Box 95 Key elements of plan to analyse quality of life data from a trial

♦ Descriptive tables including a distribution of baseline and follow-up data and a report on compliance

♦ Analysis of the stated hypotheses as outlined in the protocol

♦ Expanded and sensitivity analyses to explore the key results

♦ Exploratory analyses to generate new hypotheses

(data are collected over several timepoints). All of these aspects are difficult enough to deal with individually, but combined they represent formidable problems.

As for more traditional outcome measures it is useful to have a general plan for the analysis which should include the components set out in Box 9.5.

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