Clinicians’ fidelity to intended use of point-of-care decision aids in randomized trials was suboptimal and suggests that those trials may have underestimated the efficacy of decision aids when used as intended. Alternatively, these findings challenge our assumptions of what are key components of effective decision aids and the role of decision aids in creating meaningful conversations that facilitate SDM.
The trials from which we drew the encounter videos used in this study all concluded that the tools were effective in promoting SDM, improving patient knowledge, and increasing patient involvement, at the current level of fidelity. Therefore, while fidelity to the intended use of decision aids may be important, it may not be completely necessary to achieve acceptable levels of SDM. Alternatively, other factors may be more important for facilitating high levels of SDM. However, we did observe that higher clinician fidelity was associated with important SDM outcomes, suggesting that more faithful implementation of the decision aids may lead to greater patient knowledge and increased involvement of the patient by the clinician regardless of the role other factors play. Alternative implementation strategies, including innovative approaches to training in SDM and further refinement of the decision aids may provide a means to increase SDM in this context.
Long lists of barriers and facilitators for SDM have been published [20, 21]. Key barriers include patient characteristics, the clinical situation, patient preferences, and time pressures, whereas key facilitators include clinician motivation, patient characteristics, and the practicality of SDM in the clinical context . Our trials have shown that many of these barriers fail to operate in the context of our decision aids, including concerns for time, lack of pertinence to the patients seen, and willingness to use (with 70% to 95% of patients and clinicians declaring interest in using the tools the next time they face a similar decision across our studies). Detailed analyses within the ‘black box’ of the clinical encounter, however, reveal how tenuous the unskilled implementation of decision aids can be and how much potential efficacy may not have been realized in our trials. While the fidelity checklist highlights several behaviors thought to facilitate SDM, including transfer of knowledge and facilitation of patient understanding of difficult concepts, it is relatively mute on other facilitators, such as clinician motivation, clinician interpersonal skills and patient characteristics. While these latter facilitators are challenging to quantify given their nature, they undoubtedly play a key role in facilitating SDM. Our analysis gave some insight into the role clinician bias can play as a barrier to SDM. Although not included in the calculation of the overall fidelity score, we observed that clinicians made recommendations to patients about the course of action to take in 46% of encounters, and 75% of these recommendations were not solicited by the patient. Although it is possible that some of these recommendations reflected a skillful synthesis of the patient’s stated values and preferences with the best available evidence, the video reviewers qualitatively noted that these recommendations usually appeared to reflect personal biases the clinician had implied earlier in the clinical consultation. Although clinician recommendations in the context of these trials may not put patients at risk for physical harm, given that there was clinical equipoise with respect to all of the included decisions, patients are harmed when they are not permitted to make decisions in keeping with their personal values and preferences. Therefore, while training interventions like those used in our decision aid trials may play a role in facilitating SDM by ensuring that certain steps are followed in the use of decision aids, SDM may yet reach its full potential through addressing more basic issues of interpersonal skills and motivation of the professional and the professional culture of SDM.
Although suboptimal, when considered in the context of the minimal training used with these decision aids, the observation that a mean fidelity score of 58% was observed in our trials should be considered a success. While higher fidelity scores appear to be associated with important outcomes and thus are optimal, we recognize that 100% fidelity may not be feasible for every clinical encounter. For instance, a clinician may be operating in a time-limited encounter and choose to focus on only the most pertinent aspects of the decision aid for the individual patient. Although imperfect implementation of our decision aids is not ideal, it is preferred to the alternative of the clinician making a paternalistic decision on behalf of the patient without consideration of their personal context. Alternatively, because a patient and clinician may have already discussed aspects of the patient’s care covered on the decision aid in previous discussions, a clinician may be able to forego certain aspects of the usage instructions included on the fidelity checklist. Our results did show a wide range of fidelity scores, suggesting that there are ‘bright spots’ where fidelity is perfect, and ‘dark spots’ where fidelity is zero. Further exploration of ‘bright spots’ and ‘dark spots’ may shed light on barriers and facilitators of optimal decision aid implementation. This analysis may reveal which aspects of training interventions should be emphasized and which are perhaps less important. Ultimately, while it is clear that the behaviors on the fidelity checklist are important for facilitating knowledge transfer and engagement of the patient, the role of other clinician behaviors in facilitating SDM remains unclear.
While there remain many definitions of shared decision making, all of which place variable emphasis on different clinician behaviors , we operationalize SDM in its most basic form as a conversation between the clinician and patient where the clinician brings knowledge based on the best available evidence and the patient brings his or her personal preferences, and the two are merged. We have shown that specific clinician behaviors included on the fidelity scale facilitate the one-way transfer of knowledge from clinician to patient and also serve to engage the patient in the clinical encounter, and therefore, these behaviors should be highlighted when decision aid use is demonstrated. However, our study leaves questions about other facilitators of SDM when decision aids are used, such as personal attributes of the clinician, explicit values clarification exercises, and the culture of the medical practice. It is also unclear what role patients might play in facilitating SDM, as our study only analyzed clinician behaviors. We have also only analyzed shared decision making in the context of decision aids, fully realizing that decision aids are not a prerequisite for SDM.
Our findings may justify an emphasis on the need for a patient-centered culture in which to frame SDM. While it is plausible that the unsolicited recommendations clinicians made in the context of these trials were offered according to the clinicians’ understanding of patients’ personal needs, values and preferences in accordance with SDM, our reviewers judged that the vast majority of unsolicited recommendations seemed to instead reflect the clinicians’ personal agendas. This finding, if replicated, would suggest that clinicians are still reluctant to let patients participate in decision making when the views of the patient might differ from those of the clinician . Together, poor clinician fidelity to the presentation of options with their pros and cons and failure to frame the discussion within the context of uncertainty about a clear ‘best’ course of action represent poor clinician uptake and implementation of core tenets of SDM.
An alternative implication of our findings is that the elements of decision aid use we thought were key are in fact not technically necessary to promote SDM, thus explaining the lack of correlation of fidelity with other trial outcomes. As explained above, the fidelity checklist only takes into account certain quantifiable behaviors, but other factors including interpersonal skills, motivation of the professional, and the professional culture certainly play a role. This questions the validity of the checklist as a standalone tool and more importantly of our assumptions about how decision aids work. Readers can directly judge the face validity of our fidelity checklist (see Additional file 1). Also, it may be important to debate whether all checklist items should carry the same weight or whether some items should be considered essential or given greater weight.
Given our findings, we invite the community conducting research on SDM to not leave the effects of their interventions on the clinical encounter within a ‘black box.’ It is evident that a simple checklist approach may contribute to the analysis of SDM intervention implementation, but more sophisticated video coding may yield greater insights. For instance, the fidelity checklist noted the presence or absence of behaviors, but did not note their duration or the sequence in which they manifested. Other video coding techniques may support these analyses and could be applied to the same recordings analyzed here and others as they accrue as part of the routine conduct of our work . If other groups were to also video record encounters – both intervention and control – we could conduct more comparative work and pool results, increasing precision and applicability.