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Robotic cystectomy and the Internet: Separating fact from fiction
Urologic Oncology: Seminars and Original Investigations 29 (2011) 393–397
Original article
Robotic cystectomy and the Internet: Separating fact from fiction Raj S. Pruthi, M.D.*, Jim Belsante, M.D., Raj Kurpad, M.D., Matthew E. Nielsen, M.D., Eric M. Wallen, M.D. Division of Urologic Surgery, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA Received 19 March 2009; received in revised form 9 April 2009; accepted 10 April 2009
Abstract Introduction: Patients commonly use the Internet to acquire health information. While a large amount of health-related information is available, the accuracy is highly variable. We sought to evaluate the current web-based information that exists with regard to robotic cystectomy. Methods: Two common search engines (Google and Yahoo) were used to search the term “robotic cystectomy” and obtain the top 50 websites for each. These 100 sites were analyzed with regard to type of site, presence and accuracy of information on bladder cancer, and of information related to robotic cystectomy outcomes (surgical/oncologic, functional, and recovery). In addition, information taken from Intuitive Corp website was identified, as was the presence (or absence) and literature-based references. Results: Of the 100 sites, 61 were surgeon/provider sites, 23 links to articles, 8 news stories, 3 patient support sites, 3 meeting program, and 2 were the Intuitive site. Analysis of all 61 provider sites showed that 13% provided factually accurate information, 7% had both factual and erroneous information, and 80% had no information on bladder cancer. With regard to the purported benefits and outcomes of the robotic approach, a significant number of the sites had nonevidence-based claims with regard surgical/oncologic aspects (54%), functional recovery (26%), and surgical recovery (47%). Information taken directly from the Intuitive site was found on 33% sites, with 16% sites having a direct link. Only 4 provider sites (7%) had listed any references. Conclusions: These findings suggest that surgeons provide the majority of Internet information but do not often present evidence-based information and often over-state claims and outcomes of the robotic approach. This highlights the need for providers to deliver factual and evidence-based information to the public, and not suggest untrue/unproven claims that seem to presently occur. © 2011 Elsevier Inc. All rights reserved. Keywords: Bladder cancer; Cystectomy; Robotic-assisted; Laparoscopic; Internet
1. Introduction Radical cystectomy remains the “gold standard” of treatment for patients with muscle invasive urothelial carcinoma of the bladder, and for those with high-risk recurrent noninvasive disease, providing efficacy with regard to local control and long-term disease-free survival. In recent years, surgeons have begun to report single institution case series of minimally invasive approaches to radical cystectomy, including laparoscopic and, more recently, robotic-assisted techniques, building on the increasing experiences of this surgical modification in prostate cancer. Recent robotic cystectomy case series have demonstrated the surgical feasibil* Corresponding author. Tel.: ⫹1-919-966-2574; fax: ⫹1-919-9660098. E-mail address: [email protected] (R.S. Pruthi). 1078-1439/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.urolonc.2009.04.010
ity of this procedure, with the potential of lower surgical blood loss, more rapid return of bowel function, and even hospital discharge [1–5]. Notwithstanding these experiences and observations, it must be clearly recognized that at this point, high levels of clinical evidence with regard to benefits of robotic cystectomy are absent in peer-reviewed literature, and the current experiences represent single institution case series with limited comparisons with historic controls at best. Despite theses low levels of evidence (Oxford level 4), there appears to be increasing promise and promotion of robotic assisted cystectomy directed toward patients [6]. While healthcare providers remain the most important source of specific medical knowledge, patients are increasingly seeking additional sources of medical information. To this end, the Internet is perhaps the most important resource of added information when patients and their family seek out supplementary knowledge. [7,8] The contribution of
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Internet-based information may be particularly significant, given the limited amount of knowledge on novel techniques such as robotic cystectomy. Indeed, Matthews et al. have demonstrated that the Internet is a common and influential source for “nontraditional” treatments, despite the poor quality of information provided [9]. Furthermore, all information (including both standard and nontraditional therapies) presented on the Internet does not typically undergo the rigorous scientific validation and peer review process adhered to in the medical literature, and much of the information may be hearsay or anecdotal at best [7,8]. In order to evaluate the quality of information available on the Internet for robotic cystectomy, we sought to utilize commonly used search engines to research sites related to “robotic cystectomy” to access their content, validity, scientific accuracy, and evidence-based information provided, with particular attention to sites by medical providers.
