COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans
Introduction: 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 m...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423000704 |
| _version_ | 1797799953622368256 |
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| author | Louise Marston Marie Le Novere Federico Ricciardi Irwin Nazareth Alan Carson Mark Edwards Laura H. Goldstein Jonathan Marsden Hayley Noble Markus Reuber Jon Stone Rachael M. Hunter Glenn Nielsen |
| author_facet | Louise Marston Marie Le Novere Federico Ricciardi Irwin Nazareth Alan Carson Mark Edwards Laura H. Goldstein Jonathan Marsden Hayley Noble Markus Reuber Jon Stone Rachael M. Hunter Glenn Nielsen |
| author_sort | Louise Marston |
| collection | DOAJ |
| description | Introduction: 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. Methods: 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. Discussion: The COVID-19 mitigation strategy and analysis plans are designed to maintain the integrity of the trial while providing meaningful results. Trial registration: ISRCTN56136713. |
| first_indexed | 2024-03-13T04:27:21Z |
| format | Article |
| id | doaj.art-d2aa850c469d4636a531e4c66067b9c0 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-03-13T04:27:21Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-d2aa850c469d4636a531e4c66067b9c02023-06-20T04:20:17ZengElsevierContemporary Clinical Trials Communications2451-86542023-06-0133101124COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plansLouise Marston0Marie Le Novere1Federico Ricciardi2Irwin Nazareth3Alan Carson4Mark Edwards5Laura H. Goldstein6Jonathan Marsden7Hayley Noble8Markus Reuber9Jon Stone10Rachael M. Hunter11Glenn Nielsen12Department of Primary Care and Population Health, UCL, London, UK; Priment Clinical Trials Unit, UCL, London, UKDepartment of Primary Care and Population Health, UCL, London, UK; Priment Clinical Trials Unit, UCL, London, UKDepartment of Statistical Science, UCL, London, UKDepartment of Primary Care and Population Health, UCL, London, UK; Priment Clinical Trials Unit, UCL, London, UKCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, Edinburgh, UKNeurosciences Research Centre, Molecular and Clinical Sciences Research Institute, St George's, University of London, London, UKKing's College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, De Crespigny Park, London, UKSchool of Health Professions, University of Plymouth, Plymouth, UKNeurosciences Research Centre, Molecular and Clinical Sciences Research Institute, St George's, University of London, London, UKAcademic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Sheffield, UKCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, Edinburgh, UKDepartment of Primary Care and Population Health, UCL, London, UK; Priment Clinical Trials Unit, UCL, London, UKNeurosciences Research Centre, Molecular and Clinical Sciences Research Institute, St George's, University of London, London, UK; Corresponding author.Introduction: 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. Methods: 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. Discussion: The COVID-19 mitigation strategy and analysis plans are designed to maintain the integrity of the trial while providing meaningful results. Trial registration: ISRCTN56136713.http://www.sciencedirect.com/science/article/pii/S2451865423000704Randomised controlled trialCOVID-19Clinical trialStatisticsHealth economicsPhysiotherapy |
| spellingShingle | Louise Marston Marie Le Novere Federico Ricciardi Irwin Nazareth Alan Carson Mark Edwards Laura H. Goldstein Jonathan Marsden Hayley Noble Markus Reuber Jon Stone Rachael M. Hunter Glenn Nielsen COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans Contemporary Clinical Trials Communications Randomised controlled trial COVID-19 Clinical trial Statistics Health economics Physiotherapy |
| title | COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans |
| title_full | COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans |
| title_fullStr | COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans |
| title_full_unstemmed | COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans |
| title_short | COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans |
| title_sort | covid 19 and the physio4fmd trial impact mitigating strategies and analysis plans |
| topic | Randomised controlled trial COVID-19 Clinical trial Statistics Health economics Physiotherapy |
| url | http://www.sciencedirect.com/science/article/pii/S2451865423000704 |
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