- Email: [email protected]
Hype Cycle in Radiation Oncology
International Journal of
Radiation Oncology biology
physics
www.redjournal.org
EDITORIAL
Hype Cycle in Radiation Oncology Thomas Bortfeld, PhD,* and Lawrence B. Marks, MDy *Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; and yDepartment of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina Received Mar 6, 2013, and in revised form Mar 19, 2013. Accepted for publication Mar 22, 2013 Are you usually overwhelmed or underwhelmed with the quality, usability, and functionality of new commercial products? Is your answer different for personal products (eg, cell phones, personal computers) versus those in your professional life? We believe that personal commercial products generally seem to be better evolved (ie, more usable and functional) than are the products we purchase in our professional lives. Why is this? We think it might be related to the “hype cycle.” The technological nature of many radiation oncology advances makes them prone to overhype and subject to the “hype cycle” (1). We herein discuss the unique characteristics of the hype cycle in radiation oncology, along with its implications. We offer a modified hype cycle with 3 phases: (1) skeptical resistance, (2) hype, and (3) post-hype.
Three Phases of the Radiation Oncology Hype Cycle The 3 phases of the radiation oncology hype cycle are illustrated in Figure 1.
Phase 1: Skeptical resistance In radiation oncology, the interval from novel technology invention to clinical tool can be long (eg, 10 years), after which the hype may or may not take off. The initial delay reflects, in part, the inherent complexities and safety concerns with radiation. However, the delay also reflects inertia and resistance based on deeply ingrained traditions (2). Even when the potential benefits of a new technology are understood, education and associated credentialing can take time. Although faster initial deployment of a new technology for initial testing by a few clinics may be Reprint requests to: Thomas Bortfeld, PhD, Massachusetts General Hospital and Harvard Medical School, Department of Radiation Oncology,
Int J Radiation Oncol Biol Phys, Vol. 86, No. 5, pp. 819e821, 2013 0360-3016/$ - see front matter Ó 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ijrobp.2013.03.027
desirable, the delayed process does allow marginal ideas to be discarded at an early stage.
Phase 2: Hype Once the major engineering/development challenges are addressed, and a “critical mass” of optimistic parties exists, the transition from skeptical resistance to hype often happens abruptly. At this stage there are mutually reinforcing incentives motivating providers, institutions, patients, and vendors to celebrate and perhaps overstate the utility of some novel approaches. Early adopters of new novel technologies are incentivized to celebrate their potential benefits. There are academic and often financial rewards for centers able to deliver the “most advanced” technologies. Fame, notoriety, and financial factors are strong incentives for physicians and scientists, who are often driven to succeed and motivated to push science forward. Similar incentives apply to institutions as well. Similarly, patients and their families advocate for the most novel approach, believing that newer is better (Fig. 2).
Phase 3: Obsolescence or evolution The end of the hype phase occurs as users gain a more realistic understanding of the strengths and weaknesses of the technology. At this transition, it is natural to expect a healthy process of evolution (eg, whereby some problems are resolved, enabling a smooth evolution into the “slope of enlightenment” and finally entering into the “plateau of productivity”). However, this “evolution” seems to not always happen in radiation oncology. Instead, we see the post-hype phase to often have stagnation, followed sometimes by a rapid drop into obsolescence (Fig. 1). In our opinion, the “lack of evolution,” although understandable, has a major negative effect on our field. As one progresses through the 30 Fruit St, Boston, MA 02114. Tel: (617) 724-1180; E-mail: tbortfeld@ partners.org Conflict of interest: none.
820
International Journal of Radiation Oncology Biology Physics
Bortfeld and Marks Skeptical Resistance Phase
Groups involved in early assessments
Post-Hype Phase: Obsolescence or Evolution?