Table 1 Summary of literature-based findings [1–5, 13–16] regarding outcomes of robotic cystectomy (literature search as of 12/15/08 via PubMed)
2. Methods
Procedural recovery
Two common search engines (Google and Yahoo) were used to search the term “robotic cystectomy” and obtain the top 50 URL (uniform resource locater) (or “websites”) for each search engine. Google and Yahoo together represent the 2 most common search engines accounting for over 80% of searches performed according to recent Nielsen ratings and the latest ComScore survey [10,11]. Of note, the search for robotic cystectomy retrieved a total of 43,700 sites and 58,800 sites for Google and Yahoo, respectively, and the analysis was performed from 11/28/08 to 12/20/08. These 100 sites were then analyzed with regard to a variety of factors. First, sites were categorized by the type of site as follows: provider (academic or private), patient support group, link to publication, medical news, meeting program, etc. Second, provider sites were reviewed for the presence and accuracy of information on bladder cancer. Third, each provider site was carefully studied for the presence and accuracy of information related to robotic cystectomy outcomes. This analysis included an evaluation of information in the following categories: (1) surgical/oncologic measures, (2) functional recovery (specifically potency and voiding function for neobladders), and (3) surgical recovery (including factors related to pain, bowel function, hospital discharge, and return to work/activity). Fourth, provider sites were evaluated as to the presence of information taken from directly (verbatim) from the website of the Intuitive Corporation (maker of the DaVinci robotic surgical platform) and with regard to the presence of direct links to the Intuitive site. Last, the presence (or absence) of literature references were recorded for each provider site. As the reference standard for bladder cancer information, Campbell-Walsh Urology textbook (9th edition) was used as the sole reference [12]. For information regarding robotic cystectomy, a PubMed search was performed, and all case series were studied with regard to surgical, oncologic, func-
Outcome parameter
Current evidence in the literature
Oncologic efficacy
No evidence of superiority versus open approach. Current reports have demonstrated the potential for similar outcomes (vs. open) on surgical pathology (e.g., lymph node yield, positive soft tissue margins) and on short-term follow-up (level 4). There currently exists evidence for the potential of lower blood loss (and transfusion requirements) with robotic approach (level 4). There is also some evidence for prolonged operating room times with robotics (level 4). Complication rates (vs. open) appear similar (level 4), but little comparative data exists. No evidence for improved potency or neobladder function with the robotic approach (data absent). Some evidence for more rapid return of bowel function and hospital discharge (level 4). One report of potential for reduced postoperative narcotic requirement (level 4). No evidence for improved quality of life measures or a more rapid return to work/ activities (data absent).
Surgical measures
Functional outcomes
tional, and recovery outcome measures [1–5,13–16]. Of note, all current reports represent single-institution cases series and thereby represent Oxford level evidence of 4 (range 1 ⫽ best to 5 ⫽ worst) [6]. A summary of robotic cystectomy literature-based outcomes is shown in Table 1.
