Table 1

Adequate Sequence Generation

Coin toss, throwing a dice, shuffling, drawing lots (from a container). Partial: drawing a card from a pack.

Computer- or calculator-generated sequence (including minimisation and biased-coin/urn design). Partial: “random permuted blocks”.

Random number table or statistical tables. Partial: random numbers, randomisation table.

Randomised Latin square design.

Inadequate Sequence Generation

Randomised Latin square. For example, allocation by alternation, birthdate, day of week.

Adequate Allocation Concealment

Central randomisation: with contacting details and/or statement that central office retained schedule; must apply to all patients. Partial: vague statement of central randomisation.

Independent 3rd party: allocates interventions and retains schedule, or statement that allocator has no knowledge of patients. Partial: 3rd party, but unclear treatment allocation.

3rd party cluster randomisation: 3rd party has no knowledge of clusters. Partial: unclear what 3rd party knew.

Different parties (including one of authors): should have no knowledge of the patients and retain the schedule.

Secure computer assisted method, e.g. locked file. Partial: as adequate, but unclear access.

Sequentially numbered, opaque, sealed envelopes - all required, else partial.

Serially numbered, identical containers, allocated sequentially - all required, else partial.

Inadequate allocation concealment

For example, schedule known in advance, birthdate, case record number.

From: 5, Methods used to develop the guideline

Cover of Irritable Bowel Syndrome in Adults
Irritable Bowel Syndrome in Adults: Diagnosis and Management of Irritable Bowel Syndrome in Primary Care [Internet].
NICE Clinical Guidelines, No. 61.
National Collaborating Centre for Nursing and Supportive Care (UK).
Copyright © 2008, Royal College of Nursing.

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