Secondary Outcome Variable

During competitive events, the pacing strategy depends upon how an athlete feels at a specific moment and the distance remaining. It may be expressed as the Hazard Score (HS) with momentary HS being shown to provide a measure of the likelihood of changing power output (PO) within an event and summated HS as a marker of how difficult an event is likely to be perceived to be. This study aimed to manipulate time trial (TT) starting strategies to establish whether the summated HS, as opposed to momentary HS, will improve understanding of performance during a simulated cycling competition. Seven subjects (peak PO: 286 ± 49.7 W) performed two practice 10-km cycling TTs followed by three 10-km TTs with imposed PO (±5% of mean PO achieved during second practice TT and a self-paced TT). PO, rating of perceived exertion (RPE), lactate, heart rate (HR), HS, summated HS, session RPE (sRPE) were collected. Finishing time and mean PO for self-paced (time: 17.51 ± 1.41 min; PO: 234 ± 62.6 W), fast-start (time: 17.72 ± 1.87 min; PO: 230 ± 62.0 W), and slow-start (time: 17.77 ± 1.74 min; PO: 230 ± 62.7) TT were not different. There was a significant interaction between each secondary outcome variable (PO, RPE, lactate, HR, HS, and summated HS) for starting strategy and distance. The evolution of HS reflected the imposed starting strategy, with a reduction in PO following a fast-start, an increased PO following a slow-start with similar HS during the last part of all TTs. The summated HS was strongly correlated with the sRPE of the TTs (r = 0.88). The summated HS was higher with a fast start, indicating greater effort, with limited time advantage. Thus, the HS appears to regulate both PO within a TT, but also the overall impression of the difficulty of a TT.

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Impact of maternal medication for opioid use disorder on neurodevelopmental outcomes of infants treated for neonatal opioid withdrawal syndrome

Journal of Neonatal-Perinatal Medicine ◽

10.3233/npm-200615 ◽

2021 ◽

pp. 1-11

Author(s):

R.S. King ◽

E. Peacock-Chambers ◽

D. Wilson ◽

J. Shimer ◽

S. Foss ◽

...

Keyword(s):

Negative Impact ◽

Study Groups ◽

Opioid Use Disorder ◽

Secondary Outcome ◽

Outcome Variable ◽

Opioid Use ◽

Short Term ◽

Neurodevelopmental Outcomes ◽

Discharge Disposition ◽

Secondary Outcome Variable

BACKGROUND: Increasing rates of maternal opioid use disorder has led to greater number of opioid exposed newborns (OENs). Maternal enrollment in medication for opioid use disorder (MOUD) program improves short term neonatal outcomes. This study aimed at assessing neurobehavioral outcomes for OENs. METHODS: Retrospective observational cohort study of OENs between Jul 2006 and Dec 2018. Two study groups were identified as initiation of medication for opioid use disorder (MOUD) prior to diagnoses of pregnancy or after. Primary outcome variables were enrollment in and duration of EI services. Secondary outcome variable was diagnoses of a behavioral and/or developmental disorder (BDD) during the study period. RESULTS: Of 242 infants, 113 were enrolled in EI and BDD diagnoses data was available for all infants [age range 6 to 12 years], 82% infants had exposure to maternal MOUD, while 18% were exposed to either maternal prescription non-MOUD opioids or illicit opioids. Maternal MOUD initiation prior to pregnancy was associated with improved short term outcomes for OENs. Almost a third of infants were diagnosed with a BDD with no differences between the two study groups. CONCLUSION: Early initiation of maternal MOUD improved short term outcomes and discharge disposition for OENs. Prolonged in-utero exposure to opioids presents a potential for negative impact on neurodevelopmental and behavioral outcomes. These risks must be considered to increase access and adherence to EI services, as well as to focus on non-opioid based maternal MOUD. Longitudinal studies assessing the safety of MOUD on short and long-term child health outcomes are needed.