3. Results Of the 50 Google sites, 23 were surgeon/provider sites, 18 links to articles, 4 news stories, 3 patient support sites, 1 meeting program, and 1 was the Intuitive Corporation site. Of the 50 Yahoo sites, 38 were surgeon/provider sites, 5 links to articles, 4 news stories, 2 meeting programs, and 1 was the Intuitive site. Analysis of all 61 provider sites showed that 64% were academic-affiliated and 36% were private practice sites. With regard to information on bladder cancer itself, 13% of the provider sites contained factual information, 7% had both factual and erroneous data, and 80% had no information. (No site had purely erroneous bladder cancer information.) Information taken directly from the Intuitive site was found in 33% sites (9 academic and 11 private). Ten (16%) of the provider sites had a direct link to the Intuitive site. Only 4 provider sites (7%) listed any references, and the remainder (93%) had no literature-based references. Regarding provider-based information, Table 2 demonstrates the findings of the site analysis related to robotic
R.S. Pruthi et al. / Urologic Oncology: Seminars and Original Investigations 29 (2011) 393–397
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Table 2 Analysis of provider Internet sites based on accuracy of purported surgical/oncologic, functional, and recovery outcomes Surgical/oncologic
ALL (n ⫽ 61) Google (n ⫽ 23) Yahoo (n ⫽ 38)
Functional
Recovery
Unsub
Both
Factual
Absent
Unsub
Both
Factual
Absent
Unsub
Both
Factual
Absent
39% 35% 42%
15% 30% 5%
5% 4% 5%
41% 31% 48%
26% 30% 24%
0% 0% 0%
0% 0% 0%
74% 70% 76%
26% 39% 18%
21% 22% 21%
13% 22% 8%
40% 17% 53%
Unsub ⫽ unsubstantiated data/claims (not present in peer-reviewed literature); Factual ⫽ data/claims that have basis in peer-reviewed literature; Both ⫽ having data/claims that are both unsubstantiated and factual; Absent ⫽ no data/claims made.
cystectomy outcomes for the entire group and stratified by search engine used. With regard to information on surgical/ oncologic outcomes, 24 sites (39%) had solely unsubstantiated claims, 9 (15%) had both evidence-based and unsubstantiated information, 25 (41%) had no information, and only 3 (5%) had purely evidence-based data. Information on functional (sexual, urinary) were unsubstantiated in 16 (26%) sites, and absent in 45 (74%) sites. Regarding procedural/physical recovery, 16 (26%) of sites had only unsubstantiated information, 13 (21%) contained both unsubstantiated and evidenced-based information, 24 (40%) had absent information, and only 8 (13%) had evidenced-based data. In summary, a significant number of the sites had nonevidence-based claims with regard surgical/oncologic aspects (54%), functional recovery (26%), and surgical recovery (47%). Table 3 provides some examples of nonevidence-based claims reported on some provider sites.
4. Discussion According to NielsenNet ratings, a recent Harris Poll, approximately 80% of Americans have access to the Internet in their home [17,18]. Furthermore, pursuit of healthrelated information represents the third most common reason for accessing the Internet by users, with a rising trend over the last 5 years [19]. These findings appear to be particularly applicable for the cancer patients in whom access to the Internet may fulfill natural desires to further educate themselves about their disease, with the benefits of convenience and anonymity [8]. (Indeed, a large percentage of oncology patients have reported that they seek such additional knowledge due to the feelings that the information provided by their physician is deemed deficient) [20]. To this point, a recent study by the National Trend Survey demonstrated that whereas cancer patients desire and appreciate information received from their physician, the majority utilized the Internet as an important (and often initial) source of information [21]. Approximately 70% of these information seekers have stated that such information influenced decisions related to their care [19]. Moreover, the Internet sometimes provides the only mechanism through which a patient may obtain information that is otherwise more difficult to encounter, including novel or nontradi-
tional approaches [9]. In the present case, minimally invasive approaches to bladder cancer, including robotic-assisted laparoscopic surgery, may be considered novel and, to some degree, untested, at least by the highest levels of clinical evidence. Despite the tremendous potential for information and education that the Internet provides and given the desire for and reliance on such information by patients, it is clear from a variety of studies that health information found on the Internet is patently deficient, and this has even been shown for bladder cancer in particular [7–9,22,23]. The “anarchic” nature of the Internet in its current state leads to unverified and often faulty information; making therapeutic decisions Table 3 Examples of non-evidenced based claims from provider