Pre-intervention Characteristics Research Articles

Abstract WP180: Novel Machine Learning Model for Prediction of Futile Recanalization in Acute Ischemic Stroke Patients With Anterior Circulation Large Vessel Occlusion

Introduction: Up to 50% of acute ischemic stroke (AIS) patients who undergo successful mechanical thrombectomy (MT) fail to achieve favorable outcomes (futile recanalization). In this study we aim to develop a machine learning (ML) model to predict futile recanalization (FR) in AIS patients who undergo MT. Methods: We used data from an ongoing large, multicenter database from 2013 to 2023. We included AIS patients treated with MT for ICA, M1, or M2 occlusion with successful recanalization (modified Thrombolysis in Cerebral Infarction [mTICI] score ≥ 2C) and procedure durations under 60 minutes. FR was defined as successful recanalization with 90-day modified Rankin Scale (mRS) 3-6. The dataset was divided into 75% for training and 25% for external validation. Using the Caret Package in R, multiple models were tested, and their performances were evaluated by the area under the curve (AUC) of receiver operating. Both baseline and pre-interventional characteristics were incorporated into the model. The selected model was then externally validated on a 25% validation dataset. Results: Among 2,546 qualified patients, FR occurred in 1,342 (52.7%). In univariate analysis, baseline characteristics were significantly different between FR and non-FR groups. The M5P model demonstrated the highest performance (AUC: 0.833; 95% CI: 0.7989-0.852; PPV: 0.8101) in comparison to other tested models such as logistic regression (AUC: 0.74), RF (AUC: 0.78), J48 (AUC: 0.78), SVM (AUC: 0.79), and GB (AUC: 0.79). The external validation of the model showed satisfactory results (AUC: 75.25; 95% CI: 70-80; PPV: 76.87). Conclusion: Utilizing clinical, pre-procedural, and imaging parameters, the M5P model can efficiently predict F) in AIS patients before attempting MT. This tool can assist neurointerventionalists in adequately choosing their MT candidates.

Transsplenic tract closure after transsplenic portalvenous access using gelfoam-based tract plugging

BackgroundTo assess the feasibility and safety of a gelfoam torpedo plugging technique for embolization of the transsplenic access channel in adult patients following transvenous portal vein interventions.Materials and methodsBetween 09/2016 and 08/2021, an ultrasound guided transsplenic portalvenous access (TSPVA) was established in twenty-four adult patients with a 21-G needle and 4-F microsheath under ultrasound guidance. Afterwards, sheaths ranging from 4-F to 8-F were inserted as needed for the procedure. Following portal vein intervention, the splenic access tract was embolized with a gelfoam-based tract plugging (GFTP) technique. TSPVA and GFTP were performed twice in two patients. Patients’ pre-interventional and procedural characteristics were analyzed to assess the feasibility and safety of the plugging technique according Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system. Values are given as median (minimum;maximum). Subgroup analysis of intercostal vs. subcostal puncture site for TSPVA was performed using the two-sided Mann–Whitney-U test or Student’s t-test and Fisher’s exact test. Level of significance was p < 0.05.ResultsThe study population’s age was 56 (29;71) years and 54% were female patients. Primary liver disease was predominantly liver cirrhosis with 62% of the patients. Pre-interventional model for end-stage liver disease score was 9 (6;25), international normalized ratio was 1.15 (0.86;1.51), activated partial thromboplastin time was 33s (26s;52s) and platelet count was 88.000/µL (31.000;273.000/µL). Ascites was present in 76% of the cases. Craniocaudal spleen diameter was 17cm (10cm;25cm). Indication for TSPVA was assisted transjugular intrahepatic portosystemic shunt placement in 16 cases and revision in two cases, portal vein stent placement in five cases and variceal embolization in three cases. TSPVA was successfully established in all interventions; interventional success rate was 85% (22/26). The splenic access time was 33min (10min;133min) and the total procedure time was 208min (110min;429min). Splenic access was performed with a subcostal route in 11 interventions and with an intercostal route in 15 interventions. Final sheath size was 4-F in 17 cases, 5-F in three cases, 6-F in five cases, 7-F in two cases and 8-F in one case. A median of two gelfoam cubes was used for GFTP. TSPVA- and GFTP-related complications occurred in 4 of 26 interventions (15%) with a subcapsular hematoma of the spleen in two patients (CIRSE grade 1), access-related infection in one patient (CIRSE grade 3) and both in one patient (CIRSE grade 3). In detail, one access-related complication occurred in a patient with subcostal TSPVA (CIRSE grade 1 complication) and the other three complications occurred in patients with intercostal TSPVA (one CIRSE grade 1 complication and two CIRSE grade 3 complication) (p = 0.614). No patient required interventional or surgical treatment due to puncture tract bleeding.ConclusionGelfoam-based plugging of the puncture tract was feasible and safe for transsplenic access in adult patients undergoing percutaneous portal vein interventions. The lack of major bleeding complications and complete absorption of the gelatine sponge make it a safe alternative to transjugular and transhepatic access and re-interventions via the splenic route.

