Crossover Group Research Articles

Is high-flow nasal cannula noninferior to nasal CPAP for the initial management of preterm infants?

Commentary on: Roberts CT, Owen LS, Manley BJ, Frøisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG, for the HIPSTER Trial Investigators. Nasal high-flow therapy for primary respiratory support in preterm infants. N Engl J Med 2016; 375: 1142–51. PMID 27653564. The study question builds on the group's earlier work, which demonstrated HFNC was noninferior to nCPAP as postextubation support 1. Noninferiority trials are designed to show whether a new treatment is ‘not unacceptably less efficacious’ than the standard of care 2. A new treatment that is nearly as effective may be acceptable to providers and patients if it is less invasive, less costly or more convenient. 3 Of note, the authors defined a 20% margin for noninferiority in their earlier study 1, and a 10% difference in the rate of treatment failure between HFNC and nCPAP here may be too conservative. In contrast to studies of HFNC as postextubation support 1, 4, Roberts et al. found HFNC as primary support to be not only inferior to nCPAP, but the difference was obvious prior to full recruitment, and was significant in both the intention-to-treat and per-protocol analyses. The authors posit the higher rate of treatment failure in the HFNC group ‘may reflect its reduced effectiveness in infants with surfactant-deficient lungs’. Were this the case, the HFNC group should have had higher need for subsequent surfactant therapy than the CPAP group, but the rates of surfactant administration were equivalent. Treatment failure (in either group) may have occurred after the window during which surfactant is considered to be most efficacious (<24–48 hours of life) and thus was not used. Defining ‘treatment failure’ by two objective and three somewhat subjective criteria complicates the interpretation of the results. Apnoea in particular is subjective in terms of nursing documentation, and the inability to blind caregivers to mode of respiratory support may have impacted the perceived frequency and severity of apneic episodes. In practice, failure of noninvasive respiratory support typically means need for intubation and mechanical ventilation, but intubation rates during the treatment period were not significantly different between the HFNC and nCPAP groups. Approximately 30 infants on HFNC had treatment failure but stabilised on nCPAP; 40 infants failed HFNC and ultimately required intubation and surfactant. While this confirms something about nCPAP therapy was superior to HFNC, it seems unlikely to indicate such a substantial treatment effect that continued enrolment in the study would have been unsafe or unethical. Overall rates of intubation and pneumothorax were the same, length of stay was unchanged, and the rate of nasal breakdown was higher in the nCPAP group. It would be helpful to know if there was a clinically important increase in the frequency of pneumothorax and nasal breakdown specifically in the crossover group from HFNC to nCPAP. Because an increased cumulative oxygen exposure in the HFNC group is plausible, reporting the average FiO2 requirement for both groups also would be useful. Based on these findings, the standard use of HFNC as primary respiratory support in preterm infants who would otherwise receive CPAP cannot be recommended. However, the important complications of pneumothorax and intubation were ultimately not different between groups, nor did length of stay or cost of care differ significantly. This suggests HFNC may be an option for some infants without fear of significant adverse events. https://ebneo.org/2017/04/is-high-flow-nasal-cannula-noninferior-to-nasal-cpap-for-the-initial-management-of-preterm-infants/ The authors of this commentary have no conflict of interests to disclose. The authors of this commentary have no funding to disclose.

Antegrade vs Crossover Femoral Artery Access in the Endovascular Treatment of Isolated Below-the-Knee Lesions in Patients With Critical Limb Ischemia

Purpose: To evaluate the safety and effectiveness of antegrade vs crossover femoral artery access in the endovascular treatment of isolated below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI). Methods: Between January 2014 and December 2015, 224 high-risk patients (mean age 75.8±9.8 years; 151 men) with CLI underwent infragenicular interventions on 292 crural vessels in 3 European vascular centers. All patients had isolated TransAtlantic Inter-Society Consensus (TASC) C (n=26) or D (n=198) BTK lesions. Primary endpoints were freedom from access-related complications and technical success comparing the antegrade vs crossover access groups. Results: Balloon angioplasty was the most used treatment modality (169 vessels, 75.4%). The technical success rate was 88.4% in the entire cohort and 88.0% in the antegrade group vs 90.4% in the crossover group (p>0.99). In all patients, the technical success rate was higher for stenotic lesions (100%) vs occlusions (85.5%, p=0.002) and in patients with TASC C BTK lesions (100%) vs TASC D (86.9%, p=0.033). The overall freedom from access-related complications was 97.8%: 99% in the antegrade group and 90.6% in the crossover group (p=0.022). Larger sheath size (5/6-F vs 4-F) was associated with a significantly higher risk for access-related complications (7.1% vs 1.1%, respectively; p=0.047). Conclusion: The present multicenter study showed high technical success and a low incidence of access-related complications in the treatment of isolated BTK lesions using either antegrade or crossover femoral access. The antegrade approach with the use of a 4-F system seems to have a significantly lower rate of access-related complications.

