Statistical Analysis of Avian Reproduction Studies

2021 ◽  
Author(s):  
John W Green ◽  
Manousos Foudoulakis ◽  
Timothy Fredricks ◽  
Tiffany Carro ◽  
Jonathan Maul ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Study Design ◽  
Model Averaging ◽  
Study Data ◽  
Design Elements ◽  
Avian Reproduction ◽  
Reproduction Study ◽  
Data Points ◽  
Set Up ◽  
Regulatory Risk Assessment

Abstract Avian reproduction studies for regulatory risk assessment are undergoing review by regulatory authorities, often leading to requests for statistical re-analysis of older studies using newer methods, sometimes with older study data that do not support these newer methods. We propose detailed statistical protocols with updated statistical methodology for use with both new and older studies and recommend improvements in experimental study design to set-up future studies for robust statistical analyses. There is increased regulatory and industry attention to the potential use of benchmark dose (BMD) methodology to derive the point of departure in avian reproduction studies, to be used as the endpoint in regulatory risk assessment. We present benefits and limitations of this BMD approach for older studies being re-evaluated and for new studies designed for with BMD analysis anticipated. Model averaging is recommended as preferable to model selection for BMD analysis. Even for a new study following the modified experimental design analyses with BMD methodology will only be possible for a restricted set of response variables. The judicious use of historical control data, identification of outlier data points, increased use of distributions more consistent with the nature of the data collected as opposed to forcing normality-based methods, and trend-based hypothesis tests are shown to be effective for many studies, but limitations on their applicability are also recognized and explained. Updated statistical methodologies are illustrated with case studies conducted under existing regulatory guidelines that have been submitted for product registrations. Through the adoption of improved avian reproduction study design elements combined with the suggested revised statistical methodologies the conduct, analyses, and utility of avian reproduction studies for avian risk assessments can be improved.

scholarly journals Conceptualising natural and quasi experiments in public health

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Frank de Vocht ◽  
Srinivasa Vittal Katikireddi ◽  
Cheryl McQuire ◽  
Kate Tilling ◽  
Matthew Hickman ◽  
...  
Keyword(s):  
Public Health ◽  
Study Design ◽  
Grey Literature ◽  
Public Health Research ◽  
Natural Experiments ◽  
Target Trial ◽  
Design Elements ◽  
Randomized Controlled ◽  
Study Designs ◽  
The Impact

Abstract Background Natural or quasi experiments are appealing for public health research because they enable the evaluation of events or interventions that are difficult or impossible to manipulate experimentally, such as many policy and health system reforms. However, there remains ambiguity in the literature about their definition and how they differ from randomized controlled experiments and from other observational designs. We conceptualise natural experiments in the context of public health evaluations and align the study design to the Target Trial Framework. Methods A literature search was conducted, and key methodological papers were used to develop this work. Peer-reviewed papers were supplemented by grey literature. Results Natural experiment studies (NES) combine features of experiments and non-experiments. They differ from planned experiments, such as randomized controlled trials, in that exposure allocation is not controlled by researchers. They differ from other observational designs in that they evaluate the impact of events or process that leads to differences in exposure. As a result they are, in theory, less susceptible to bias than other observational study designs. Importantly, causal inference relies heavily on the assumption that exposure allocation can be considered ‘as-if randomized’. The target trial framework provides a systematic basis for evaluating this assumption and the other design elements that underpin the causal claims that can be made from NES. Conclusions NES should be considered a type of study design rather than a set of tools for analyses of non-randomized interventions. Alignment of NES to the Target Trial framework will clarify the strength of evidence underpinning claims about the effectiveness of public health interventions.

A Data Mining Approach for Risk Assessment in Car Insurance

2014 ◽  
Vol 5 (3) ◽  
pp. 11-28
Author(s):  
Ljiljana Kašćelan ◽  
Vladimir Kašćelan ◽  
Milijana Novović-Burić
Keyword(s):  
Data Mining ◽  
Risk Assessment ◽  
Risk Premium ◽  
Study Data ◽  
Functional Dependencies ◽  
Standard Methods ◽  
Data Mining Techniques ◽  
Data Mining Approach ◽  
The One ◽  
Car Insurance

This paper has proposed a data mining approach for risk assessment in car insurance. Standard methods imply classification of policies to great number of tariff classes and assessment of risk on basis of them. With application of data mining techniques, it is possible to get functional dependencies between the level of risk and risk factors as well as better results in predictions. On the case study data it has been proved that data mining techniques can, with better accuracy than the standard methods, predict claim sizes and occurrence of claims, and this represents the basis for calculation of net risk premium and risk classification. This paper, also, discusses advantages of data mining methods compared to standard methods for risk assessment in car insurance, as well as the specificities of the obtained results due to small insurance market, such is the one in Montenegro.

