A PERENNIAL AND AN EMERGING PROBLEM

The introduction of any new technology into hospitals is a perennial problem, as it is in institutions generally. However, when looking at a specific, advanced technology being introduced to a particular hospital, it can be seen as a process of an emerging problem. The problem is initially for that hospital, but it has wider implications. The wider implications involve policy at state and federal levels for both the public and private health sectors. The health professions, in particular medicine and nursing with their key interests, experience pressures in their practice and conflict with others in the same professions, and testing of the boundaries of existing hospital practice and policy. Hospital infrastructure is often traditional and somewhat inflexible, and has not necessarily accommodated the requisite changes to make the techniques and/or procedures the best possible for the patient to provide for a speedy return to health and to be discharged into the community.

Robotically supported techniques were introduced in March 2004 into Australia. Introduction was initially only into the private sector and in the two distinct areas of urology (prostate surgery) and cardiac surgery (mitral valve surgery). There are now three institutions in Australia that have access to robotic technology. While this chapter focuses predominantly on the use of robotics in prostate surgery reference is also made to cardiac surgery. The main discussion is the interplay between the interests involved and the movement, which is considered to be the transition of the patient through the hospital and ultimately to discharge into the community. The problem at this level is that there is a new advanced technique for prostate surgery (a medical interest), but complementary ward plans and procedures are yet to be developed and implemented (particularly a nursing interest). The implementation is required to adapt current nursing care to this new technology and to the ‘new’ patients with special needs across several hospital locations including intensive care (relevant for cardiac patients) and the general ward and in subsequent policies for discharge into the community.

The context for the discussion is the emphasis since the early 1980s on economic rationalism and managerialism in the health sector, which has as its components cost saving, efficiency, decreased length of stay, enhanced throughput, diagnosis-related groups (DRGs, as a means of categorising like groups of diseases), and effectiveness of outcomes. The use of robotics in prostate surgery demonstrates an emerging problem in much more than its technical novelty. It has implications for future federal government planning; the Australian Health Ministers’ Advisory Council (AHMAC) has identified cancer as a National Health Priority Area (NHPA). In addition, the National Health and Medical Research Council (NHMRC) has identified a range of health issues that are deemed to be important in the timeframe of the NHMRC Strategic Plan 2003–2006. The implications of an ageing Australian population on healthcare resources has resulted in ageing-related research being recognised as a high priority for the NHMRC (NHMRC 2003).

THE ROBOT

The word ‘robot’ comes from the Czech word robota, meaning forced labour, and is defined as a computer-controlled, reprogrammable mechanical device that is equipped with actuators and sensors (Camarillo et al. 2004). Robot development began in the 1940s with the initial intention of using them to manipulate hazardous items from a safe distance. Their use then extended to agriculture, the military, space and oceanographic exploration, and education. There has, however, been a slow crossover of the use of robotics into the field of medicine (Lanfranco et al. 2004). Robotic-assisted surgical techniques are proliferating rapidly across the world and have been reported predominantly, but not exclusively, in the past 8 years as being used for urological, abdominal and cardiac surgical procedures.

The evolution of robots into the surgical arena was due largely to the progression of, and subsequent difficulties associated with, minimally invasive surgical techniques (Darzi & Munz 2004). Minimally invasive (MIV) surgery involves passing instruments and viewing equipment through small incisions to the surgical site. Long manipulators are used to perform surgical procedures with manual guidance. While MIV surgery has many advantages, substantial difficulties associated with the procedure, such as poor touch feedback, loss of 3-dimensional vision and poor ergonomics of the tools, have all been reported (Camarillo et al. 2004, Hemal & Menon 2004) making it a difficult technique for the operator to master (Menon et al. 2003). To overcome this, the clinical introduction of robotic systems, such as the teleoperated da Vinci system, has opened up a new era of MIV surgery with the potential to eliminate many of these obstacles. From the literature it can be concluded that robotic surgery has a number of benefits over traditional surgery, for the surgeon, the patient and the healthcare institution.