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Betulin-Based Oleogel to Improve Wound Healing in Dystrophic Epidermolysis Bullosa: A Prospective Controlled Proof-of-Concept Study

Dermatology Research and Practice ◽

10.1155/2017/5068969 ◽

2017 ◽

Vol 2017 ◽

pp. 1-10 ◽

Cited By ~ 15

Author(s):

Agnes Schwieger-Briel ◽

Dimitra Kiritsi ◽

Christoph Schempp ◽

Cristina Has ◽

Hauke Schumann

Keyword(s):

Wound Healing ◽

Epidermolysis Bullosa ◽

Statistical Significance ◽

Treatment Options ◽

Pilot Trial ◽

Secondary Outcome ◽

Outcome Variable ◽

Birch Bark ◽

Accelerate Wound Healing ◽

Secondary Outcome Variable

Introduction. Skin fragility and recurrent wounds are hallmarks of hereditary epidermolysis bullosa (EB). Treatment options to accelerate wound healing are urgently needed. Oleogel-S10 contains a betulin-rich triterpene extract from birch bark. In this study, we tested the wound healing properties of topical Oleogel-S10 in patients with dystrophic EB. Methods. We conducted an open, blindly evaluated, controlled, prospective phase II pilot trial in patients with dystrophic EB (EudraCT number 2010-019945-24). Healing of wounds treated with and without topical Oleogel-S10 was compared. Primary efficacy variable was faster reepithelialization as determined by 2 blinded experts. The main secondary outcome variable of the study was percentage of wound epithelialization. Results. Twelve wound pairs of 10 patients with dystrophic EB were evaluated. In 5 of 12 cases, both blinded reviewers considered epithelialization of the intervention wounds as superior. In 3 cases, only one reviewer considered Oleogel-S10 as superior and the other one as equal to control. Measurements of wound size showed a trend towards accelerated wound healing with the intervention but without reaching statistical significance. Conclusion. Our results indicate a potential for faster reepithelialization of wounds in patients with dystrophic EB when treated with Oleogel-S10 but larger studies are needed to confirm significance.

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Endoscopic Brow Lift Without Muscle Resection: Objective and Subjective Changes in Intereyebrow Width

The American Journal of Cosmetic Surgery ◽

10.1177/0748806819884424 ◽

2019 ◽

Vol 37 (2) ◽

pp. 97-103

Author(s):

Brian A. Hollabaugh ◽

Jon Perenack ◽

Brian J. Christensen

Keyword(s):

Secondary Outcome ◽

Outcome Variable ◽

P Value ◽

Brow Lift ◽

Aesthetic Appearance ◽

The Aesthetic ◽

Endoscopic Brow Lift ◽

Relationship Of ◽

The Relationship ◽

Pearson Correlations

The purpose of this study is to evaluate the objective and subjective changes in medial intereyebrow distance following endoscopic brow lift without corrugator resection. The authors designed a retrospective cohort study. The eligible patients included those receiving endoscopic brow lifts at Williamson Cosmetic Center in Baton Rouge, LA between June 1, 2014 and March 31, 2018. The primary outcome variable was the distance between the left and right medial brow. The secondary outcome variables were nonsurgeon evaluator’s perception of the change in intereyebrow distance and the aesthetics of the intereyebrow region. The relationship of the outcome variables to the primary predictor (time point—preoperative and postoperative) was analyzed using paired sample t-tests. The relationship of the outcome variables to the other predictors was analyzed using Pearson correlations. A P-value of less than .05 was considered significant. A total of 41 patients were included in the study. The average age was 55.3 ± 8.5 years and all patients were women. The average time from surgery to postoperative photos was 6.2 ± 3.2 (range: 3-15) months. The average preoperative intereyebrow width was 31.5 mm, and the average postoperative width was 33.1 mm ( P < .0001). Correct perception of the intereyebrow change was found to be positively correlated with increasing patient age ( P = .047) and increasing change in intereyebrow width ( P = .008). The intereyebrow distance was perceived as aesthetic for 73.4% ± 31.0% of preoperative patients and 76.1% ± 27.6% of postoperative patients ( P = .346). Patients with a preoperative intereyebrow distance perceived as aesthetic are very likely to be perceived as aesthetic postoperatively (correlation coefficient 0.817, P-value < .0001). Following endoscopic brow lift without corrugator muscle resection, there is a small, but statistically significant increase in the intereyebrow distance. However, this change was not associated with negative perception of the aesthetic appearance of the intereyebrow region.