Electroconvulsive therapy or clozapine for adolescents with treatment-resistant schizophrenia: an explorative analysis on symptom dimensions

Objective This study sought to compare pre-intervention patient characteristics and post-intervention outcomes in a naturalistic sample of adolescent inpatients with treatment-resistant psychotic symptoms who received either electroconvulsive therapy (ECT) or clozapine. Methods Data of adolescents with schizophrenia/schizoaffective disorder receiving ECT or clozapine were retrospectively collected from two tertiary-care psychiatry-teaching university hospitals. Subscale scores of the Positive and Negative Symptom Scale (PANSS) factors were calculated according to the five-factor solution. Baseline demographics, illness characteristics, and post-intervention outcomes were compared. Results There was no significant difference between patients receiving ECT (n = 13) and clozapine (n = 66) in terms of age, sex, and the duration of hospital stay. The ECT group more commonly had higher overall illness and aggression severity. Smoking was less frequent in the clozapine group. Baseline resistance/excitement symptom severity was significantly higher in the ECT group, while positive, negative, affect, disorganisation, and total symptom scores were not. Both interventions provided a significant reduction in PANSS scores with large effect sizes. Conclusion Both ECT and clozapine yielded high effectiveness rates in adolescents with treatment-resistant schizophrenia/schizoaffective disorder. Youth receiving ECT were generally more activated than those who received clozapine.

Predictors for NYHA recovery and 1-year mortality after mitral TEER

Abstract Background Mitral regurgitation (MR) is the second-most frequent valvular heart disease in Europe and frequently aggravates heart failure (HF) symptoms. Mitral transcatheter-edge-to-edge repair (TEER) can be considered in eligible patients, for both primary (in inoperable cases) or secondary severe MR. However, intervention is not advised in severe comorbid patients in whom it is not expected to prolong survival for over 1 year. Purpose Evaluate characteristics associated with HF New York Heart Association (NYHA) class recovery, and one-year all-cause mortality after mitral TEER for severe MR. Methods All mitral TEER procedures for primary and secondary MR conducted in a single-centre between 2014 and 2020 were retrospectively analyzed. The primary endpoint was defined as a reduction of at least one NYHA class in the first month after intervention, and a secondary endpoint considered a recovery of at least two NYHA classes. Survival status 12 months after mitral TEER was also consulted. Clinical, echocardiographic and blood-analysis data were explored as characteristics associated with the endpoints defined, using Pearson's Chi-squared test, Wilcoxon rank sum test and Fisher's exact test, as appropriate. A p&amp;lt;0.05 was considered statistically significant. Results From 103 mitral TEER procedures, 86 (83%) had full information about pre- and post-intervention NYHA class, as well as survival status at 12 months. There was a higher proportion of primary MR among NYHA non-responders (47% versus 25%, p=0.034), but no differences for secondary MR. Higher surgical risk patients (EuroSCORE II) tended to have exhibit more NYHA recovery, though not reaching statistical significance (p=0.068). Both a more advanced NYHA class at baseline and lower N-terminal pro-brain natriuretic peptide (NTproBNP) levels were linked to a higher symptomatic recovery (2048 versus 5676pg/ml, p&amp;lt;0.001). Also, persisting MR after TEER of at least grade 3/4 was more frequent in non-NYHA responders. Regarding NYHA improvement of at least two classes, it was observed in 13% patients, and these also had a more advanced NYHA class at baseline and lower NTproBNP basal levels, and exhibited a lower estimated systolic pulmonary artery pressure and inferior vena cava (IVC) diameter. Finally, 10 (11.6%) of mitral TEER patients died in the first 12 months, and no statistically significant associations were found regarding pre-intervention characteristics and survival. Conclusions This study suggests that three-fifths of severe MR improve their NYHA class after TEER, but only one-fourth for primary MR. Earlier intervention – with lower NTproBNP levels, less severe pulmonary hypertension, and lower IVC diameters – is associated with more symptomatic HF improvement. All-cause mortality in the first year is still significant, exposing a need for better patient selection. However, these findings represent exploratory deductions of a relatively low number, single-centre, patients. Funding Acknowledgement Type of funding sources: None.

Evaluating effectiveness of public health intervention strategies for mitigating COVID-19 pandemic.