Hype Phase
Motivations
Clinical application Ability to impact design
Stagnation
Patient
Provider
Vendor
Clinical
Cure, Prestige, Science, Ego, Financial
Cure, Prestige, Science, Market Share, Financial
Early encouraging reports leads to commercialization and marked increase in number of users
10
20
30
time (years)
Idea Progressive engineering advances increase clinical feasibility Fig. 1. Three phases of the radiation oncology hype cycle (red curve, labeled “Clinical application”). The black curve (labeled “Ability to impact design”) shows the inverse relationship between the hype and the ability to impact the design of the technology. The diamond-shaped dots (blue) represent the number of publications with “tomotherapy” in the title or abstract published in the years between 1993 and 2012, as per PubMed. These data are indicative of the hype in terms of visibility and clinical use. developmental cycle, it becomes challenging to make modifications to the underlying product (Fig. 2). Therefore, the earliest adapters and designers have tremendous impact on the manner in which these technologies will be used. By the time a wide audience can more globally assess the clinical utility of a particular new technology’s design, it is often impractical to make fundamental changes. Furthermore, governmental agencies (eg, the US Food and Drug Administration [FDA]) provide fairly intensive oversight of these activities. Products usually undergo testing and evaluation before they are brought to market. Although this oversight is largely very positive, the rigor of this evaluation may hinder the refinement and improvements of technologies once they have received initial FDA approval.
Role of the Industry/Vendors in Amplifying the Hype Cycle The development and clinical deployment of many advanced radiation oncology technologies requires active involvement of industrial partners. Some fundamental developments of the past (eg, 3-dimensional planning, and to some degree intensity modulated radiation therapy [IMRT]) were initially developed and clinically deployed within academic centers and only later commercialized. Today, vendors get involved in early development and are often the primary initiators driving development. This trend is likely to persist owing to increasing complexities of technologies, the difficulty of acquiring research and development funding from agencies other than industry, and the
Much more potential for refinement and assessment
Barriers to further refinement and assessment; e.g. • acknowledge prior inadequacies • costs • FDA • retraining • Market forces
X
Real refinement and assessment
Fig. 2. Rapid/wide deployment of overhyped technology hinders refinement and objective assessment. This might be due to a confluence of incentives driving this process, as shown. increasingly tougher government regulations. Although the involvement of industry is generally desirable and positive, it does come at a price. Companies may promote “over-hype” by aggressively marketing products that are premature and/or not really innovative. We perceive that vendors are in a challenging situation. On one hand, vendors want users to believe that they are providing continuously improving technologies. On the other hand, real improvements are hard to come by; really good ideas can be elusive, costly, and require meaningful engineering/technological changes. Products are often marketed as “new” when they merely represent repackaging of previously available technologies. Incremental improvements are often “trumped up” and touted to have greater impact than they do. For the nonexperts, especially the patient, it is difficult to distinguish marketing gimmicks from real innovation. The “magic of the marketplace” that drives continuous innovation in many commercial areas (eg, smart phones) is not so active in medicine. It is nearly impossible for institutions to readily change vendors, or some their clinical products, because of their cost and intertwined functionality with other components of a center’s clinical practice. Therefore, once a vendor is firmly established in the marketplace, it is challenging for competitors to make inroads into that marketplace, even if they can offer an improved product. The cost of linear accelerators and treatment planning systems prohibit the rapid switching between vendors that is often needed for a robust capitalist marketplace. Consumers rapidly move between different vendors of smart phones, personal computers, electronics, and the like. The dynamic of radiation oncology is not the same.
Hype Makes It Challenging to Generate Objective Data to Assess Technologies There is an inherent “Catch-22” here. For the most part the only people who can generate objective data regarding the usability and utility of novel technologies are those who have made the investment to purchase these technologies. At that point, the potential evaluator is no longer fully objective. It is hard for a “usual institution” that has recently invested a large sum of money, personnel, space, and other resources to institute a new technology to then conduct studies to objectively assess their prior
Volume 86 Number 5 2013 investments. The cost (both financial and emotional) of illustrating one’s own earlier misjudgments is often too high. Reports of early clinical experiences with new technologies are almost always positive. The authors of the occasional negative reports of new technologies should be commended (3, 4). In some situations it might be reasonable to ask vendors to perform postmarket assessments of their new technologies, similar to what is considered in other areas (5).
