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Copyright © 2021 TutorsIndia. All rights 1
How To Establish And Evaluate Clinical Prediction Models
Dr. Nancy Agnes, Head,
Technical Operations, Tutorsindia
info@ tutorsindia.com
Keywords:
Statistical analysis help, clinical research
analysis, data collection services, clinical
prediction models, multiple linear
regression analysis, logistic regression
analysis, Clinical Research & Analytics,
statistics services, clinical trial data
analysis, External Validation Of Clinical
Prediction Models
I. INTRODUCTION
The use of a parametric/semi-
parametric/non-parametric mathematical
model to estimate the probability that a
subject currently has a certain condition or
the possibility of a certain outcome in the
future is referred to as a clinical predictive
model. Various regression analysis
approaches are used to model clinical
prediction models, and the statistical
nature of regression analysis is to find
"quantitative causality." To put it another
way, regression analysis is a quantitative
assessment of how much X impacts Y.
Multiple linear regression models, logistic
regression models, and Cox regression
models are all widely used approaches.
The secret to statistical analysis, data
modelling, and project design is assessing
and verifying prediction models' efficacy.
It is also the most difficult aspect of data
analysis technology.
II. CLINICAL PREDICTION MODEL
A clinical prediction model is a tool used
in healthcare to measure estimates of the
likelihood of the future course of a specific
patient outcome using multiple clinical or
non-clinical predictors. A realistic
checklist for developing a valid prediction
model is presented in a clinical prediction
model. A clinical prediction model can be
used in various clinical contexts, including
screening for asymptomatic illness,
forecasting future events such as disease,
and assisting doctors in their decision-
making and health education. Despite the
positive effects of clinical prediction
models on practice, prediction modelling
is a difficult process that necessitates
Copyright © 2021 TutorsIndia. All rights 2
meticulous statistical analysis and sound
clinical judgments.
III. STEPS TO ESTABLISHING A
CLINICAL PREDICTION MODEL
There exist several types of research
detailing the methods to construct clinical
prediction models. However, there is no
proper method to construct the prediction
model in medicine. The construction and
evaluation of prediction models are
classified into five steps.
Step 1:Gathering the ideations and
questions for enhancing the model.
It incorporates structuring the research
questions, such as finding the target
variable for predicting which age group of
the targeted people you want to predict.
For instance, gathering one patient details
and use it as a trained data set to test the
other data set of another patient's details.
[1].
Step 2: Selection of data
Data collection is a vital part of statistical
or clinical research. Nevertheless, the
perfect data and a perfect model can't
exist. It would be nice to look for the most
appropriate.
S.NO DISEASE SYMPTOMS
1 CANCER Unusual lump,
changes in the
mole, cough
and
hoarseness,
unusual
diarrhoea and
constipation
2 CARDIOVASCULAR
DISEASE
Chest pain,
chest tightness,
shortness of
breath,
numbness and
weakness.
3 ARTHRITIS Pain in hip or
joint, swelling,
colour changes
in the skin,
loss of
appetite.
4 DIABETES Darkened area
of skin, High
blood pressure
and cholesterol
levels
The primary dataset with the endpoint of
the study and all key predictors may not be
Copyright © 2021 TutorsIndia. All rights 3
available at all the time. Secondary or
administrative data sources are mandatory.
Based on the various data types of
datasets, prediction models can be utilized.
[2] For instance, the epidemiology study is
based on the Data Mining systematic
approach.
Step 3: Ways to handle variables
Most of the time, researchers may face
challenging situations where the variables
are highly correlated to each other,
excluded in the study. Variables don't
show statistical significance or the petite
effect size. But it will contribute to the
predictive model. Researchers will handle
the missing data problems, categorical
data, etc., before getting the interference.
IV. CLINICAL PREDICTION MODELS
CODE:
Code number Disease/
Deficiency
ICD-10-R50 fever
ICD-R05 cough
ICD-10-CM-
R52
pain
ICD-9-CM-
784.0
headache
The Bayesian network was implemented to
manipulate the independent variables of
some diseases in the crucial stage of
treatment. This model predicts and offers a
way to handle the disease along with
preventive measures [3].
