Marston Louise, Le Novere Marie, Ricciardi Federico, Nazareth Irwin, Carson Alan, Edwards Mark, Goldstein Laura H, Marsden Jonathan, Noble Hayley, Reuber Markus, Stone Jon, Hunter Rachael M, Nielsen Glenn
Department of Primary Care and Population Health, UCL, London, UK.
Priment Clinical Trials Unit, UCL, London, UK.
Contemp Clin Trials Commun. 2023 Jun;33:101124. doi: 10.1016/j.conctc.2023.101124. Epub 2023 Mar 24.
Functional motor disorder (FMD) is a common cause of disabling neurological symptoms such as weakness and tremor. Physio4FMD is a pragmatic, multicentre single blind randomised controlled trial to evaluate effectiveness and cost effectiveness of specialist physiotherapy for FMD. Like many other studies this trial was affected by the COVID-19 pandemic.
The planned statistical and health economics analyses for this trial are described, as well as the sensitivity analyses designed to assess the disruption caused by COVID-19. The trial treatment of at least 89 participants (33%) was disrupted due to the pandemic. To account for this, we have extended the trial to increase the sample size. We have identified four groups based on how participants' involvement in Physio4FMD was affected; A: 25 were unaffected; B: 134 received their trial treatment before the start of the COVID-19 pandemic and were followed up during the pandemic; C: 89 were recruited in early 2020 and had not received any randomised treatment before clinical services closed because of COVID-19; D: 88 participants were recruited after the trial was restarted in July 2021. The primary analysis will involve groups A, B and D. Regression analysis will be used to assess treatment effectiveness. We will conduct descriptive analyses for each of the groups identified and sensitivity regression analyses with participants from all groups, including group C, separately.
The COVID-19 mitigation strategy and analysis plans are designed to maintain the integrity of the trial while providing meaningful results.
ISRCTN56136713.
功能性运动障碍（FMD）是导致诸如虚弱和震颤等致残性神经症状的常见原因。Physio4FMD是一项务实的多中心单盲随机对照试验，旨在评估针对FMD的专科物理治疗的有效性和成本效益。与许多其他研究一样，该试验受到了新冠疫情的影响。
描述了该试验计划的统计和卫生经济学分析，以及旨在评估新冠疫情造成的干扰的敏感性分析。由于疫情，该试验至少89名参与者（33%）的治疗受到了干扰。为此，我们扩大了试验以增加样本量。我们根据参与者参与Physio4FMD的情况受到的影响确定了四组；A组：25人未受影响；B组：134人在新冠疫情开始前接受了试验治疗，并在疫情期间接受随访；C组：89人于2020年初招募，在因新冠疫情临床服务关闭前未接受任何随机治疗；D组：88名参与者在2021年7月试验重新启动后招募。主要分析将涉及A组、B组和D组。将使用回归分析来评估治疗效果。我们将对确定的每组进行描述性分析，并分别对包括C组在内的所有组的参与者进行敏感性回归分析。
新冠疫情缓解策略和分析计划旨在保持试验的完整性，同时提供有意义的结果。
ISRCTN56136713
