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SOLAS
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The only software tool you need for analyzing incomplete data. SOLAS is the software most research statisticians and data analyst choose when working with incomplete data. Companies such as Amgen, Pfizer, Aventis, Roche, Pharmiacia and many more all use SOLAS to handle their missing data. SOLAS is also extensively used at the FDA. SOLAS complies with FDA and ICH guidelines on Sensitivity Analysis. Many leading pharma and biotech companies have already used SOLAS for imputing their missing values in datasets to be included in FAD submissions.
What
is SOLAS? SOLAS 3.0 for Missing Data Analysis offers principled approaches to missing data now has its own scripting language(optional) and features a choice of 6 imputation techniques, including 2 Multiple Imputation techniques based on the work of Prof. Donald B. Rubin. Data can be imported from a wide variety of file types including SAS (Unix/Windows), SPSS, Splus, Stata and many more. Once the data is imported, the missing data pattern can be displayed and a decision upon the most appropriate technique made. Once imputation is complete the imputed datasets can be analyzed within SOLAS or exported to a variety of other packages in the correct format. It's that simple! "Solas
is currently the only program that implements multiple imputation noniteratively
and with substantial flexibility, even including ad-hoc methods, such
as LOCF, as points of comparison for sensitivity analysis." The incorrect analysis of datasets with incomplete data can lead to biased analysis and incorrect inference. SOLAS 3.0 provides researchers with a range of imputation approaches in an easy to use, validated software package that includes principled, informed solutions to the problems presented by incomplete datasets. Why should I use SOLAS 3.0?
What are the Imputation Techniques available in SOLAS ? SOLAS 3.0 provides the user with a choice of 6 imputation techniques, two of which are Multiple Imputation techniques. (See the 'What is Multiple Imputation' section). Multiple Imputation Techniques: Predictive Model Based Multiple Imputation:
Propensity
Score Based Multiple Imputation:
Single Imputation Techniques: Hot Deck Imputation: The user specifies matching criteria in the form of variables in the dataset, in order to locate 'donors' in the dataset from whose observed data that imputed value is subsequently drawn. Effectively respondents and non-respondents are sorted into a number of imputation classes according to a user specified set of auxiliary variables. Missing values are then replaced with values taken from matching respondents (i.e. respondents that are similar with respect to the auxiliary variables).
Predicted Mean Imputation (using Regression): Imputed values are predicted using an ordinary least squares multiple regression algorithm, or a discriminant model if the data are categorical. Ordinary Least Squares Method - using this method, missing values are imputed using predicted values from the corresponding covariates using the estimated linear regression models. Discriminant Method - this is a model based method for binary or categorical variables Last
Value Carried Forward (LVCF): Imputed values are based on previously observed value. This method can only be used for longitudinal variables. Group Means: Imputed variables are set to the variable's group mean (or mode in the case of categorical data) derived from a grouping variable. Once the user has imputed for the missing values in their datasheet, SOLAS allows the user to run a number of analyses on the imputed datasheets. The analysis options in SOLAS 3.0 are as follows:
Analyzing Multiply Imputed Datasets and Combining of Results: When the user performs Multiple Imputation as their chosen imputation technique, the result is that they are left with M imputed datasets, where they began with just one. The idea behind this is to ensure valid standard errors, confidence intervals and p-values. Each of these Multiple Imputed datasets needs to be statistically analyzed by the statistical method of choice. This in effect gives the user M intermediate results, which need to be combined into a final result, from which the conclusions are drawn, according to explicit formulae. SOLAS 3.0 now automatically performs the roll-up of these results to give this final single, consistent parameter estimate. Other Important Features of SOLAS 3.0 Missing Data Pattern: The Missing Data Pattern in SOLAS 3.0 provides a clear overview of the quantity, positioning, and types of missing values in your dataset. By right clicking on any cell in the matrix, you can identify the variable and observation details. This feature allows you to study the missing data patterns and helps you to choose the most appropriate imputation techniques. Furthermore, you may also now use the Missing Value Pattern to view the monotone and non-monotone missing values in your dataset. This is a partial list of organizations who use SOLAS. ACADEMIC
GOVERNMENT AND HOSPITALS
COMMERCIAL
Because of the varied nature of Clinical Trial subjects and treatments, standard approaches to catering for missing data such as Last Value Carried Forward and Completers can sometimes be deemed as inappropriate by both biostatisticians and the regulatory authorities alike. Faced with this fact, AMGEN Inc., the world's largest biotechnology company, explored the application of several missing data imputation techniques for longitudinal clinical trials. Following discussions with the FDA, it was prospectively agreed by both parties, in order to minimize bias, to adopt a Multiple Imputation technique as the primary method for the clinical trial. The trial in question consisted of the following design features:
"Any data analyst
will have experienced problems with incomplete data and the biases they
can introduce into our results. Although the major statistical packages
provide basic missing values analysis (primarily univariate techniques),
there is a gap in the statistical software market incorporating more
advanced techniques. Statistical Solutions, the designers of SOLAS
, believe that they have filled the gap. SOLAS is a Windows-based
application boasting several methods of missing data imputation, including
the simpler methods mentioned above, such as imputing the group mean
and using regression methods. However, its highlight is multiple imputation,
where several values are imputed for each missing value rather than
one, overcoming the major drawback of univariate techniques -underestimating
the variance. The package also provides basic statistical analysis,
such as ANOVA, regression and non-parametric tests. A 300-page manual
accompanies the software, together with example data sets. The manual
is clearly written and provides many screen-shots and examples to guide
the reader. Despite this, researchers who are not fully up to speed
on replacing missing values, particularly using the multiple imputation
technique, will need to take some time to learn the principles in order
to fully appreciate what SOLAS can do. Indeed it may be necessary,
and I am sure beneficial, for any new user to attend a workshop. As
with any new software, time and thought will have to be given in order
to become competent in its use and, as SOLAS is currently the only
software of its kind, this would be more than worthwhile." "This
package will be valuable to any analyst that has to deal with missing
data on a daily basis." "The
manual contains a number of positive features and is well organised that
both the new and experienced analyst are urged to read most of it. There
is a completeness about it that is rarely achieved in software manuals."