Does the Technology Hype Distract from “Real” Innovation? This continual quest for technological advances places undue stress on the health system broadly. Users and hospitals are under continual pressure to update. Patients are continually seeking out the best gadget, and the vendors try to sell their wares. All this activity has the collateral effect of distracting us from other activities. For example, there are potential huge advantages to be reaped in our field from further exploitation of existing technologies. We are just starting to learn the utility and limitations of technologies such as IMRT, imageguided radiation therapy, and stereotactic body radiation therapy. Do we really need to include a deformable registration to implement the former technologies? Is adaptive therapy required as well? Do the improved dose distributions afforded by the newest physics/ engineering-based advances represent a meaningful incremental gain beyond that already afforded by widely available techniques? We may have reached the asymptotic portion of the yield versus effort curve for such technical advances. We can improve therapy without huge advances in costly technology (6). Altering fractionation can improve outcomes. However, we are not exploiting this enough. For example, accelerating radiation treatment in patients with non-small cell lung cancer seems advantageous (7). With chemotherapy, however, the acute esophageal reactions are sometimes too severe to warrant both chemotherapy and accelerated fractionation (8). Therefore, most patients with non-small cell lung cancer receive conventional daily fractionation with chemotherapy. A very reasonable hypothesis would be to assess whether one can use IMRT to spare the esophagus and then combine accelerated fractionation with concurrent chemotherapy. So what can we do? Cancer is a vicious disease, often with devastating effects. Any potential therapeutic improvements can
Hype cycle in radiation oncology
821
be beneficial to patients, and thus we do not want to stifle real innovation. Indeed, we ought to be proud that our field has created innovative tools that effectively palliate and cure several hundred thousand patients in the United States annually and probably millions of patients worldwide. Nevertheless, the risks of overhype are real. At a minimum, we should continually remind ourselves of the risks of overhype. Reviewers and editors of articles and books should verify that the claims are accurate. We need to be honest with ourselves and hospital administrators about these issues. New technologies should be assessed with objective, clinically meaningful metrics. Let us do what we can to assure that the tools we use on our patients provide real added value and reside on the slope of enlightenment and plateau of productivity, rather than the cliff of obsolescence.
References 1. Fenn J, Raskino M. Mastering the Hype Cycle. Cambridge, MA: Harvard University Press; 2008. 2. Kuhn TS. The Structure of Scientific Revolutions. Chicago: University of Chicago Press; 1962. 3. Pfeffer MR, Rabin T, Tsvang L, et al. Orbital lymphoma: Is it necessary to treat the entire orbit? Int J Radiat Oncol Biol Phys 2004; 60:527-530. 4. Engels B, Soete G, Verellen D. Conformal arc radiotherapy for prostate cancer: Increased biochemical failure in patients with distended rectum on the planning computed tomogram despite image guidance by implanted markers. Int J Radiat Oncol Biol Phys 2009; 74:388-391. 5. Acker MA, Pagani FD, Stough WG, et al. Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States. Circ Heart Fail 2013;6:e1-e11. 6. Bortfeld T, Jeraj R. The physical basis and future of radiation therapy. Br J Radiol 2011;84:485-498. 7. Saunders M, Dische S, Barrett A, et al. Continuous hyperfractionated accelerated radiotherapy (CHART) versus conventional radiotherapy in non-small-cell lung cancer: A randomised multicentre trial. Lancet 1997;350:161-165. 8. Belani CP, Wang W, Johnson DH, et al. Phase III study of the Eastern Cooperative Oncology Group (ECOG 2597): Induction chemotherapy followed by either standard thoracic radiotherapy or hyperfractionated accelerated radiotherapy for patients with unresectable stage IIIA and B non-small-cell lung cancer. J Clin Oncol 2005;23: 3760-3767.