scholarly journals Exploring the relation between aerosol optical depth and PM<sub>2.5</sub> at Cabauw, the Netherlands

2008 ◽  
Vol 8 (5) ◽  
pp. 17939-17986 ◽  
Author(s):  
M. Schaap ◽  
A. Apituley ◽  
R. M. A. Timmermans ◽  
R. B. A. Koelemeijer ◽  
G. de Leeuw
Keyword(s):  
The Netherlands ◽  
Ground Level ◽  
Weather Conditions ◽  
Fair Weather ◽  
Modis Aod ◽  
Data Points ◽  
Set Up ◽  
The Relationship ◽  
Lidar Observations ◽  
Pm2.5 Concentration

Abstract. To acquire daily estimates of PM2.5 distributions based on satellite data one depends critically on an established relation between AOD and ground level PM2.5. In this study we aimed to experimentally establish the AOD-PM2.5 relationship for the Netherlands. For that purpose an experiment was set-up at the AERONET site Cabauw. The average PM2.5 concentration during this ten month study was 18 μg/m3, which confirms that the Netherlands are characterised by a high PM burden. A first inspection of the AERONET level 1.5 (L1.5) AOD and PM2.5 data at Cabauw showed a low correlation between the two properties. However, after screening for cloud contamination in the AERONET L1.5 data, the correlation improved substantially. When also constraining the dataset to data points acquired around noon, the correlation between AOD and PM2.5 amounted to R2=0.6 for situations with fair weather. This indicates that AOD data contain information about the temporal evolution of PM2.5. We had used LIDAR observations to detect residual cloud contamination in the AERONET L1.5 data. Comparison of our cloud-screed L1.5 with AERONET L2 data that became available near the end of the study showed favorable agreement. The final relation found for Cabauw is PM2.5=124.5*AOD–0.34 (with PM2.5 in μg/m3) and is valid for fair weather conditions. The relationship determined between MODIS AOD and ground level PM2.5 at Cabauw is very similar to that based on the much larger dataset from the sun photometer data, after correcting for a systematic overestimation of the MODIS data of 0.05. We applied the relationship to a MODIS composite map to assess the PM2.5 distribution over the Netherlands. Spatial dependent systematic errors in the MODIS AOD, probably related to variability in surface reflectance, hamper a meaningful analysis of the spatial distribution of PM2.5 using AOD data at the scale of the Netherlands.

scholarly journals TRADITIONAL BONESETTERS

2016 ◽  
Vol 23 (06) ◽  
pp. 699-704
Author(s):  
Waqar Alam ◽  
Faaiz Ali Shah ◽  
Ashfaq Ahmed ◽  
Saeed Ahmad ◽  
Abdullah Shah
Keyword(s):  
Compartment Syndrome ◽  
Study Design ◽  
Low Cost ◽  
Cultural Beliefs ◽  
Case Series ◽  
Non Union ◽  
Appropriate Treatment ◽  
Accident And Emergency ◽  
Set Up ◽  
Study District

Objectives: To analyze the reasons for treatment by Traditional Bone Setters(TBS) and the frequency of complications in patients treated by traditional bone setters in our setup. Study Design: Descriptive case series. Place and Duration of Study: District HeadquarterHospital (DHQ) Temargarah & Lady Reading Hospital Peshawar and, Ghurki Trust TeachingHospital, Lahore from Dec 2014 to Nov 2015. Material and Methods: Patients of either genderor all ages received in outpatient department or accident and emergency of DHQ Temargarah,Lady Reading Hospital Peshawar and Ghurki Trust Teaching Hospital, Lahore with history oftrauma followed by treatment by local bonesetters were included in our study. After properhistory, examinations and investigations, appropriate treatment were given and complicationswere noted. Results: We received a total of 267 patients who were treated by Traditional bonesetters.186 were males and 81 were females. Age ranges from 1.5 years to 87 years. In majorityAdvice or pressure from family/friends taking the lead. 77(28.84%) of patients suffer because offamily or friends. 66(24.72%) of patients affected because of socio cultural beliefs, 46(17.23%)because of low cost, 35(13.11%) because of ignorance, 24(8.98%) because of fear of operation,19(7.12%) because of fear of amputation took their treatment from bone setters. The mostfrequent complication we received was malunion were found in 67(25.10%) and non-union in55(20.60%), Conclusion: Pressure from friends and family was the main reason for consultingTraditional Bone Setters for treatment in our set up and complications caused by their treatmentwere frequent and ranged from immediate compartment syndrome and gangrene of the limb tolate onset mal union, non-union and avascular non-union.