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Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17134649 ◽

2020 ◽

Vol 17 (13) ◽

pp. 4649

Author(s):

Michele Nieri ◽

Veronica Giuntini ◽

Umberto Pagliaro ◽

Monica Giani ◽

Lorenzo Franchi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Dental Plaque ◽

Controlled Trial ◽

Secondary Outcome ◽

Outcome Variable ◽

Plaque Score ◽

Plaque Removal ◽

Randomized Controlled ◽

Significant Difference ◽

Electric Toothbrush

Background: The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N). Methods: Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant (p < 0.0001). The differences were statistically significant between the U and P groups (difference −48; 95% CI from −54 to −41) favoring the P group, and between the U and H groups (difference −45; 95% CI from −52 to −39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from −2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant (p < 0.0001) favoring the P and H groups. Conclusions: The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.

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Flexible Endoscopic Evaluation of Swallowing with Sensory Testing: Patient Characteristics and Analysis of Safety in 1,340 Consecutive Examinations

Annals of Otology Rhinology & Laryngology ◽

10.1177/000348940511400301 ◽

2005 ◽

Vol 114 (3) ◽

pp. 173-176 ◽

Cited By ~ 55

Author(s):

Jonathan E. Aviv ◽

Thomas Murry ◽

Manderly Cohen ◽

Anne Zschommler ◽

Carolyn Gartner

Keyword(s):

Heart Surgery ◽

Open Heart Surgery ◽

Patient Characteristics ◽

Acid Reflux ◽

Secondary Outcome ◽

Outcome Variable ◽

Safe Procedure ◽

Airway Compromise ◽

Sensory Testing ◽

Endoscopic Evaluation

Flexible endoscopic evaluation of swallowing with sensory testing (FEESST) is a comprehensive endoscopic assessment of the sensory and motor components of a swallow. Previous studies addressing patient safety issues with respect to FEESST included relatively small numbers of patients and paid almost no attention to patient characteristics. The purpose of this study was to determine the incidence of FEESST-related complications in the outpatient and inpatient settings and to analyze patient diagnoses that led to the performance of FEESST. We performed a prospective study of FEESST complications in 1,340 consecutive evaluations performed over a 4 1/2-year period. The primary outcome variables were incidence of epistaxis and airway compromise. The secondary outcome variable was underlying patient diagnoses. The incidence of epistaxis was 1 in 1,340 (0.07%). There were no instances of airway compromise. Stroke was the most common reason for the performance of FEESST (343; 25.6%), followed by cardiac-related dysphagia (298; 22.2%) following open heart surgery (169/298; 56.7%), heart attack, congestive heart failure, or new arrhythmia. The remaining causes were head and neck cancer (207; 15.4%), pulmonary disease (141; 10.5%), chronic neurologic disease (124; 9.3%), and acid reflux disease (80; 6.0%). We conclude that FEESST is a relatively safe procedure for the sensory and motor assessment of dysphagia in a cohort of patients with a wide variety of underlying diagnoses. The emergence of cardiac surgery as a common cause of dysphagia warrants further study.

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Point-of-Care Testing

Anesthesiology ◽

10.1097/aln.0b013e318264c644 ◽

2012 ◽

Vol 117 (3) ◽

pp. 531-547 ◽

Cited By ~ 385

Author(s):

Christian Friedrich Weber ◽

Klaus Görlinger ◽

Dirk Meininger ◽

Eva Herrmann ◽

Tobias Bingold ◽

...