Radiation Oncology biology
physics
www.redjournal.org
EDITORIAL
Hype Cycle in Radiation Oncology Thomas Bortfeld, PhD,* and Lawrence B. Marks, MDy *Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; and yDepartment of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina Received Mar 6, 2013, and in revised form Mar 19, 2013. Accepted for publication Mar 22, 2013 Are you usually overwhelmed or underwhelmed with the quality, usability, and functionality of new commercial products? Is your answer different for personal products (eg, cell phones, personal computers) versus those in your professional life? We believe that personal commercial products generally seem to be better evolved (ie, more usable and functional) than are the products we purchase in our professional lives. Why is this? We think it might be related to the “hype cycle.” The technological nature of many radiation oncology advances makes them prone to overhype and subject to the “hype cycle” (1). We herein discuss the unique characteristics of the hype cycle in radiation oncology, along with its implications. We offer a modified hype cycle with 3 phases: (1) skeptical resistance, (2) hype, and (3) post-hype.
Three Phases of the Radiation Oncology Hype Cycle The 3 phases of the radiation oncology hype cycle are illustrated in Figure 1.
Phase 1: Skeptical resistance In radiation oncology, the interval from novel technology invention to clinical tool can be long (eg, 10 years), after which the hype may or may not take off. The initial delay reflects, in part, the inherent complexities and safety concerns with radiation. However, the delay also reflects inertia and resistance based on deeply ingrained traditions (2). Even when the potential benefits of a new technology are understood, education and associated credentialing can take time. Although faster initial deployment of a new technology for initial testing by a few clinics may be Reprint requests to: Thomas Bortfeld, PhD, Massachusetts General Hospital and Harvard Medical School, Department of Radiation Oncology,
Int J Radiation Oncol Biol Phys, Vol. 86, No. 5, pp. 819e821, 2013 0360-3016/$ - see front matter Ó 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ijrobp.2013.03.027
desirable, the delayed process does allow marginal ideas to be discarded at an early stage.
Phase 2: Hype Once the major engineering/development challenges are addressed, and a “critical mass” of optimistic parties exists, the transition from skeptical resistance to hype often happens abruptly. At this stage there are mutually reinforcing incentives motivating providers, institutions, patients, and vendors to celebrate and perhaps overstate the utility of some novel approaches. Early adopters of new novel technologies are incentivized to celebrate their potential benefits. There are academic and often financial rewards for centers able to deliver the “most advanced” technologies. Fame, notoriety, and financial factors are strong incentives for physicians and scientists, who are often driven to succeed and motivated to push science forward. Similar incentives apply to institutions as well. Similarly, patients and their families advocate for the most novel approach, believing that newer is better (Fig. 2).
Phase 3: Obsolescence or evolution The end of the hype phase occurs as users gain a more realistic understanding of the strengths and weaknesses of the technology. At this transition, it is natural to expect a healthy process of evolution (eg, whereby some problems are resolved, enabling a smooth evolution into the “slope of enlightenment” and finally entering into the “plateau of productivity”). However, this “evolution” seems to not always happen in radiation oncology. Instead, we see the post-hype phase to often have stagnation, followed sometimes by a rapid drop into obsolescence (Fig. 1). In our opinion, the “lack of evolution,” although understandable, has a major negative effect on our field. As one progresses through the 30 Fruit St, Boston, MA 02114. Tel: (617) 724-1180; E-mail: tbortfeld@ partners.org Conflict of interest: none.
820
International Journal of Radiation Oncology Biology Physics
Bortfeld and Marks Skeptical Resistance Phase
Groups involved in early assessments
Post-Hype Phase: Obsolescence or Evolution?
