Article type
Abstract
Background: Implementing trials in partnerships with government, consumers, and healthcare partners pose challenges for implementation and effective translation of the evidence. The COVID-19 pandemic has also caused wide-spread disruptions to the conduct of randomised controlled trials (RCTs), particularly those involving public health services.
Objectives: Using the NHMRC-funded Get Back to Healthy partnership trial as an example, this study aimed to contextualise the challenges on implementation of RCTs involving public health services in Australia, summarise the effect of common and novel contingency strategies employed to mitigate these challenges (including COVID-19), and describe key lessons learned.
Methods: The NHMRC-funded Get Back to Healthy partnership trial was co-designed with consumers (Musculoskeletal Australia) suffering from low back pain, health services (NSW Health), and major local health districts (Sydney, Southwestern, Western Local health Districts). Recruitment has been completed, and the main challenges, the effect of contingency strategies employed, and key lessons learned were summarised descriptively.
Results: The main COVID-19-related challenge affected recruitment due to the suspension of clinical services for the trial target population. This challenge has been addressed through carefully considered adjustments to trial design (i.e., expanding the trial eligibility criteria), which markedly improved trial recruitment rates. Other challenges include the rapid transition to remote consent and data collection methods, increased complexity of monitoring participant safety, and future statistical challenges with disentangling the impact of the COVID-19 pandemic from treatment effects. The key lessons learned are: (i) adaptations to trial design may be necessary (and hence the use of adaptive designs); (ii) offering remote methods may encourage trial participation from all age groups; (iii) enhanced monitoring of safety; (iv) statistical challenges are likely to occur and should be considered when interpreting trial results.
Conclusion: Key lessons learned in the implementation of large, government funded, partnership trials that involve consumers, and large healthcare organisations may be useful for informing the conduct of resilient RCTs, particularly those involving public health services, in the present and future, and inform effective translation of findings for patients, clinicians, and policy makers.
Objectives: Using the NHMRC-funded Get Back to Healthy partnership trial as an example, this study aimed to contextualise the challenges on implementation of RCTs involving public health services in Australia, summarise the effect of common and novel contingency strategies employed to mitigate these challenges (including COVID-19), and describe key lessons learned.
Methods: The NHMRC-funded Get Back to Healthy partnership trial was co-designed with consumers (Musculoskeletal Australia) suffering from low back pain, health services (NSW Health), and major local health districts (Sydney, Southwestern, Western Local health Districts). Recruitment has been completed, and the main challenges, the effect of contingency strategies employed, and key lessons learned were summarised descriptively.
Results: The main COVID-19-related challenge affected recruitment due to the suspension of clinical services for the trial target population. This challenge has been addressed through carefully considered adjustments to trial design (i.e., expanding the trial eligibility criteria), which markedly improved trial recruitment rates. Other challenges include the rapid transition to remote consent and data collection methods, increased complexity of monitoring participant safety, and future statistical challenges with disentangling the impact of the COVID-19 pandemic from treatment effects. The key lessons learned are: (i) adaptations to trial design may be necessary (and hence the use of adaptive designs); (ii) offering remote methods may encourage trial participation from all age groups; (iii) enhanced monitoring of safety; (iv) statistical challenges are likely to occur and should be considered when interpreting trial results.
Conclusion: Key lessons learned in the implementation of large, government funded, partnership trials that involve consumers, and large healthcare organisations may be useful for informing the conduct of resilient RCTs, particularly those involving public health services, in the present and future, and inform effective translation of findings for patients, clinicians, and policy makers.