80th Percentile Value Research Articles

Adherence to Botulinumtoxin Treatment: A 2-year Retrospective Claims Database Analysis (P12-11.008)

<h3>Objective:</h3> To describe treatment dynamics and persistence with botulinumtoxin (BoNT) over 2 years in a retrospective longitudinal study. <h3>Background:</h3> Understanding the use of BoNT in clinical practice is essential for improving clinical care. Real-world evidence on long-term persistence with BoNT therapy is limited. <h3>Design/Methods:</h3> This study assessed medical claims data from the IBM MarketScan database among patients with a first medical claim for BoNT (not product specific) between October 2016 and October 2019. The index date was the day of the first BoNT administration, and a 1-year washout period before this date was used to identify incident BoNT use. On-label indications were defined as those approved for abobotulinumtoxinA. Six cohorts were analyzed: 1, all patients; 2, all patients, excluding those with off-label indications at the index date; 3, all patients with on-label diagnosis during the study period; and 4, 5 and 6, all patients with diagnosis of stroke, migraine and bladder dysfunction, respectively, before the index date. The number of treatments in the 2-year follow-up period and persistency (120-day look forward from treatment date; 80th percentile value of days to next treatment) were evaluated. <h3>Results:</h3> Across all cohorts (cohort [n]: 1 [19 711], 2 [5741], 3 [3238], 4 [611], 5 [7778] and 6 [1791]), 18.8–46.9% of patients received only one injection. Proportions of patients receiving three to eight injections remained consistent, with 0.3–15.7% receiving eight injections. Mean number of treatments across cohorts was 2.1–4.7, and time between treatments (80th percentile) was 105–319 days. <h3>Conclusions:</h3> In this retrospective longitudinal real-world study, there was a large drop-off in the proportion of patients receiving BoNT treatment after first injection, with few patients receiving eight injections over 2 years in accordance with the standard treatment regimen. These data are limited in providing the underlying reasons for the drop-off; further research is warranted. <b>Disclosure:</b> Dr. Simpson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Simpson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Mr. Bouchard has received personal compensation for serving as an employee of Ipsen. Mr. Bouchard has stock in Ipsen. Dr. Page has received personal compensation for serving as an employee of Ipsen. Dr. Page has received stock or an ownership interest from Ipsen. Dr. Spurden has received personal compensation for serving as an employee of IPSEN. Mr. Goldfarb has nothing to disclose. Atul T. Patel, 15908 has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Atul T. Patel, 15908 has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for IPSEN. The institution of Atul T. Patel, 15908 has received research support from Allergan. The institution of Atul T. Patel, 15908 has received research support from Revance. The institution of Atul T. Patel, 15908 has received research support from IPSEN.

Study of streptococcal antibody (anti-streptolysin O) among healthy children in Bangladesh.

Objectives:The standard reference value of anti-streptolysin O (ASO) titre for diagnosing acute rheumatic fever (RF) in children is yet to be determined in Bangladesh. We aimed to measure the upper limit of the normal (ULN) of ASO titre among healthy children to determine the cut-off value for the diagnosis of RF in Bangladesh.Methods:A total of 400 healthy children aged 5–15 years with no history of fever, sore throat and impetigo during the last 8 weeks of the study were enrolled. The respondents were randomly selected from an urban non-slum area, an urban slum area and a rural area of Bangladesh. ASO titre was measured using a turbidimetric immunoassay based on the principle of an agglutination reaction. The 80th percentile value was considered as the ULN of ASO titre.Results:Approximately 55% of the children were male. The mean (SD) age of children was 9.1 (2.7) years. The ULN of ASO titre for 5–15 years aged children was 217.4 IU/mL.Conclusion:Our reference value of ASO titre at the 80th percentile will be an essential guide for clinicians to diagnose acute RF.

Cross-sectional study of population-specific streptococcal antibody titres in Uganda.