Coronavirus disease 2019 (COVID‐19) pandemic is an unprecedented global public health challenge. In the United States (US), state governments have implemented various non‐pharmaceutical interventions (NPIs), such as physical distance closure (lockdown), stay‐at‐home order, mandatory facial mask in public in response to the rapid spread of COVID‐19. To evaluate the effectiveness of these NPIs, we propose a nested case‐control design with propensity score weighting under the quasi‐experiment framework to estimate the average intervention effect on disease transmission across states. We further develop a method to test for factors that moderate intervention effect to assist precision public health intervention. Our method takes account of the underlying dynamics of disease transmission and balance state‐level pre‐intervention characteristics. We prove that our estimator provides causal intervention effect under assumptions. We apply this method to analyze US COVID‐19 incidence cases to estimate the effects of six interventions. We show that lockdown has the largest effect on reducing transmission and reopening bars significantly increase transmission. States with a higher percentage of non‐White population are at greater risk of increased Rt associated with reopening bars.

Effect of sex education on sexual function and sexual quality of life in women with endometriosis: A quasi-experimental study.

To evaluate the effect of a sex education program on sexual function and sexual quality of life in women with endometriosis. In a quasi-experimental study, women with endometriosis who had undergone laparoscopic surgery were assigned to an intervention group (n=36) or a control group (n=36). The intervention group received a sex education program consisting of two sessions a week (90 min each) for two consecutive weeks; the control group received none. Both groups were followed for 12 weeks. Sexual function and sexual quality of life were assessed on the Female Sexual Function Index (FSFI) and the Sexual Quality of life-Female (SQOL-F) questionnaire before the intervention, as well as 8 and 12 weeks after the intervention. Outcomes were analyzed using Student t test, the χ2 test, Fisher exact test, and repeated measures analysis of variance. The mean age of the study participants was 36.9± 5.7 years. The two groups did not differ significantly in terms of demographics and pre-intervention clinical characteristics. At the end of the study, sex education reduced female sexual dysfunction by 58.1% in the intervention group. The mean FSFI score increased significantly in the intervention group from pre-intervention to 8 and 12 weeks post-intervention compared with the scores in the control group (P< 0.001). Sex education appears to be a promising intervention for reducing sexual dysfunction and improving sexual function and sexual quality of life in women with endometriosis. Future studies should encompass longer periods of follow up to obtain further data on the efficacy of sex education in this setting.

Effect of Maternal Diet on Any Necrotizing Enterocolitis in Neonates: A Randomized Double-Blind Study.

Background: The etiology of necrotizing enterocolitis (NEC) is controversially discussed. One of the most recently proposed causes of NEC is an allergy to cow's milk protein. This study was designed to evaluate the effect of a maternal diet without bovine protein on the incidence of any NEC in very low birth weight (VLBW) infants. Materials and Methods: A pilot randomized controlled clinical trial was performed at Akbarabadi Hospital, Tehran, Iran, from December 2019 to July 2020, in women with VLBW infants. One hundred twenty mothers with VLBW neonates were randomly assigned to the intervention or the control group (60 in each). In the intervention group, mothers were given a dairy-free diet during the first 14 days after the newborn's onset of feeding. No special diet was given to the control group. The primary outcome of the study was the rate of any NEC in neonates, which was compared between groups. Any NEC was defined as Bell stage I or greater. Results: The minimum and maximum gestational ages were 26 and 33 weeks, respectively. The minimum birth weight of neonates was 700 g. The two groups did not differ significantly in terms of demographic and preinterventional clinical characteristics. Any NEC was reported in 0% and 10% (5/52) of neonates in the intervention and control groups, respectively; the difference was statistically significant (p = 0.028). The NEC symptoms began ∼34 days after birth. Four cases of NEC were classified as Bell stage I, and one was classified as Bell stage II. No statistical association was registered between sex, gestational age, birth weight, and the onset of feeding with the incidence of any NEC. Conclusion: The use of a cow's milk protein-free diet in mothers and exclusive breastfeeding in preterm VLBW infants may reduce the incidence of NEC. We recommend further studies with larger sample sizes in a multicenter setting. The study was registered at the Iranian Registry of Clinical Trials (IRCT20200415047086N1).