sites with regard to surgical, oncologic, functional, and recovery outcomes [28 –30] “Not so long ago at all, cystectomy was performed using a traditional open surgical procedure; and therefore usually involved notable tissue and nerve damage, significant blood loss and carried a greater risk of post-operative infections and complications. By comparison, the robotic-assisted laparoscopic cystectomy may seem a bit like a kind of state-of-the-art miracle” [28]. “In reality, the robotic cystectomy is simply a newer and more effectual minimally invasive bladder cancer surgical method. It that makes use of the Da Vinci Robotic Surgical System and imitates a surgeon’s movements—it offers bladder cancer patients the prospect of a more effective surgical and less problematic post-surgical outcome. It is fast becoming the favored surgical answer to cancer of the bladder” [28]. “The magnification offered by the robotic system grants our surgeons better precision during the procedure, thus, sparing vital delicate nerves and muscle tissue. The benefits of robotic cystectomy: spares vital muscle and delicate nerve tissue, shorter hospital stay, faster return to normal activity, minimal blood loss, minimized chances of postoperative incontinence or impotence, minimized chances of complications commonly associated with cystectomy, minimal postoperative pain” [29]. “Da Vinci Robotic Cystectomy (also known as Robotic Assisted Cystectomy) is the most advanced method of performing Cystectomy . . . decreases risk and speeds recovery” [30]. “Before you decide on which course of action would be right for you, it may help you to know that open surgery patients can experience five times the loss of blood, have four times the risk of other complications, a high chance of infection, incontinence or impotence and are forced to spend roughly three times as much time in the hospital as patients who opt for robotic-assisted surgery. Roboticassisted cystectomy also offers patients a cancer removal rate that is 14% higher” [28].
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based on such information may be potentially harmful, particularly for life-threatening illnesses such as cancer [22]. There have been several attempts to establish “codes of conduct” for Internet sites, for example, by the Health on the Net Foundation (HON), by the European Union (EU), and more recently by the Health Summit Working Group [24 –26]. Despite these efforts, it is clear that information provided in the vast majority of sites remains deficient. Whereas there exist significant shortcomings of Internetderived information, it is interesting that the majority of patients utilizing the Internet for health-related reasons remain enthusiastic about its use, with the vast majority (80% to 93%) deeming the information to be trustworthy [7,19,20,27]. In the present study, one of the most important outcome measures was in regard to reports of surgical resection and oncologic efficacy. At this point in the urologic literature, there is simply no evidence to support that robotic approaches offer a more oncologically complete or efficacious operation [1–5,13–16]. Furthermore, despite claims of improved magnification, instrument dexterity, and other purported benefits of robotic approaches, there exists no evidence to suggest that robotic cystectomy is an inherently technically superior operation compared with the open approach. Indeed, the only operative variable that has been demonstrated in several case series to be potentially beneficial in a robotic approach is the potential for reduced blood loss [1–5,13–16]. Despite the absence of evidence-based information, over 50% of the sites described surgical and oncologic benefits or robotic cystectomy that have no scientific rationale based on the current literature. Of note, 20% of the sites did report some validated benefits, and these were all related to the potential for lower blood loss. What is perhaps most alarming is that one site (one of the highest ranking sites on both Google and Yahoo) claims “a cancer removal rate that is 14% higher” with the robotic approach. Certainly, a scientific basis for such a confusing statement is absent, and claims of a more thorough oncologic operation are simply unfounded. Next, the present study analyzed claims for superior functional outcomes, i.e., potency or continence in the case of orthotopic neobladders. Again, there exist no present literature reporting or comparing erectile function after robotic cystectomy and, thereby, any claims supporting its superiority did not have evidence-based justification in this procedure and patient population [1–5,13–16]. These same conclusions are also true for the potential for improved neobladder continence with robotic cystectomy. Despite this, over 25% of the evaluated sites reported the potential for improved functional outcomes with the robotic approach. We also evaluated the potential for improved postoperative recovery with a robotic-assisted approach. Although there is no randomized study evaluating outcomes compared with the open approach, several case series have suggested lower pain, faster recovery of bowel function, and
