Patient-reported outcomes in meta-analyses - part 2: methods for improving interpretability for decision-makers

Systematic reviews and meta-analyses of randomized trials that include patient-reported outcomes (PROs) often provide crucial information for patients, clinicians and policy-makers facing challenging health care decisions. Based on emerging methods, guidance on improving the interpretability of meta-analysis of patient-reported outcomes, typically continuous in nature, is likely to enhance decision-making. The objective of this paper is to summarize approaches to enhancing the interpretability of pooled estimates of PROs in meta-analyses. When differences in PROs between groups are statistically significant, decision-makers must be able to interpret the magnitude of effect. This is challenging when, as is often the case, clinical trial investigators use different measurement instruments for the same construct within and between individual randomized trials. For such cases, in addition to pooling results as a standardized mean difference, we recommend that systematic review authors use other methods to present results such as relative (relative risk, odds ratio) or absolute (risk difference) dichotomized treatment effects, complimented by presentation in either: natural units (e.g. overall depression reduced by 2.4 points when measured on a 50-point Hamilton Rating Scale for Depression); minimal important difference units (e.g. where 1.0 unit represents the smallest difference in depression that patients, on average, perceive as important the depression score was 0.38 (95%CI 0.30 to 0.47) units less than the control group); or a ratio of means (e.g. where the mean in the treatment group is divided by the mean in the control group, the ratio of means is 1.27, representing a 27%relative reduction in the mean depression score).

Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial

IMPORTANCE International guidelines advocate a 7- to 14-day course of systemic glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease (COPD). However, the optimal dose and duration are unknown. OBJECTIVE To investigate whether a short-term (5 days) systemic glucocorticoid treatment in patients with COPD exacerbation is noninferior to conventional (14 days) treatment in clinical outcome and whether it decreases the exposure to steroids. DESIGN, SETTING, AND PATIENTS REDUCE: (Reduction in the Use of Corticosteroids in Exacerbated COPD), a randomized, noninferiority multicenter trial in 5 Swiss teaching hospitals, enrolling 314 patients presenting to the emergency department with acute COPD exacerbation, past or present smokers (≥20 pack-years) without a history of asthma, from March 2006 through February 2011. INTERVENTIONS Treatment with 40 mg of prednisone daily for either 5 or 14 days in a placebo-controlled, double-blind fashion. The predefined noninferiority criterion was an absolute increase in exacerbations of at most 15%, translating to a critical hazard ratio of 1.515 for a reference event rate of 50%. MAIN OUTCOME AND MEASURE Time to next exacerbation within 180 days. RESULTS Of 314 randomized patients, 289 (92%) of whom were admitted to the hospital, 311 were included in the intention-to-treat analysis and 296 in the per-protocol analysis. Hazard ratios for the short-term vs conventional treatment group were 0.95 (90% CI, 0.70 to 1.29; P = .006 for noninferiority) in the intention-to-treat analysis and 0.93 (90% CI, 0.68 to 1.26; P = .005 for noninferiority) in the per-protocol analysis, meeting our noninferiority criterion. In the short-term group, 56 patients (35.9%) reached the primary end point; 57 (36.8%) in the conventional group. Estimates of reexacerbation rates within 180 days were 37.2% (95% CI, 29.5% to 44.9%) in the short-term; 38.4% (95% CI, 30.6% to 46.3%) in the conventional, with a difference of -1.2% (95% CI, -12.2% to 9.8%) between the short-term and the conventional. Among patients with a reexacerbation, the median time to event was 43.5 days (interquartile range [IQR], 13 to 118) in the short-term and 29 days (IQR, 16 to 85) in the conventional. There was no difference between groups in time to death, the combined end point of exacerbation, death, or both and recovery of lung function. In the conventional group, mean cumulative prednisone dose was significantly higher (793 mg [95% CI, 710 to 876 mg] vs 379 mg [95% CI, 311 to 446 mg], P < .001), but treatment-associated adverse reactions, including hyperglycemia and hypertension, did not occur more frequently. CONCLUSIONS AND RELEVANCE In patients presenting to the emergency department with acute exacerbations of COPD, 5-day treatment with systemic glucocorticoids was noninferior to 14-day treatment with regard to reexacerbation within 6 months of follow-up but significantly reduced glucocorticoid exposure. These findings support the use of a 5-day glucocorticoid treatment in acute exacerbations of COPD. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN19646069.