Transcarotid Access for Mechanical Thrombectomy in Acute Ischemic Stroke: A Meta-Analysis and Systematic Review

ObjectivesDespite the success of mechanical thrombectomy in large vessel acute ischemic stroke, recanalization may fail due to difficult anatomic access or peripheral arterial occlusive disease. In these cases, transcarotid access may be used as an alternative, but it has not gained prominence due to safety concerns. Our objective was to assess the efficacy and safety of transcarotid access for mechanical thrombectomy. Materials and MethodsPreferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to perform a systematic review with articles published from 2010 to 2020 summarizing pre-intervention characteristics, techniques utilized, and outcomes of patients undergoing mechanical thrombectomy via trans-carotid puncture. We performed a meta-analysis of clinical outcomes, reperfusion times and overall complications rates of trans-carotid approach. ResultsSix studies describing 80 total attempts at carotid access, 72 of which were successful (90% success rate), were included. Direct carotid puncture was most often used as a rescue technique (87% of patients) secondary to failed femoral access. Successful recanalization was achieved in 76% of patients. 90 day modified Rankin Scale ≤ 2 was achieved in 28% of patients. Carotid puncture-reperfusion time was 32 min (CI = 24–40, p < 0.001). Cervical complications occurred at a rate of 26.5% (95% CI = 17%–38%). Only 1.3% (1/80 patients) had a fatal outcome and 96% of complications required no intervention. ConclusionsOur results on the safety and efficacy of transcarotid access suggests that this approach is a viable alternative to failed thrombectomy when transfemoral or trans-radial access may be impractical.

The effect of vitamin D on recurrence of uterine fibroids: A randomized, double-blind, placebo-controlled pilot study

Backgroundand purpose: A deficiency of vitamin D has been suggested as one of the principal risk factors for uterine fibroids (UFs). We aimed to investigate the effect of vitamin D supplementation on the recurrence of UFs. Materials and methodsIn a randomized, double-blind, placebo-controlled pilot study, women who had undergone hysteroscopic myomectomy from November 2017 to June 2020 were randomly given either vitamin D (1000 IU tablet; n = 55), or placebo (n = 54) daily for 12 months. Both groups were followed and compared in regard of the primary outcomes of the study, which were recurrence rates, size, and numbers of UFs based on three-dimensional transvaginal ultrasound investigation (3D-TVS). Data analysis was performed by the intention-to-treat (ITT) approach. ResultsThe mean age of the study participants was 37.9 ± 6.5 years. The two groups did not differ significantly in terms of demographic and pre-intervention clinical characteristics. The administration of vitamin D supplements for one year reduced recurrence rates of UFs by 50% (p = 0.17). Vitamin D also reduced the size of recurrent UFs in the intervention group compared to controls (−7.7 mm), the difference was statistically different (p < 0.001). No adverse effect of vitamin D was reported in the present study. ConclusionBased on these results, vitamin D appears to be a promising and safe agent in the prevention of recurrence and reduction of the size of recurrent UFs, although further well-designed and appropriately powered studies are required to demonstrate a significant difference in the size and number of recurrent UFs.

Depressed and Socioeconomically Disadvantaged Mothers' Progression Into a Randomized Controlled Mobile Mental Health and Parenting Intervention: A Descriptive Examination Prior to and During COVID-19.

Infants of low-income and depressed mothers are at high risk for poor developmental outcomes. Early parenting mediates infant experiences from birth, and early intervention can support sensitive and responsive parent practices that optimize infant outcomes via promoting developmental competencies. However, low-income and depressed mothers experience substantial challenges to participating in early intervention. They also have extremely limited access to interventions targeting depression. Interventions targeting maternal depression and parent practices can improve maternal and infant outcomes. Mobile internet-based interventions overcome numerous barriers that low-resource mothers face in accessing home-based interventions. Pandemic-related stressors likely reduce family resources and exacerbate distress of already heavily-burdened mother-infant dyads. During crises such as the COVID-19 pandemic, evidence-based remote coaching interventions are paramount. This article reports on a mobile intervention for improving maternal mood and increasing parent practices that promote infant development. An ongoing randomized controlled trial study provided a unique opportunity to monitor progression from referral to intervention initiation between two groups of depressed mothers: those prior to the pandemic and during the pandemic. The study also examines mother and infant characteristics at baseline. The sample consisted primarily of Black mothers experiencing extreme poverty who self-referred to the study in a large southern city, which is one of the most income disparate in the United States. Prior to the pandemic, 97% of study participants successfully progressed from consent to intervention, as compared to significantly fewer–86%–during the pandemic. Mother-infant dyads during COVID-19, as compared to those prior to COVID-19, displayed similar pre-intervention demographic characteristics and intrapersonal characteristics.

Pre-intervention characteristics of the mosquito species in Benin in preparation for a randomized controlled trial assessing the efficacy of dual active-ingredient long-lasting insecticidal nets for controlling insecticide-resistant malaria vectors.

