The randomized fast-track trial in palliative care: role, utility and ethics in the evaluation of interventions in palliative care?

Abstract

Randomized trials are the gold standard method for evaluating treatments and services in health care. However, they are often difficult to complete in palliative care, and suffer from poor recruitment. To introduce the randomized fast-track trial and its potential use in palliative care. The randomized fast-track trial is a form of randomized trial with two periods. In the first, the trial runs as a normal randomized trial. In the second period, the standard (control) group also are offered the intervention. The design is adapted from a 'wait list' design (sometimes called a deferred entry or delayed intervention trial) but is both less confusing for patients, who are not on waiting lists, and more appropriate to the nature of services offered. The methodology has the advantage of being more acceptable to many patients, clinicians and ethics committees than standard randomized trials, because all patients will eventually be offered the intervention. Yet it has the rigour of a traditional randomized trial. However, care is needed to ensure the correct timing for the first period, before the standard group receive the intervention. The analysis of data in the second period is complex. The fast-track trial has been used successfully in palliative care among patients severely affected by multiple sclerosis, chronic obstructive pulmonary disease and cancer. It is best suited to evaluations of palliative care services among patients who have longer prognoses, for example of several months or more although it has been used in people with prognoses of weeks.