The robotic system provides the surgeon with restoration of hand–eye coordination that was lost with MIV surgery. The instruments are easier to manipulate from an upright position at the console. The 3-dimensional vision allows for depth and perception and high-resolution video magnification, thus improving precision (Kernstine 2004, Lanfranco et al. 2004). The computer software of the robotic system allows elimination of hand tremors (Lanfranco et al. 2004, Mohr et al. 2001).

The demonstrated general benefits for patients include smaller incision sites, reduced bleeding and hence a reduced need for blood transfusion and reduced rate of occurrence of bacterial infections. Other potential benefits include reduced surgically related pain as a result of the lack of an extensive incision, and earlier mobility, hence faster patient recovery resulting in decreased length of hospital stay. Patients are reported as recovering faster at home, they begin to enjoy their leisure activities sooner and return to work earlier.

PROSTATE CANCER

Future trend analyses of the Australian population indicate that the number of people aged 55–64 years is projected to increase by more than 50% over the next two decades. As the number of people under the age of 65 declines, the number over the age of 65 will double in the next half century. By 2031, it is estimated that those people over the age of 65 years will account for more than a quarter of the Australian population (Australian Bureau of Statistics [ABS] 1999, 2001).

Prostate cancer, a disease that most often occurs in the older male (Crowe & Costello 2003), is the second most common cause of cancer-related deaths in men and is a major health concern worldwide (Crowe & Costello 2003, Humphreys et al. 2004). It is the most common form of cancer among men over 55 years of age (Jemal et al. 2002). In Australia, prostate cancer is the most commonly diagnosed cancer in males and was the leading site of new cancer in Victoria in 2003. In 2003, prostate cancer was diagnosed in 3441 men in Victoria (Anti-Cancer Council of Victoria 2005). In light of the ageing of the Australian population the incidence of prostate cancer is hypothesised to rise. Deciding the best treatment for prostate cancer that has not extended beyond the capsule of the gland (referred to as ‘localised’) is a challenge for the consumer as there is a range of treatment modalities available, including surgery, radiotherapy and hormone therapy, or combinations of these.

Traditionally, radical prostatectomy surgery was routinely performed using the standard technique of open retropubic approach (prostate gland is removed through an incision in the lower abdomen). Generally, radical prostatectomy is recommended only for men in good health who have a life expectancy of 10 years or more. Studies of men with localised prostate cancer, typically treated by prostatectomy, indicate that specific problems persist following surgery. The reported sequelae following prostate surgery include incontinence, erectile dysfunction and delayed wound healing. All have an impact on the physical and mental wellbeing of men. Reports of negative outcomes following surgery have stopped some men from getting treatment.

However, surgical treatment of prostate cancer has changed dramatically over the past decade with significant implications for recovery. For example, MIV techniques reduce the impact of surgery on the tissues surrounding the prostate gland. Robotic-assisted urologic surgery has many demonstrated benefits for patients, including decreased length of hospital stay, and decreased blood loss (Ahlering et al. 2003) and hence a reduced need for blood transfusion. Other benefits reported include less postoperative pain (Tewari et al. 2003), reduced bladder catheter time and improved continence rates (Abbou et al. 2001; Ahlering et al. 2003). The improved ability to preserve the delicate structural integrity of the pelvic floor with robotic-assisted surgery results in an overall improved functional ability.

The first robotic-assisted laparoscopic urologic surgical procedure reported was in 1995 (Abbou et al. 2001). The first totally endoscopic telerobotic radical prostatectomy surgery was first reported as being preformed in 2000 (Binder et al. 2004). The distinct advantage of robotic systems in robotic-assisted radical prostatectomy is the ability to use instruments with seven degrees of freedom at the wrist that allows precise dissection of tissues and easier movement of the instruments within the pelvis (Atug et al. 2006). This technology driven procedure has spread rapidly over the past 4 years. Binder et al. reported that by 2004, 5200 radical prostatectomies (RPs) had been performed worldwide, making RPs the most frequent single surgical procedure performed with robotic assistance. It has since been reported that as patient demand for this type of surgery has increased, 10% of urology hospitals in the US now have da Vinci robots (Davies 2006). In 2004, a private healthcare institution was the first Australian hospital to implement robotic-assisted surgery using the da Vinci robot for urology patients. It is expected that the number of patients who undergo robotic urologic surgery in Australia will follow the US trend and increase rapidly as surgeons become more proficient in using this new technology. Patients will seek robotic-assisted surgery as they become more aware of the potential postoperative benefits offered.

