Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

Contains fulltext : 110505.pdf (publisher's version ) (Open Access)BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

Coordination of lingual and mandibular gestures for different manners of articulation

In Articulatory Phonology the jaw is not controlled individually but serves as an additional articulator to achieve the primary constriction. In this study the timing of jaw and tongue tip gestures for the coronal consonants /s, , t, d, n, l/ is analysed by means of EMMA. The findings suggest that the tasks of the jaw for the fricatives are to provide a second noise source and to stabilise the tongue position (more pronounced for /s/). For the voiceless stop, the speakers seem to aim at a high jaw position for producing a prominent burst. For /l/ a low jaw position is essential for avoiding lateral contact and for the apical articulation of this sound

Speech motor control in fluent and dysfluent speech production of an individual with apraxia of speech and Broca’s aphasia

Apraxia of speech (AOS) is typically described as a motor-speech disorder with clinically well-defined symptoms, but without a clear understanding of the underlying problems in motor control. A number of studies have compared the speech of subjects with AOS to the fluent speech of controls, but only a few have included speech movement data and if so, this was primarily restricted to the study of single articulators. If AOS reflects a basic neuromotor dysfunction, this should somehow be evident in the production of both dysfluent and perceptually fluent speech. The current study compared motor control strategies for the production of perceptually fluent speech between a young woman with apraxia of speech (AOS) and Broca’s aphasia and a group of age-matched control speakers using concepts and tools from articulation-based theories. In addition, to examine the potential role of specific movement variables on gestural coordination, a second part of this study involved a comparison of fluent and dysfluent speech samples from the speaker with AOS. Movement data from the lips, jaw and tongue were acquired using the AG-100 EMMA system during the reiterated production of multisyllabic nonwords. The findings indicated that although in general kinematic parameters of fluent speech were similar in the subject with AOS and Broca’s aphasia to those of the age-matched controls, speech task-related differences were observed in upper lip movements and lip coordination. The comparison between fluent and dysfluent speech characteristics suggested that fluent speech was achieved through the use of specific motor control strategies, highlighting the potential association between the stability of coordinative patterns and movement range, as described in Coordination Dynamics theory

Effects of linguistic correlates of stuttering on EMG activity in nonstuttering speakers

Contains fulltext : 21923___.PDF (publisher's version ) (Open Access)In this study changes in upper lip and lower lip integrated electromyographic (IEMG) amplitude and temporal measures related to linguistic factors known for their influence on stuttering were investigated. Nonstuttering subjects first read and then verbalized sentences of varying length (sentence length factor), in which meaningless but phonologically appropriate character strings were varied in their position within the sentence (word position factor) and their size (word size factor). It was hypothesized that the production of stressed, vowel-rounding gestures of words in initial position, longer words, and words in longer sentences would be characterized by specific changes in IEMG amplitude that would reflect an increase in speech motor demands, intuitively defined as articulatory effort. Basically, the findings corroborated our assumptions, showing that words in sentence initial position have shorter word and vowel durations in combination with an increase in IEMG activity. Similarly, we found shorter vowel durations for longer words, and in sentence final position an increase in IEMG activity. For longer sentences we found a clear increase in speech rate, but contrary to our expectations a decrease in IEMG activity. It was speculated that this might relate to the use of a movement reduction strategy to allow higher speech rates with increased coarticulation. These findings were discussed both for their implications in normal speech production, as well as for their possible implications for explaining stuttering behavior. To this end our data can illustrate both why stutterers might run a higher risk of stuttering at these linguistic loci of stuttering, and why they might come up with a strategic solution to decrease the motor demands in speech production. The basic outcome of this study shows that higher order (linguistic) specifications can have clear effects on speech motor production