Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used

Abstract

BackgroundMany complex intervention trials fail to show an intervention effect. Although this may be due to genuine ineffectiveness, it may also be the result of sub-optimal intervention design, implementation failure or a combination of these. Given current financial constraints and the pressure to reduce waste and increase value in health services research, pre-trial strategies are needed to reduce the likelihood of design or implementation failure and to maximise the intervention’s potential for effectiveness. In this scoping review, we aimed to identify and synthesise the available evidence relating to the strategies and methods used to ‘optimise’ complex interventions at the pre-trial stage.MethodsWe searched MEDLINE, CINAHL, AMED, PsycINFO and ProQuest Nursing & Allied Health Source for papers published between January 2000 and March 2015. We included intervention development and optimisation studies that explored potential intervention weaknesses and limitations before moving to a definitive randomised controlled trial (RCT). Two reviewers independently applied selection criteria and systematically extracted information relating to the following: study characteristics; intervention under development; framework used to guide the development process; areas of focus of the optimisation process, methods used and outcomes of the optimisation process. Data were tabulated and summarised in a narrative format.ResultsWe screened 3968 titles and 231 abstracts for eligibility. Eighty-nine full-text papers were retrieved; 27 studies met our selection criteria. Optimisation strategies were used for a range of reasons: to explore the feasibility and acceptability of the intervention to patients and healthcare professionals; to estimate the effectiveness and cost-effectiveness of different combinations of intervention components; and to identify potential barriers to implementation. Methods varied widely across studies, from interviews and focus groups to economic modelling and probability analysis.ConclusionsThe review identifies a range of optimisation strategies currently used. Although a preliminary classification of these strategies can be proposed, a series of questions remain as to which methods to use for different interventions and how to determine when the intervention is ready or ‘optimised enough’ to be tested in a RCT. Future research should explore potential answers to the questions raised, to guide researchers in the development and evaluation of more effective interventions.

The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

“…To the best of our knowledge, the EMPOWER-SUSTAIN project is the first self-management e-health intervention designed for patients with MetS in the Malaysian primary care setting. The pilot randomised controlled trial will be conducted to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN intervention, including recruitment rate, methods of randomisation, retention rate, selection of primary and secondary outcome measures, sample size calculation, whether the intervention could be delivered as intended, and methods of statistical analysis to evaluate the potential effectiveness [44,45]. All of these aspects will be useful for further exploration in a larger definitive trial.…”

“…In this pilot study, the feasibility of implementing the EMPOWER-SUSTAIN Self-Management e-Health Intervention for patients with MetS in a primary care clinic will be evaluated. These include acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and its potential effectiveness (i.e., the effect size) [44,45].…”

Improving swallowing outcomes in patients with head and neck cancer using a theory-based pretreatment swallowing intervention package: protocol for a randomised feasibility study

“…By undertaking a feasibility study and identifying key uncertainties, any future study may be optimised to make best use of resources. 50 This study follows earlier work on intervention development bringing together expertise from different fields including clinical dysphagia management and behaviour change. It benefits from the use of newer paradigms in health research including the use of consultative and consensus meetings to devise a treatment manual to specify the content of usual care, a common omission when reporting such interventions.…”

Optimising a complex stroke caregiver support programme in practice: a participatory action research study

“…The in-vivo optimisation strategy (Palmer et al 2013) allowed us early on to acquire real-life experiences. Conceptual strengths and weaknesses (Levati et al 2016), as well as practical 'teething problems', were detected early on and an immediate response to these was possible. By systematically verifying the new concept´s completeness and feasibility in practice, a conceptual maturation was achieved, as proposed by Bleijenberg et al (2018).…”

“…Optimisation aims to improve the effectiveness of an intervention and to increase its acceptability and feasibility in practice (Sermeus 2015). Optimisation is a process, which may include verifying the intervention´s components (Levati et al 2016), completing and fitting the components to the practice, and prioritising the components according to the objectives of the intervention (Bleijenberg et al 2018). Stakeholders´participation and engagement is considered helpful in the optimisation of a complex intervention (Bleijenberg et al 2018).…”