A Data Mining Approach for Risk Assessment in Car Insurance

Big Data ◽  
2016 ◽  
pp. 2028-2046
Author(s):  
Ljiljana Kašćelan ◽  
Vladimir Kašćelan ◽  
Milijana Novović-Burić
Keyword(s):  
Data Mining ◽  
Risk Assessment ◽  
Risk Premium ◽  
Study Data ◽  
Functional Dependencies ◽  
Standard Methods ◽  
Data Mining Techniques ◽  
Data Mining Approach ◽  
The One ◽  
Car Insurance

This paper has proposed a data mining approach for risk assessment in car insurance. Standard methods imply classification of policies to great number of tariff classes and assessment of risk on basis of them. With application of data mining techniques, it is possible to get functional dependencies between the level of risk and risk factors as well as better results in predictions. On the case study data it has been proved that data mining techniques can, with better accuracy than the standard methods, predict claim sizes and occurrence of claims, and this represents the basis for calculation of net risk premium and risk classification. This paper, also, discusses advantages of data mining methods compared to standard methods for risk assessment in car insurance, as well as the specificities of the obtained results due to small insurance market, such is the one in Montenegro.

Pediatric blinatumomab preparation: Risk assessment on SmPC for software compliance

2020 ◽  
pp. 107815522096639
Author(s):  
Mario Cirino ◽  
Riccardo Provasi ◽  
Irina Cebulec ◽  
Clara Palmieri ◽  
Paolo Schincariol ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Poor Prognosis ◽  
Computer Processing ◽  
Second Phase ◽  
Preparation Process ◽  
Critical Issues ◽  
Adults And Children ◽  
Two Phases ◽  
Set Up ◽  
Cancer In Children

Introduction Blinatumomab is an anticancer drug used in the treatment of Acute Lymphoblastic Leukaemia (ALL) in both adults and children. ALL is the most common form of cancer in children and patients who are refractory to standard treatments have poor prognosis. The preparation of blinatumomab is unique and extremely complex. It’s important to carry out any information to identify all the critical issues related to the preparation of blinatumomab: sharing procedure between prescribers, staff of the Centralized Chemotherapy Preparation Unit [Unità Farmaci Antiblastici (UFA)] and administering nurses aimed at reducing the clinical risk related to the management of the drug blinatumomab and to obtain correct prescriptions on the real dose to be prepared, safe worksheets with computer processing of all variables (volumes to be added and corresponding dose of drug) and complete labels containing all the information necessary for the control of the preparation and its correct infusion. Methods A computerized process involves the use of specific software to which precise instructions must be given. This study is divided into two phases, the first one focused on the analysis of Summary of Product Characteristics (SmPC) and the extrapolation of any unclear part of SmPC. The second phase involved the manufacturer to answer a questionnaire. Results This comparison with the company allowed to perfect the blinatumomab preparation process leading to: 1. allow the patient to be discharged and return a few times for infusions and consequently reduce the number of medical prescriptions; 2. set up the drug for each patient every 4 days; 3. reduce costs related to devices, staff employed. Conclusion Computerizing the preparation of anti-blastic drugs is a necessary path for the safety of the patient and all the operators involved, however it may be necessary to make changes in the preparation process to allow the software to work correctly. The comparison between pharmacist, clinician and, where necessary, the manufacturer of the drug, was effective in the preparation of this drug.

Assessing Metal Mine Effects using Benthic Invertebrates for Canada's Environmental Effects Program

2002 ◽  
Vol 37 (1) ◽  
pp. 251-278 ◽  
Author(s):  
Nancy E. Glozier ◽  
Joseph M. Culp ◽  
Trefor B. Reynoldson ◽  
Robert C. Bailey ◽  
Richard B. Lowell ◽  
...  
Keyword(s):  
Study Design ◽  
Environmental Effects ◽  
Fish Habitat ◽  
Data Interpretation ◽  
Benthic Invertebrate ◽  
Primary Objective ◽  
Metal Mining ◽  
Design Elements ◽  
Metal Mine ◽  
Mine Effluent

Abstract In Canada, the Metal Mining Effluent Regulation is a mechanism developed from the Fisheries Act (R.S., c. F-14, s.1) under which the effects of mine effluent on fish and fish habitat (i.e., benthic invertebrate communities) is determined by Environmental Effects Monitoring (EEM) studies. The Metal Mining EEM (MM EEM) program proceeds in a tiered manner, commencing with determining whether an effect is present and continuing with determining extent, magnitude and cause of the effect. The benthic invertebrate monitoring component of the MM EEM program includes consideration of study design elements such as confounding factors, monitoring frequency, statistical study design, appropriate community endpoints and standardized approaches to site descriptions, field and laboratory methods and data interpretation. We present the approaches and rationale recently adopted for the benthic component of Canada's Metal Mining EEM program. A primary objective of this program was to outline a consistent national program that was scientifically defensible and that would produce the necessary information to evaluate the effectiveness of current pollution regulations.

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