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Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in
Michael R Backhouse1, Daniel J Parker2, Stewart C Morison3
1Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Insights
This study developed standardized interventions for children with flat feet (pes planus). A modified Nominal Group Technique ensured interventions reflect current practice for exercise, orthoses, and advice.
Area of Science:
- Pediatric orthopedics
- Clinical trial methodology
- Rehabilitation science
Background:
- Symptomatic flat feet (pes planus) in children present a management challenge with varied clinical approaches.
- Developing standardized interventions is crucial for evaluating treatment effectiveness in pediatric pes planus.
- This study focused on the development process for three complex interventions for pes planus.
Purpose of the Study:
- To develop and standardize three complex interventions for pediatric symptomatic flat feet (pes planus).
- To evaluate exercise and advice, exercise with prefabricated orthoses, and exercise with custom orthoses.
- To ensure interventions reflect contemporary clinical practice and allow for adaptability.
Main Methods:
- A modified Nominal Group Technique (NGT) was employed, combining electronic surveys with face-to-face meetings.
- This novel approach facilitated consensus among 16 healthcare professionals (podiatrists, orthotists, physiotherapists, orthopedic surgeon).
- The NGT process refined a logic model and selected options for each intervention arm.
Main Results:
- Consensus was reached on a logic model, incorporating psychosocial impacts and shared decision-making.
- Shortlists of options were agreed upon for prefabricated and custom orthoses, exercise targets, and health education.
- The developed interventions are adaptable while maintaining integrity for pragmatic application.
Conclusions:
- A modified NGT successfully produced adaptable, coherent interventions for pediatric pes planus.
- The consensus process ensured interventions align with current clinical practice.
- This methodology may serve as a template for developing complex interventions in other clinical trials.
Background:
Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions.
Methods:
We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice.
Results:
In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice.
Conclusions:
Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.
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