Definitions

1. Treatment allocation was the only variable independently related to survival (odds ratio 0.45 [95% CI 0.25-0.81], p=0.02).
2. Treatment allocation was concealed from investigators and parents of participating infants.
3. Treatment allocation was concealed from patient and physicians doing the assessments by use of sealed envelopes.
4. Treatment allocation was stratified according to flare-up treatment (nutrition or medication alone).
5. Treatment allocation was based on a computer-generated list of random numbers with varying block size.

Cell Frequencies

1. When calculating odds ratios, 0.5 was added to each of the cell frequencies in the 2 × 2 table showing response by treatment allocation.

Treatment Response

1. An interaction (P = 0.025) between treatment allocation and disease location on treatment response was identified.

Random

1. A quasi experimental design is one in which treatment allocation is not random.

Physicians

1. Two physicians, both blinded to treatment allocation, evaluated each patient at every trial visit.

Randomisation

1. To prevent selection bias, treatment allocation should be based on randomisation (Box 1), a method that is almost ubiquitous in clinical treatment trials.

Trial

1. The code for treatment allocation was only broken once the trial was completed.

Investigators

1. Participants, parents, investigators, research assistants and caregivers were blinded to treatment allocation.

Patients

1. All patients and investigators, including the surgeon, physiotherapists and data analysts, remained blind to treatment allocation until after data analysis.

Treatment Allocation

1. All physicians who had contact with patients were masked to treatment allocation.
2. Patients and investigators were masked to treatment allocation.

Categories

1. Masked
2. Investigators
3. Randomisation
4. Stratified
5. Concealed
6. Books about "Treatment Allocation" in Amazon.com
   

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