PD59-06 QUALITY OF LIFE SCORES IN PATIENTS WITH SMALL RENAL MASSES WHO HAVE UNDERGONE RENAL MASS BIOPSY COMPARED TO THOSE WHO HAVE NOT: ANALYSIS OF THE DISSRM REGISTRY.

You have accessJournal of UrologyKidney Cancer: Localized: Active Surveillance1 Apr 2017PD59-06 QUALITY OF LIFE SCORES IN PATIENTS WITH SMALL RENAL MASSES WHO HAVE UNDERGONE RENAL MASS BIOPSY COMPARED TO THOSE WHO HAVE NOT: ANALYSIS OF THE DISSRM REGISTRY. Alice Semerjian, Ridwan Alam, Hiten Patel, Mark Riffon, Michael Johnson, Peter Chang, Andrew Wagner, James McKiernan, Bruce Trock, Mohamad Allaf, and Phillip Pierorazio Alice SemerjianAlice Semerjian More articles by this author , Ridwan AlamRidwan Alam More articles by this author , Hiten PatelHiten Patel More articles by this author , Mark RiffonMark Riffon More articles by this author , Michael JohnsonMichael Johnson More articles by this author , Peter ChangPeter Chang More articles by this author , Andrew WagnerAndrew Wagner More articles by this author , James McKiernanJames McKiernan More articles by this author , Bruce TrockBruce Trock More articles by this author , Mohamad AllafMohamad Allaf More articles by this author , and Phillip PierorazioPhillip Pierorazio More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2634AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Renal mass biopsy (RMB) can be employed as an adjunct to the decision-making process for patients with small renal masses. It is hypothesized that the pathological diagnosis provided by RMB purports a QOL advantage by alleviating cancer-related uncertainty and anxiety. This study evaluates the influence of RMB on QOL in a large prospective registry of patients with SRM. METHODS The DISSRM (Delayed Intervention and Surveillance for Small Renal Masses) Registry is a multi-institutional study that prospectively follows patients with SRM who elect primary intervention (PI) or active surveillance (AS). Patients complete SF12 QOL questionnaire at enrollment, 6 and 12 months, and subsequently on an annual basis. SF12 scores, MCS (Mental Component Summary) and PCS (Physical Component Summary) were compared between patients who had RMB versus those who did not in the PI, AS, and crossover groups separately using ANOVA and linear regression mixed modeling. RESULTS 619 patients were identified in the DISSRM Registry, of whom 320 were in the AS arm and 299 in the PI arm. 84 patients (13.6%) underwent biopsy, 34 (40.6%) in the PI group, 35 (41.6%) in the AS group, and 15 (17.8%) in the AS group who crossed over. Median age, ECOG performance status and Charlson comorbidity Index (CCI) were similar regardless of biopsy status among the AS and PI groups. In PI patients, there were no significant differences between SF12, MCS or PCS (p>0.092) or changes in SF12, MCS, or PCS (p>0.162) in patients who underwent biopsy and those who did not across all time points up to 84 months. In the AS patients who did not crossover, no differences in SF12, MCS and PCS were seen between patients who had biopsy and those who did not (p>0.0564). PCS declined over time in patients who stayed on AS without biopsy (p<0.001), but all other measures were unchanged over time (p>0.7291). In the crossover group, SF12, MCS, and PCS were lower at 24 and 48 months in patients who had not undergone biopsy (p=0.002). These patients were older (72.5 vs 67.2, p=0.003), had higher CCI (p=0.004), and lower ECOG performance status (p=0.045). There were no changes to SF12, MCS, or PCS scores in crossover patients regardless of biopsy status over time (p>0.1513). CONCLUSIONS AS and PI patients who underwent RMB during follow-up in DISSRM did not have significant changes in quality of life scores over time, nor did they have worse scores than their counterparts who did not undergo biopsy. A pathological diagnosis through RMB did not appear to have a beneficial or detrimental effect on QOL while on AS. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1135 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Alice Semerjian More articles by this author Ridwan Alam More articles by this author Hiten Patel More articles by this author Mark Riffon More articles by this author Michael Johnson More articles by this author Peter Chang More articles by this author Andrew Wagner More articles by this author James McKiernan More articles by this author Bruce Trock More articles by this author Mohamad Allaf More articles by this author Phillip Pierorazio More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Effects of a systemic enzyme therapy in healthy active adults after exhaustive eccentric exercise: a randomised, two-stage, double-blinded, placebo-controlled trial

