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Table 3 Relationship between qualitative process evaluation and mixed-methods fidelity analysis

From: Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

Element of intervention fidelityQualitative theme(s)ExplanationInforming design of data collectionPotential 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) populationPodiatrists 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 populationCompliance 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 populationPodiatrist 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 interventionQuantitative 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 interventionWhether 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 interventionQuantitative 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 interventionTraining and support provided to podiatrists regarding intervention deliveryQualitative 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 practicePerceived 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 practiceDescriptively present outcomes by intervention components delivered