This study provides detailed characteristics of vector populations in preparation for a three-arm cluster randomized controlled trial (RCT) aiming to compare the community impact of dual active-ingredient (AI) long-lasting insecticidal nets (LLINs) that combine two novel insecticide classes-chlorfenapyr or pyriproxifen-with alpha-cypermethrin to improve the prevention of malaria transmitted by insecticide-resistant vectors compared to standard pyrethroid LLINs. The study was carried out in 60 villages across Cove, Zangnanando and Ouinhi districts, southern Benin. Mosquito collections were performed using human landing catches (HLCs). After morphological identification, a sub-sample of Anopheles gambiae s.l. were dissected for parity, analyzed by PCR for species and presence of L1014F kdr mutation and by ELISA-CSP to identify Plasmodium falciparum sporozoite infection. WHO susceptibility tube tests were performed by exposing adult An. gambiae s.l., collected as larvae from each district, to 0.05% alphacypermethrin, 0.75% permethrin, 0.1% bendiocarb and 0.25% pirimiphos-methyl. Synergist assays were also conducted with exposure first to 4% PBO followed by alpha-cypermethrin. An. gambiae s.l. (n = 10807) was the main malaria vector complex found followed by Anopheles funestus s.l. (n = 397) and Anopheles nili (n = 82). An. gambiae s.l. was comprised of An. coluzzii (53.9%) and An. gambiae s.s. (46.1%), both displaying a frequency of the L1014F kdr mutation >80%. Although more than 80% of people slept under standard LLIN, human biting rate (HBR) in An. gambiae s.l. was higher indoors [26.5 bite/person/night (95% CI: 25.2-27.9)] than outdoors [18.5 b/p/n (95% CI: 17.4-19.6)], as were the trends for sporozoite rate (SR) [2.9% (95% CI: 1.7-4.8) vs 1.8% (95% CI: 0.6-3.8)] and entomological inoculation rate (EIR) [21.6 infected bites/person/month (95% CI: 20.4-22.8) vs 5.4 (95% CI: 4.8-6.0)]. Parous rate was 81.6% (95%CI: 75.4-88.4). An. gambiae s.l. was resistant to alpha-cypermethrin and permethrin but, fully susceptible to bendiocarb and pirimiphos-methyl. PBO pre-exposure followed by alpha-cypermethrin treatment induced a higher 24 hours mortality compared to alphacypermethrin alone but not exceeding 40%. Despite a high usage of standard pyrethroid LLINs, the study area is characterized by intense malaria transmission. The main vectors An. coluzzii and An. gambiae s.s. were both highly resistant to pyrethroids and displayed multiple resistance mechanisms, L1014F kdr mutation and mixed function oxidases. These conditions of the study area make it an appropriate site to conduct the trial that aims to assess the effect of novel dual-AI LLINs on malaria transmitted by insecticide-resistant vectors.

Development and content validation of the Safe Surgery Organizational Readiness Tool: A quality improvement study

BackgroundRecent efforts to increase access to safe and high-quality surgical care in low- and middle-income countries have proven successful. However, multiple facilities implementing the same safety and quality improvement interventions may not all achieve successful outcomes. This heterogeneity could be explained, in part, by pre-intervention organizational characteristics and lack of readiness of surgical facilities. In this study, we describe the process of developing and content validating the Safe Surgery Organizational Readiness Tool. Materials and methodsThe new tool was developed in two stages. First, qualitative results from a Safe Surgery 2020 intervention were combined with findings from a literature review of organizational readiness and change. Second, through iterative discussions and expert review, the Safe Surgery Organizational Readiness Tool was content validated. ResultsThe Safe Surgery Organizational Readiness Tool includes 14 domains and 56 items measuring the readiness of surgical facilities in low- and middle-income countries to implement surgical safety and quality improvement interventions. This multi-dimensional and multi-level tool offers insights into facility members’ beliefs and attitudes at the individual, team, and facility levels. A panel review affirmed the content validity of the Safe Surgery Organizational Readiness Tool. ConclusionThe Safe Surgery Organizational Readiness Tool is a theory- and evidence-based tool that can be used by change agents and facility leaders in low- and middle-income countries to assess the baseline readiness of surgical facilities to implement surgical safety and quality improvement interventions. Next steps include assessing the reliability and validity of the Safe Surgery Organizational Readiness Tool, likely resulting in refinements.

For which younger siblings of children with autism spectrum disorder does parent-mediated intervention work?

In this second of two primary papers, we examined two pre-intervention characteristics that might describe for whom a parent-implemented intervention, "Improving Parents As Communication Teachers," worked. Investigators randomized 97 high-risk siblings and their primary parent to either the Improving Parents As Communication Teachers or control group, used intent-to-treat analysis, and used assessors and coders who were blinded to group assignment. We predicted that a combined risk score (incorporating young siblings' sex, multiplex status, and behavioral risk) would describe the subgroup for whom Improving Parents As Communication Teachers affected the targeted skills related to reducing communication challenges. We also predicted that pre-intervention level of parents' depressive symptoms would describe the parents whose parenting stress and effectiveness as parents would be improved by learning to use Improving Parents As Communication Teachers. In girls with only one older sibling with autism spectrum disorder and who scored at low risk on an autism spectrum disorder screen, parental receipt of Improving Parents As Communication Teachers training had an indirect effect on children's expressive language ability or autism spectrum disorder diagnosis through earlier effects on high-risk siblings' intentional communication or expressive vocabulary. We did not confirm our prediction regarding Improving Parents As Communication Teachers' effect on parenting-related stress or sense of parenting effectiveness.

