сокрытие случайной последовательности с помощью конвертов

English translation: sealed envelope randomization | random allocation concealment by [sealed] envelopes

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:сокрытие случайной последовательности с помощью конвертов
English translation:sealed envelope randomization | random allocation concealment by [sealed] envelopes
Entered by: Dylan Edwards

09:01 Jul 29, 2023
Russian to English translations [PRO]
Medical - Mathematics & Statistics / clinical trial
Russian term or phrase: сокрытие случайной последовательности с помощью конвертов
Рандомизация выполнялась на 2 группы методом генерации случайной последовательности распределения с помощью таблицы случайных чисел с вероятностью попадания в группы, равной 50%, использовался метод *сокрытия случайной последовательности с помощью конвертов*.
Dylan Edwards
United Kingdom
Local time: 09:02
sealed envelope randomization | random allocation concealment by [sealed] envelopes
Explanation:
Allocation Concealment Mechanism

"The doxycycline and placebo were in capsule form and identical in appearance. They were pre-packed in bottles and consecutively numbered for each woman according to the randomization schedule. Each woman was assigned an order number and received the capsules in the corresponding pre-packed bottle."

"The allocation sequence was concealed from the researcher (JR) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminum foil inside the envelope was used to render the envelope impermeable to intense light. To prevent subversion of the allocation sequence, the name and date of birth of the participant was written on the envelope and a video tape made of the sealed envelope with participant details visible. Carbon paper inside the envelope transferred the information onto the allocation card inside the envelope and a second researcher (CC) later viewed video tapes to ensure envelopes were still sealed when participants' names were written on them. Corresponding envelopes were opened only after the enrolled participants completed all baseline assessments and it was time to allocate the intervention."

The second example was described in great detail, and we can guess how important the randomization and concealment were.

Who Generated the Allocation Sequence, Who Enrolled Participants, and Who Assigned Participants to Interventions?

"Determination of whether a patient would be treated by streptomycin and bed-rest (S case) or by bed-rest alone (C case) was made by reference to a statistical series based on random sampling numbers drawn up for each sex at each center by Professor Bradford Hill (this means that the stratification was done by sex and center); the details of the series were unknown to any of the investigators or to the coordinator. After acceptance of a patient by the panel, and before admission to the streptomycin center, the appropriate numbered envelope was opened at the central office; the card inside told, if the patient was to be an S or a C case, and this information was then given to the medical officer of the center."

"Details of the allocated group were given on colored cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared at the NPEU and kept in an agreed location on each ward. Randomization took place at the end of the 2nd stage of labor when the midwife considered a vaginal birth was imminent. To enter a woman into the study, the midwife opened the next consecutively numbered envelope."

"Block randomization was by a computer generated random number list prepared by an investigator with no clinical involvement in the trial. We stratified by admission for an oncology related procedure. After the research nurse had obtained the patient's consent, she telephoned a contact who was independent of the recruitment process for allocation consignment."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3942596/

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Note added at 1 час (2023-07-29 10:06:55 GMT)
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"sealed envelope randomization" - результатов: примерно 2810
https://www.google.ru/search?q="sealed envelope randomizatio...
Selected response from:

Oleg Lozinskiy
Russian Federation
Local time: 11:02
Grading comment
Thank you
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +1sealed envelope randomization | random allocation concealment by [sealed] envelopes
Oleg Lozinskiy


  

Answers


53 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
sealed envelope randomization | random allocation concealment by [sealed] envelopes


Explanation:
Allocation Concealment Mechanism

"The doxycycline and placebo were in capsule form and identical in appearance. They were pre-packed in bottles and consecutively numbered for each woman according to the randomization schedule. Each woman was assigned an order number and received the capsules in the corresponding pre-packed bottle."

"The allocation sequence was concealed from the researcher (JR) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminum foil inside the envelope was used to render the envelope impermeable to intense light. To prevent subversion of the allocation sequence, the name and date of birth of the participant was written on the envelope and a video tape made of the sealed envelope with participant details visible. Carbon paper inside the envelope transferred the information onto the allocation card inside the envelope and a second researcher (CC) later viewed video tapes to ensure envelopes were still sealed when participants' names were written on them. Corresponding envelopes were opened only after the enrolled participants completed all baseline assessments and it was time to allocate the intervention."

The second example was described in great detail, and we can guess how important the randomization and concealment were.

Who Generated the Allocation Sequence, Who Enrolled Participants, and Who Assigned Participants to Interventions?

"Determination of whether a patient would be treated by streptomycin and bed-rest (S case) or by bed-rest alone (C case) was made by reference to a statistical series based on random sampling numbers drawn up for each sex at each center by Professor Bradford Hill (this means that the stratification was done by sex and center); the details of the series were unknown to any of the investigators or to the coordinator. After acceptance of a patient by the panel, and before admission to the streptomycin center, the appropriate numbered envelope was opened at the central office; the card inside told, if the patient was to be an S or a C case, and this information was then given to the medical officer of the center."

"Details of the allocated group were given on colored cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared at the NPEU and kept in an agreed location on each ward. Randomization took place at the end of the 2nd stage of labor when the midwife considered a vaginal birth was imminent. To enter a woman into the study, the midwife opened the next consecutively numbered envelope."

"Block randomization was by a computer generated random number list prepared by an investigator with no clinical involvement in the trial. We stratified by admission for an oncology related procedure. After the research nurse had obtained the patient's consent, she telephoned a contact who was independent of the recruitment process for allocation consignment."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3942596/

--------------------------------------------------
Note added at 1 час (2023-07-29 10:06:55 GMT)
--------------------------------------------------

"sealed envelope randomization" - результатов: примерно 2810
https://www.google.ru/search?q="sealed envelope randomizatio...

Oleg Lozinskiy
Russian Federation
Local time: 11:02
Native speaker of: Native in RussianRussian
PRO pts in category: 8
Grading comment
Thank you

Peer comments on this answer (and responses from the answerer)
agree  mk_lab
7 hrs
  -> Thank you, Michael!
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