faster hospital discharge with robotic vs. open cystectomy by comparing to historical controls [1–5]. Whereas over one-third of the sites did report these evidence-based benefits of recovery, almost half of the provider sites reported advantages (i.e., faster return to work) that are not supported in peer-reviewed literature. It was also surprising to see the amount of information on provider sites that was extracted from the Intuitive Surgical site on robotic cystectomy. Although Intuitive Surgical may be attempting to provide clear and concise information on the potential of robotic cystectomy, there are inherent and potentially significant conflicts of interest that exist in their reporting of robotic cystectomy advantages. Therefore, information from their site, particularly information that is not referenced, cannot be considered a scientific and unbiased source of information. Nevertheless, many providers (33%) utilize this information verbatim on their own sites, and a significant percentage (16%) actually provided direct links back to the Intuitive site and that information. It is concerning that the majority of the URLs were provider sites, with 64% of the sites being university-related providers or institutions, and 36% of the sites not being affiliated with a university (i.e., “private”). Certainly, all physicians should provide information at the highest and unbiased levels of evidence. However, it is our opinion that it is incumbent upon academic institutions, whose charge often involves research and clinical excellence, to provide only scientifically rigorous information at levels that are expected in peer-reviewed literature. In either case (academic or private), all health care professionals should seek to deliver factual and evidence-based information to the public and not suggest untrue or unproven claims that seem to be the present case. As of December, 2008, there are 47 papers on robotic cystectomy that exist in the English literature. Although there are no prospective randomized controlled trials described, and none of the reports are of the highest levels of objective evidence, all of these represent single-institution experiences and case series, and only a few have comparisons to even historical open experiences. Despite these low levels of evidence, there presently exists some literature by which providers can resource and report on the potential benefits of the robotic approach, such as lower blood loss, less pain, faster return of bowel function, and even faster hospital discharge [1–5,13–16]. Indeed, our institution’s experience with this procedure has been favorable. In addition, some of these early case series also do not demonstrate any early inferiority with regard to pathologic outcomes vs. the open approach [1–5,13–16]. However, reporting oncologic or surgical superiority (apart from blood loss), significant functional benefits, and improved postsurgical recovery (beyond hospital discharge) hint of self-promotion, and are speculative or anecdotal at best. Given the fact that many patients utilize the Internet for health-related information, and since the majority of these individuals are
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enthusiastic about its use and deem the information to be trustworthy, such misleading reports by providers may have significant and potentially deleterious influences on a patient’s awareness and expectations about treatment. Ultimately, it is our patients who may be potentially harmed with misinformation, unsound decisions, and even eventually treatment regret. All of these concerns are particularly meaningful when one considers the life-threatening nature of cancer, specifically urothelial cancer.
5. Conclusions The majority of the information available on the internet with regard to robotic cystectomy is supplied by surgeons/ providers. This information is highly variable with much of the information provided being unsubstantiated with little or no evidence-based data. Reported results generally tended to overstate claims of the robotic approach, particularly with regard to surgical and oncologic ability, functional outcomes, and surgical recovery. Furthermore, information directly adapted from the Intuitive site was seen in a significant number of provider sites. These findings seem to show that providers are not presenting evidence-based information to patients and are often over-stating the claims and outcomes of the robotic approach. We feel that such findings should highlight the need for health care professionals to deliver factual and evidence-based information to the public, and not to suggest untrue or unproven claims that seem to be the present case for this potentially life-threatening disease.