Evaluation of a city-wide school-located influenza vaccination program in Oakland, California, with respect to vaccination coverage, school absences, and laboratory-confirmed influenza: A matched cohort study.

It is estimated that vaccinating 50%-70% of school-aged children for influenza can produce population-wide indirect effects. We evaluated a city-wide school-located influenza vaccination (SLIV) intervention that aimed to increase influenza vaccination coverage. The intervention was implemented in ≥95 preschools and elementary schools in northern California from 2014 to 2018. Using a matched cohort design, we estimated intervention impacts on student influenza vaccination coverage, school absenteeism, and community-wide indirect effects on laboratory-confirmed influenza hospitalizations. We used a multivariate matching algorithm to identify a nearby comparison school district with pre-intervention characteristics similar to those of the intervention school district and matched schools in each district. To measure student influenza vaccination, we conducted cross-sectional surveys of student caregivers in 22 school pairs (2017 survey, N = 6,070; 2018 survey, N = 6,507). We estimated the incidence of laboratory-confirmed influenza hospitalization from 2011 to 2018 using surveillance data from school district zip codes. We analyzed student absenteeism data from 2011 to 2018 from each district (N = 42,487,816 student-days). To account for pre-intervention differences between districts, we estimated difference-in-differences (DID) in influenza hospitalization incidence and absenteeism rates using generalized linear and log-linear models with a population offset for incidence outcomes. Prior to the SLIV intervention, the median household income was $51,849 in the intervention site and $61,596 in the comparison site. The population in each site was predominately white (41% in the intervention site, 48% in the comparison site) and/or of Hispanic or Latino ethnicity (26% in the intervention site, 33% in the comparison site). The number of students vaccinated by the SLIV intervention ranged from 7,502 to 10,106 (22%-28% of eligible students) each year. During the intervention, influenza vaccination coverage among elementary students was 53%-66% in the comparison district. Coverage was similar between the intervention and comparison districts in influenza seasons 2014-2015 and 2015-2016 and was significantly higher in the intervention site in seasons 2016-2017 (7%; 95% CI 4, 11; p < 0.001) and 2017-2018 (11%; 95% CI 7, 15; p < 0.001). During seasons when vaccination coverage was higher among intervention schools and the vaccine was moderately effective, there was evidence of statistically significant indirect effects: The DID in the incidence of influenza hospitalization per 100,000 in the intervention versus comparison site was -17 (95% CI -30, -4; p = 0.008) in 2016-2017 and -37 (95% CI -54, -19; p < 0.001) in 2017-2018 among non-elementary-school-aged individuals and -73 (95% CI -147, 1; p = 0.054) in 2016-2017 and -160 (95% CI -267, -53; p = 0.004) in 2017-2018 among adults 65 years or older. The DID in illness-related school absences per 100 school days during the influenza season was -0.63 (95% CI -1.14, -0.13; p = 0.014) in 2016-2017 and -0.80 (95% CI -1.28, -0.31; p = 0.001) in 2017-2018. Limitations of this study include the use of an observational design, which may be subject to unmeasured confounding, and caregiver-reported vaccination status, which is subject to poor recall and low response rates. A city-wide SLIV intervention in a large, diverse urban population was associated with a decrease in the incidence of laboratory-confirmed influenza hospitalization in all age groups and a decrease in illness-specific school absence rate among students in 2016-2017 and 2017-2018, seasons when the vaccine was moderately effective, suggesting that the intervention produced indirect effects. Our findings suggest that in populations with moderately high background levels of influenza vaccination coverage, SLIV programs are associated with further increases in coverage and reduced influenza across the community.

Effects of a naturalistic intervention on the speech outcomes of young children with cleft palate

Purpose: The purpose of this study was to investigate the extent to which a naturalistic communication intervention, Enhanced Milieu Teaching with Phonological Emphasis (EMT + PE) improved the speech outcomes of toddlers with cleft palate with or without cleft lip (CP ± L)Method: This study was a stratified randomised controlled trial.Setting: Treatment was delivered in a university clinic by a trained speech-language pathologist.Thirty children aged between 15 and 36 months (M = 25) with nonsyndromic CP ± CL and typical cognitive development were randomly assigned to a treatment (EMT + PE) or business as usual comparison condition.Participants in the EMT + PE treatment group received 48, 30-min sessions, over a 6-month period. Fidelity of treatment was high across participants.The primary outcome measures were percent consonants correct (PCC), consonant inventory, compensatory articulation errors, and nasal emission.Result: Regression analyses controlling for pre-intervention child characteristics were conducted for PCC and consonant inventory. Intervention was not a significant predictor of post-intervention outcome. Words per minute differentiated the children who benefitted from the intervention from those who did not. Reduction in compensatory errors and nasal emission occurred in both groups but to a greater degree in the EMT + PE group.Conclusion: EMT + PE is a promising early speech intervention for young children with CP ± L, especially for children with higher rates of word use.

