What are the Possible Options for Handling Patients in Statistical Analysis
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Instructions
A two-arm (active vs placebo) RCT is planned to ascertain if it is useful to supplement the diet of pregnant women in the 1st and 2nd trimesters with substance X as a means of enhancing neurocognitive development of the infant 18 months after birth. The trial is funded by the nation’s peak health research funding agency (so it might be NHMRC or US NIH or UK MRC). Recruitment of eligible mothers will be via obstetric practices and hospital pre-natal classes/clinics. Among the eligibility criteria is that, prior to randomisation, a mum should not already be taking substance X. Two issues arose that adversely affected the rate of recruitment: (i) Just as the study was getting underway, the funding body (which had itself funded the study on the basis that there was little or no level 1 (i.e. RCT) evidence to support the supplementation of women on a population basis) issued a “guidelines” paper calling for population- based supplementation of bread and other foodstuffs with substance X. The general media took up the story. Many more women than expected were found to be ineligible, as they were taking multivitamin pills (perhaps for other reasons, e.g. iron or folate supplementation) that also happened to contain substance X. (ii) (a) What might you have done in the design phase of the trial to avoid or mitigate the risk of such issues? [2 marks] (b) What strategies might you now adopt to help ensure the ongoing viability of the trial? [2 marks] Following randomisation into the trial, it is discovered that a number of women in the placebo group began taking supplements containing substance X. (c) What are the possible options for handling these patients in the statistical analysis? [3 marks] (d) of the options you mentioned in (c) above, indicate and justify the particular option you would recommend? [1 mark]
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