHI-informant was moderate for complex VHs (Cohen's kappa = 0.44; 95% confidence interval [CI]: 0.13-0.75; t = 3.43, df = 58, p = 0.001) and feeling of presence (Cohen's kappa = 0.35; 95% CI: 0.00-0.70; t = 2.75, df = 58, p = 0.006), but agreement was poor for illusions (Cohen's kappa = 0.25; 95% CI: -0.07-0.57; t = 2.36, df = 58, p = 0.018) and passage hallucinations (Cohen's kappa = 0.16; 95% CI: -0.04-0.36; t = 2.26, df = 58, p = 0.024). CONCLUSION When assessing VHs in PD patients, it is best to rely on patient information, because not all patients share the details of their hallucinations with their caregivers.