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Randell R, Honey S, Hindmarsh J, et al. A realist process evaluation of robot-assisted surgery: integration into routine practice and impacts on communication, collaboration and decision-making. Southampton (UK): NIHR Journals Library; 2017 Jun. (Health Services and Delivery Research, No. 5.20.)
A realist process evaluation of robot-assisted surgery: integration into routine practice and impacts on communication, collaboration and decision-making.
Show detailsOverview
This chapter presents the first part of phase 1 of our study, a review of the literature undertaken to refine and add to the candidate theories established from the academic literature that were presented in Chapter 3. The review focused on identification of stakeholders’ theories, looking at grey literature, opinion pieces, letters, editorials and the discussion sections of quantitative studies of RAS, which contained ideas and assumptions regarding how RAS might successfully be introduced and how it might impact on communication and decision-making.
Overview of search results
The search retrieved 485 references. Twenty-seven were systematic reviews of studies of colorectal RAS, 159 were systematic reviews of studies of RAS, either of surgical specialties beyond colorectal surgery or not restricted to a particular specialty, 121 were individual studies of colorectal RAS and 178 were editorials or commentaries. These were evaluated together with 188 websites. Two hundred and twenty-eight papers, made up of 22 systematic reviews of colorectal RAS, 94 other systematic reviews of RAS, 37 individual studies of colorectal RAS and 75 editorials or commentaries, were identified as relevant, along with 34 websites. There was considerable repetition of theories across the sources we identified.
Findings
Issues of implementation
The robot-assisted surgery implementation chain
The term ‘implementation chain’ is used to refer to the series of interconnected processes through which an intervention is introduced and delivered to produce immediate and intermediate outcomes and ultimate impacts (both short and long term). The introduction of complex interventions into practice typically involves long implementation chains, influenced by stakeholders at different levels within and beyond the organisation.50 The way in which an intervention is implemented across different settings is likely to vary, affecting the ultimate impacts of that intervention and often leading to unintended consequences.50,143 Thus, it is recommended that, both within realist reviews and prior to entering the field as part of a realist evaluation, the implementation chain of an intervention is mapped, identifying which intermediate outcomes need to occur in order to create the context for positive final outcomes, as well as examining the blockages to effective implementation and the contexts that support the flow of implementation.50,52 Our intention was not to look at the evolution of RAS as a technology over time. Rather, our interest was in the implementation chain from the point at which the purchasing of a surgical robot by a hospital is considered as an option to the point at which RAS is used on a routine basis in that hospital.
The review revealed a number of decision points in the implementation chain of RAS, which are summarised in Figure 3. The first decision is the decision of whether or not to purchase a da Vinci robot, and there appeared to be a number of stakeholders involved in this decision. In most studies that described the introduction of RAS, this had been led by surgeons. However, also involved was whoever would be paying for the initial purchase of the robot (in many NHS trusts, some or all of the funds came from the hospital’s local charity16) and whoever would be paying the ongoing costs associated with RAS.
For the surgeons, a number of motivations for the introduction of RAS were described. The theory, promoted by Intuitive Surgical, that the increased precision and control RAS offers the surgeon will result in improved patient outcomes was reiterated in many papers. In robot-assisted colorectal surgery, rates of conversion to open surgery are generally found to be low, providing support for this theory144–146 (although, with such studies being non-randomised and authored by RAS enthusiasts, this could be due to case selection). Another motivation was the ergonomic benefits that the robot is anticipated to offer to the surgeon. With the surgeon using natural hand movements147 and sitting at the console,148 the awkward and unnatural positions often required during laparoscopy are removed. This suggests motivation to undertake RAS would be greater among those surgeons who were familiar with Intuitive Surgical’s marketing of the da Vinci robot and/or the published literature on the clinical and ergonomic benefits of RAS. RAS also was seen as a way of providing more patients with the benefits of minimally invasive surgery, being easier to learn than laparoscopy,149,150 suggesting that the motivation to undertake RAS would be greater in those surgical specialties for which laparoscopic surgery was found to be harder and/or among those surgeons who had struggled to adapt to laparoscopic surgery. Surgeons’ natural interest in the development of new tools was also seen as a contextual factor supporting the growth of RAS.151
At the organisational level, the drivers behind and contextual factors influencing the decision to support the purchase of a robot were less clear, although a couple of benefits for the organisation were identified. For example, RAS was perceived as attractive to surgical trainees, so a hospital may support the decision if ownership of a da Vinci robot was seen as a way to attract the best trainees,15,152 or as a way of attracting highly trained surgeons who already have experience of RAS.16 The importance of surgeons obtaining the support of the hospital administration and nursing management was emphasised. This support was necessary not only for the initial purchase of the robot but also to ensure the provision of adequate resources while staff are on the learning curve, such as additional OT time.152,153 How to obtain this support was not explicated, although one report described the need to create a ‘shared vision’ of what the introduction of RAS would enable, starting with the administrators.154 The underlying theory seems to be that, by being engaged in this process of imagining potential future benefits of RAS, the hospital administration and nursing management will perceive RAS as an innovation that can assist in achieving the organisation’s goals and so will be willing to invest the necessary resources to assist its integration into routine practice.
