In this tab there are various initialization settings of a trial. For a new trial following setting can be configured:
1) Trial Title: Enter trial title in this text box. In the case of network trial, the first few word must not contain invalid characters(those that can not come in file names (\\/:* ?"<>| for windows).
2) Sample Size: Select the trial sample size here. Use up and down arrows to increase or decrease the value.
3) Network Sync: If this is a network trial (that is, a multi-center trial), select this option. A small dialog will be displayed, prompting for the url of the trial repository. To know more about trial repositories and how to have one, see the section on "Trial repositories"
4) Trial Description: Enter some informative texs describing your clinical trial.
5) Probability Method: The method used for calculating the assignment probabilities. There are two choices. Biased coin minimization which include the effect of allocation ratios into the computation, and naive method which do not include the effect of allocation ratios in the computation. These options only is meaningfull when we have unequal allocation ratios. Regardless of this selection, the effect of allocation ratios will be included in the computation of imbalance score. If you selected the bised coin minimization, you have to select the base probability, that is the probabilty of assignement for the group with lowest allocation ratio. The default value is 0.7, and it can be varied from 0.10 to 1.0.
6) Distance Measure: In this section you have to select the distanc measure used to calculate the imbalance score. There are four options here. Marginal balance computes the cummulative difference between every possible pairs of level counts. This is the default method and the one which is recommended. Rage calculates the difference between the maximum and the mimimum value in level counts. Standard deviation calculates the standard deviation of level counts and variance calculate the variance. All of these measures uses adjusted level counts. Adjustment performs relative to the values of allocation ratios.
7) Trial Properties: Miscelaneous trial properties such as co-ordinator, moderator, investigator, data analyser, etc. Each property must have a name and value (description). To add a property click the add button, then edit the added property. The added property has the name "Property Name" and the value "Property Value". The name and value should be edited to something meaningfull to make it usable. To delete a property select it and click the delete button. To edit a property name or value, select the row by one click and then click the name or value again. The you can edit the name or value. There is a 'Date' button which insert a row into the properties table consisting of the enrolled date. After finishing the edit, press Enter key to fix the name of value.
You have to define the trial groups. For each group a name and an allocation ratio are needed. Click add to add a new group. A default group with the name "Group n" with n starting from 1, and and allocation ratio of 1 is added. You can edit the group name to some meaningfull names and the allocation ratio to your desired value. To edit click on the group name or allocation ratio, then enter the new value. You can use up and down arrow keys of mouse to set the allocation ration. Allocation ratio must be entered as an integer value. After finishing the edit, hit enter key to fix the edited value. Allocation ratios are integer numeric values. Click delete to delete the selected group.
Variables or prognostic factors, are the subject factors which are selected to minimize subject based on them. To add a new variable select the Variables tab and click the add button. Alternatively you can press Control + V to add a new variable. A variable will be added to the list and a dialog will appear for editing different aspects of this new variables as follows:
1) Variable Name: Enter a unique label for this variable. The label must not be used for more than one variable.
2) Variable Weight: Enter a flout number indication the relative importance of this variable for minimization. You may choose a value of zero if the variable should not include in the minimization. This is used when you want some extra-variables only to supply additional information.
3) Variable Levels: Each variable must have at least two levels to be usefull for entering minimization. Click the add button to add a new level. A level with a default name of "Level n" with n ranging from 0 onward will be added to the list. To change the name of he level, click on the level to select it, then click for another time to start editing. Please note that this is not a double click action, although it also may be used. Label names must be unique for each variable. After finishing the edit of the lable, press enter key to fix the value. To delete a lable select it and then click the Delete button.
Clicking the Reset button will set all aspect of the variable to the original values. After all aspects of the variable has been set, click the Save button to save the new variable and add it to the list of variables. Click Cancel button to cancel editing the new variable. Please note that this will not lead to deletion of the variable. It only cancel all edit of the new variable. If you want to delete any variable, select it from the variable list and hit the Delete button. To edit a variable from the list, double click it in the list. This way the edit variable will appear again and you can set different aspects of the variable and save it.
Subjects enrolled in the trial will be listed in allocation table. Each row consists of the following information: sequential case number (#), unique identifier (UI), group to which the subject assigned. Remaining columns consists of variable names which lists the level of each variable for the subject. Subject can be added, edited or deleted in this tab. Please note that working on subjects is only possible after initial setup and save of the trial. To add a subject click the Add button. 'Allocation add' dialog will appears. Select levels of each variable corresponding to the new subject. In addition you can add custom properties to the new subject. There are 'Add', 'Delete' and 'Date' buttons for adding and deleting properties related to the new subject or the date of enrollment. You can also edit the properties by clicking and typing over them. After finishing with the new subject click the Add button at the buttom of the dialog to add the new case to the list. Another dialog will apears displaying the selected levels and the group the subject enrolled to (minimized to), asking for your final confirmation. Click Yes to add the subject or No to cancel adding. To edit a subject, select the subject from the list and press enter key, or double click the subject in the list. The 'Allocation Edit' dialog will appear. You can change the subject levels or group and you can add/delete/edit subject properties. Please note that editing a previously allocated subject is not generally recommended and its use must be limited to situations where you have made mistakes regarding a previuosly enrolled subject. After finishing allocation edit click Save button to save changes. A dialog will apear asking for final confirmation. Click Yes to save the changes. To delete a subject from the list, select it from the list and click Delete button. A dialog will apear asking for delete confirmation. Click Yes to delete the subject. Please note that deleting a previously enrolled subject is not recommended and its use must be limited to cases where the subject has not in reality been enrolled. If the subject list is empty, you can unlock the trial and go to set up phase of the trial by clicking the delete button. A dialog will appear, click yes to unlock the trial. There is a Refresh button which refresh the subjects list. Genrally there is no need to use this button, but in network trial you may click this button to refresh the list, although this is not required too.
In this tab you can see the frequency of sifferent variable levels in each group. This is useful to see a report of already allocated subjects. The table also shows row and col totals and grand total. In addition there is an special usage for this table as follow: During initial setup of the trial, after you have defined groups and variables, you can define an initial frequency table as a pool of already enrolled subjects. This is usefull when you have already enrolled a number of subjects (using other tools or software) and you want to use MinimPy for the remaining cases. To do this, after you have defined groups and variable during intial trial setup, go to the Table tab and click the 'Start Edit' button at the bottom of the window. The button label will change to 'Save as Initial Table'. The click on individual cells of the table and enter corresponding counts of levels for each variable in each group. The cells corresponding to the total values are not editable and they will be updated automatically after entering other cells value. If there is any discrepancy in level counts some total values will display a value of '-1'. You must revise the values to correct the mistake. When all totals shows the sums the table is ready to save. Click the button 'Save as Initial Table' to save the table as the initial table. Click 'Clear/Refresh' button to clear the table. Please note that after saving the initial setup, this table no longer can be edited.
In this tab you can see four different scale of overal trial balance (marginal balance, range, variance, SD), and the balances for each variable or for each level within each variable. To see the balance values for levels of a variable click the + sign beside the name of the variable to expand it. The last two rows of the table shows the mean and max values for each scale. The lower the numeric values of these balance, the more balance we have in our trial.
In this tab you can see a quick start guide with images of different steps for initializing and allocation of subjects.