Does Immediate Access to Birth Control Help Prevent Pregnancy? A Comparison of Onsite Provision Versus Off Campus Referral for Contraception at Two School-Based Clinics

PURPOSE: The purpose of this study was to assess the impact of different policies on access to hormonal contraception and pregnancy rates at two high school-based clinics. METHODS: Two clinics in high schools (Schools A and B), located in a large urban district in the southwest US, provide primary medical care to enrolled students with parental consent; the majority of whom have no health insurance coverage. The hormonal contraceptive dispensing policy of at School clinic A involves providing barrier, hormonal and emergency contraceptive services on site. School clinic B uses a referral policy that directs students to obtain contraception at an off-campus affiliated family planning clinic. Baseline data (age, race and history of prior pregnancy) on female students seeking hormonal contraception at the two clinics between 9/2008-12/2009 were extracted from an electronic administrative database (AHLERS Integrated System). Data on birth control use and pregnancy tests for each student was then tracked electronically through 3/31/2010. The outcomes measures were accessing hormonal contraception and positive pregnancy tests at any point during or after birth control use were started through 12/2009. The appointment keeping rate for contraceptive services and the overall pregnancy rates were compared between the two schools. In addition the pregnancy rates were compared between the two schools for students with and without a prior history of pregnancy. RESULTS: School clinic A: 79 students sought hormonal contraception; mean age 17.5 years; 68% were > 18 years; 77% were Hispanic; and 20% reported prior pregnancy. The mean duration of the observation period was 13 months (4-19 months). All 79 students received hormonal contraception (65% pill and 35% long acting progestin injection) onsite. During the observation period, the overall pregnancy rate was 6% (5/79); 4.7% (3/63) among students with no prior pregnancy. School clinic B: 40 students sought hormonal contraception; mean age 17.5 years; 52% > 18 years; 88 % were Hispanic; and 7.5% reported prior pregnancy. All 40 students were referred to the affiliated clinic. The mean duration of the observation period was 11.9 months (4-19 months). 50% (20) kept their appointment. Pills were dispensed to 85% (17/20) and 15% (3/20) received long acting progestin injection. The overall pregnancy rate was 20% (8/40); 21.6% (8/37) among students with no prior pregnancy. A significantly higher frequency of students seeking hormonal contraception kept their initial appointment for birth control at the school dispensing onsite contraception compared to the school with a referral policy for contraception (p<0.05). The pregnancy rate was significantly higher for the school with a referral policy for contraception compared to the school with onsite contraceptive services (p< 0.05). The pregnancy rate was also significantly higher for students without a prior history of pregnancy in the school with a referral policy for contraception (21.6%) versus the school with onsite contraceptive services (4.7%) (p< 0.05). CONCLUSION: This preliminary study showed that School clinic B with a referral policy had a lower appointment keeping rate for contraceptive services and a higher pregnancy rate than School clinic A with on-site contraceptive services. An on-site dispensing policy for hormonal contraceptives at high school-based health clinics may be a convenient and effective approach to prevent unintended first and repeat pregnancies among adolescents who seek hormonal contraception. This study has strong implications for reproductive health policy, especially as directed toward high-risk teenage populations.

Bounds for the probability generating functional of a Gibbs point process

We derive explicit lower and upper bounds for the probability generating functional of a stationary locally stable Gibbs point process, which can be applied to summary statistics such as the F function. For pairwise interaction processes we obtain further estimates for the G and K functions, the intensity, and higher-order correlation functions. The proof of the main result is based on Stein's method for Poisson point process approximation.