References [1] Galich A, Sterrett S, Nazemi T, et al. Comparative analysis of early perioperative outcomes following radical cystectomy by either the robotic or open method. JSLS 2006;10:145–50. [2] Rhee JJ, Lebeau S, Smolkin M, et al. Radical cystectomy with ileal conduit diversion: Early prospective evaluation of the impact of robotic assistance. BJU Int 2006;98:1059 – 63. [3] Pruthi RS, Wallen EM. Robotic assisted laparoscopic radical cystoprostatectomy: Operative and pathological outcomes. J Urol 2007; 178(3 Pt 1):814 – 8. [4] Wang GJ, Barocas DA, Raman JD, et al. Robotic vs. open radical cystectomy: Prospective comparison of perioperative outcomes and pathological measures of early oncological efficacy. BJU Int 2008; 101:89 –93. [5] Guru KA, Wilding GE, Piacente P, et al. Robot-assisted radical cystectomy vs. open radical cystectomy: Assessment of postoperative pain. Can J Urol 2007;14:3753– 6. [6] Phillips B, Ball C, Sackett D, et al. 1998 [cited 2008 12/15]; Available from: http://cebm2.minervation.net/docs/levels.html. [7] Ekman A, Hall P, Litton JE. Can we trust cancer information on the Internet? A comparison of interactive cancer risk sites. Cancer Causes Control 2005;16:765–72.
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[8] Huang GJ, Penson DF. Internet health resources and the cancer patient. Cancer Invest 2008;26:202–7. [9] Matthews SC, Camacho A, Mills PJ, et al. The Internet for medical information about cancer: Help or hindrance? Psychosomatics 2003; 44:100 –3. [10] Burns E. Almost 12 billion U.S. searches conducted in July. 2008 [cited 2008 12/1]; available from: http://searchenginewatch.com/ 3630718. [11] Sullivan D. NielsenNet ratings search engine ratings. [cited 2008 12/1]; Available from: http://searchenginewatch.com/2156451. [12] Schoenberg M, Gonzalgo M. Management of Invasive and Metastatic Bladder Cancer. In: Wein A KL, Novick A, Partin A, editors. Campbell-Walsh Urology, 9th ed. Philadelphia, PA: Elsevier Health Sciences, 2008. p. 2468 –78. [13] Pruthi RS, Wallen EM. Is robotic radical cystectomy an appropriate treatment for bladder cancer? Short-term oncologic and clinical follow-up in 50 consecutive patients. Urology 72:617–20, 2008, Discussion 620 –2. [14] Haber GP, Crouzet S, Gill IS. Laparoscopic and robotic assisted radical cystectomy for bladder cancer: A critical analysis. Eur Urol 2008;54:54 – 62. [15] Hemal AK, Abol-Enein H, Tewari A, et al. Robotic radical cystectomy and urinary diversion in the management of bladder cancer. Urol Clin North Am 2004;31:719 –29, viii. [16] Butt ZM, Perlmutter AE, Piacente PM, et al. Impact of body mass index on robot-assisted radical cystectomy. JSLS 2008;12:241–5. [17] Nielsen/Net ratings. Three out of four Americans have access to the Internet according to Nielsen/Netratings. [cited 2008 12/1]; Available from: http://www.nielsen-netratings.com/pr/pr.040318/pdf. [18] HarrisInteractive.com. Over three-quarters of all U.S. Adults—approximately 172 million—now Online. [cited 2008 12/1]; Available from: http://www.harrisinteractive.com/harris_poll/index.asp?PID⫽668. [19] Fox S, L R. Vital decisions. How internet users decide what information to trust when they or their loved ones are sick. Pew Internet and American Life Project; 2002 May 22. [20] Chen X, Siu LL. Impact of the media and the internet on oncology: Survey of cancer patients and oncologists in Canada. J Clin Oncol 2001;19:4291–7. [21] Hesse BW, Nelson DE, Kreps GL, et al. Trust and sources of health information: The impact of the Internet and its implications for health care providers: Findings from the first Health Information National Trends Survey. Arch Intern Med 2005;165:2618 –24. [22] Al-Bahrani A, Plusa S. The quality of patient-orientated internet information on colorectal cancer. Colorectal Dis 2004;6:323– 6. [23] Lee CT, Smith CA, Hall JM, et al. Bladder cancer facts: Accuracy of information on the Internet. J Urol 2003;170:1756 – 60. [24] HONcode. HON code of conduct (HONcode) for medical and health Web sites. [cited 2008 12/1]; Available from: http://www.hon.ch/ HONcode/Conduct.html. [25] Quality Criteria for Health Related Websites. [cited 2008 12/1]; Available from: http://europa.eu.int/inforamtion_society/eeurope/ ehealth/quality/draft_guidelines/index_en.html. [26] Health Summit working Group. Information quality tool. [cited 2008 12/1]; Available from: http://hitiweb.mitretek.org/docs/criteria.html. [27] Four-country survey finds most cyberchondriacs believe online healthcare information is trustworthy, easy to find and understand. 2002 [cited 2008 12/1]; Available from: http://www.harrisinteractive. com/news/allnewsbydate.asp?NewsID⫽464. [28] Laparoscopic cystectomy. [cited 2008 12/1]; Available from: http:/// www.roboticoncology.com/laparoscopic-cystectomy. [29] Robotic Cystectomy. [cited 2008 12/1]; Available from: http://www. roboticurology.com/Robotic_Cystectomy.html. [30] USA Delaware. [cited 2008 12/1]; Available from: http://www. usadelaware.com/medical_briefs/robotic_surgery_cystectomy.html.