A contextual factor that appeared to influence the decision-making of both surgeons and administrators was the attitude of patients and the public to RAS. Intuitive Surgical’s marketing of the da Vinci robot has been characterised as aggressive151 and in the USA it has included direct-to-patient advertising on billboards and the internet,155 with the result that RAS has become a symbol of providing enhanced care.151 In the context of competition among surgeons and hospitals, this perception of RAS among patients and the public is seen as a significant factor in the rapid growth in the purchase of da Vinci robots.151 This creates a cycle in which, having purchased a robot and wanting to maximise its use, surgeons and hospitals promote RAS to patients, further increasing public enthusiasm for RAS.150 This promotion of RAS by surgeons and hospitals is not unique to the USA; a number of NHS trust websites were found to promote the benefits of RAS, particularly in relation to prostate cancer, emphasising the advanced, cutting-edge technology and the high cost of the system, with some trust websites describing hospital open days during which members of the public could see and try the robot. Furthermore, the presence of a robot was seen as a means of ‘raising the profile’ of a trust and enabling it to attract patients from ‘elsewhere’ (presumably outside the local catchment area), thus increasing patient volume within the trust.156
The decision to buy a robot includes a decision about what model of da Vinci robot to purchase, and this appeared to be a decision with implications for the subsequent integration of RAS into practice, including the feasibility of using the robot for particular operations. To date, there have been five different models of the da Vinci robot in use: standard, S, S HD, Si HD and Xi. The standard da Vinci, introduced in 1999, has been discontinued, and technical support in terms of the availability of parts and services stopped in 2014.157 The larger size of the standard da Vinci compared with later models potentially increases the likelihood of external collision of the robotic arms and also makes it more difficult to manoeuvre. The increased likelihood of collision of the robotic arms and the shorter arms have been cited as reasons why rectal cancer resections must be performed as hybrid operations when using the standard system.157
Following the decision to purchase a robot, presumably led by a particular surgical specialty, there is then the decision about which (other) surgical specialties the robot should be used for. In many NHS trusts, RAS was initially introduced in urology, for undertaking radical prostatectomy for prostate cancer.16 The advantages of RAS seem to apply especially to procedures carried out in the pelvis or rectum because surgeons are operating in limited space, where laparoscopic surgery may be difficult.144,158
Alongside decisions about who will be using RAS are decisions about what training the surgeons and OT teams should receive, although who was involved in such decisions and what influenced the decisions was not reported in the studies. The studies we reviewed described a number of features of RAS surgeons have to become familiar with: the procedure of docking the robot, including the set-up of the robotic arms; how to control the robot and troubleshoot; how to deal with the absence of tactile information; and how to mentally visualise the spatial relationships of the robotic arms, to minimise external clashing of robotic arms and to optimise manoeuvrability and range of motion.159–162 Training provided for surgeons by Intuitive Surgical was reported to consist of a two-day course with practice in an animal laboratory, but without performance-based end points or verification of skill, leading some to argue that it is an ‘antiquated educational method’ that should be replaced by carefully structured standardised simulator curricula.163 Intuitive Surgical has since introduced online training modules and there is a simulator curriculum that can be undertaken on the robot itself.
In relation to training for the rest of the team, a well-trained team was described as necessary to ensure the smooth running of a robot-assisted operation.147 The scrub practitioner and circulating practitioner need to acquire new skills and need to learn their part in draping and docking the robot, how to change instruments, and troubleshooting.164,165 The first assistant will need to learn all of this, as well as have an understanding of basic laparoscopic surgery. Specific training for first assistants, involving dry-laboratory training, personal instruction sessions, videos and surgery observation, was described.166 Although studies occasionally talked of theatre nurses participating in training,167 generally there was little mention of training for the wider OT team.
