Allocation concealment in randomised trials: defending against deciphering

@article{Schulz2002AllocationCI,
  title={Allocation concealment in randomised trials: defending against deciphering},
  author={Kenneth F. Schulz and David A. Grimes},
  journal={The Lancet},
  year={2002},
  volume={359},
  pages={614-618}
}

Randomization and allocation concealment: a practical guide for researchers.

Mechanisms and direction of allocation bias in randomised clinical trials

TLDR
Inadequate allocation concealment may exaggerate treatment effects in some trials while underestimate effects in others, and the hypothesis provides a theoretical overview of the main factors responsible for the direction of allocation bias.

Concealed allocation in randomised trials.

  • M. Elkins
  • Mathematics, Psychology
    Journal of physiotherapy
  • 2013

Using scratch card technology for random allocation concealment in a clinical trial with a crossover design

TLDR
An allocation concealment method that reduced the possibility of selection bias for a randomized, open-label, crossover trial to evaluate device function of four female condom (FC) types and was well liked by study staff.

Allocation concealment continues to be misunderstood.

Allocation concealment and blinding in clinical trials

TLDR
RCTs are considered the strongest research design to estimate the effects of health interventions and randomization is a process that aims at producing groups that are similar in terms of both known and unknown prognostic factors.

Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study

TLDR
Most randomised clinical trials have unclear allocation concealment on the basis of the trial publication alone, and most of these trials also have unclear allocations concealment according to their protocol.

Syddansk Universitet Mechanisms and direction of allocation bias in randomised clinical trials

TLDR
Inadequate allocation concealment may exaggerate treatment effects in some trials while underestimate effects in others, and the hypothesis provides a theoretical overview of the main factors responsible for the direction of allocation bias.
...

References

SHOWING 1-10 OF 62 REFERENCES

The Landscape and Lexicon of Blinding in Randomized Trials

TLDR
The landscape and lexicon of blinding in randomized trials in the hope of untangling some of that terminology, which is widely recognized as reducing differential assessment of outcomes of interest.

Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

TLDR
Empirical evidence is provided that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias.

The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration

TLDR
The CONSORT statement (or simply CONSORT) comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial, aimed at first reports of two-group parallel designs.

Comparing like with like: some historical milestones in the evolution of methods to create unbiased comparison groups in therapeutic experiments.

  • I. Chalmers
  • Biology
    International journal of epidemiology
  • 2001
TLDR
This complementary paper introduces and discusses some milestones between 1662 and 1948 in the development of methods to control selection biases when assembling therapeutic comparison groups, to ensure, as far as possible, that 'like is compared with like'.

Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals.

TLDR
Proper randomization is required to generate unbiased comparison groups in controlled trials, yet the reports in these journals usually provided inadequate or unacceptable information on treatment allocation, suggesting that nonrandom manipulation of comparison groups and selective reporting of baseline comparisons may have occurred.

Statistical properties of randomization in clinical trials.

  • J. Lachin
  • Mathematics
    Controlled clinical trials
  • 1988

How well are randomized controlled trials reported in the dermatology literature?

TLDR
There is the need for higher methodological quality in clinical trial reporting in dermatology journals and the adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports.

Unbiased research and the human spirit: the challenges of randomized controlled trials.

  • K. Schulz
  • Medicine
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
  • 1995
TLDR
The author contends that the noncompliance encountered by Klein and associates reflects the fact that randomized trials are anathema to the human spirit and stresses that, although RCTs are indispensible to the advancement of medical knowledge, they necessitate assiduous attention to matters of design and implementation.
...