ANALYSIS OF THE PROBLEM

Outcomes

Randomised controlled trials (RCTs) are considered the ‘gold standard’ in research evidence, represent the highest level of evidence, and are the best way of evaluating an intervention (Hamer & Collinson 1999, Karakiewicz et al. 2006). An RCT is an experimental design that manipulates a variable within the trial, with a group used as a control for which that variable is not manipulated. By having a control group and a second group ‘blinded’ to the intervention an RCT attempts to reduce bias and often requires groups that are sufficiently large to demonstrate power (Hamer & Collinson 1999). However, many constraints, such as ethical, economic or social, render the conduct of RCTs difficult (Karakiewicz et al. 2006). There are a number of recognised methodological issues related to the conduct of RCTs and robotic-assisted prostatectomy surgery and, as such, there is a paucity of prospective randomised data related to treatments for localised prostate cancer reported in the literature.

Patient preference for a particular treatment modality is an important consideration. The values people place on perceived quality of life post-procedure and the associated risk associated with that procedure influence the acceptability of a treatment modality (NHMRC 2002). Many men undergoing prostatectomy surgery are able to access a number of resources to inform them of the outcomes associated with a particular surgical technique. This informs their decision making about the best treatment options for them. It is, therefore, understandable that patients are reluctant to enter into a trial that might result in them undergoing a perceived inferior type of surgery. Interestingly, an American study found that patients appear to be attracted to high-tech surgery despite surprisingly limited comprehension of the technology behind robotic-assisted prostatectomy (Binder 2006). There is also the added issue of surgeon reluctance to randomise between defined groups. For example, a particular surgeon who has a preference (and therefore a bias, based on non-gold standard evidence) for a particular treatment modality to treat the underlying condition will usually practice only that particular surgical technique. For other patients, selection of surgery technique is simply a result of the surgery available; for example, some patients might not wish to travel to another centre for surgery if that means they leave their support network. Therefore, interpretation of the outcomes reported in non-randomised studies must be done with caution as selection criteria of patients into these studies might have influenced outcomes (NHMRC 2002). Information on treatment outcomes related to localised prostate cancer reported in the research literature often comes from relatively small cohorts at specialised academic centres as it is these centres that have access to the technology. In summary, the uses and value of robotic-assisted radical prostatectomy surgery have not been fully established (Giulianotti et al. 2003, Lanfranco et al. 2004).

Not only is our understanding of patient long-term outcomes after robotic-assisted surgery limited because of the relatively recent arrival of the technology, the issue of the health trajectory of patient recovery in both traditional and less invasive surgical contexts has not been examined. In addition, very little is known of the health trajectory of patient recovery after robotic-assisted surgery within the setting of an ageing Australia and advances in technology. This lack of knowledge of the trajectory of patient recovery is concerning. While patients might benefit from the recent advances in science and technology, the introduction of, and rapid advances in, the use of new technology often exceeds knowledge relevant to patient care.

Using the example of cardiac surgery to highlight this point, there are only three major research studies reported since 1990 that have attempted to investigate the trajectory of recovery after traditional cardiac surgery; all were conducted in North America (Barnason et al. 2000, King 2000, Tack & Gillis 1990). While these outcome studies are useful in informing our understanding of patients’ functional recovery, the methods and measures used have not been tested for their sensitivity to variability in outcomes that would be expected with different surgical techniques and different patient demography, in particular older patients with comorbid conditions. An important omission in terms of outcomes associated with MIV surgery is the omission of measures in the early hyperacute and acute transitions where most differences would be expected. Understanding the patient trajectory of recovery after cardiac surgery has implications for the preparation of patients for surgery as well as providing a focus for interventions during the recovery phases.

As stated above, advances in technology related to surgery often lead to less invasion and a subsequent reduction in length of stay in hospital. This often alters patient recovery, which subsequently alters the traditional patient care requirements in the acute care setting. This has implications for discharge planning and preparation of patients for transitions in their recovery; problems that were traditionally dealt with within acute care environments are transferred to the community setting potentially before there are medical and nursing systems in place to deal with them.