BackgroundSystemic enzyme therapy may improve symptoms of exhaustive eccentric exercise due to anti-inflammatory properties.MethodsIn a randomised, placebo-controlled, two-stage clinical trial, systemic enzyme therapy (Wobenzym) was administered for 72 hours before...

Using two languages to inform and inspire: a case study using bilingual digital technology to educate healthcare students demonstrating the importance of language choice in enhancing communication and patient care in Wales

Welsh is the indigenous language of Wales, the Welsh Language (Wales) Measure (2011) means that English and Welsh have equal parity in Wales. Many nursing students are now embarking on their studies having completed their formal education throughout the medium of Welsh and thus feel more comfortable studying in their mother tongue. Therefore, Bangor University aims to teach Welsh speakers alongside English speakers and offers a choice to their students so they can study in their preferred language. This case study examines how a bilingual ethos can be incorporated to provide a dynamic approach to teaching using pre-recorded lectures and innovative group work. Presentations are recorded in two different languages and are supported by a gapped handbook, ensuring that students focus on the most important aspects of the lecture. The pre-recorded lecture capture is available for students to access after the lecture to reinforce the learning. Crossover group work (Mortiboys, 2010) was included to ensure that each member of the class contributed to discussions and fully understood the topic of managing pain in various scenarios.This resulted in a stimulating session which increased students' motivation and fostered ownership and interest in digital technology, but at the same time met the language and educational needs of a diverse population of students.

PP038 EQ-5D-3L Electronic Version Development For The Brazilian Population

INTRODUCTION:Quality of Life (QoL) is considered to be an important outcome which is widely used in Health Technology Assessment (HTA). In economic evaluations QoL is represented by quality-adjusted life years (QALYs) - adding utility scores to the years of life lived in a determined health status (1). The EuroQol - 5 dimensions (EQ-5D) is a QoL questionnaire that generates utility scores and provides a simple and generic measure of health (2). Electronic QoL instruments have been reported equivalent to paper-based methods, however no studies have assessed agreement between EQ-5D application methods in Brazil (3). Thus, our study aimed to evaluate the measurement equivalence between the original (paper) and adapted (tablet) versions of the EQ-5D-3L Brazilian questionnaire.METHODS:A cross-sectional study was conducted on 509 adult individuals selected at random in economically different regions of two major Brazilian cities. EQ-5D-3L and Visual Analogue Scale, paper and tablet versions, were applied. Subjects were randomized to two groups; one group assigned for test-retest assessment using only electronic media (tablet-tablet), and a crossover group - half of which answered the tablet version before the paper questionnaire (tablet-paper), and the other half which answered the tablet version after the paper questionnaire (paper-tablet). There was a washout period of a minimum of 24 hours and maximum of 7 days between applications. The Intraclass Correlation Coefficient (ICC) and kappa coefficient were used to determine the agreement between methods. The level of significance was set at .05 for all analyses.RESULTS:Females predominated in all groups, and the mean age ranged from 41 to 44 years. In the crossover group the obtained ICC values were: .76 (CI .58–.89) for EQ-5D scores and .77 (CI .68–.84) for Visual Analogue Scale (VAS) scores in the tablet-paper subjects; .83 (CI .75–.89) for EQ-5D scores and .75 (CI .67–.85) for VAS scores in the paper-tablet subjects. In the test-retest group, the ICC values were .85 (CI .73–.91) for EQ-5D scores, .79 (CI .66–.87) for VAS scores. Kappa values were higher than .69 in test-retest group. Internal consistency was similar between methods.CONCLUSIONS:Paper and tablet versions of the EQ-5D were equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar.