Step 4: Generating model
There are no proper rules to select a
particular model for the statistical analysis.
There are some standard methods to build
a model using Linear regression analysis,
logistic regression analysis, and Cox
models. Sometimes the clinical data
encounters over-fitting of the model and
its results in as estimates. This over-fitting
issue can be detected using Akaike
Information Criteria or Bayesian
Information Criteria. The smaller AIC and
BIC values result in a good fit for the
model. [4] Using Multivariate prediction
models for analyzing the different
characteristics of various patients.
Step 5: Evaluation and validation of the
model After building the model, it is
necessary to evaluate and validate the
predictive power of the model. The key
components that evaluate the model are
calibration which plots the proportion, and
discrimination classifies the events like
success or failure. There are two types of
data validation, namely internal and
external validation of the model. Internal
Copyright © 2021 TutorsIndia. All rights 4
validation evaluates the model within the
data, whereas external validation can be
done using the re-sampling technique,
usually through bootstrapping. It means
you are creating or generating new data
sets with similar characteristics to the
original data and validating the study's
method through the newly created or
bootstrapped data. Further, there are
several statistical measures to evaluate the
model. Some of them are ROC curve,
AUC curve, sensitivity and specificity,
likelihood ratio, R square value,
calibration plot, c-index, Hosmer-
Lemeshow test, AIC, BIC, etc.
Figure 1: Slope of Calibration plot –
Source: Stevens and Poppe (2020)
Besides, Stevens and Poppe (2020)
suggested the Cox- calibration slope using
a logistic regression model instead of
using the predictive model's calibration
slope. This suggestion has been made after
the scrutiny of around 33 research articles
and found that most of the validation is
external validation and identified the
validity using the calibration slope.
Figure 2: This flow diagram illustrates the
progress through the various phases of the
CARDAMON phase II clinical trial,
including the impact of COVID‐19 on the
70 patients on maintenance K across the
two treatment arms at the start of the
lockdown period. The 15 patients who
stopped K maintenance joined the 170
patients who were already on long‐term
follow‐up on 24 March 2020, bringing the
number up to a total of 185. SCT, stem cell
transplantation; K, carfilzomib; C,
cyclophosphamide; d, dexamethasone [6].
V. FUTURE SCOPE:
Based on the patient details, we can
predict the further severe causation of
disease in the future. By gathering the data
from a single patient may help to predict
other similar patients for better treatment.
Copyright © 2021 TutorsIndia. All rights 5
Big data support for manipulating vast
amounts of clinical trials, without
complexitsimultaneously with high
accuracy.
TABLE 1 Concepts and Techniques of
Clinical prediction models:
S.NO METHODS PURPOSES REFERENCES
1 Data Collection
using Surveys
To train and test the
data between two
patients
[1]
2 Epidemiology study Data mining of data
sets
[2]
3 Bayesian Network To predict the
characteristics based
on the independent
variable
[3]
4 Multivariate analysis To manipulate the
independent
variables
[4]
REFERENCES:
1. Schmidt, André, et al. "Improving prognostic
accuracy in subjects at clinical high risk for
psychosis: systematic review of predictive
models and meta-analytical sequential testing
simulation." Schizophrenia Bulletin 43.2
(2017): 375-388.
2. Bagherzadeh-Khiabani, Farideh, et al. "A
tutorial on variable selection for clinical
prediction models: feature selection methods in
data mining could improve the results."
Journal of clinical epidemiology 71 (2016): 76-
85.
3. Chowdhury, Mohammad Ziaul Islam, and
Tanvir C. Turin. "Variable selection strategies
and their importance in clinical prediction
modeling." Family medicine and community
health 8.1 (2020).
4. Iba, Katsuhiro, et al. "Re-evaluation of the
comparative effectiveness of bootstrap-based
optimism correction methods in the
development of multivariable clinical
prediction models." BMC Medical Research
Methodology 21.1 (2021): 1-14.
5. Stevens, R. J. and Poppe, K. K. (2020).
Validation of Clinical Prediction Models: What
does the "Calibration Slope" Really Measure?.
