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Let us now look in more detail at the reasons for randomization given by these two men. We should realize that Fisher was able to approach controlled experimentation with much stronger organizational support than Hill. Rothamsted had been the home of field trials for many decades, and his colleagues in the 1920s needed no persuasion of the need for simultaneous controlled comparisons. They knew better than to compare fertilizers on different fields, or to compare a particular variety one year with another variety in the previous year. The only question was how to allocate treatments to plots. By contrast, the case for controlled trials in medicine was far from secure in the late 1930s. Voices were certainly heard in praise of the pioneers of ‘fair’ comparisons, such as Lind, but others advocated historical comparisons or argued that controlled allocation ignored the uniqueness of the individual and was perhaps unethical. So Hill had to make the general case for simultaneous control as well as the more specific case for randomization.

Fisher repeatedly and consistently gave the same justification for randomization. In 1926 3 he wrote:

One way of making sure that a valid estimate of error will be obtained is to arrange the plots deliberately at random, so that no distinction can creep in between pairs of plots treated alike and pairs treated differently; in such a case an estimate of error, derived in the usual way from the variation of sets of plots treated alike, may be applied to test the significance of the observed difference between the averages of plots treated differently.

And again in The Design of Experiments 4 (the quotation being from p. 26 of the 6th edition, 1951):

The purpose of randomisation ... is to guarantee the validity of the test of significance, this test being based on an estimate of error made possible by replication.

Fisher regarded randomization as the unique means by which the random error variance would be correctly estimated, thus validating the significance tests which were at the heart of his analyses. If, for instance, the agricultural experimenter tried to balance the perceived fertility of the plots receiving different treatments he would tend to overestimate the error, so that differences would actually be more significant than they appeared to be, although if he guessed wrong the effect might be in the opposite direction. Similarly Fisher would criticize a common practice in animal experimentation, to balance the mean weights of animals in different groups. The aim to allow for relevant factors like soil fertility or animal weight was laudable, but should be approached by forming blocks of more homogeneous plots or animals and randomizing within these. Moreover, randomization provided a partial safeguard against failure of the assumption usually made in the statistical theory, that random variation followed a normal distribution. In practice no distributions are exactly normal, and some are very far from being so, but in a certain sense the tests can be shown to be approximately correct even under non-normality. Furthermore, if the worst comes to the worst, an exact test can be carried out by considering the permutations that would have occurred to the data if all the possible random assignments had been made—a so-called ‘randomization test’.

Each author was asked to review the literature (based on screening examination of titles and abstracts and manuscript full-text examination, as well as abstraction of relevant variables/data from eligible studies/reports), evaluate the evidence, and determine the strength of the recommendations along with an evidence summary supporting each recommendation. The panel reviewed all recommendations, their strength, and quality of evidence. For recommendations in the category of good practice statements that should not be graded, we followed published principles by the GRADE working group on how to identify such recommendations and use appropriate wording choices [ 13 ]. Accordingly, a formal GRADE rating was not pursued for those statements as these statements would make it clear that they would do greater good than harm or greater harm than good, and thus a study would not be warranted to address such a question. Discrepancies were discussed and resolved, and all panel members are in agreement with the final recommendations.

The panel met face-to-face on 3 occasions and conducted numerous monthly subgroup and full panel conference calls to complete the work of the guideline. The panel as a whole reviewed all individual sections. The guideline was reviewed and approved by the IDSA Standards and Practice Guidelines Committee (SPGC) and SHEA Guidelines Committee as well as both organizations’ respective Board of Directors (BOD). The guideline was endorsed by ASHP, SIDP, and PIDS.

All members of the expert panel complied with the IDSA policy on conflicts of interest, which requires disclosure of any financial, intellectual, or other interest that might be construed as constituting an actual, potential, or apparent conflict. To provide thorough transparency, IDSA requires full disclosure of all relationships, regardless of relevancy to the guideline topic [ 14 ]. Evaluation of such relationships as potential conflicts of interest (COI) is determined by a review process that includes assessment by the SPGC chair, the SPGC liaison to the development panel, and the BOD liaison to the SPGC, and, if necessary, the COI Task Force of the Board. This assessment of disclosed relationships for possible COI is based on the relative weight of the financial relationship (ie, monetary amount) and the relevance of the relationship (ie, the degree to which an association might reasonably be interpreted by an independent observer as related to the topic or recommendation of consideration). See Acknowledgments section for disclosures reported to IDSA.

At annual intervals and more frequently if needed, IDSA and SHEA will determine the need for revisions to the guideline on the basis of an examination of the current literature and the likelihood that any new data will have an impact on the recommendations. If necessary, the entire expert panel will be reconvened to discuss potential changes. Any revision to the guideline will be submitted for review and approval to the appropriate Committees and Boards of IDSA and SHEA.

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