Reply to Janaudis-Ferreira et al.: One Step at a Time: A Phased Approach to Behavioral Treatment Development in Pulmonary Rehabilitation

From the Authors:

We thank Janaudis-Ferreira and colleagues for their interest in our randomized controlled trial (1) and their important contribution to the debate surrounding strategies to improve uptake of posthospitalization pulmonary rehabilitation. They make some salient points and we appreciate the opportunity to respond.

Janaudis-Ferreira and colleagues emphasize the importance of a progressive and systematic framework to guide the development of an intervention, citing the Obesity-related Behavioral Intervention Trials (ORBIT) model developed by the NIH. In particular, they express concern that we paid insufficient attention to the development of the intervention before we conducted a randomized controlled trial.

Our team included experienced mixed-methods, qualitative, and implementation science researchers, as well as a patient and public involvement group. For details regarding the development of the intervention, we refer readers to the online supplement of our work (1). In summary, we used a methodology known as experience-based codesign (EBCD), which provides a framework whereby stakeholders (primarily patients and staff) can feel empowered and work together to improve experiences for patients and their families, as well as staff.

For those unfamiliar with EBCD, there are parallels to the ORBIT model and other frameworks for developing complex interventions. Following our original observation that there were low referral and uptake rates (2) for posthospitalization pulmonary rehabilitation even though it is an evidence-based and highly effective intervention (3), we conducted video-recorded qualitative interviews with patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease (COPD) and the hospital healthcare staff responsible for their care. Patients reported that little information about pulmonary rehabilitation was provided at the time of hospital discharge. Members of the healthcare staff described having limited personal knowledge about and experience with pulmonary rehabilitation and noted that time pressure was a barrier to providing information to patients. Clips from these videos, illustrating the key themes and experiences (known as “touch-points”), were subsequently combined and edited to produce a touch-points video. This edited video was then played at three key stakeholder feedback events: one for patients, one for healthcare professionals, and one for both patients and healthcare professionals. The priority that resulted from these stakeholder events was to develop an education package that would allow previous patients to tell prospective patients about the benefits of pulmonary rehabilitation in a visual manner that could be delivered without significantly affecting staff time. Codesign meetings were held to develop the intervention (creation and filming of the video) and to determine how and at which point in the patient pathway it would be delivered.

A feasibility study was conducted to compare delivery of the video via tablet computer with delivery of the video via patient bedside television systems. The latter was not taken forward owing to patients’ difficulties with accessing the video and the nonuniversal availability of bedside systems. During the feasibility study, both patients and staff found the video delivered by the tablet video to be acceptable and feasible, and we were able to estimate likely recruitment rates and the feasibility of the outcome measures. We also refined the delivery of the intervention to keep researchers blinded to treatment allocation. The development of the intervention and conduct of the feasibility study occurred between 2011 and 2015, equivalent to phases 1 and 2 of the ORBIT methodology. Our recently published randomized controlled trial (1) is the equivalent of ORBIT phase 3 (conducting an efficacy trial).

Janaudis-Ferreira and colleagues speculate that if we had used the ORBIT model to develop the intervention, we would have had the opportunity to strengthen the behavioral component of the intervention with a view to making it more effective. As we acknowledged in our paper, there were several reasons why the video may have not had an adjunctive effect over standard care (delivery of a COPD discharge bundle), including the lack of an added counseling element. However, during the EBCD process, stakeholders (patients and staff) appreciated that a priority for the intervention was that it should be low cost (with staff time being the most expensive component of behavioral interventions) and easily implementable.

We note recent work from the team of Drs. Bourbeau and Janaudis-Ferreria in which they tested a pulmonary rehabilitation taster session for patients hospitalized with acute exacerbation of COPD (4). Although they used the ORBIT methodology, the intervention they developed was only acceptable to six out of 31 patients (19%) (4). Furthermore, they largely used a quantitative approach to assess the feasibility, acceptability, and safety of their intervention. We propose that had Janaudis-Ferreria and colleagues incorporated a qualitative methodology such as EBCD (which empowers patients and other stakeholders to codesign an intervention), they might have produced a more patient-friendly and feasible intervention that could be evaluated in an efficacy trial.