Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in...

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.