Reversible cerebral vasoconstriction syndrome and cervical artery dissection in 20 patients

OBJECTIVES To describe clinical-radiologic characteristics in a prospective series of patients having both confirmed reversible cerebral vasoconstriction syndrome (RCVS) and cervical artery dissection (CeAD). METHODS From January 2004 to December 2011, from our prospective cohorts of RCVS and CeAD, we studied patients with both conditions. RESULTS Of 173 RCVS cases and 285 CeAD cases, 20 patients (18 women, 2 men; mean age 41 years) had both RCVS and CeAD. Main associated conditions were migraine (12/20) and postpartum (5/18). Clinical features included severe headache in all patients, neck pain in 15, focal neurologic deficit in 9, and seizures in 4. Pain was the only symptom in 10 patients. All patients had multifocal cerebral vasoconstriction. There were brain lesions in 12 patients, cortical subarachnoid hemorrhage in 11, posterior reversible encephalopathy syndrome in 4, intracerebral hemorrhage in 3, and infarcts in 4. CeAD involved one artery in 13 patients and multiple arteries in 7. CeAD mostly affected vertebral arteries (25 of 30 CeAD). Only one vertebral CeAD was associated with a related symptomatic infarct. At 3 months, 18 patients had fully recovered, all patients showed reversal of cerebral vasoconstriction, and 21 dissected arteries had normalized, whereas 9 arteries showed residual stenosis (7) and/or aneurysm (3). CONCLUSION The association of RCVS and CeAD was found in 12% of our patients with RCVS and 7% of our patients with CeAD. Underlying mechanisms are unknown. In practice, our results point to the need for a systematic study of both cervical and intracranial arteries in the 2 conditions.

Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function.

INTRODUCTION: The objective of this study was to evaluate the effects of two different mean arterial blood pressure (MAP) targets on needs for resuscitation, organ dysfunction, mitochondrial respiration and inflammatory response in a long-term model of fecal peritonitis. METHODS: Twenty-four anesthetized and mechanically ventilated pigs were randomly assigned (n = 8/group) to a septic control group (septic-CG) without resuscitation until death or one of two groups with resuscitation performed after 12 hours of untreated sepsis for 48 hours, targeting MAP 50-60 mmHg (low-MAP) or 75-85 mmHg (high-MAP). RESULTS: MAP at the end of resuscitation was 56 ± 13 mmHg (mean ± SD) and 76 ± 17 mmHg respectively, for low-MAP and high-MAP groups. One animal each in high- and low-MAP groups, and all animals in septic-CG died (median survival time: 21.8 hours, inter-quartile range: 16.3-27.5 hours). Norepinephrine was administered to all animals of the high-MAP group (0.38 (0.21-0.56) mcg/kg/min), and to three animals of the low-MAP group (0.00 (0.00-0.25) mcg/kg/min; P = 0.009). The high-MAP group had a more positive fluid balance (3.3 ± 1.0 mL/kg/h vs. 2.3 ± 0.7 mL/kg/h; P = 0.001). Inflammatory markers, skeletal muscle ATP content and hemodynamics other than MAP did not differ between low- and high-MAP groups. The incidence of acute kidney injury (AKI) after 12 hours of untreated sepsis was, respectively for low- and high-MAP groups, 50% (4/8) and 38% (3/8), and in the end of the study 57% (4/7) and 0% (P = 0.026). In septic-CG, maximal isolated skeletal muscle mitochondrial Complex I, State 3 respiration increased from 1357 ± 149 pmol/s/mg to 1822 ± 385 pmol/s/mg, (P = 0.020). In high- and low-MAP groups, permeabilized skeletal muscle fibers Complex IV-state 3 respiration increased during resuscitation (P = 0.003). CONCLUSIONS: The MAP targets during resuscitation did not alter the inflammatory response, nor affected skeletal muscle ATP content and mitochondrial respiration. While targeting a lower MAP was associated with increased incidence of AKI, targeting a higher MAP resulted in increased net positive fluid balance and vasopressor load during resuscitation. The long-term effects of different MAP targets need to be evaluated in further studies.

