What to write
Informal or formal frameworks, models, concepts, and/or theories used to explain the problem, any reasons or assumptions that were used to develop the intervention(s), and reasons why the intervention(s) was expected to work.
Explanation
The label ‘rationale’ for this guideline item refers to the reasons the authors have for expecting that an intervention will ‘work.’ A rationale is always present in the heads of researchers; however, it is important to make this explicit and communicate it in healthcare quality improvement work. Without this, learning from empirical studies may be limited and opportunities for accumulating and synthesising knowledge across studies restricted.1
Authors can express a rationale in a variety of ways, and in more than one way in a specific paper. These include providing an explanation, specifying underlying principles, hypothesising processes or mechanism of change, or producing a logic model (often in the form of a diagram) or a programme theory. The rationale may draw on a specific theory with clear causal links between constructs or on a general framework which indicates potential mechanisms of change that an intervention could target.
A well developed rationale allows the possibility of evaluating not just whether the intervention had an effect, but how it had that effect. This provides a basis for understanding the mechanisms of action of the intervention, and how it is likely to vary across, for example, populations, settings and targets. An explicit rationale leads to specific hypotheses about mechanisms and/or variation, and testing these hypotheses provides valuable new knowledge, whether or not they are supported. This knowledge lays the foundation for optimising the intervention, accumulating evidence about mechanisms and variation, and advancing theoretical understanding of interventions in general.
The first example shows how a theory (the ‘Fit between Individuals, Task and Technology’ framework) can identify and clarify the social and technological barriers to healthcare improvement work. The study investigated engagement with a computerised system to support decisions about postoperative deep vein thrombosis (DVT) prophylaxis: use of the framework led to 11 distinct barriers being identified, each associated with a clearly specified intervention which was undertaken.
The second example illustrates the use of an integrative theoretical framework for intervention development.2 The authors used an integrative framework rather than a specific theory/model/framework. This was in order to start with as comprehensive a framework as possible, since many theories of behaviour change are partial. This example provides a clear description of the framework and how analysing the target behaviour using an integrative theoretical model informed the selection of intervention content.
Interventions may be effective without the effects being brought about by changes identified in the hypothesised mechanisms; on the other hand, they may activate the hypothesised mechanisms without changing behaviour. The knowledge gained through a theory-based evaluation is essential for understanding processes of change and, hence, for developing more effective interventions. This paper also cited evidence for, and examples of, the utility of the framework in other contexts.
Examples
Example 1
The team used a variety of qualitative methods …to understand sociotechnical barriers. At each step of collection, we categorised data according to the FITT (‘Fit between Individuals, Task, and Technology’)model criteria … Each component of the activity system (ie, user, task and technology) was clearly defined and each interface between components was explored by drawing from several epistemological disciplines including the social and cognitive sciences. The team designed interventions to address each identified FITT barrier……. By striving to understand the barriers affecting activity system components and the interfaces between them, we were able to develop a plan that addressed user needs, implement an intervention that articulated with workflow, study the contextual determinants of performance, and act in alignment with stakeholder expectations.3
Example 2
…We describe the development of an intervention to improve medication management in multimorbidity by general practitioners (GPs), in which we applied the steps of the BCW(Behaviour Change Wheel)4 to enable a more transparent implementation of the MRC (Medical Research Council) framework for design and evaluation of complex interventions….
…we used the COM-B (capability, opportunity, motivation—behaviour) model to develop a theoretical understanding of the target behaviour and guide our choice of intervention functions. We used the COM-B model to frame our qualitative behavioural analysis of the qualitative synthesis and interview data. We coded empirical data relevant to GPs’ …capabilities, …opportunities and …motivations to highlight why GPs were or were not engaging in the target behaviour and what needed to change for the target behaviour to be achieved.
The BCW incorporates a comprehensive panel of nine intervention functions, shown in Figure 1, which were drawn from a synthesis of 19 frameworks of behavioural-intervention strategies. We determined which intervention functions would be most likely to effect behavioural change in our intervention by mapping the individual components of the COM-B behavioural analysis onto the published BCW linkage matrices…5
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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