Following on from this is the decision of which operations to use the robot for and on which patients, a decision typically made by the consultant surgeon. This is not a one-off decision but one that is likely to evolve over time as a surgeon’s experience with RAS increases. Some authors recommended starting with more straightforward procedures and then gradually moving to increasingly difficult procedures,167 the underlying theory seeming to be that, by gaining experience with simpler procedures, the surgeon builds up his or her skills, providing him or her with both the skills and the confidence to be able to take on more challenging procedures. A contextual factor that influences the decision of whether or not to undertake an operation with robot assistance is the patient condition, as the longer operation duration of RAS (discussed below) may be prohibitive in certain patients, although it can be difficult to assess who those patients are.168 Another contextual factor that influences the decision is the anticipated benefit, which is based on the details of the operation to be performed and characteristics of the patient. For example, in the context of rectal cancer surgery, maximum benefit was reported to be expected in cases involving mid to lower rectal cancer, male patients (due to the narrower pelvises), obese patients and patients who have had preoperative chemoradiation therapy.169,170
Alongside this are decisions about how to undertake a particular operation with the robot, again a decision typically undertaken by the consultant surgeon and again not a one-off decision but one likely to evolve over time. For example, in robot-assisted rectal cancer surgery, there is no standardised technique and the decision has to be made whether to perform it as a hybrid operation or totally robot assisted.171 As noted above, this decision will be influenced by the model of robot the hospital has acquired. However, there are also other factors that influence the decision. Performing a hybrid operation removes the need to redock the robot, which can add to the duration of the operation,171 and thus the decision may be influenced by concerns about time. This ties in with concerns about the patient condition; if patient factors mean that the operation is likely to be difficult and require considerable time, a hybrid operation is more likely. Experience seems to be an important contextual factor that influences surgeons’ decisions about how to perform an operation. For example, it has been suggested that, for surgeons experienced in laparoscopic surgery, a hybrid approach is preferable, as their increased experience will mean that they feel more comfortable carrying out the first phase of the operation that way,171,172 while a totally robot-assisted procedure may be preferable for surgeons who have less experience of laparoscopic surgery, despite the need to redock.173 Another decision relates to the positioning of the ports through which the instruments are inserted, and some authors described not wanting to follow the layouts suggested by other surgeons experienced in RAS because they wanted to adapt the positioning they used for laparoscopic operations, again presumably wanting to build on their existing experience.167
The challenges of robot-assisted surgery
Despite the various motivations for undertaking RAS, it was perceived to introduce its own challenges. For example, surgeons’ reports of the experience of RAS described how the bulk of the robot made it difficult to manoeuvre,152,153 although, as described above, the extent of this challenge will depend on the model of robot. In some review articles, authors argued that the difficulty of moving the robot represents a patient safety issue if prompt conversion to open surgery becomes necessary so that the robot needs to be moved out of the way,158,174 although whether this had caused problems in practice was unclear. This challenge may reduce the willingness of surgeons to undertake RAS, particularly for multiquadrant operations that require the robot to be repositioned during the operation.
Another challenge was that RAS had been found to extend operation duration. Not only does this increase costs by increasing staff and OT time but some authors argued that it can put patients at risk from complications caused by being under anaesthesia for longer.170 We identified conflicting theories about how RAS increases operation duration. Some authors argued that it is due to the time required to set up and dock the robot.144,175 Others pointed to the time required to reposition and redock the robot during multiquadrant operations.171,176 Yet others pointed to a longer operative time, perceived as being due to collisions of the robotic arms, itself a consequence of lack of experience with proper positioning of the robotic ports.169 It has also been argued that longer operation duration is related to the lack of tactile information, leading surgeons to move more slowly because they have to rely on visual information only.177 However, one study found no difference in overall duration because, although the set-up time was significantly longer, this was balanced out by a significantly shorter operative time, which the authors argued was due to the technical advantages that the robot provides to the surgeon.178 Given the high cost of purchasing and maintaining a robotic system, minimising additional costs associated with increased operation duration was perceived by some as essential for ensuring that RAS is integrated into routine practice.147,179
Overall, there was broad agreement in the perception that operation duration decreases as experience increases, with this often being attributed to a decrease in set-up time.145,147,180 Thus, the underlying theory is that when the team is experienced and well trained, their knowledge and experience enables them to quickly undertake the tasks required for setting up the robot. With experience, surgeons have reported that they find visual cues sufficient for estimating the tension exerted on the tissue.172 As familiarity with positioning the robot increases, there should be fewer collisions of the robotic arms, also helping to reduce operation duration.169
Several strategies were reported that might reduce operation duration by accelerating the acquisition of experience. One strategy was to have a dedicated robotic team114–116,152,154,170,181–183 that can ‘work through the learning curve and, if possible, all robotic cases’.164 The underlying theory is that by working through all robot-assisted cases, the team more quickly becomes familiar and confident with the equipment and tasks associated with setting up the robot, allowing team members to complete the necessary tasks more quickly, reducing set-up time. Although typically discussed in relation to the surgeon’s learning curve,184 the theory suggests that the number and frequency of robot-assisted operations that take place within the organisation are contextual factors that impact the effectiveness of this strategy. Other contextual factors described were the level of motivation154 and stability of the team.113 Thus, a team that is not motivated may work through the robot-assisted operations but not engage with them as an opportunity to learn and, consequently, the increased experience of RAS may not translate into increased efficiency in robot set-up.