Use of the Essential Nutrition Actions framework improved child growth in Bangladesh.

The Essential Nutrition Actions (ENA) framework is an evidence-based set of cost-effective, integrated tools for training health and community workers to promote optimal nutrition practices for the first 1,000days. This ENA pilot project (ENAPP) was implemented with United States Agency for International Development (USAID) funding from August 2008 to September 2009 in six unions of the working area of an existing USAID-funded, Title II programme in southern Bangladesh. ENAPP, which targeted governmental and non-governmental service providers, was intended to strengthen the behaviour change component of the nutrition strategy of this project. Following a qualitative review of ENAPP's activities, this evaluation uses administrative (growth monitoring) data and propensity score matching of pre-intervention characteristics to create multiple counterfactuals for difference-in-difference estimations of the impact of ENAPP on child nutritional status. Records indicated that government and community healthcare workers received intensive training, and these staff reported that they could effectively integrate ENA messages into their existing responsibilities. Both longitudinal and cross-sectional analyses indicate that ENAPP was successful in increasing children's weight-for-age z-scores, and the difference in z-scores between the treatment and the comparison group increased with time. The materials and methods used in this pilot project should be scaled up, based on the success of these tools and the project's ability to link with and influence the local health system.

Bronchoscopic and histologic findings during lymphatic intervention for plastic bronchitis

Percutaneous lymphatic intervention (PCL) is a promising new therapy for plastic bronchitis (PB). We characterized bronchoalveolar lavage (BAL) and cast morphology in surgically repaired congenital heart disease (CHD) patients with PB during PCL. We quantified respiratory and bronchoscopic characteristics and correlated them with post-intervention respiratory outcomes. We retrospectively reviewed patients with PB and surgically repaired CHD undergoing PCL and bronchoscopy at our institution. Pre-intervention characteristics, bronchoscopy notes, BAL cell counts, virology, and cultures were collected. A pathologist blinded to clinical data reviewed cast specimens. Respiratory outcomes were evaluated through standardized telephone questionnaire. Sixty-two patients were included with a median follow-up of 20 months. No patients experienced airway bleeding, obstruction, or prolonged intubation related to bronchoscopy. Of BAL infectious studies, the positive results were 4 (8%) fungal, 6 (11%) bacterial, and 6 (14%) viral. Median BAL count per 100 cells for neutrophils, lymphocytes, and eosinophils were 13, 10, and 0, respectively. Of 23 bronchial casts analyzed, all contained lymphocytes, and 19 (83%) were proteinaceous, with 14 containing neutrophils and/or eosinophils. Median BAL neutrophil count was greater in patients with proteinaceous neutrophilic or eosinophilic casts compared to casts without neutrophils or lymphocytes (P = 0.030). Post-intervention, there was a significant reduction in respiratory medications and support and casting frequency. The predominance of neutrophilic proteinaceous casts and high percentage of positive BAL infectious studies support short-term fibrinolytic and anti-infective therapies in PB in select patients. Flexible bronchoscopy enables safe assessment of cast burden. PCL effectively treats PB and reduces respiratory therapies.

Cardiac events within one year after a subarachnoid haemorrhage: The predictive value of troponin elevation after aneurysm occlusion.

BackgroundPatients who survive after an aneurysmal subarachnoid haemorrhage (ASAH) have an increased incidence of cardiovascular events compared with the general population. We assessed whether troponin elevation after aneurysm occlusion, as marker of myocardial injury, can predict long-term cardiac events.MethodsWe analysed a prospectively collected cohort of 159 patients with ASAH and early aneurysm occlusion, in whom routine post-intervention troponin I (TnI) measurements were performed. With competing risk regression modelling we estimated the association between TnI elevation after aneurysm occlusion and major adverse cardiac events within one year. Secondary outcome measures were all-cause mortality and neurological condition within one year. The predictive value of post-intervention TnI was compared with the predictive value of pre-intervention characteristics using c-statistics and the integrated discrimination improvement index.ResultsSubdistribution hazard ratios for TnI elevation and major adverse cardiac events at one year were 1.05 (95% confidence interval (CI) 1.03–1.07) per 10 ng/l increase in TnI and 7.91 (95% CI 1.46–43.0) for any TnI elevation. After adjustment for pre-intervention variables, the subdistribution hazard ratios were 1.47 (95% CI 0.81–2.67) per 10 ng/l and 9.00 (95% CI 1.62–50.1) for any elevation. The c-statistic was 0.71 for TnI elevation as a continuous measure and 0.69 for any TnI elevation. The integrated discrimination improvement index showed a minimum improvement in prediction of 0.08 (interquartile range 0.06 to 0.09) for TnI as a continuous measure and 0.003 (interquartile range −0.004 to 0.01) for any TnI elevation, when compared with pre-intervention characteristics.ConclusionTnI elevation after occlusion of a ruptured intracranial aneurysm predicts the occurrence of a major adverse cardiac event within one year after ASAH.

