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Table 4 Guidelines for carrying out process evaluations within complex rehabilitation interventions research

From: The generation of consensus guidelines for carrying out process evaluations in rehabilitation research

Section No Recommendation
Theoretical work
  1.1 Review and state the theoretical underpinnings of the rehabilitation intervention under investigation
1.2 Review and state the theoretical underpinnings of the implementation approach of the rehabilitation intervention under investigation
1.3 Describe in depth the structure of the rehabilitation intervention in terms of its components and their potential interactions
Design and Methods
  2.1 Provide a clear definition of chosen terminology (e.g. adherence, fidelity, integrity etc.)
2.2 Have a defined scope and clear aims and objectives - a process evaluation protocol should be produced
2.3 Clearly describe and justify the use of a set of measures and evaluation criteria for the process evaluation
2.4 Provide a detail description and justification of selected process evaluation data collection methods
2.5 Clearly explain and justify chosen timings for process evaluation data collection
2.6 Collect relevant/appropriate data from both intervention and control sites
2.7 Use a variety of methods and strategies to gather data, including both qualitative and quantitative approaches
2.8 Should aim at publishing its results alongside outcome evaluation results (in order to reduce the chance of biases)
2.9 Address the interactions between process and outcome evaluations (e.g. researchers should decide if they take the risk of threatening the outcome evaluation via evaluating processes or if they accept that there will be tailoring which can be guided through the process evaluation)
Context
  3.1 Clearly describe and investigate contextual factors and their potential impact on the process and outcome evaluation. The role of context in shaping both implementation (e.g. how it’s done) and impact (whether it works) should be clearly investigated
3.2 Account for the dynamic nature of context - investigate contextual changes and their potential impact on the process and outcome evaluation over time
Recruitment and Retention
  4.1 Review the outcome evaluation’s recruitment procedures in order to identify potential recruitment barriers and facilitators
4.2 Review the strategies that the outcome evaluation has in place to maximize participant retention levels
4.3 Clearly describe the strategies and criteria informing the recruitment of participants into the process evaluation
4.4 Investigate the barriers and facilitators to the recruitment of participants into the process evaluation
Intervention staff
  5.1 Review the characteristics of the outcome evaluation intervention staff (e.g. level of skill, experience, number, demographics, motivations and perceptions regarding the outcome evaluation) and identify those potentially impacting on intervention delivery and impact
5.2 Review the training provided to intervention staff in order to identify possible impacts on outcomes. Explore issues such as: does the training define a performance criteria and set of goals to achieve? Is skill acquisition/competence of intervention staff assessed post training? Does the training include systems in place in order to maintain and support staff’s skills over time?
5.3 Review the outcome evaluation’s strategies in place to assess competence of intervention staff over time in order to identify possible learning curve effects
Delivery of the intervention
  6.1 Investigate any strategies in place in order to guide, inform and measure the tailoring of the outcome evaluation intervention
6.2 Review and assess the quality of any implementation strategies to improve/support the fidelity of the proposed intervention.
6.3 Investigate, in detail, barriers and enablers to the implementation and delivery of the intervention and evidence surrounding the chances of implementation failure
6.4 Review the strategies in place in order to measure the ‘dose delivered’
6.5 Review the strategies in place in order to measure the ‘dose received’
6.6 Investigate in detail participants’ experiences and acceptability of the intervention
Results
  7.1 Describe in detail the synthesis of process evaluation and outcome evaluation results
7.2 The theoretical underpinnings behind both, the outcome evaluation intervention and its implementation should inform the explanations and the synthesis of process and outcome evaluation results
  1. It is strongly recommended to consider these guidelines alongside recommendations on reporting outcome evaluations (e.g. CONSORT statement)
  2. These guidelines are of use to researchers carrying out research on complex rehabilitation interventions and the recommendations will need to be considered and adapted accordingly depending on the research stage/phase or type of study (e.g. feasibility trial, main trial, etc.)
  3. These guideline recommendations build on the following assumptions about the nature of complexity in complex intervention rehabilitation research:
  4. - Complex rehabilitation interventions are those made up of a number of components, which interact with each other, and with patient and other factors to bring about changes in patient outcomes
  5. - The impact of complex interventions is greater than the sum of the effects of their component parts, and is a product of both the changes embedded in both the intervention hypotheses and the implementation approaches used. In other words, and in order to provide explanations of how a complex intervention works, for who and under what circumstances, this guideline considers that outcome evaluation and process evaluation are inextricably linked