Early bone apposition to hydrophilic and hydrophobic titanium implant surfaces: a histologic and histomorphometric study in minipigs.

OBJECTIVE The first objective of this pilot study was to evaluate the impact of the hydrophilicity on the early phases of osseointegration. The second objective was to compare two hydrophilic implant surfaces with different geometries, surface roughness, and technologies achieving hydrophilicity. MATERIAL AND METHODS Twelve weeks after extraction, all four quadrants of nine minipigs received three dental implants, alternating between hydrophilic microrough surfaces (INICELL and SLActive) and a conventional hydrophobic microrough surface. After 5, 10, and 15 days of submerged healing, ground sections were prepared and subjected to histologic and histomorphometric analysis. RESULTS The histologic analysis revealed a similar healing pattern among the hydrophilic and hydrophobic implant surfaces, with extensive bone formation occurring between day 5 and day 10. With BIC values of greater than 50% after 10 days, all examined surfaces indicated favorable osseointegration at this very early point in healing. At day 15, the mean new bone-to-implant contact (newBIC) of one hydrophilic surface (INICELL; 55.8 ± 14.4%) was slightly greater than that of the hydrophobic microrough surface (40.6 ± 20.2%). At day 10 and day 15, an overall of 21% of the implants had to be excluded from analysis due to inflammations primarily caused by surgical complications. CONCLUSION Substantial bone apposition occurs between day 5 and day 10. The data suggest that the hydrophilic surface can provoke a slight tendency toward increased bone apposition in minipigs after 15 days. A direct comparison of two hydrophilic surfaces with varying geometries is of limited relevance.

Lack of fifth anchoring point and violation of the insertion of the rotator cuff during antegrade humeral nailing: pitfalls in straight antegrade humeral nailing.

Antegrade nailing of proximal humeral fractures using a straight nail can damage the bony insertion of the supraspinatus tendon and may lead to varus failure of the construct. In order to establish the ideal anatomical landmarks for insertion of the nail and their clinical relevance we analysed CT scans of bilateral proximal humeri in 200 patients (mean age 45.1 years (sd 19.6; 18 to 97) without humeral fractures. The entry point of the nail was defined by the point of intersection of the anteroposterior and lateral vertical axes with the cortex of the humeral head. The critical point was defined as the intersection of the sagittal axis with the medial limit of the insertion of the supraspinatus tendon on the greater tuberosity. The region of interest, i.e. the biggest entry hole that would not encroach on the insertion of the supraspinatus tendon, was calculated setting a 3 mm minimal distance from the critical point. This identified that 38.5% of the humeral heads were categorised as 'critical types', due to morphology in which the predicted offset of the entry point would encroach on the insertion of the supraspinatus tendon that may damage the tendon and reduce the stability of fixation. We therefore emphasise the need for 'fastidious' pre-operative planning to minimise this risk.

Anteverting periacetabular osteotomy for symptomatic acetabular retroversion: results at ten years.

BACKGROUND Acetabular retroversion is associated with pincer-type femoroacetabular impingement and can lead to hip osteoarthritis. We report the ten-year results of a previously described patient cohort that had corrective periacetabular osteotomy for the treatment of symptomatic acetabular retroversion. METHODS Clinical and radiographic parameters were assessed preoperatively and at two and ten years postoperatively. A Kaplan-Meier survivorship analysis of the twenty-two patients (twenty-nine hips) with a mean follow-up (and standard deviation) of 11 ± 1 years (range, nine to twelve years) was performed. In addition, a univariate Cox regression analysis was done with conversion to total hip arthroplasty as the primary end point and progression of the osteoarthritis, a fair or poor result according to the Merle d'Aubigné score, or the need for revision surgery as the secondary end points. RESULTS The mean Merle d'Aubigné score improved significantly from 14 ± 1.4 points (range, 12 to 17 points) preoperatively to 16.9 ± 0.9 points (range, 15 to 18 points) at ten years (p < 0.001). There were also significant improvements with regard to hip flexion (p = 0.003), internal rotation (p = 0.003), and adduction (p = 0.002) compared with the preoperative status. No significant increase of the mean Tönnis osteoarthritis score was seen at ten years (p = 0.06). The cumulative ten-year survivorship, with conversion to a total hip arthroplasty as the primary end point, was 100%. The cumulative ten-year survivorship in achievement of one of the secondary end points was 71% (95% confidence interval, 54% to 88%). Predictors for poor outcome were the lack of femoral offset creation and overcorrection of the acetabular version resulting in excessive anteversion. CONCLUSIONS Anteverting periacetabular osteotomy for acetabular retroversion leads to favorable long-term results with preservation of the native hip at a mean of ten years. Overcorrection resulting in excessive anteversion of the hip and omitting concomitant offset creation of the femoral head-neck junction are associated with an unfavorable outcome.

Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis

BACKGROUND For patients with acute iliofemoral deep vein thrombosis, it remains unclear whether the addition of intravascular high-frequency, low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis. METHODS AND RESULTS In a controlled clinical trial, 48 patients (mean age 50±21 years, 52% women) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis (N=24) or conventional catheter-directed thrombolysis (N=24). Thrombolysis regimen (20 mg r-tPA over 15 hours) was identical in all patients. The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score, obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment. The percentage of thrombus load reduction was 55%±27% in the ultrasound-assisted catheter-directed thrombolysis group and 54%±27% in the conventional catheter-directed thrombolysis group (P=0.91). Adjunctive angioplasty and stenting was performed in 19 (80%) patients and in 20 (83%) patients, respectively (P>0.99). Treatment-related complications occurred in 3 (12%) and 2 (8%) patients, respectively (P>0.99). At 3-month follow-up, primary venous patency was 100% in the ultrasound-assisted catheter-directed thrombolysis group and 96% in the conventional catheter-directed thrombolysis group (P=0.33), and there was no difference in the severity of the post-thrombotic syndrome (mean Villalta score: 3.0±3.9 [range 0-15] versus 1.9±1.9 [range 0-7]; P=0.21), respectively. CONCLUSIONS In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen, the addition of intravascular ultrasound did not facilitate thrombus resolution. CLINICAL TRIAL REGISTRATION URL http://www.clinicaltrials.gov. Unique identifier: NCT01482273.

What does professionalisation mean? Perceptions of professionalisation in swiss sport federations

Introduction: Organisational changes in sports federations are often associated with a drift from a volunteer driven to an increasingly business-like phenomenon (Shilbury & Ferkins, 2011). This process of transfor-mation is be called as “professionalization”. Accordingly, professionalization seems to be an appropriate strategy for sport organisations in order to meet organizational pressure due to challenges of a more complex and dynamic changing environment adequately. Despite the increasing research interest and the attempts for systematization on the phenomenon of professionalization it still remains unclear what does the term professionalization exactly mean (Dowling et al., 2014). Thus, there is a lack of a consistent concept of professionalization that is needed in order to explore different facets and perspectives of this phenomenon more validly. Against this background following question emerged: What is the suitable concept of professionalization for analyzing the actual ongoing processes of change, adaption or transformation in sport federations? Methods: Dealing with this question, following two-step approach was choosen: (1) In a first step a scholar’s perspective at professionalisation of sport organisations will be displayed in order to explore both the common ground as well as divergences and inconsistencies in previous approaches. Therefore, a literature review is indicated. (2) In a second step, and in contrast to previous studies we will consider a practical point of view by a so called second-order observation of experts to gain valuable insights into current thinking and acting towards professionalization in sport federations. In doing so, a hermeneutical approach is used, which is about understanding the meaning of contexts by grasping the everyday world, and draw insight and meaning from it (Shilbury et al., 2013). Accordance with hermeneutics, the explorative interpretive knowledge of expert interviews was used. The interviews were conducted with a sample of six selected experts, who have both dedicated insider knowledge and the overall view of all Swiss sport federations. Results and discussion: The summaries of literature review could be categorized into two research currents. The one defines professionalization as a structural process towards professional status of occupations. The other defines it in a broader sense as an organisational change towards a business-like approach. Whereas the first perspective there is a broad scientific consensus that second isn’t that clear, however. Explorative analysis of interview data reveals different themes in relation to professionalization of sports federation. First theme deals with a changed philosophy as more strategic alignment towards for-profit, efficiency and quality orientation. Second theme refers to paid work associated with more competence orientation and balanced governance between paid and voluntary work. Third theme deals with acting shift towards more rationalization and efficiency by implementation of innovative management and communication tools. Based on findings of both our review of scholar`s perspective as well insights from experts we will provide – in the sense of synthesis – a more clear understanding of what does professionalization mean that can be useful in terms of further studies. References: Dowling, M., Edwards, J. & Washington, M. (2014). Understanding the concept of professionalisation in sport management research. Sport Management Review, 17 (4), 520–529. Shilbury, D., Ferkins, L. & Smythe, L. (2013). Sport governance encounters: Insights from lived experiences. Sport Management Review, 16,349–363. Shilbury, D., & Ferkins, L. (2011). Professionalisation, sport governance and strategic capability. Managing Leisure, 16, 108–127.