Keyword(s):

Cardiac Surgery ◽

Blood Loss ◽

Sample Size ◽

Point Of Care ◽

Postoperative Blood Loss ◽

Secondary Outcome ◽

Outcome Variable ◽

Transfusion Rate ◽

Outcome Parameters ◽

Hemostatic Therapy

Introduction The current investigation aimed to study the efficacy of hemostatic therapy guided either by conventional coagulation analyses or point-of-care (POC) testing in coagulopathic cardiac surgery patients. Methods Patients undergoing complex cardiac surgery were assessed for eligibility. Those patients in whom diffuse bleeding was diagnosed after heparin reversal or increased blood loss during the first 24 postoperative hours were enrolled and randomized to the conventional or POC group. Thromboelastometry and whole blood impedance aggregometry have been performed in the POC group. The primary outcome variable was the number of transfused units of packed erythrocytes during the first 24 h after inclusion. Secondary outcome variables included postoperative blood loss, use and costs of hemostatic therapy, and clinical outcome parameters. Sample size analysis revealed a sample size of at least 100 patients per group. Results There were 152 patients who were screened for eligibility and 100 patients were enrolled in the study. After randomization of 50 patients to each group, a planned interim analysis revealed a significant difference in erythrocyte transfusion rate in the conventional compared with the POC group [5 (4;9) versus 3 (2;6) units [median (25 and 75 percentile)], P<0.001]. The study was terminated early. The secondary outcome parameters of fresh frozen plasma and platelet transfusion rates, postoperative mechanical ventilation time, length of intensive care unit stay, composite adverse events rate, costs of hemostatic therapy, and 6-month mortality were lower in the POC group. Conclusions Hemostatic therapy based on POC testing reduced patient exposure to allogenic blood products and provided significant benefits with respect to clinical outcomes.

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Poor post-operative growth in infants with two-ventricle physiology

Cardiology in the Young ◽

10.1017/s1047951111000229 ◽

2011 ◽

Vol 21 (4) ◽

pp. 421-429 ◽

Cited By ~ 23

Author(s):

Jeffrey B. Anderson ◽

Bradley S. Marino ◽

Sharon Y. Irving ◽

J. Felipe García-España ◽

Chitra Ravishankar ◽

...

Keyword(s):

Cardiac Disease ◽

Surgical Repair ◽

Hospital Length Of Stay ◽

Secondary Outcome ◽

Outcome Variable ◽

Normal Infant ◽

Z Score ◽

Poor Growth ◽

Congenital Cardiac Disease ◽

Weight For Age

AbstractBackgroundAdequate nutritional support is essential for normal infant growth and development. Infants with congenital cardiac disease are known to be at risk for growth failure. We sought to describe perioperative growth in infants undergoing surgical repair of two-ventricle congenital cardiac disease and assess for predictors of their pattern of growth.Materials and methodsFull-term infants who underwent surgical repair of two-ventricle congenital cardiac disease at a single institution were enrolled in a retrospective cohort study performed following a larger prospective study. Infants with facial, gastrointestinal, or neurologic anomalies, trisomy chromosomal abnormality, birth weight less than 2500 grams, or those transferred to another institution before discharge home were excluded. The primary outcome was change in weight-for-age z score from surgery to discharge. Our secondary outcome variable was post-operative hospital length of stay.ResultsA total of 76 infants met the inclusion criteria. Medain age at surgery was 5 days with a range from 1 to 44. The median weight-for-age z score at surgery was −0.2 with a range from −2.9 to 2.8 and by discharge had dropped to −1.2 with a range from −3.4 to 1.8. The median change in weight-for-age z score from surgery to discharge was −1.0 with a range from −2.3 to 0.2. Delayed post-operative nutrition (p < 0.001) and reintubation following initial post-operative extubation (p = 0.001) were associated with decrease in weight-for-age z score.ConclusionsInfants undergoing repair of two-ventricle congenital cardiac disease had poor growth in the post-operative period. This may be mitigated by early initiation of post-operative nutrition.