A serious game for children with Attention Deficit Hyperactivity Disorder: Who benefits the most?

ObjectiveThe aim of the current study was to identify which subgroups of children with Attention Deficit Hyperactivity Disorder (ADHD) benefitted the most from playing a Serious Game (SG) intervention shown in a randomized trial to improve behavioral outcomes.MethodPre-intervention characteristics [i.e., gender, age, intellectual level of functioning, medication use, computer experience, ADHD subtype, severity of inattention problems, severity of hyperactivity/impulsivity problems, comorbid Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD) symptoms] were explored as potential moderators in a Virtual Twins (VT) analysis to identify subgroups for whom the SG intervention was most effective. Primary outcome measures were parent-reported time management, planning/organizing and cooperation skills.ResultsTwo subgroups were identified. Girls (n = 26) were identified as the subgroup that was most likely to show greater improvements in planning/organizing skills as compared to the estimated treatment effect of the total group of participants. Furthermore, among the boys, those (n = 47) with lower baseline levels of hyperactivity and higher levels of CD symptoms showed more improvements in their planning/organizing skills when they played the SG intervention as compared to the estimated treatment effect of the total group of participants.ConclusionUsing a VT analysis two subgroups of children with ADHD, girls, and boys with both higher levels of CD and lower levels of hyperactivity, were identified. These subgroups mostly benefit from playing the SG intervention developed to improve ADHD related behavioral problems. Our results imply that these subgroups have a higher chance of treatment success.

Functional Strength Training and Movement Performance Therapy for Upper Limb Recovery Early Poststroke-Efficacy, Neural Correlates, Predictive Markers, and Cost-Effectiveness: FAST-INdiCATE Trial.

Variation in physiological deficits underlying upper limb paresis after stroke could influence how people recover and to which physical therapy they best respond. To determine whether functional strength training (FST) improves upper limb recovery more than movement performance therapy (MPT). To identify: (a) neural correlates of response and (b) whether pre-intervention neural characteristics predict response. Explanatory investigations within a randomised, controlled, observer-blind, and multicentre trial. Randomisation was computer-generated and concealed by an independent facility until baseline measures were completed. Primary time point was outcome, after the 6-week intervention phase. Follow-up was at 6 months after stroke. With some voluntary muscle contraction in the paretic upper limb, not full dexterity, when recruited up to 60 days after an anterior cerebral circulation territory stroke. Conventional physical therapy (CPT) plus either MPT or FST for up to 90 min-a-day, 5 days-a-week for 6 weeks. FST was "hands-off" progressive resistive exercise cemented into functional task training. MPT was "hands-on" sensory/facilitation techniques for smooth and accurate movement. The primary efficacy measure was the Action Research Arm Test (ARAT). Neural measures: fractional anisotropy (FA) corpus callosum midline; asymmetry of corticospinal tracts FA; and resting motor threshold (RMT) of motor-evoked potentials. Covariance models tested ARAT change from baseline. At outcome: correlation coefficients assessed relationship between change in ARAT and neural measures; an interaction term assessed whether baseline neural characteristics predicted response. 288 Participants had: mean age of 72.2 (SD 12.5) years and mean ARAT 25.5 (18.2). For 240 participants with ARAT at baseline and outcome the mean change was 9.70 (11.72) for FST + CPT and 7.90 (9.18) for MPT + CPT, which did not differ statistically (p = 0.298). Correlations between ARAT change scores and baseline neural values were between 0.199, p = 0.320 for MPT + CPT RMT (n = 27) and -0.147, p = 0.385 for asymmetry of corticospinal tracts FA (n = 37). Interaction effects between neural values and ARAT change between baseline and outcome were not statistically significant. There was no significant difference in upper limb improvement between FST and MPT. Baseline neural measures did not correlate with upper limb recovery or predict therapy response. Current Controlled Trials: ISRCT 19090862, http://www.controlled-trials.com.