A number of surgeons also recommended having a dedicated robotic OT,152,185 so that the bulky robot does not need to be moved between OTs, reducing the time spent setting up and putting away the robot and thereby reducing the overall operation duration.
Impact of robot-assisted surgery on communication and teamwork
Reporting on their experience of undertaking RAS, surgeons described how the physical separation of the surgeon from the rest of the team and the lack of visual contact make it harder for the team to hear the surgeon’s oral instructions,152 particularly if the surgeon becomes immersed in the console.154 Consequently, it has been suggested the team needs to listen more carefully,152 again implying the need for a motivated team. There is a perception that, if the team does not respond in this way, communication is compromised.152,158 Although the consequences of this were not explicated in the literature we reviewed, one consequence may be a further increase in operation duration, as communication failure is known to be a significant predictor of deviation in expected length of operation.186 The use of directional cues is considered to be problematic in RAS, potentially resulting in confusion, time-wasting and patient injury.164 This problem occurs, presumably, because the separation means that team members do not have the same physical context as the surgeon to understand such deictic instructions and, again, the surgeon is unable to support those instructions with gestures.
The impact of RAS on communication between the surgeon and the first assistant was another area in which we found conflicting theories. Some authors argued that communication between the surgeon and first assistant is particularly important in RAS, especially during instrument exchanges, when failure in communication could lead to ‘inadvertent adjustment, movement and complete removal of an instrument that is in use’.164 However, it has also been argued that less co-ordination and communication may be required between the surgeon and the first assistant because the surgeon controls the camera and, if four robotic arms are used, can do more of the retraction (instead of this being done by the first assistant).157,187
Strategies for overcoming the communication challenges focused on the use of standardised communication. The use of ‘readback’, in which team members repeat back instructions in a precise, clear, standardised manner, has been advocated, particularly for instrument exchanges and other key transition points.154 This allows the surgeon to check that his or her instructions have been heard correctly (remembering that, being in the console, they are unable to draw on visual cues to determine this) and, if not, to correct any misunderstandings before they result in actions that could have negative consequences for the patient. The use of agreed terms has been recommended for RAS.164 The use of anatomic or OT references by the surgeon, rather than directional cues, has been recommended while moving the patient or robot during docking, again to reduce the risk of misunderstandings.164
The impact of robot-assisted surgery on decision-making
There were competing theories in the literature concerning the impact of RAS on decision-making. Some surgeons reported a ‘tendency for surgeons to bury themselves in the console’, with surgeons ‘block[ing] out the operating room’.154 This suggests a reduction in the surgeon’s situational awareness. Some surgeons recommended positioning the console so that the surgeon has a clear view of the patient and can immediately see the patient when looking up from the console.164
There may be beneficial impacts of RAS on surgeon decision-making. It has been argued that, immersed in the console, the surgeon’s ‘distractibility’ is reduced, which could potentially have a positive impact on patient outcomes.188 This is supported by recent research that reveals that the number of intraoperative interruptions is significantly associated with surgeons’ experienced distraction, and interruptions in the form of case-irrelevant communication in particular are linked to increased surgeon distraction.189 Others suggest that the 3D image creates a sense of immersion, which presumably contributes to reduced distractibility.190
Robot-assisted surgery may also impact on surgeon decision-making by reducing the surgeon’s level of stress. Some surgeons have argued that stress arising from a difficult operation may lead a surgeon to decide to convert from laparoscopic surgery to open surgery.171 By removing the awkward and unnatural movements required during laparoscopy191 and enabling the surgeon to sit comfortably at the console,148 RAS reduces physical discomfort.192 This leads to the theory that, owing to the ergonomic benefits of RAS, surgeon stress is reduced, which may influence the decision of whether to convert, potentially resulting in a lower rate of conversion.171
Robot-assisted surgery also impacts on surgeon decision-making by changing the ability of the surgeon to use tactile perception to determine anatomic information. This is considered to be a major limitation of RAS.193 A significant contextual factor here is the surgeon’s experience, with surgeons finding visual information sufficient for informing their decision-making as their experience of RAS increases.172
Summary
Our review revealed the series of decisions made in the process of introducing RAS and the series of challenges that need to be overcome if RAS is to be successfully integrated into practice. OT teams have responded by developing creative solutions to mitigate, address or work around the challenges of RAS. Many of the quantitative studies of RAS included in the review were small case series (descriptive non-randomised studies) undertaken within a single institution and thus our review adds to the existing literature by drawing together and finding patterns in the experiences of multiple OT teams.
