The importance of assessing outcomes that matter to patients is clearly illustrated – in a very negative fashion – by early trials of epidural analgesia given to women for pain relief during labour.
In the 1990s researchers reviewed the experience with controlled trials of epidural versus non-epidural analgesia. They estimated that, despite millions of women having been offered an epidural block over the preceding 20 years, fewer than 600 appeared to have participated in reasonably unbiased comparisons with other forms of pain relief.
They identified nine comparison trials that could be confidently analyzed. The comparisons were commonly measured in terms of levels of hormones and other substances believed to reflect stress during labour. Outcomes for the baby were also the focus of some attention.
Yet any comparison of the pain reported by the women themselves was absent in all but two of the trials. In other words, those conducting the trials had largely overlooked an outcome that was surely of supreme importance – how effectively a woman’s pain had been relieved.