Despite substantial variation of streptococcal antibody titres among global populations, there is no data on normal values in sub-Saharan Africa. The objective of this study was to establish normal values for antistreptolysin O (ASO) and antideoxyribonuclease B (ADB) antibodies in Uganda. This was an observational cross-sectional study. This study was conducted at Mulago National Referral Hospital, which is located in the capital city, Kampala, and includes the Uganda Heart Institute. Participants (aged 0-50 years) were recruited. Of 428 participants, 22 were excluded from analysis, and 183 (44.4%) of the remaining were children aged 5-15 years. ASO was measured in-country by nephelometric technique. ADB samples were sent to Australia (PathWest) for analysis by enzyme inhibition assay: 80% upper limit values were established. The median ASO titre in this age group was 220 IU/mL, with the 80th percentile value of 389 IU/mL. The median ADB titre in this age group was 375 IU/mL, with the 80th percentile value of 568 IU/mL. The estimated Ugandan paediatric population standardised 80% upper-limit-of-normal ASO and ADB titres is higher than many global populations. Appropriateness of using population-specific antibody cutoffs is yet to be determined and has important implications for the sensitivity and specificity of rheumatic fever diagnosis.

Establishing Cutoffs for Streptococcal Antibody Titers in Uganda: Implications for Rheumatic Fever Diagnosis

Background: Central to rheumatic fever (RF) diagnosis is evidence of streptococcal exposure, specifically antistreptolysin O (ASO) and antideoxyribonuclease B (ADB) antibodies. It is unknown if these antibody titers should be adjusted to the background exposure rates of GAS or if published standards should be used. Here, we establish the normal values of ASO and ADB in Uganda and examine RF case detection using published vs. population-specific thresholds. Methods: Participants (age 0-50 years) were recruited. ASO was measured in-country by nephelometric technique. ADB samples were sent to Australia (PathWest) for ADB determination by enzyme inhibition assay, and 80% upper limit values by age were established. The published standard values for ASO (200IU/ml) and ADB (375IU/ml) were compared to the Ugandan 80% upper limit of normal values (ULN) for RF case detection in children 5-15 years. Findings: Of the 428 participants, 16 were excluded (9 sore throat, 1 skin sores, 5 fever, 4 echocardiograms showing occult RHD), and 183 of the remaining were children 5-15 years. The median ASO titer in this age group was 220 IU/ml, with the 80th percentile value of 389 IU/ml. The median ADB titer in this age group was 375 IU/ml, with the 80th percentile value of 568 IU/ml. Application of new Ugandan cutoffs to 528 children enrolled in our prospective RF study, reduced the number of definite RF cases to 120/528 (22·7%), as compared to 173/528 (32·8%) using published normal values. Interpretation: The 80th percentile ULN for ASO and ADB are higher in Uganda than in other countries. Applying these higher values to RF diagnosis in Uganda results in higher diagnostic specificity, but some unknown loss in sensitivity. Implications of over-diagnosis and missed cases will be explored through a longitudinal follow-up study of children in the RF research program. Funding Statement: This work was supported by the American Heart Association (#17SFRN33670607), the DELTAS Africa Initiative (DEL-15-011 to THRiVE-2), and General Electric. Declaration of Interests: There were no conflicts of interest in conducting this study. Ethics Approval Statement: Institutional review board (IRB) approval was obtained from the Research and Ethics Committee at Makerere University School of Medicine, the Children’s National Medical Center IRB, and the Uganda National Council for Science and Technology IRB. We approached all participants for their consent, and the study was explained in detail by a research nurse in the participants’ primary language. All participants provided written informed consent before information was collected and children were enrolled only if written consent was obtained from a parent or guardian and written assent by children aged 8 years or older.

Spatial assessment of pesticide leaching risk to groundwater: sub-national decision making and model output aggregation.

This study compares standard regulatory methodology (fixed scenarios and models) to spatial modelling at a 1km landscape resolution for the evaluation of predicted environmental concentrations of pesticides in groundwater. The use of spatial modelling in the decision-making processes is discussed and three options for the sub-national evaluation and restriction of substances based on spatial environmental fate modelling are examined. Wheat and sugar beet are tested with two modified FOCUS substances (A and D) in the PEARL and GeoPEARL models. The 80th percentile value in time and space, aggregated to three different sub-national divisions of interest to a regulator, is used as a regulatory relevant output. Means and medians of predicted environmental concentrations at the national level are not useful summary statistics in the age of extensive and freely available geospatial data. A better statistic to use is the P80 (or other desired threshold/percentile combination) in time and space of predicted environmental concentration, combined with flexible and adaptable sub-divisions of the country based on the desired protective target. Tier 3b modelling is shown to provide an increase in localism and regulatory nuance over Tier 1 scenarios when combined with soil and aquifer type sub-national units. © 2019 Society of Chemical Industry.