Original article
Robotic cystectomy and the Internet: Separating fact from fiction Raj S. Pruthi, M.D.*, Jim Belsante, M.D., Raj Kurpad, M.D., Matthew E. Nielsen, M.D., Eric M. Wallen, M.D. Division of Urologic Surgery, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA Received 19 March 2009; received in revised form 9 April 2009; accepted 10 April 2009
Abstract Introduction: Patients commonly use the Internet to acquire health information. While a large amount of health-related information is available, the accuracy is highly variable. We sought to evaluate the current web-based information that exists with regard to robotic cystectomy. Methods: Two common search engines (Google and Yahoo) were used to search the term “robotic cystectomy” and obtain the top 50 websites for each. These 100 sites were analyzed with regard to type of site, presence and accuracy of information on bladder cancer, and of information related to robotic cystectomy outcomes (surgical/oncologic, functional, and recovery). In addition, information taken from Intuitive Corp website was identified, as was the presence (or absence) and literature-based references. Results: Of the 100 sites, 61 were surgeon/provider sites, 23 links to articles, 8 news stories, 3 patient support sites, 3 meeting program, and 2 were the Intuitive site. Analysis of all 61 provider sites showed that 13% provided factually accurate information, 7% had both factual and erroneous information, and 80% had no information on bladder cancer. With regard to the purported benefits and outcomes of the robotic approach, a significant number of the sites had nonevidence-based claims with regard surgical/oncologic aspects (54%), functional recovery (26%), and surgical recovery (47%). Information taken directly from the Intuitive site was found on 33% sites, with 16% sites having a direct link. Only 4 provider sites (7%) had listed any references. Conclusions: These findings suggest that surgeons provide the majority of Internet information but do not often present evidence-based information and often over-state claims and outcomes of the robotic approach. This highlights the need for providers to deliver factual and evidence-based information to the public, and not suggest untrue/unproven claims that seem to presently occur. © 2011 Elsevier Inc. All rights reserved. Keywords: Bladder cancer; Cystectomy; Robotic-assisted; Laparoscopic; Internet
1. Introduction Radical cystectomy remains the “gold standard” of treatment for patients with muscle invasive urothelial carcinoma of the bladder, and for those with high-risk recurrent noninvasive disease, providing efficacy with regard to local control and long-term disease-free survival. In recent years, surgeons have begun to report single institution case series of minimally invasive approaches to radical cystectomy, including laparoscopic and, more recently, robotic-assisted techniques, building on the increasing experiences of this surgical modification in prostate cancer. Recent robotic cystectomy case series have demonstrated the surgical feasibil* Corresponding author. Tel.: ⫹1-919-966-2574; fax: ⫹1-919-9660098. E-mail address: [email protected] (R.S. Pruthi). 1078-1439/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.urolonc.2009.04.010
ity of this procedure, with the potential of lower surgical blood loss, more rapid return of bowel function, and even hospital discharge [1–5]. Notwithstanding these experiences and observations, it must be clearly recognized that at this point, high levels of clinical evidence with regard to benefits of robotic cystectomy are absent in peer-reviewed literature, and the current experiences represent single institution case series with limited comparisons with historic controls at best. Despite theses low levels of evidence (Oxford level 4), there appears to be increasing promise and promotion of robotic assisted cystectomy directed toward patients [6]. While healthcare providers remain the most important source of specific medical knowledge, patients are increasingly seeking additional sources of medical information. To this end, the Internet is perhaps the most important resource of added information when patients and their family seek out supplementary knowledge. [7,8] The contribution of