Hype Phase
Motivations
Clinical application Ability to impact design
Stagnation
Patient
Provider
Vendor
Clinical
Cure, Prestige, Science, Ego, Financial
Cure, Prestige, Science, Market Share, Financial
Early encouraging reports leads to commercialization and marked increase in number of users
10
20
30
time (years)
Idea Progressive engineering advances increase clinical feasibility Fig. 1. Three phases of the radiation oncology hype cycle (red curve, labeled “Clinical application”). The black curve (labeled “Ability to impact design”) shows the inverse relationship between the hype and the ability to impact the design of the technology. The diamond-shaped dots (blue) represent the number of publications with “tomotherapy” in the title or abstract published in the years between 1993 and 2012, as per PubMed. These data are indicative of the hype in terms of visibility and clinical use. developmental cycle, it becomes challenging to make modifications to the underlying product (Fig. 2). Therefore, the earliest adapters and designers have tremendous impact on the manner in which these technologies will be used. By the time a wide audience can more globally assess the clinical utility of a particular new technology’s design, it is often impractical to make fundamental changes. Furthermore, governmental agencies (eg, the US Food and Drug Administration [FDA]) provide fairly intensive oversight of these activities. Products usually undergo testing and evaluation before they are brought to market. Although this oversight is largely very positive, the rigor of this evaluation may hinder the refinement and improvements of technologies once they have received initial FDA approval.
Role of the Industry/Vendors in Amplifying the Hype Cycle The development and clinical deployment of many advanced radiation oncology technologies requires active involvement of industrial partners. Some fundamental developments of the past (eg, 3-dimensional planning, and to some degree intensity modulated radiation therapy [IMRT]) were initially developed and clinically deployed within academic centers and only later commercialized. Today, vendors get involved in early development and are often the primary initiators driving development. This trend is likely to persist owing to increasing complexities of technologies, the difficulty of acquiring research and development funding from agencies other than industry, and the
Much more potential for refinement and assessment
Barriers to further refinement and assessment; e.g. • acknowledge prior inadequacies • costs • FDA • retraining • Market forces
X
Real refinement and assessment
Fig. 2. Rapid/wide deployment of overhyped technology hinders refinement and objective assessment. This might be due to a confluence of incentives driving this process, as shown. increasingly tougher government regulations. Although the involvement of industry is generally desirable and positive, it does come at a price. Companies may promote “over-hype” by aggressively marketing products that are premature and/or not really innovative. We perceive that vendors are in a challenging situation. On one hand, vendors want users to believe that they are providing continuously improving technologies. On the other hand, real improvements are hard to come by; really good ideas can be elusive, costly, and require meaningful engineering/technological changes. Products are often marketed as “new” when they merely represent repackaging of previously available technologies. Incremental improvements are often “trumped up” and touted to have greater impact than they do. For the nonexperts, especially the patient, it is difficult to distinguish marketing gimmicks from real innovation. The “magic of the marketplace” that drives continuous innovation in many commercial areas (eg, smart phones) is not so active in medicine. It is nearly impossible for institutions to readily change vendors, or some their clinical products, because of their cost and intertwined functionality with other components of a center’s clinical practice. Therefore, once a vendor is firmly established in the marketplace, it is challenging for competitors to make inroads into that marketplace, even if they can offer an improved product. The cost of linear accelerators and treatment planning systems prohibit the rapid switching between vendors that is often needed for a robust capitalist marketplace. Consumers rapidly move between different vendors of smart phones, personal computers, electronics, and the like. The dynamic of radiation oncology is not the same.
Hype Makes It Challenging to Generate Objective Data to Assess Technologies There is an inherent “Catch-22” here. For the most part the only people who can generate objective data regarding the usability and utility of novel technologies are those who have made the investment to purchase these technologies. At that point, the potential evaluator is no longer fully objective. It is hard for a “usual institution” that has recently invested a large sum of money, personnel, space, and other resources to institute a new technology to then conduct studies to objectively assess their prior
Volume 86 Number 5 2013 investments. The cost (both financial and emotional) of illustrating one’s own earlier misjudgments is often too high. Reports of early clinical experiences with new technologies are almost always positive. The authors of the occasional negative reports of new technologies should be commended (3, 4). In some situations it might be reasonable to ask vendors to perform postmarket assessments of their new technologies, similar to what is considered in other areas (5).