Validation and Calibration of Freeway Reliability Methodology in the Highway Capacity Manual: Method and Case Studies

Traffic congestion costs drivers an average of $1,200 a year in wasted fuel and time, with most travelers becoming less tolerant of unexpected delays. Substantial efforts have been made to account for the impact of non-recurring sources of congestion on travel time reliability. The 6th edition of the Highway Capacity Manual (HCM) provides a structured guidance on a step-by-step analysis to estimate reliability performance measures on freeway facilities. However, practical implementation of these methods poses its own challenges. Performing these analyses requires assimilation of data scattered in different platforms, and this assimilation is complicated further by the fact that data and data platforms differ from state to state. This paper focuses on practical calibration and validation methods of the core and reliability analyses described in the HCM. The main objective is to provide HCM users with guidance on collecting data for freeway reliability analysis as well as validating the reliability performance measures predictions of the HCM methodology. A real-world case study on three routes on Interstate 40 in the Raleigh-Durham area in North Carolina is used to describe the steps required for conducting this analysis. The travel time index (TTI) distribution, reported by the HCM models, was found to match those from probe-based travel time data closely up to the 80th percentile values. However, because of a mismatch between the actual and HCM estimated incident allocation patterns both spatially and temporally, and the fact that traffic demands in the HCM methods are by default insensitive to the occurrence of major incidents, the HCM approach tended to generate larger travel time values in the upper regions of the travel time distribution.

Mid-luteal estradiol levels of poor/good responders and intracytoplasmic sperm injection.

Objective:To assess mid-luteal estradiol (E2) levels in poor and good responders and determine its effect on the outcome after intracytoplasmic sperm injection (ICSI).Methods:The current study was carried out in females who underwent ICSI from June 2011 to September 2013 in “Islamabad Clinic Serving Infertile Couples”. They were categorized into good and poor responders on the basis of female age ≤40 years, basal follicle stimulating hormone ≤12 mIU/ml, and antral follicle count >5, respectively. Their mid-luteal E2 measured on the day of embryo transfer was stratified into groups (A-E) on the basis of 20th, 40th, 60th and 80th percentile values. The outcome was categorized into non-pregnant with beta human chorionic Gonadotrophin (hCG) 5-25 m IU/ml, and clinical pregnancy with beta hCG>25 m IU/ml.Results:The conception rate was 12% (63/513) in poor responders and 72% (237/329) in good responders respectively. The mid-luteal E2 levels were higher in conception as compared to non-conception cycles (p<0.001) in good and poor responders.Conclusion:Maximum pregnancies in poor and good responders (53% and 98% respectively) with mid-luteal E2 levels above 80th percentiles confirm the role of the increase in mid-luteal E2 for augmentation in conception rate of females after ICSI.

Spatiotemporal variability of ground-level ozone and influence of smoke in Treasure Valley, Idaho

The hourly concentrations of atmospheric ozone (O3) were measured at seven locations throughout the Treasure Valley during the summer of 2007, indicating a concentration gradient up to 30 percent, with the lowest levels measured on the northeast and the highest on the southwest parts of the Treasure Valley. A weak “weekend” effect was observed on Saturday despite morning NOx levels that were lower than those measured during the weekdays. The lowest ozone levels were measured on Sundays because of the absence of NOx emissions. The contribution of wildfire smoke was qualitatively assessed through the geospatial analysis of air mass backward trajectories along with the locations and durations of wildfires. For at least three sites, there was evidence of the direct contribution of wildfire smoke in four of the nine multi-day O3 events in which the measured ozone levels were higher than the 80th percentile value. For the rest five high O3 events, four of them had weaker indications of the influence of smoke, while one event (on July 4, 2007) was associated with the extended use of fireworks. During the high O3 events influenced by wildfires, max hourly and mean daily O3 concentrations were up to 15ppbv and 12ppbv, respectively, higher than those regularly measured in the Treasure Valley.