Cost

An institution easily determines some costs associated with the introduction of new technology but other costs are harder to characterise. Operative costs that must be taken into consideration include equipment cost and operative time. Equipment costs are easily identified; the initial purchase cost of the robot and associated equipment is approximately $3 million. Disposable equipment used during an operation can also be quantified. Other expenses required to accommodate the robotic system include setting up the facilities in which the surgery is performed; for example, ensuring the operating room is large enough to house the system. Operative times are perhaps more difficult to quantify. There is the initial cost of training surgeons and operating room staff in the use of the equipment. Related to these ongoing costs is the cost in terms of the time it takes for the surgeon to learn how to operate the da Vinci system and the extent of the in vivo learning curve associated with learning how to operate the technology on real patients. There is an inherent assumption that there is an initial learning curve associated with the use of this technology. This impacts directly on operative time, which then affects the number of operations the institution can conduct on a particular day. Comparisons with operation time presented in the research literature for other forms of surgery for localised prostate cancer must be done with caution because of the potential existence of an operator learning curve. Ongoing costs, that have yet to be identified, include upgrades of software and equipment and annual ongoing equipment maintenance.

The cost of new technology is typically borne by the institution in the first few years of use (Lotan et al. 2004) and robotic-assisted technology is unlikely to prove any different. It might be that the large initial set-up cost incurred by the institution is offset by the benefits of less traumatic surgery, resultant decreased length of stay (LOS) for patients and therefore lower overall hospital costs (Donias et al. 2003). While LOS has been reported in the literature for robotic cohorts, it is a difficult variable to compare and one must be cautious when doing so, due to the many staff and institutional variables that can have a direct effect on LOS. For example, in relation to the reported robotic-assisted urological and cardiac procedures European hospitals have a general tendency for longer hospital stays (Lotan et al. 2004). In the Australian context, institutional variables might affect length of stay, for example, a private institution might report greater patient LOS where patient turnover is perhaps not regarded as such an imperative as in the public health sector. However, the gains to an institution of an associated shorter LOS might be overshadowed by the purchase costs and ongoing operative equipment and maintenance costs. With the increasing emphasis on efficient allocation of healthcare resources it is important that methods are developed not only to determine benefits of a particular treatment but also to assess all costs related to that treatment.

In summary, investment into, and the subsequent integration of, robotic technology is undoubtedly a substantial undertaking for any institution. Given the significant costs associated with robotic technology, the challenge for the institution is to gain maximum benefit from the technology. A strategically wise organisation will strive to become early adopters of a new technology and as such will have attempted to predict the future of that technology. While an institution must assess the potential ‘overuse’, ‘under use’ and ‘misuse’ of the resource, the over-riding question that must be asked is ‘Has the technology enhanced patient care?’ (Gerhardus 2003). It must be remembered that technology alone does not and cannot be expected to improve the efficiency and effectiveness of patient care (Thielst 2007).

Access

Can we ensure that this type of technology is within the reach of everyone? To this the answer is probably an emphatic ‘No’. Australia has a population of approximately 20.6 million (ABS 2006). The healthcare system in Australia involves three levels: federal, state/territory and local. The Australian government influences policy makers and health services through financial arrangements with state and territory governments. State and territory governments have a major responsibility for public hospitals. Both the private and public health systems in Australia are challenged by rising costs and changing population demographics. One of the most significant reforms in healthcare funding has been the movement towards prospective reimbursement for hospitals. Victoria was the first Australian state to introduce casemix funding in 1993. The casemix classification system in the acute care sector, adopted in Victoria, utilises DRGs. These DRGs have two different and very separate uses – first, as the basis for the funding of hospitals and, second, as a management information system. In simple terms casemix funding is a performance-oriented arrangement. Hospitals that achieve higher output have the ability to achieve more government revenue, hence a shortened length of hospital stay becomes a high priority.

The introduction of new technology, such as robotic technology, raises major allocation problems because the potential cost to the public healthcare budget and the economic benefit to the state must be evident. The introduction of new technologies into the healthcare sector are influenced by the interplay between government policy, market forces, availability of public funding and regulation (Hailey 1997).