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Efficacy of multi-powered continuous positive airway pressure device on neonates bearing respiratory distress syndrome: an observational analytical study

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20215004 ◽

2021 ◽

Vol 9 (1) ◽

pp. 240

Author(s):

Jagadeesh . ◽

Bhavana M. S. ◽

Megha Singh ◽

Kavitha . ◽

Ravi Chander

Keyword(s):

Heart Rate ◽

Continuous Positive Airway Pressure ◽

Respiratory Distress ◽

Airway Pressure ◽

Analytical Study ◽

Positive Airway Pressure ◽

Therapeutic Option ◽

Secondary Outcome ◽

Survival Duration ◽

Outcome Variable

Background: CPAP (continuous positive airway pressure), an effective intervention for respiratory distress in neonates. Following the development of simple, safe and relatively inexpensive CPAP devices. Saans (CPAP device) is one such portable, easy to use device which is operable in low resource settings, can be used as T-piece resuscitator in the delivery room and during transport. The aim of this study was to evaluate the efficacy of a low cost, multi-powered and easy to use CPAP device Saans, developed by Coeo Labs Pvt. Ltd., Bangalore, on neonates with respiratory distress.Methods: An observational analytical study per the protocol, 35 neonates gestational age >30 weeks were enrolled. Primary outcome variable was the need for mechanical ventilation. Secondary outcome variables were the rate of survival, duration of oxygen in hours, duration of ventilation in hours, duration of hospital stay in days, change Downe score, SAS score, heart rate, respiratory rate and FiO2 from enrolment 6 hours of intervention.Results: 89% (31 neonates) enrolled with respiratory distress. 11% (4 neonates) failed to improve on CPAP therapy. A significant decline in the need for FiO2, mean Downe score, mean R and heart rate observed from the baseline 6 hours CPAP (p<0.001), t test analysis, factors significantly associated CPAP failure were high FiO2 at 1 hour and high positive end-expiratory pressure within 1 hour initiating CPAP (p<0.001).Conclusions: Saans (CPAP device), successful therapeutic option for neonates with respiratory distress and can be effective even in a resource-constrained clinical setting.

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Retropalatal Cross-Sectional Area Is Predictive of Obstructive Sleep Apnea in Patients With Syndromic Craniosynostosis

The Cleft Palate-Craniofacial Journal ◽

10.1177/1055665619882571 ◽

2019 ◽

Vol 57 (5) ◽

pp. 560-565 ◽

Cited By ~ 1

Author(s):

Cory M. Resnick ◽

Jason K. Middleton ◽

Carly E. Calabrese ◽

Karan Ganjawalla ◽

Bonnie L. Padwa

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Upper Airway ◽

Cross Sectional Area ◽

Secondary Outcome ◽

Outcome Variable ◽

Sectional Area ◽

Cross Sectional ◽

Syndromic Craniosynostosis ◽

Obstructive Sleep

Objective: There is a high rate of obstructive sleep apnea (OSA) in patients with syndromic craniosynostosis (SCS). Little is known about the airway anatomy in this population. The purpose of this study is to characterize the 3 dimensional (3D) upper airway in patients with SCS with and without OSA. Design: This is a retrospective study of patients with SCS treated at Boston Children’s Hospital from 2000 to 2015. Patients were divided into OSA and no-OSA groups based on polysomnography. Predictor variables included age, sex, body mass index (BMI), and 3D upper airway measurements. The primary outcome variable was the presence or absence of OSA. Secondary outcome variables were apnea–hypopnea index and oxygen saturation nadir. Descriptive and bivariate statistics were computed, and significance was set as P < .05. Results: There were 24 patients: 16 in the OSA group and 8 in the no-OSA group. The 2 groups did not differ significantly by age, BMI, or syndromic diagnosis. The presence of OSA was associated with a smaller minimum retropalatal cross-sectional area (minRPCSA; P < .001). In a logistic regression model controlling for age, sex, and upper airway length, minRPCSA was the primary predictor of OSA ( P ≤ .002). Receiver operating characteristic analysis determined minRPCSA = 55.3 mm2 to be the optimal diagnostic threshold for OSA, with sensitivity = 100% and specificity = 87.5% ( P < .001). Conclusion: A minRPCSA ≤55.3 mm2 is predictive of the presence of OSA in patients with SCS.

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