The impact of COVID-19 on musculoskeletal clinical trials

The impact of COVID-19 on musculoskeletal clinical trials: Results from an ANZMUSC survey.

Ferreira G, Zadro J, O’Keefe M, Maher C, Buchbinder R, Latimer J (2020).

 

Background: The COVID-19 pandemic has greatly impacted the work of researchers globally including in the field of musculoskeletal research. With that in mind, ANZMUSC sought to understand the impact of the COVID-19 pandemic on researchers and their clinical trials within the musculoskeletal field across Australia and New Zealand.

Methods: ANZMUSC sent a survey to all its members (n = 388) in June 2020, with two subsequent reminders in July and August, inviting members to provide information on the impact of the pandemic on their research. Members were eligible if they were investigators in a randomised controlled trial that had been recruiting immediately before the pandemic began, or had planned to start recruiting shortly before the pandemic began. The survey included questions about (i) the impact of the COVID-19 pandemic on their professional and research life, and (ii) the number of trials on which the respondent was a named investigator. Other questions included whether the pandemic had impacted (iii) recruitment, (iv) funding, (v) staff, or (vi) data collection in the trials they were investigators for, and (vii) whether protocol modifications to existing trials had been made because of the COVID-19 pandemic. Data were described as frequencies and proportions. 

Main findings: We obtained a total of 109 responses (response rate: 21%). Respondents were from seventeen institutions across Australia and New Zealand. Respondents were investigators in over 40 trials. Sixty-one percent of respondents said their professional life and/or research work had been impacted by the COVID-19 pandemic. Eighty-two percent of respondents said trial recruitment had been impacted, 31% said funding had been impacted, 62% said staff had been impacted, 67% said data collection had been impacted, and 57% said modifications to trial protocols had to be made due to the COVID-19 pandemic. 

Reasons that impacted recruitment included: cancelation of elective surgery, recruitment being terminated at Universities, GPs being too busy to recruit. Reasons that impacted funding included: continuing to pay staff salary despite recruitment having been halted, uncertainty about whether funding schemes were going to extend the timeline for access to funding, funders freezing funding, and the impossibility of extending grants.

The COVID-19 pandemic affected different members of staff, including clinicians, research assistants, PhD students, and Postdoctoral fellows. Concerns with delays to submit PhD theses and achieve fellowship milestones were voiced by respondents. Some clinicians had to go back to clinical /teaching roles due to lack of research activity. An important shift in duties was noted by some research staff to focus on activities that could be conducted remotely. 

Reasons that impacted data collection include prohibited face to face contact with participants and hospital equipment not being available for research purposes. The consequences of those impacts included the inability to collect data for several participants, a need to replace traditional data collection routines with alternative, less reliable ones. Common reasons that led to trial protocols being changed included stopping recruitment and shifting treatment, when possible, from in-person appointments to telehealth.

Implications: The COVID-19 pandemic has negatively impacted the conduct of clinical trials within the musculoskeletal field across Australia and New Zealand. The results provide preliminary evidence that important musculoskeletal clinical trials designed to answer the most pressing clinical questions in the field, have been/will be affected by the COVID-19 pandemic. In some instances, if further support is not provided, practice changing clinical trials may be abandoned or the results biased by small sample sizes and insufficient power to find an effect.

 

A letter Challenges faced by musculoskeletal health research in Australia and New Zealand due to the COVID‐19 pandemic was also published in the Internal Medicine Journal (IMJ) here.