Left atrial remodeling, early repolarization pattern, and inflammatory cytokines in professional soccer players

OBJECTIVES: Although regular physical exercise clearly reduces cardiovascular morbidity risk, long-term endurance sports practice has been recognized as a risk factor for atrial fibrillation (AF). However, the mechanisms how endurance sports can lead to AF are not yet clear. The aim of our present study was to investigate the influence of long-term endurance training on vagal tone, atrial size, and inflammatory profile in professional elite soccer players. METHODS: A total of 25 professional major league soccer players (mean age 24+/-4 years) and 20 sedentary controls (mean age 26+/-3 years) were included in the study and consecutively examined. All subjects underwent a sports cardiology check-up with physical examination, electrocardiography, echocardiography, exercise testing on a bicycle ergometer, and laboratory analysis [standard laboratory and cytokine profile: interleukin (IL)-6, tumor necrosis factor (TNF)-alpha, IL-8, IL-10]. RESULTS: Athletes were divided into two groups according to presence or absence of an early repolarization (ER) pattern, defined as a ST-segment elevation at the J-point (STE) >/=0.1mm in 2 leads. Athletes with an ER pattern showed significantly lower heart rate and an increased E/e' ratio compared to athletes without an ER pattern. STE significantly correlated with E/e' ratio as well as with left atrial (LA) volume. The pro-inflammatory cytokines IL-6, IL-8, TNF-alpha as well as the anti-inflammatory cytokine IL-10 were significantly elevated in all soccer players. However, athletes with an ER pattern had significantly higher IL-6 plasma levels than athletes without ER pattern. Furthermore, athletes with "high" level IL-6 had significantly larger LA volumes than players with "low" level IL-6. CONCLUSIONS: Athletes with an ER pattern had significantly higher E/e' ratios, reflecting higher atrial filling pressures, higher LA volume, and higher IL-6 plasma levels. All these factors may contribute to atrial remodeling over time and thus increase the risk of AF in long-term endurance sports.

Contextualizing local-scale point sample data using global-scale spatial datasets: Lessons learnt from the analysis of large-scale land acquisitions

