Acceptability of health care interventions: A theoretical framework and proposed research agenda

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

This study investigates the boundary conditions (feasibility, safety, and efficacy) of an expressive writing intervention for individuals with post-traumatic stress disorder [PTSD]. Randomized trial with baseline and 3-month follow-up measures of PTSD severity and symptoms, mood states, post-traumatic growth, and (post-only) cortisol reactivity to trauma-related stress. Volunteers with a verified diagnosis of PTSD (N=25) were randomly assigned to an experimental group (writing about their traumatic experience) or control group (writing about time management). Expressive writing was acceptable to patients with PTSD and appeared safe to utilize. No changes in PTSD diagnosis or symptoms were observed, but significant improvements in mood and post-traumatic growth were observed in the expressive writing group. Finally, expressive writing greatly attenuated neuroendocrine (cortisol) responses to trauma-related memories. The present study provides insight into several boundary conditions of expressive writing. Writing did not decrease PTSD-related symptom severity. Although patients continue to exhibit the core features of PTSD, their capacity to regulate those responses appears improved following expressive writing. Dysphoric mood decreased after writing and when exposed to traumatic memories, participants' physiological response is reduced and their recovery enhanced.

Head and neck cancer and its treatment have profound effects on function, self-image, and mental health. Fears of recurrence are one of the major concerns of cancer survivors that endure and can influence the patients' ability to adjust and plan for the future. This paper describes the design and development of the adjustment to the fear, threat or expectation of recurrence (AFTER) intervention which targets recurrence fears, inappropriate checking behaviour, and beliefs about cancer, adopting recognized cognitive behavioural and health psychology principles, particularly Leventhal's self-regulation model. The intervention includes structured sessions, manualized delivery by a specialist nurse, invitation to caregiver, expression of fears, examination and change of beliefs, and checking behaviour. Initial testing showed acceptability (nurse satisfaction ratings by patient) of the intervention which may have applicability for patients who have been treated with cancer at other sites.