Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
School of Health and Society, University of Salford, Salford, UK.
Trials. 2022 Apr 11;23(1):286. doi: 10.1186/s13063-022-06251-7.
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.
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.
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.
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.
患有症状性扁平足（平足症）的儿童经常需要接受治疗，但对于如何最好地管理他们的病情仍存在不确定性。不同专业之间以及同一专业内部的治疗方法差异较大。我们计划开展一项三臂试验，以评估三种常用于平足症的干预措施（运动和建议、运动和建议加预制矫形器以及运动和建议加定制矫形器）。这些干预措施都很复杂，在开展试验前需要进行开发。本文重点介绍了开发干预措施所经历的过程。
我们使用改良名义小组技术，将电子调查与两次面对面会议相结合，以就最终逻辑模型和每个干预措施的选项达成共识。在连续会议中使用名义小组技术并结合问卷是一种创新方法，使我们能够开发出反映当代临床实践的复杂干预措施。
共有 16 名医疗保健专业人员参加了共识会议。其中包括 11 名足病医生、2 名矫形师、2 名物理治疗师和 1 名骨科医生。两次会议都批准了逻辑模型，并进行了修订，以反映平足症及其治疗的更广泛的心理社会影响，以及在实践中越来越多地使用共同决策。还为预制和定制矫形器、伸展和强化运动的目标结构以及健康教育和建议的内容商定了简短的选项清单。
我们对名义小组技术的新颖修改产生了一个连贯的逻辑模型和每个干预措施的简短选项清单，这些清单明确允许适应性。我们就每个干预措施中允许的范围达成共识，以保持其完整性，并使其能够进行调整和实际应用。将调查数据与面对面会议相结合的过程确保了干预措施反映了当代实践，并可为其他试验提供模板。