Effects of Long-Term Ruxolitinib (RUX) on Bone Marrow (BM) Morphology in Patients with Myelofibrosis (MF) Enrolled in the COMFORT-I Study

Effects of Long-Term Ruxolitinib (RUX) on Bone Marrow (BM) Morphology in Patients with Myelofibrosis (MF) Enrolled in the COMFORT-I Study

Randomised sham-controlled double-blind multicentre clinical trial to ascertain the effect of percutaneous radiofrequency treatment for lumbar facet joint pain.

The aim of this study was to compare the effect of a percutaneous radiofrequency heat lesion at the medial branch of the primary dorsal ramus with a sham procedure, for the treatment of lumbar facet joint pain. A randomised sham-controlled double blind multicentre trial was carried out at the multidisciplinary pain centres of two hospitals. A total of 60 patients aged > 18 years with a history and physical examination suggestive of facet joint pain and a decrease of ≥ 2 on a numerical rating scale (NRS 0 to 10) after a diagnostic facet joint test block were included. In the treatment group, a percutaneous radiofrequency heat lesion (80oC during 60 seconds per level) was applied to the medial branch of the primary dorsal ramus. In the sham group, the same procedure was undertaken without for the radiofrequency lesion. Both groups also received a graded activity physiotherapy programme. The primary outcome measure was decrease in pain. A secondary outcome measure was the Global Perceived Effect scale (GPE). There was a statistically significant effect on the level of pain in the factor Period (T0-T1). However, there was no statistically significant difference with the passage of time between the groups (Group × Period) or in the factor Group. In the crossover group, 11 of 19 patients had a decrease in NRS of ≥ 2 at one month crossover (p = 0.65). There was no statistically significant difference in satisfaction with the passage of time between the groups (Group × Period). The independent factors Group and Period also showed no statistically significant difference. There was no statistically significant Group × Period effect for recovery, neither an effect of Group or of Period. The null hypothesis of no difference in the decrease in pain and in GPE between the treatment and sham groups cannot be rejected. Post hoc analysis revealed that the age of the patients and the severity of the initial pain significantly predicted a positive outcome. Cite this article: Bone Joint J 2016;98-B:1526-33.

Randomized Sham-controlled Double-Blind Multicenter Clinical Trial to Ascertain the Effect of Percutaneous Radiofrequency Treatment for Sacroiliac Joint Pain: Three-month Results.

Objectives:To investigate the effect of a percutaneous radiofrequency (RF) heat lesion compared with a sham procedure, applied to the lateral branches of L5, S1, S2, S3, and S4 nerve roots.Materials and Methods:Sixty patients aged 18 years and above with a medical history and physical examination suggestive for sacroiliac joint pain and a reduction of 2 or more on a numerical rating scale (NRS, 0 to 10) after a sacroiliac joint test block were included in this study. Treatment group: percutaneous RF heat lesion at the lateral branches of S1, S2, S3, and S4 nerve roots and the posterior ramus dorsalis of L5; sham group: same procedure as the treatment group except for the RF heat lesion. Primary outcome measure: pain reduction (NRS). Secondary outcome measure: Global Perceived Effect.Results:No statistically significant differences in pain level over time between the groups (Group×Period) (F1,58=0.353; P=0.56) nor within the treatment Group (F1,58=0.212; P=0.65) were found. The Period factor, however, yielded a significant difference (F1,58=61.67; P<0.001), that is, when pooled together the mean pain level of the patients was significantly reduced at T1 compared with T0. In the crossover group, 42.1% experienced a reduction in NRS of 2 or more at 1 month (P=0.65). No statistically significant difference in satisfaction over time between the groups was found (F1,50=2.1; P=0.15). The independent factors Group (F1,50=2.02; P=0.16) and Period (F1,50=0.95; P=0.33) also showed no statistically significant difference. The same applies to recovery: no statistically significant Group×Period effect (F1,51=0.09; P=0.77) was found, neither an effect of Group (F1,51=0.004; P=0.95) nor of Period (F1,51=0.27; P=0.60).Discussion:The hypothesis of no difference in pain reduction or in Global Perceived Effect between the treatment and sham group cannot be rejected.Level of Evidence:Level 1A.