"In
general, SOLAS is an easy-to-work with program. The display windows
are well organized and the desired option is usually easy to find. The
importing and exporting capabilities are quite good and an easy to follow
reference guide is provided with the program" "The
core of the program, missing value imputation is a solid addition to the
statistical software armamentarium and is simple to utilize." The issue of Missing Data is the subject of increasing debate in contemporary statistics. In any given study, missing data can have many causes. For instance, respondents may be unwilling to answer some questions (item non-response) or refuse to participate in a study (unit non-responses). In addition, transcription errors and dropouts in follow up studies and clinical trials can frequently occur. The
incorrect analysis of datasets with incomplete data can lead to biased
analysis and incorrect inferences. SOLAS 2proovides e researchers
witha range of single and multiple imputation approaches so that the user
can apply the most appropriate approach to their problem. When some data
are missing, standard variable by variable analysis may be based on divergent
sets of cases, and standard multivariate methods are designed only for
the analysis of complete cases. The real problem with single imputation
is that the single value being imputed, cannot itself reflect the uncertainty
about the actual value. Therefore analyses that treat imputed values like
observed values will systematically underestimate this uncertainty, leading
to standard errors that are too small, p-values that are systematically
too significant and confidence intervals which systematically cover less
than their nominal coverages.
Enter
Multiple Imputation - First proposed by Rubin in the 1970's, the method
imputes several values (M) for each missing value, to represent the uncertainty
about which values to impute. Analytical incorporation of the uncertainty
due to missing data is generally very complicated. Multiple Imputation
is a technique to perform this incorporation of the uncertainty about
missing data, making use of available software advances in this area.
With
Multiple Imputation, the first set of (M) imputed values is used to form
the first completed dataset and so on. The M versions of completed datasets
are analyzed by standard complete data methods and the results are combined
using simple rules to yield single combined estimates, standard errors,
p-values, that formally incorporate missing data uncertainty. The pooling
of the results of the analyses performed on the multiply imputed datasets,
implies that the resulting point estimates are averaged over the M completed
sample points, and the resulting standard errors and p-values are adjusted
according to the variance of the corresponding M completed sample point
estimates. This variance called the 'between imputation variance', provides
a measure of the extra inferential uncertainty due to missing data.
Note:
Multiple Imputation has been proven in independent research to be able
to correct for the systematic inferential failings produced by ignoring
missing data and the ad-hoc approaches of single imputation.
With
Multiple Imputation, when the statistical model adequately describes the
data and the imputations are generated from the predictive distribution
of the missing data, given the observed data, the difference between M
imputed values for each missing data entry will properly reflect the extra
uncertainty due to the missing data.
Major Advantages of Multiple Imputation:
Multiple Imputation
Statistical Features
Pentium processor recommended, 32MB RAM, 14MB Hard Disk Space and Windows 95 or higher
Script Language Facility (Optional)
This new facility allows the reproduction of the same results for a particular imputed dataset at a later date, because all choices such as seed values and predictor variables are saved, ensuring exact replication of results. Imputations can be quickly re-run using different predictor variables to see the effect it has on the results. Simulation runs also become easy with this new Script Language facility In addition, this ability to save and access imputation set-ups can help to simplify the documentation when submitting to a regulatory agency. The Script Language facility comes with it's own manual that explains the language. This manual comes as standard documentation along with an imputation manual and a systems manual. This is an optional functionality. If you wish to use this option, you can upgrade to activate the option. Contact us for details. |
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