Table 3 Relationship between qualitative process evaluation and mixed-methods fidelity analysis
Element of intervention fidelity | Qualitative theme(s) | Explanation | Informing design of data collection | Potential interface with quantitative analysis/interpretation of trial findings |
|---|---|---|---|---|
Content; Frequency/Duration (dose, dose delivery); Coverage (reach) Was each of the intervention components implemented as intended? Is the frequency and duration of the intervention as intended? What proportion of the target group participated in the intervention? | Challenges of delivering a multifaceted intervention to an older (≥ 65 years) population | Podiatrists do not prescribe elements of the intervention for health or medical reasons Podiatrists modify and adapt intervention components to suit individuals’ needs and capabilities | Qualitative work to identify appropriate adaptations for trial population | Compliance analysis of trial results according to delivery of intervention as intended (including appropriate adaptations) |
Recruitment What recruitment procedures were used? What factors affect attrition? | Challenges of delivering a multifaceted intervention to an older population | Podiatrist felt the intervention was better suited to older patients who were still ‘fit, healthy and mobile’ | Question on ‘intervention log’ of perceived suitability of patient for intervention | Quantitative description of characteristics of perceived suitability for the intervention by service providers Subgroup analysis of trial results according to service provider rated suitability of the intervention for the participant |
Participant responsiveness How far participants respond to, or are engaged by, an intervention | Patient views of the intervention Is falls prevention a priority for the patient? Previous trial experience | Whether patients felt the intervention would be of benefit Previous experiences of orthotics or exercises Whether reducing risk of falls was a priority for patients Previous and current experience of taking part in research and the trial | Questions on participant baseline questionnaire on participant beliefs and strengths of beliefs of the effectiveness of the intervention | Quantitative description of variation in participant beliefs regarding the effectiveness of the intervention and associated characteristics. Subgroup analysis of trial results according to beliefs and strengths of beliefs of the effectiveness of the intervention at baseline |
Comprehensiveness of intervention description/strategies to facilitate implementation How specific is the intervention? Intervention complexity When aiming to evaluate implementation fidelity, what are the specific strategies put in place to optimise the level of fidelity achieved, e.g. provision of manuals, training and incentives? | Practical issues with adhering to and delivering the intervention | Whether podiatrists felt they had received sufficient training and support throughout the trial DVDs and booklets helped podiatrists and patients to deliver and adhere to exercises. Additional follow-up visits and more time to deliver the intervention were recommended by podiatrists ‘Information overload’ | Quantitative assessment of adequacy of training, complexity of intervention and confidence in delivering intervention | Quantitative description of variation in perceived ability to deliver intervention and association with delivery as intended |
Quality of delivery The way that those responsible for delivering the intervention deliver it | Practical issues with adhering to and delivering the intervention | Training and support provided to podiatrists regarding intervention delivery | Qualitative observations to produce quality score for each ‘therapist’ | Sensitivity analyses treating fidelity as a measure of compliance Exploring jointly the impact of practitioner fidelity alongside patient compliance within a non-compliance framework |
Program differentiation/Context Identifying unique features of different components of programs and identifying which elements are essential | How does the REFORM intervention compare to routine practice | Perceived similarities and differences between the trial intervention and routine practice Concerns regarding the time and cost of delivering the intervention | Qualitative work to identify features of complex intervention most likely to be incorporated into routine practice | Descriptively present outcomes by intervention components delivered |