This paper examines how the geospatial accuracy of samples and sample size influence conclusions from geospatial analyses. It does so using the example of a study investigating the global phenomenon of large-scale land acquisitions and the socio-ecological characteristics of the areas they target. First, we analysed land deal datasets of varying geospatial accuracy and varying sizes and compared the results in terms of land cover, population density, and two indicators for agricultural potential: yield gap and availability of uncultivated land that is suitable for rainfed agriculture. We found that an increase in geospatial accuracy led to a substantial and greater change in conclusions about the land cover types targeted than an increase in sample size, suggesting that using a sample of higher geospatial accuracy does more to improve results than using a larger sample. The same finding emerged for population density, yield gap, and the availability of uncultivated land suitable for rainfed agriculture. Furthermore, the statistical median proved to be more consistent than the mean when comparing the descriptive statistics for datasets of different geospatial accuracy. Second, we analysed effects of geospatial accuracy on estimations regarding the potential for advancing agricultural development in target contexts. Our results show that the target contexts of the majority of land deals in our sample whose geolocation is known with a high level of accuracy contain smaller amounts of suitable, but uncultivated land than regional- and national-scale averages suggest. Consequently, the more target contexts vary within a country, the more detailed the spatial scale of analysis has to be in order to draw meaningful conclusions about the phenomena under investigation. We therefore advise against using national-scale statistics to approximate or characterize phenomena that have a local-scale impact, particularly if key indicators vary widely within a country.

Pelvic floor muscle electromyography during different running speeds: an exploratory and reliability study.

PURPOSE Stress urinary incontinence (SUI) affects women of all ages including young athletes, especially those involved in high-impact sports. To date, hardly any studies are available testing pelvic floor muscles (PFM) during sports activities. The aim of this study was the description and reliability test of six PFM electromyography (EMG) variables during three different running speeds. The secondary objective was to evaluate whether there was a speed-dependent difference between the PFM activity variables. METHODS This trial was designed as an exploratory and reliability study including ten young healthy female subjects to characterize PFM pre-activity and reflex activity during running at 7, 9 and 11 km/h. Six variables for each running speed, averaged over ten steps per subject, were presented descriptively, tested regarding their reliability (Friedman, ICC, SEM, MD) and speed difference (Friedman). RESULTS PFM EMG variables varied between 67.6 and 106.1 %EMG, showed no systematic error and were low for SEM and MD using the single value model. Applying the average model over ten steps, ICC (3,k) were >0.75 and SEM and MD about 50 % lower than for the single value model. Activity was found to be highest in 11 km/h. CONCLUSION EMG variables showed excellent ICC and very low SEM and MD. Further studies should investigate inter-session reliability and PFM reactivity patterns of SUI patients using the average over ten steps for each variable as it showed very high ICC and very low SEM and MD. Subsequently, longer running distances and other high-impact sports disciplines could be studied.

Complex syntax in autistic spectrum disorders: A study with relative clauses

Background The few studies that have evaluated syntax in autism spectrum disorder (ASD) have yielded conflicting findings: some suggest that once matched on mental age, ASD and typically developing controls do not differ for grammar, while others report that morphosyntactic deficits are independent of cognitive skills in ASD. There is a need for a better understanding of syntax in ASD and its relation to, or dissociation from, nonverbal abilities. Aims Syntax in ASD was assessed by evaluating subject and object relative clause comprehension in adolescents and adults diagnosed with ASD with a performance IQ within the normal range, and with or without a history of language delay. Methods & Procedures Twenty-eight participants with ASD (mean age 21.8) and 28 age-matched controls (mean age 22.07) were required to point to a character designated by relative clauses that varied in syntactic complexity. Outcomes & Results Scores indicate that participants with ASD regardless of the language development history perform significantly worse than age-matched controls with object relative clauses. In addition, participants with ASD with a history of language delay (diagnosed with high-functioning autism in the DSM-IV-TR) perform worse on subject relatives than ASD participants without language delay (diagnosed with Asperger syndrome in the DSM-IV-TR), suggesting that these two groups do not have equivalent linguistic abilities. Performance IQ has a positive impact on the success of the task for the population with ASD. Conclusions & Implications This study reveals subtle grammatical difficulties remaining in adult individuals with ASD within normal IQ range as compared with age-matched peers. Even in the absence of a history of language delay in childhood, the results suggest that a slight deficit may nevertheless be present and go undetected by standardized language assessments. Both groups with and without language delay have a similar global performance on relative clause comprehension; however, the study also indicates that the participants with reported language delay show more difficulty with subject relatives than the participants without language delay, suggesting the presence of differences in linguistic abilities between these subgroups of ASD.