Randomized sham‐controlled, double‐blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain

BackgroundInvestigate the effect of percutaneous radiofrequency compared to a sham procedure, applied to the ramus communicans for treatment of lumbar disc pain.MethodsRandomized sham‐controlled, double‐blind, crossover, multicenter clinical trial. Multidisciplinary pain centres of two general hospitals. Sixty patients aged 18 or more with medical history and physical examination suggestive for lumbar disc pain and a reduction of two or more on a numerical rating scale (0–10) after a diagnostic ramus communicans test block. Treatment group: percutaneous radiofrequency treatment applied to the ramus communicans; sham: same procedure except radiofrequency treatment. Primary outcome measure: pain reduction. Secondary outcome measure: Global Perceived Effect.ResultsNo statistically significant difference in pain level over time between the groups, as well as in the group was found; however, the factor period yielded a statistically significant result. In the crossover group, 11 out of 16 patients experienced a reduction in NRS of 2 or more at 1 month (no significant deviation from chance). No statistically significant difference in satisfaction over time between the groups was found. The independent factors group and period also showed no statistically significant effects. The same applies to recovery: no statistically significant effects were found.ConclusionsThe null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected. Post hoc analysis revealed that none of the investigated parameters contributed to the prediction of a significant pain reduction.SignificanceInterrupting signalling through the ramus communicans may interfere with the transition of painful information from the discs to the central nervous system. Methodological differences exist in studies evaluating the efficacy of radiofrequency treatment for lumbar disc pain. A randomized, sham‐controlled, double‐blind, multicenter clinical trial on the effect of radiofrequency at the ramus communicans for lumbar disc pain was conducted. The null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected.

Diagnostic stability of autism spectrum disorder in toddlers prospectively identified in a community-based setting: Behavioural characteristics and predictors of change over time.

Autism spectrum disorder diagnoses in toddlers have been established as accurate and stable across time in high-risk siblings and clinic-referred samples. Few studies have investigated diagnostic stability in children prospective identified in community-based settings. Furthermore, there is a dearth of evidence on the individual behaviours that predict diagnostic change over time. The stability and change of autism spectrum disorder diagnoses were investigated from 24 to 48 months in 77 children drawn from the Social Attention and Communication Study. Diagnostic stability was high, with 88.3% overall stability and 85.5% autism spectrum disorder stability. The behavioural markers at 24 months that contributed to diagnostic shift off the autism spectrum by 48 months included better eye contact, more directed vocalisations, the integration of gaze and directed vocalisations/gestures and higher non-verbal developmental quotient. These four variables correctly predicted 88.7% of children into the autism spectrum disorder-stable and autism spectrum disorder-crossover groups overall, with excellent prediction for the stable group (96.2%) and modest prediction for the crossover group (44.4%). Furthermore, non-verbal developmental quotient at 24 months accounted for the significant improvement across time in 'Social Affect' scores on the Autism Diagnostic Observation Schedule for both groups and was the only unique predictor of diagnostic crossover. These findings contribute to the body of evidence on the feasibility of diagnoses at earlier ages to facilitate children's access to interventions to promote positive developmental outcomes.

A Pilot Study on Culottes versus Crossover Single Stenting for True Coronary Bifurcation Lesions.

The purpose of our study was to compare clinical and angiographic outcomes of planned culottes technique with that of provisional crossover single stenting in the treatment of true coronary bifurcation lesions (CBL) with drug-eluting stent (DES). True CBL patients (n = 104) were randomly assigned to either the provisional stenting of the side branch (crossover group) or the culottes group. Additional side branch (SB) stenting in the crossover group was required if there was thrombolysis in myocardial infarction flow ≤ 1 flow). The primary end point was the occurrence of major adverse cardiac events (MACE) at nine months, including cardiac death, myocardial infarction, target lesion/vessel revascularization and in-stent thrombosis. The secondary end point was angiographic in-segment restenosis at nine months. The rate of MACE at nine months was similar between the crossover and culottes groups (7.7% vs. 7.7%, p = 1.000). Additional SB stenting in the crossover group was required in 3.8% of patients. There was one procedural occlusion of SB in the crossover group. At nine months, the rate of in-segment restenosis was similar in the parent main vessel (0% vs. 1.9%, p = 1.000), main branch (1.9% vs. 7.7%, p = 0.363) and SB (17.3% vs. 9.6%, p = 0.250) between the crossover and culottes groups, respectively. This study demonstrated that there is no significant difference in cumulative MACE or in-segment restenosis between crossover and culottes groups. Larger randomized clinical trials are warranted to re-evaluate the outcomes of the provisional crossover stenting versus the culottes stenting techniques utilizing DES for true CBL.

The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye

PurposeTo evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye.MethodsThe prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group).ResultsAt 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378).ConclusionA single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes.