Accounting for uncertainty in pedotransfer functions in vulnerability assessments of pesticide leaching to groundwater

A simulation tool for site-specific vulnerability assessments of pesticide leaching to groundwater was developed, based on the pesticide fate and transport model MACRO, parameterized using pedotransfer functions and reasonable worst-case parameter values. The effects of uncertainty in the pedotransfer functions on simulation results were examined for 48 combinations of soils, pesticides and application timings, by sampling pedotransfer function regression errors and propagating them through the simulation model in a Monte Carlo analysis. An uncertainty factor, f(u), was derived, defined as the ratio between the concentration simulated with no errors, c(sim), and the 80th percentile concentration for the scenario. The pedotransfer function errors caused a large variation in simulation results, with f(u) ranging from 1.14 to 1440, with a median of 2.8. A non-linear relationship was found between f(u) and c(sim), which can be used to account for parameter uncertainty by correcting the simulated concentration, c(sim), to an estimated 80th percentile value. For fine-textured soils, the predictions were most sensitive to errors in the pedotransfer functions for two parameters regulating macropore flow (the saturated matrix hydraulic conductivity, K(b), and the effective diffusion pathlength, d) and two water retention function parameters (van Genuchten's N and alpha parameters). For coarse-textured soils, the model was also sensitive to errors in the exponent in the degradation water response function and the dispersivity, in addition to K(b), but showed little sensitivity to d. To reduce uncertainty in model predictions, improved pedotransfer functions for K(b), d, N and alpha would therefore be most useful.

Interaction of Temperature and Solar Radiation Effect Sorghum Growth Under Drip Irrigated Saline Water

We investigated the impact of the interaction of temperature and solar radiation on the sorghum (Sorghum bicolor L.) growth during three years continuously 2004, 2005 and 2006. Sorghum was grown in dune sand in a plastic greenhouse. The saline irrigation water was 7.32 dS m-1 and control treatment was irrigated by good quality water (0.11 dS m-1). The time series statistical parameters; mean, median, CV and the 80th percentile values (PC80), assessed to discriminate the temporal sensitivity of the temperature and solar radiation indicated that CV followed by PC80 are better than median and mean. Sorghum growth and grain yield depended on the interaction between temperature and solar radiation under saline condition rather than individual effect

Cross-sectional relations of urinary sodium excretion to cardiac structure and hypertrophy: The Framingham Heart Study

Increased sodium intake has been positively associated with high blood pressure (BP) and hypertensive target organ damage, but associations with cardiac structure in nonhypertensive individuals have yielded inconsistent results. We tested the hypothesis that sodium intake is associated with left ventricular (LV) mass and left ventricular hypertrophy (LVH), independent of BP, in the community. We analyzed the cross-sectional relationships between urinary sodium excretion and LV measurements in a community-based sample of 2660 Framingham Offspring Study participants (mean age 58 years, 56% women and 44% men). Participants with known coronary artery disease, congestive heart failure, or renal failure as well as those using diuretics were excluded. Urinary sodium excretion was measured on a spot urine sample and was indexed to urinary creatinine. In sex-specific, multivariable linear regression models adjusting for covariates known to influence LV measurements, log urinary sodium was not associated with LV mass, wall thickness, end-diastolic dimensions, or left atrial size in either sex. Urinary sodium was not related to LVH defined as LV mass >/= sex-specific 80th percentile value. In analyses restricted to hypertensive individuals (n = 983, 470 women), urinary sodium was not associated with LV mass or LVH. In our large community-based sample, urinary sodium excretion was not related to LV mass, function, or hypertrophy.