Journal of clinical epidemiology, 118, pp. 93–
99.
6. Camilleri, Marquita, et al. "COVID‐19 and
myeloma clinical research–experience from the
CARDAMON clinical trial." British Journal of
Haematology 192.1 (2021): e14.

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How to establish and evaluate clinical prediction models - Statswork

  • 1. Copyright © 2021 TutorsIndia. All rights 1 How To Establish And Evaluate Clinical Prediction Models Dr. Nancy Agnes, Head, Technical Operations, Tutorsindia info@ tutorsindia.com Keywords: Statistical analysis help, clinical research analysis, data collection services, clinical prediction models, multiple linear regression analysis, logistic regression analysis, Clinical Research & Analytics, statistics services, clinical trial data analysis, External Validation Of Clinical Prediction Models I. INTRODUCTION The use of a parametric/semi- parametric/non-parametric mathematical model to estimate the probability that a subject currently has a certain condition or the possibility of a certain outcome in the future is referred to as a clinical predictive model. Various regression analysis approaches are used to model clinical prediction models, and the statistical nature of regression analysis is to find "quantitative causality." To put it another way, regression analysis is a quantitative assessment of how much X impacts Y. Multiple linear regression models, logistic regression models, and Cox regression models are all widely used approaches. The secret to statistical analysis, data modelling, and project design is assessing and verifying prediction models' efficacy. It is also the most difficult aspect of data analysis technology. II. CLINICAL PREDICTION MODEL A clinical prediction model is a tool used in healthcare to measure estimates of the likelihood of the future course of a specific patient outcome using multiple clinical or non-clinical predictors. A realistic checklist for developing a valid prediction model is presented in a clinical prediction model. A clinical prediction model can be used in various clinical contexts, including screening for asymptomatic illness, forecasting future events such as disease, and assisting doctors in their decision- making and health education. Despite the positive effects of clinical prediction models on practice, prediction modelling is a difficult process that necessitates
  • 2. Copyright © 2021 TutorsIndia. All rights 2 meticulous statistical analysis and sound clinical judgments. III. STEPS TO ESTABLISHING A CLINICAL PREDICTION MODEL There exist several types of research detailing the methods to construct clinical prediction models. However, there is no proper method to construct the prediction model in medicine. The construction and evaluation of prediction models are classified into five steps. Step 1:Gathering the ideations and questions for enhancing the model. It incorporates structuring the research questions, such as finding the target variable for predicting which age group of the targeted people you want to predict. For instance, gathering one patient details and use it as a trained data set to test the other data set of another patient's details. [1]. Step 2: Selection of data Data collection is a vital part of statistical or clinical research. Nevertheless, the perfect data and a perfect model can't exist. It would be nice to look for the most appropriate. S.NO DISEASE SYMPTOMS 1 CANCER Unusual lump, changes in the mole, cough and hoarseness, unusual diarrhoea and constipation 2 CARDIOVASCULAR DISEASE Chest pain, chest tightness, shortness of breath, numbness and weakness. 3 ARTHRITIS Pain in hip or joint, swelling, colour changes in the skin, loss of appetite. 4 DIABETES Darkened area of skin, High blood pressure and cholesterol levels The primary dataset with the endpoint of the study and all key predictors may not be
  • 3. Copyright © 2021 TutorsIndia. All rights 3 available at all the time. Secondary or administrative data sources are mandatory. Based on the various data types of datasets, prediction models can be utilized. [2] For instance, the epidemiology study is based on the Data Mining systematic approach. Step 3: Ways to handle variables Most of the time, researchers may face challenging situations where the variables are highly correlated to each other, excluded in the study. Variables don't show statistical significance or the petite effect size. But it will contribute to the predictive model. Researchers will handle the missing data problems, categorical data, etc., before getting the interference. IV. CLINICAL PREDICTION MODELS CODE: Code number Disease/ Deficiency ICD-10-R50 fever ICD-R05 cough ICD-10-CM- R52 pain ICD-9-CM- 784.0 headache The Bayesian network was implemented to manipulate the independent