Changing orientations to corporal punishment: A randomized, control trial of the efficacy of a motivational approach to psycho-education.

OBJECTIVE: To evaluate the efficacy of a motivational interviewing (MI) approach in changing positive attitudes toward corporal punishment (CP), behavioral intentions, and behavior. CP has been linked to a variety of negative outcomes for children, and parents' attitudes toward CP strongly predicts its use. Five brief interventions have been reported in the literature designed to target CP attitudes. The current study adopts a novel approach by evaluating the effects of a brief, psycho-educational intervention incorporating aspects of MI. METHOD: Forty-three mothers of children ages 3 to 5 completed 1 motivational psycho-education session. Participants were randomly assigned to intervention or waitlist, completing assessments at baseline, postintervention, and 1-month follow-up. After follow-up, the waitlist condition crossed over, completing the intervention and further assessments. RESULTS: The intervention was associated with greater reductions in CP attitudes and intentions versus the waitlist; these effects were replicated in the crossover group. Further, participants' in-session change-talk predicted greater changes in CP attitudes. The effect size of the current approach was stronger than the prior interventions. CONCLUSIONS: MI is a promising approach to address parental use of CP, though this approach needs replication with a larger sample. Several ways of incorporating this approach on a wider scale are considered. ©2016 American Psychological Association Language: en

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

BackgroundThe need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD).ObjectiveThe aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial.MethodsParticipants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up.ResultsAfter 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time.ConclusionsPlan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV).

Radiofrequency catheter ablation maintains its efficacy better than antiarrhythmic medication in patients with paroxysmal atrial fibrillation: On-treatment analysis of the randomized controlled MANTRA-PAF trial

BackgroundThe Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) is a randomized trial comparing radiofrequency catheter ablation (RFA) to antiarrhythmic drugs (AADs) as first-line treatment of paroxysmal atrial fibrillation (PAF). In order to eliminate the clouding effect of crossover we performed an on-treatment analysis of the data. Methods and resultsPatients (n=294) were divided into three groups: those receiving only the assigned therapy (RFA and AAD groups) and those receiving both therapies (crossover group). The primary end points were AF burden in 7-day Holter recordings at 3, 6, 12, 18, and 24months and cumulative AF burden in all recordings. At 24months, AF burden was significantly lower in the RFA (n=110) than in the AAD (n=92) and the crossover (n=84) groups (90th percentile 1% vs. 10% vs. 16%, P=0.007), and more patients were free from any AF (89% vs. 73% vs. 74%, P=0.006). In the RFA, AAD and the crossover groups 63%, 59% and 21% (P<0.001) of the patients had no AF episodes in any Holter recording, respectively. Quality of life improved significantly in all groups. There were no differences in serious adverse events between the RFA, AAD and crossover groups (19% vs. 8% vs. 23%) (P=0.10). ConclusionsIn the treatment of antiarrhythmic therapy naïve patients with PAF long-term efficacy of RFA was superior to AAD therapy. Thus, it is reasonable to offer RFA as first-line treatment for highly symptomatic patients who accept the risks of the procedure and are aware of frequent need for reablation(s).

Dietary Glycemia Reversibly Contributes to Age‐related Macular Degeneration and Metabolic Disease in Aged C57Bl/6J Mice

Dietary Glycemia Contributes Reversibly to Age-related Macular Degeneration and Metabolic Disease in Aged C57Bl/6J Mice Objective Consuming high glycemia diets is a risk factor for Age-related Macular Degeneration (AMD) in humans. We sought to test in aging C57Bl/6J mice whether a high glycemic index (GI) diet would lead to AMD and other metabolic changes, and if the damage is reversible. Methods: 1-year old mice were fed high or low GI diets for one year. A crossover group had their diets shifted from high to low GI at the mid-point. Retina pathology, metabolic parameters, metabolites, advanced glycation end-products, and microbiota were measured. Results: Mice fed a high GI diet developed obesity and insulin resistance. Many metabolic pathways, including tyrosine, citrate, and ascorbate pathways, and gut microbiomes showed diet-associated changes. High GI-fed mice showed loss of photoreceptor cells and retina pathology consistent with early AMD. Pathology was less prominent in mice in the low GI or crossover groups. Conclusions Chronic consumption of a high glycemia diet induces metabolic disease and AMD, which can be reversed by lowering dietary glycemia, suggesting that diet could be a primary intervention in treatment of early AMD. Funded by NIH (RO1EY012121, RO1EY13250) and USDA (1950-510000-060-01A)

12-Month Blood Pressure Results of Catheter-Based Renal Artery Denervation for Resistant Hypertension: The SYMPLICITY HTN-3 Trial

BackgroundResults of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure. ObjectivesThis study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group). MethodsEligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed. ResultsThe 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (−15.5 ± 24.1 mm Hg vs. −18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by −32.9 ± 28.1 mm Hg at 6 months, but this response regressed to −21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg. ConclusionsThese data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261)

Watchful waiting in incisional hernia: Is it safe?

