Acceptability of healthcare interventions

Background: Problems with acceptability of healthcare interventions can undermine the validity of randomised evaluation studies. Hence, assessing acceptability is an important methodological issue. However, the research literature provides little guidance on how to define and assess acceptability. Acceptability of a healthcare intervention could be different, depending on the perspective taken: patients and healthcare professionals may have different views. Perceptions of acceptability may also change according to when acceptability is assessed, in relation to a person’s engagement with the intervention. A person can have perceptions about prospective acceptability (i.e. prior to taking part in the intervention); concurrent acceptability (i.e. whilst taking part in the intervention) and retrospective acceptability (after participating in the intervention). Objectives: The overall aim of this programme of research was to define acceptability in the context of healthcare interventions and to develop a Theoretical Framework of Acceptability (TFA) that can be applied to assess acceptability from two stakeholder perspectives: healthcare professionals and patients. The specific objectives were to: 1) Identify, from the published literature, how the acceptability of healthcare interventions has been defined, operationalised and theorised; 2) Theorise the concept of acceptability and develop a theoretical framework of acceptability (TFA) to guide assessment and develop preliminary assessment tools; 3) Use the tools to apply the TFA to assess intervention acceptability qualitatively, and 4) Apply pre-validation methods to develop preliminary versions of two TFA-based questionnaires. Methods: Six studies were conducted: 1. A systematic overview of reviews of published studies to investigate how the acceptability of healthcare interventions has been defined, theorised and assessed. The results of this study formed the basis for study 2. 2. Inductive and deductive methods of reasoning were applied to theorise acceptability and to develop the Theoretical Framework of Acceptability (TFA). 3. Semi-structured interviews with eligible participants who declined to participate in a Randomised Controlled Trial (RCT) comparing a new patient-led model of care with standard care, for managing blepharospasm and hemifacial spasm. The TFA was applied to identify whether participants’ reasons for refusal were associated with prospective acceptability of the intervention or with other factors. 4. Application of the TFA to analyse semi-structured interviews to assess healthcare professionals’ retrospective acceptability of two feedback interventions delivered in a research programme aimed at developing and evaluating audit and feedback interventions to increase evidence-based transfusion practice. 5. An extension of Study 3: semi-structured interviews with patients who agreed to participate in the RCT, at three-month follow-up, to assess patients’ concurrent acceptability of the standard model of care and the patient led model of care for managing blepharospasm and hemifacial spasm. 6. Pre-validation methods were applied to develop two TFA-based questionnaires applicable to the RCTs described in Studies 3, 4 and 5. Results: Study 1: acceptability had not been theorised and there was no standard definition used in the literature. Operational definitions of acceptability were often reported and often reflected measures of observed behaviour. Study 2: proposed definition: Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. The TFA was proposed as a multi-component framework that can be applied to assess intervention acceptability across three temporal perspectives: prospective, concurrent and retrospective. The TFA consists of seven component constructs: Affective attitude, Burden, Ethicality, Intervention Coherence, Opportunity Costs, Perceived Effectiveness and Self-efficacy. Studies 3-5: It was feasible to apply the TFA in these empirical studies. Study 6: Two acceptability questionnaires were developed; the TFA informed the development of items reflecting the seven component constructs of the TFA. Conclusion: Despite frequent claims that the acceptability of healthcare interventions has been assessed, acceptability research could be more robust. Investigating acceptability as a multi-component construct resulted in richer information about the acceptability of each intervention, and suggestions for enhancing intervention acceptability across three temporal perspectives. The TFA offers the research community a systematic and theoretical approach to advance the science and practice of acceptability assessment for healthcare interventions