Discussion
low initiation, CHIs
RECRUITMENT
The COVID pandemic has disrupted a large number of clinical trials across the translational spectrum, a reality that highlights the important issue of how to report modifications that occur in response to extenuating circumstances [The study team believed the FRAME was well-suited to our goal of characterizing modifications to the OPTIMIZE trial. First, FRAME recognizes that who participates in decisions about modifications is an important consideration. In the context of patient-centered research that is designed to inform end-users, engaging a diverse set of stakeholders in the decision-making to the greatest extent possible is essential. The COVID-related suspension of enrollment in our trial allowed the study team to engage with patients, providers, and health care leaders on our external advisory panel and incorporate their input into the ongoing process of determining our modifications.Engaging patients on our advisory panel helped clarify some of the reasons for lower-than-expected treatment initiation. Wide variation in insurance coverage for nonpharmacologic treatments for persons with cLBP is well-established [As the OPTIMIZE team identified these barriers to treatment, we had considerable discussions with representatives of the funder and stakeholders about appropriate modifications. These discussions focused on balancing considerations around pragmatically reflecting the reality that many persons referred to CHIs chose not to initiate treatment, with concerns that low initiation risked attenuating intervention effects [Our experience with our modifications to the recruitment process has been positive thus far. One year after resuming enrollment, the rate of treatment initiation into phase I improved from 65 to 71%, and for phase II, improved from 43 to 57%. Changes to the recruitment process and increased treatment initiation have also had a positive impact on rates of obtaining follow-up assessments as treatment discontinuation and loss-to-follow-up are known to be related [An important consideration highlighted by FRAME and consistent with PCORI methodologic standards is the relationship between modifications and intervention fidelity [The study team discussed standardizing delivery (in-person or telehealth) for all CHIs in the trial (PT, CBT, and MORE). This option would have preserved consistency in the form of CHI delivery, which is appealing in more explanatory trials or with less complex interventions [Prior to the COVID pandemic, there was a considerable discussion around standards for transparent reporting of modifications of study interventions due to anticipated or unanticipated factors for CER and pragmatic studies [