Potential effects of a major navigation project (Paraguay-Paraná Hidrovía) on inundation in the Pantanal floodplains

The Pantanal wetland of Brazil, a vast complex of seasonally inundated floodplains along the Paraguay River, is renowned for its outstanding biological resources. A proposed navigation project known as the Paraguay–Parana Waterway (or Hidrovia) would deepen the Paraguay River channel to facilitate year-round navigation through the Pantanal. The possibility of decreases in river levels (stage) has aroused concerns in relation to the potential environmental impacts, however the poor understanding of the hydrological relationships between rivers and floodplains has hampered evaluation of these impacts. The present study evaluates the potential impact of river modifications on adjacent floodplains by examining the relationship between the Paraguay River stage and the extent of floodplain inundation. Satellite observations of flooded area (from passive microwave emission; monthly data for 1979–1987) are plotted against river stage from several stations throughout the region to show the stage–inundation relationships for eight subregions along the Paraguay River. Scenarios in which the Paraguay River stage is decreased from the 20th and 80th percentile values reveal large potential impacts on inundation. For stage decreases of 0.10 and 0.25 m, the total flooded area is reduced by 1430 and 3830 km2 at low-water, and by 2410 and 5790 km2 at high-water, respectively. The floodplains of the two northernmost subregions appear to be most susceptible to reductions in flooding, losing more than half of their flooded area with a 0.25-m decrease in the low-water stage. The ecological impacts of these reductions in flooded area may be particularly severe at low water, when the few areas that typically remain flooded throughout the dry season serve as important refuges for aquatic animals. These results underscore the need for better understanding of the hydrology of the integrated river floodplain systems in the Pantanal before river channel modifications are carried out. Copyright © 1999 John Wiley & Sons, Ltd.

The establishment of provisional quality assurance guidelines for assessing the hygienic adequacy of the lamb carcass cooling process

The hygienic consequence of a lamb carcass cooling process can be assessed by evaluating the product's time-temperature history at a site within the carcass cavity adjacent to the 5th and 6th lumbar vertebrae. From these data, a numerical value, the process hygiene index, is generated which reflects the amount of potential bacterial growth the process allows and is proposed as an alternative quality assurance tool for assessing lamb cooling processes. Two hygienically acceptable lamb cooling processes, one producing carcasses destined for freezing and the other producing carcasses destined for chilled processing, were monitored. Acceptable cooling processes can be conveniently described in terms of a three class sampling plan where the maximum acceptable value (M) is the highest value obtained and the target value (m) is determined as the 80th percentile value of the pooled data from acceptable runs. The number (c), the proportion of sample values that may lie between (m) and (M), is determined from the acceptable run with the highest sample values. For the process yielding carcasses destined for freezing M = 15, m = 14 and c = 20% while for that producing carcasses for chilled processing M = 9, m = 6 and c = 60%. For both processes a minimum of five samples was tested per process run. Based on these values, provisional processing guidelines for the hygienic cooling of lamb carcasses are suggested.

Determination of light-chain myosin in pregnancy and under tocolysis.

Cardiac toxicity of tocolysis containing hexoprenaline (0.3 microgram/min) and the beta 1-blocking agent metoprolol (0.01 mg/min) was investigated using a recently developed monoclonal antibody arised against light-chain myosin in 15 patients and compared with the results in 51 control subjects. There was an increase in the median and 80th percentile values 2, 6, 12 and 24 hours after the beginning of tocolysis but no statistically significant difference between these values and the normal ones could be shown.

Blood pressure distribution and determinants of higher levels of blood pressure in Japanese rural adolescents.

The blood pressures (BP) and anthropometric values of 1,014 Japanese rural school children aged 12-17 years old were measured at one-year interval. The strongest correlation for systolic BP (SBP) was weight and for diastolic BP (DBP) it was age. Larger values of weight, body mass index, triceps skinfold thickness and smaller increment of height showed significant discriminative powers in differentiating the subjects who had been above the age-sex specific 80th percentile value (H-H group) from those who had been below the 20th percentile value (L-L group) for both SBP and DBP. Subjects with a family history of hypertension (FHH) had higher SBP than those without a FHH, and were more prevalent in H-H group for SBP. These results indicate that larger body size and more mature stature are determinants of higher levels of BP during adolescence, and that FHH affects SBP only in this period.