Table 6 summarises as CMO configurations the theories at the end of the review (to enable the reader to track how the theories develop over the course of the study, the theories are labelled and numbered, with I for theories relating to implementation, T for theories relating to communication and teamwork, and D for theories relating to decision-making). Following Dalkin et al.,55 we separate out resources and reasoning within the mechanism, drawing attention to the particular resources provided or taken away by RAS.
In relation to implementation, the review introduced a new theory regarding organisational support. However, with the majority of studies and reviews being authored by surgeons, what was not clear was the extent to which the broader OT team was engaged in the process of implementation and was encouraged to identify benefits of the technology, despite the motivation of the team appearing to be an important contextual factor in strategies designed to support the integration of RAS. Therefore, this candidate theory was taken forward to the interviews for further exploration and refinement.
Theories I3 and I4 describe strategies for overcoming the challenge associated with RAS of increased operation duration, so we present these strategies as the resource. What is clear from considering these theories is that, although discussion of context in realist evaluation is typically concerned with the contexts that determine whether or not a strategy is effective, there are contextual factors that determine if introducing the strategies is feasible. This includes the support of hospital administration and nursing management, to agree to the creation of a dedicated robotic OT and to facilitate the scheduling of rotas to enable a robotic team to develop. Also important are the financial and material resources of the hospital; the feasibility of having a dedicated OT depends on the availability of OTs and the frequency of robot-assisted operations.
A topic relating to implementation raised by the review, but on which there was not enough information contained in the papers retrieved by our search strategies to develop a theory, was that of training in RAS needed by the OT team. Given time constraints, rather than returning to the literature to carry out further searching, we took this forward as an idea to be explored in the interviews.
The review identified less literature concerned with the impact of RAS on communication and decision-making in the OT. However, the findings of the review suggest that RAS can hinder communication. This is due to the physical separation of the surgeon from the rest of the team, which makes it harder for the team to hear the surgeon’s requests. What was not clear were the consequences of this. Therefore, rather than having a specific theory to take forward for refinement in the interviews, we took this forward as an idea for exploration in the interviews, drawing on the substantive theories introduced in Chapter 3 relating to communication and teamwork to provide prompts. Similarly, the findings of the review in relation to co-ordination between the surgeon and the first assistant – whether more or less co-ordination was required – could not be clearly articulated as a realist theory, owing to the absence of information about the contexts in which, and the mechanisms through which, co-ordination would be achieved, so again this was taken forward as a topic for exploration in the interviews. Having not identified information within the review to support their refinement, the candidate theories ‘co-ordination’ and ‘training’ were taken forward to the interviews as they were. Formatting these theories as CMO configurations highlighted gaps in our understanding regarding the contexts in which these challenges would be experienced, gaps that we sought to fill in the interviews.
In relation to decision-making, we started the review with one candidate theory, ‘situational awareness’. The findings of the review supported this theory, but also highlighted variation in the extent to which surgeons remain within the console, which would impact the need for the team to orally communicate information. The review also introduced a number of new theories regarding the impact of RAS on decision-making. What was not clear from the review were the contexts in which the ergonomics of the console could be expected to trigger a decrease in stress and tiredness, a gap in our understanding that we sought to explore during the interviews.
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