variables of some diseases in the crucial stage of treatment. This model predicts and offers a way to handle the disease along with preventive measures [3]. Step 4: Generating model There are no proper rules to select a particular model for the statistical analysis. There are some standard methods to build a model using Linear regression analysis, logistic regression analysis, and Cox models. Sometimes the clinical data encounters over-fitting of the model and its results in as estimates. This over-fitting issue can be detected using Akaike Information Criteria or Bayesian Information Criteria. The smaller AIC and BIC values result in a good fit for the model. [4] Using Multivariate prediction models for analyzing the different characteristics of various patients. Step 5: Evaluation and validation of the model After building the model, it is necessary to evaluate and validate the predictive power of the model. The key components that evaluate the model are calibration which plots the proportion, and discrimination classifies the events like success or failure. There are two types of data validation, namely internal and external validation of the model. Internal
  • 4. Copyright © 2021 TutorsIndia. All rights 4 validation evaluates the model within the data, whereas external validation can be done using the re-sampling technique, usually through bootstrapping. It means you are creating or generating new data sets with similar characteristics to the original data and validating the study's method through the newly created or bootstrapped data. Further, there are several statistical measures to evaluate the model. Some of them are ROC curve, AUC curve, sensitivity and specificity, likelihood ratio, R square value, calibration plot, c-index, Hosmer- Lemeshow test, AIC, BIC, etc. Figure 1: Slope of Calibration plot – Source: Stevens and Poppe (2020) Besides, Stevens and Poppe (2020) suggested the Cox- calibration slope using a logistic regression model instead of using the predictive model's calibration slope. This suggestion has been made after the scrutiny of around 33 research articles and found that most of the validation is external validation and identified the validity using the calibration slope. Figure 2: This flow diagram illustrates the progress through the various phases of the CARDAMON phase II clinical trial, including the impact of COVID‐19 on the 70 patients on maintenance K across the two treatment arms at the start of the lockdown period. The 15 patients who stopped K maintenance joined the 170 patients who were already on long‐term follow‐up on 24 March 2020, bringing the number up to a total of 185. SCT, stem cell transplantation; K, carfilzomib; C, cyclophosphamide; d, dexamethasone [6]. V. FUTURE SCOPE: Based on the patient details, we can predict the further severe causation of disease in the future. By gathering the data from a single patient may help to predict other similar patients for better treatment.
  • 5. Copyright © 2021 TutorsIndia. All rights 5 Big data support for manipulating vast amounts of clinical trials, without complexitsimultaneously with high accuracy. TABLE 1 Concepts and Techniques of Clinical prediction models: S.NO METHODS PURPOSES REFERENCES 1 Data Collection using Surveys To train and test the data between two patients [1] 2 Epidemiology study Data mining of data sets [2] 3 Bayesian Network To predict the characteristics based on the independent variable [3] 4 Multivariate analysis To manipulate the independent variables [4] REFERENCES: 1. Schmidt, André, et al. "Improving prognostic accuracy in subjects at clinical high risk for psychosis: systematic review of predictive models and meta-analytical sequential testing simulation." Schizophrenia Bulletin 43.2 (2017): 375-388. 2. Bagherzadeh-Khiabani, Farideh, et al. "A tutorial on variable selection for clinical prediction models: feature selection methods in data mining could improve the results." Journal of clinical epidemiology 71 (2016): 76- 85. 3. Chowdhury, Mohammad Ziaul Islam, and Tanvir C. Turin. "Variable selection strategies and their importance in clinical prediction modeling." Family medicine and community health 8.1 (2020). 4. Iba, Katsuhiro, et al. "Re-evaluation of the comparative effectiveness of bootstrap-based optimism correction methods in the development of multivariable clinical prediction models." BMC Medical Research Methodology 21.1 (2021): 1-14. 5. Stevens, R. J. and Poppe, K. K. (2020). Validation of Clinical Prediction Models: What does the "Calibration Slope" Really Measure?. Journal of clinical epidemiology, 118, pp. 93– 99. 6. Camilleri, Marquita, et al. "COVID‐19 and myeloma clinical research–experience from the CARDAMON clinical trial." British Journal of Haematology 192.1 (2021): e14.