• Clearly, there are national, state and territory government committees established to examine the role of the public sector and the introduction of new technologies. However, there appears to be limited material available in the public domain on the perceived role of robotic-assisted technology and the work of these advisory committees. At the federal level the Medical Services Advisory Committee (MSAC) was established as part of the 1997–98 budget. The role of MSAC is to advise the Australian Minister for Health and Ageing on the strength of evidence relating to the safety and effectiveness of new medical technologies and procedures and to determine if public funding should be supported in relation to the introduction of a new technology (Department of Health and Ageing 2005, Department of Human Services 2006). The Health Policy Advisory Committee on Technology (HealthPACT), which is a sub-committee of the MSAC, has the role of assisting the introduction of new and emerging technologies into the public sector with some consideration to the private sector. HealthPACT has oversight of the recently established Horizon Scanning Unit, whose role is to identify and undertake assessments of new and emerging technologies. At a state level the Victorian Policy Advisory Committee on Clinical Practice and Technology (VPACT), was established by the Victorian Department of Human Services (DHS) to consider and make recommendations on the introduction and use of existing technologies and clinical practices in the public health services in Victoria (DHS 2006). Recommendations from these committees have traditionally influenced whether or not to fund technologies, levels of funding and placement of technologies (Hailey 1997). In the Australian context only three healthcare institutions have robotic technology. In Victoria one private healthcare facility has this technology available where patients come from overseas, interstate, regional, country, and metropolitan areas, to have robotic-assisted urology and cardiac surgery. This in itself is interesting in that it is the private sector that has become the early adopter of the high-cost robotic technology. This is very unusual as most similar innovations occur in the large publicly funded teaching hospitals.

Medicare, the universal health insurance plan in operation in Australia since 1984 and regulated by the Australian government, has a dominant place in the funding and control of many health technologies. If a technology is not included under items on the Medicare Benefits Schedule (MBS) – which robotic radical prostatectomy is not – typically some costs will be met by the patient, with private insurance cover being limited (Hailey 1997). The surgery is not currently included under the MBS. Therefore, patients having robotic-assisted surgery can incur out-of-pocket expenses in the $1000s. This immediately restricts access to those prepared to pay the market price for access to the technology, or to travel interstate or overseas.

CONCLUSION

Perhaps, with Dery, these problems are not ‘undesirable situations, discrepancies between a given state and a desired state, or bridgeable discrepancies’ (Dery 1984 p 26), rather, they ‘are better treated as opportunities for improvement’ (Dery 1984 p 27, and Ch 1 in this book). In short, before the policy window (Kingdon 1984) opens sufficiently to allow the potential demands from men’s health groups, from the medical profession and from the media to coincide with a newly sensitised, or new, minister for health, or prime minister, or department secretary for health, progress with the introduction of robotic surgery for prostate cancer into the public hospital system will be slow. It is on the ‘decision agenda’ (Kingdon 1984) but awaiting its turn or a confluence of circumstances. Nudging the window to open is the ageing population and the presence of cancer on the Australian government’s national diseases priorities list and the listing of older people as a priority age group for health interventions (AIHW 2007). The costs of robotic surgery for prostate cancer in money, nursing and medical resources, in time, and in energy to pursue its wider application are balanced by potentially better patient outcomes, by more equitable access, shorter hospital, and thus less costly, stays, by being the most commonly diagnosed cancer in men, and by values that see men’s health as requiring more emphasis in policy.

A heightened awareness among men about their health makes prostate cancer an emotive area, in the context of an ageing population, a public health sector with inadequate funding to keep pace with changing technology, and an extremely expensive technology with an as yet limited introduction. People are increasingly technologically literate and use web-based information on the latest technology to demand the latest surgical technique if it is represented as less invasive and with improved health outcomes. How the future unfolds in this area might well reflect the dynamics of Lin’s (2003) competing rationalities (see also Ch 2).

References

Abbou C -C, Hoznek A, Salomon L., et al. Laparoscopic radical prostatectomy with a remote controlled robot. The Journal of Urology. 2001;165:1964-1966.

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