Does the Technology Hype Distract from “Real” Innovation? This continual quest for technological advances places undue stress on the health system broadly. Users and hospitals are under continual pressure to update. Patients are continually seeking out the best gadget, and the vendors try to sell their wares. All this activity has the collateral effect of distracting us from other activities. For example, there are potential huge advantages to be reaped in our field from further exploitation of existing technologies. We are just starting to learn the utility and limitations of technologies such as IMRT, imageguided radiation therapy, and stereotactic body radiation therapy. Do we really need to include a deformable registration to implement the former technologies? Is adaptive therapy required as well? Do the improved dose distributions afforded by the newest physics/ engineering-based advances represent a meaningful incremental gain beyond that already afforded by widely available techniques? We may have reached the asymptotic portion of the yield versus effort curve for such technical advances. We can improve therapy without huge advances in costly technology (6). Altering fractionation can improve outcomes. However, we are not exploiting this enough. For example, accelerating radiation treatment in patients with non-small cell lung cancer seems advantageous (7). With chemotherapy, however, the acute esophageal reactions are sometimes too severe to warrant both chemotherapy and accelerated fractionation (8). Therefore, most patients with non-small cell lung cancer receive conventional daily fractionation with chemotherapy. A very reasonable hypothesis would be to assess whether one can use IMRT to spare the esophagus and then combine accelerated fractionation with concurrent chemotherapy. So what can we do? Cancer is a vicious disease, often with devastating effects. Any potential therapeutic improvements can
Hype cycle in radiation oncology
821
be beneficial to patients, and thus we do not want to stifle real innovation. Indeed, we ought to be proud that our field has created innovative tools that effectively palliate and cure several hundred thousand patients in the United States annually and probably millions of patients worldwide. Nevertheless, the risks of overhype are real. At a minimum, we should continually remind ourselves of the risks of overhype. Reviewers and editors of articles and books should verify that the claims are accurate. We need to be honest with ourselves and hospital administrators about these issues. New technologies should be assessed with objective, clinically meaningful metrics. Let us do what we can to assure that the tools we use on our patients provide real added value and reside on the slope of enlightenment and plateau of productivity, rather than the cliff of obsolescence.
References 1. Fenn J, Raskino M. Mastering the Hype Cycle. Cambridge, MA: Harvard University Press; 2008. 2. Kuhn TS. The Structure of Scientific Revolutions. Chicago: University of Chicago Press; 1962. 3. Pfeffer MR, Rabin T, Tsvang L, et al. Orbital lymphoma: Is it necessary to treat the entire orbit? Int J Radiat Oncol Biol Phys 2004; 60:527-530. 4. Engels B, Soete G, Verellen D. Conformal arc radiotherapy for prostate cancer: Increased biochemical failure in patients with distended rectum on the planning computed tomogram despite image guidance by implanted markers. Int J Radiat Oncol Biol Phys 2009; 74:388-391. 5. Acker MA, Pagani FD, Stough WG, et al. Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States. Circ Heart Fail 2013;6:e1-e11. 6. Bortfeld T, Jeraj R. The physical basis and future of radiation therapy. Br J Radiol 2011;84:485-498. 7. Saunders M, Dische S, Barrett A, et al. Continuous hyperfractionated accelerated radiotherapy (CHART) versus conventional radiotherapy in non-small-cell lung cancer: A randomised multicentre trial. Lancet 1997;350:161-165. 8. Belani CP, Wang W, Johnson DH, et al. Phase III study of the Eastern Cooperative Oncology Group (ECOG 2597): Induction chemotherapy followed by either standard thoracic radiotherapy or hyperfractionated accelerated radiotherapy for patients with unresectable stage IIIA and B non-small-cell lung cancer. J Clin Oncol 2005;23: 3760-3767.