Incisional hernia (IH) is among the most common postoperative complications after abdominal surgery. Operative treatment (OT) using mesh is the treatment of choice. A strategy of watchful waiting (WW) might be a considered in some patients. This retrospective study compares the outcomes of WW and OT. All patients presenting with IH in an academic surgery department between January 2004 and December 2009 were analyzed according to whether they were treated by WW or OT. Crossovers between both groups were also analyzed. Patient characteristics, information about the initial abdominal operative procedure, symptoms at presentation, and characteristics of the hernia were collected retrospectively. In case of OT, postoperative complications were analyzed. In total, 255 patients were included; 151 (59%) in the OT group and 104 (41%) in WW group. The median follow-up was 68 months (interquartile range [IQR], 52-93). The reasons for WW were the absence of symptoms in 34 patients (33%), comorbidities in 24 (23%), and obesity in 23 (22%). During follow-up, 34 patients (33%) crossed over from WW to OT. Eight of the crossovers (24%) were emergency repairs owing to incarceration at a median of 1 month (IQR, 1-5) after the start of WW. The incidence of unexpected intraoperative intestinal perforation was greater in the crossover group (13%) compared with the OT group (2%; P = .002). Postoperative fistulas were seen in 7% of patients who crossed over from WW to OT versus 0% in primary OT (P = .002). Postoperatively, 3 patients died, 2 of whom were treated operatively after belonging initially to the WW group. WW for IH leads to high crossover rates with significantly greater incidence of intraoperative perforations, fistulas, and mortality, than in the OT group, particularly in patients who require emergency repair of IH owing to incarceration.

Twelve-Month Follow-Up of a Randomized Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Region Pain.

The objective of this study was to report the long-term outcomes of cooled radiofrequency (CRF) lateral branch neurotomy (LBN) as a treatment for sacroiliac (SI) region pain. Whereas the 1-, 3-, 6-, and 9-month outcomes of this procedure compared to sham treatment were previously reported, this current report shows the 12-month outcomes of CRF/LBN treatment for SI region pain. This study originally included 51 subjects who were randomized 2:1 to receive CRF/LBN treatment or a sham intervention, respectively, for SI region pain. Subjects and assessors were blinded for 3months. At that time, sham participants were permitted to receive CRF/LBN, designated as "crossover" study subjects, and followed for 6 additional months. For the purpose of this evaluation, the original CRF/LBN-treated study subjects were followed for a total of 12months. Study participants were 18 to 88years of age and had chronic (symptomatic for >6months) axial back pain. All subjects were qualified for study inclusion following positive responses to dual lateral branch blocks. Lateral branch neurotomy was performed by CRF to ablate the S1 to S3 lateral branches and the L5 dorsal ramus. Pain was measured by a numerical rating scale (NRS) and Short Form 36-bodily pain (SF36-BP) scores. The Oswestry disability index and Short Form 36-physical functioning (SF36-PF) assessment each served to evaluate subject disability. Treatment successes ("responders") in the originally treated CRF/LBN group at 12months, and in the crossover group at 6months, were also determined. In the original CRF/LBN treatment group, 12-month outcomes compared to baseline were favorable, with a mean 2.7 point drop in the NRS score, a 13.9 decrease in the ODI, and a 15.8 increase in SF-36BP. In the crossover study group, 6-month outcomes were also favorable, with a mean NRS score decrease of 2.5 points, a reduction in ODI of 8.8, and an increase in SF36-BP of 11.9. These favorable 12-month results illustrate the durability of effective CRF/LBN-mediated treatment of SI region pain for selected patients. Furthermore, successful CRF/LBN treatments in unblinded crossover study subjects demonstrate the unlikelihood that such positive outcomes are attributable to a "placebo" effect, and suggest that CRF/LBN is an effective therapeutic option for alleviating pain, and improving physical function and quality of life, with few complications.