method of randomization: block
unit of randomization: Number of patients
In this study, the randomized block method is used as six blocks with equal proportions of groups (36 different permutations - abcabc, abcacb, abcbca, ..., cabcab) from one to thirty-six numbering and then random selection of blocks are performed using the production of a random number between 1 and 36
The packages are printed and placed in separate envelopes, and according to the order of the person who provides the drug, she provides the desired letter from the drug group or the pharmaceutical form.
In this study, we will use the restricted randomization method (blockrandomization). Blocking is usually used in order to create a balance in the number of samples allocated to each of the study groups. This feature helps the researchers so that the number of samples allocated to each of the studied groups is equal. The size of all the blocks is equal and we will have 6 blocks in this three-group experiment. The randomization tool is also from the production software. Random allocation software is used. In addition to simple randomization, these random sequence generation softwares are capable of generating random sequences using the blocking method. For concealment, we use allocation concealment, which is the method used. It refers to the implementation of random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual. By using opaque sealed envelopes with random sequence (Sequentially numbered, sealed, opaque envelopes). In this method, each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
The participants do not know which treatment they will receive, and the referring physician also does not know about the assigned treatment. The person interviewing the patients does not know about the treatment received by the patients.
Random allocation list that uses the software
Random Allocation Software is produced in random permutation blocks and is available to the assistant, based on which the drugs will be allocated to the diseases in order. It will be explained to the participants that they are in a study and the groups will be introduced and mentioned that they will be randomly assigned to one of the groups.
By using opaque sealed envelopes with random sequence (Sequentially numbered, sealed, opaque envelopes). In this method, each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.