394
R.S. Pruthi et al. / Urologic Oncology: Seminars and Original Investigations 29 (2011) 393–397
Internet-based information may be particularly significant, given the limited amount of knowledge on novel techniques such as robotic cystectomy. Indeed, Matthews et al. have demonstrated that the Internet is a common and influential source for “nontraditional” treatments, despite the poor quality of information provided [9]. Furthermore, all information (including both standard and nontraditional therapies) presented on the Internet does not typically undergo the rigorous scientific validation and peer review process adhered to in the medical literature, and much of the information may be hearsay or anecdotal at best [7,8]. In order to evaluate the quality of information available on the Internet for robotic cystectomy, we sought to utilize commonly used search engines to research sites related to “robotic cystectomy” to access their content, validity, scientific accuracy, and evidence-based information provided, with particular attention to sites by medical providers.
Table 1 Summary of literature-based findings [1–5, 13–16] regarding outcomes of robotic cystectomy (literature search as of 12/15/08 via PubMed)
2. Methods
Procedural recovery
Two common search engines (Google and Yahoo) were used to search the term “robotic cystectomy” and obtain the top 50 URL (uniform resource locater) (or “websites”) for each search engine. Google and Yahoo together represent the 2 most common search engines accounting for over 80% of searches performed according to recent Nielsen ratings and the latest ComScore survey [10,11]. Of note, the search for robotic cystectomy retrieved a total of 43,700 sites and 58,800 sites for Google and Yahoo, respectively, and the analysis was performed from 11/28/08 to 12/20/08. These 100 sites were then analyzed with regard to a variety of factors. First, sites were categorized by the type of site as follows: provider (academic or private), patient support group, link to publication, medical news, meeting program, etc. Second, provider sites were reviewed for the presence and accuracy of information on bladder cancer. Third, each provider site was carefully studied for the presence and accuracy of information related to robotic cystectomy outcomes. This analysis included an evaluation of information in the following categories: (1) surgical/oncologic measures, (2) functional recovery (specifically potency and voiding function for neobladders), and (3) surgical recovery (including factors related to pain, bowel function, hospital discharge, and return to work/activity). Fourth, provider sites were evaluated as to the presence of information taken from directly (verbatim) from the website of the Intuitive Corporation (maker of the DaVinci robotic surgical platform) and with regard to the presence of direct links to the Intuitive site. Last, the presence (or absence) of literature references were recorded for each provider site. As the reference standard for bladder cancer information, Campbell-Walsh Urology textbook (9th edition) was used as the sole reference [12]. For information regarding robotic cystectomy, a PubMed search was performed, and all case series were studied with regard to surgical, oncologic, func-
Outcome parameter
Current evidence in the literature
Oncologic efficacy
No evidence of superiority versus open approach. Current reports have demonstrated the potential for similar outcomes (vs. open) on surgical pathology (e.g., lymph node yield, positive soft tissue margins) and on short-term follow-up (level 4). There currently exists evidence for the potential of lower blood loss (and transfusion requirements) with robotic approach (level 4). There is also some evidence for prolonged operating room times with robotics (level 4). Complication rates (vs. open) appear similar (level 4), but little comparative data exists. No evidence for improved potency or neobladder function with the robotic approach (data absent). Some evidence for more rapid return of bowel function and hospital discharge (level 4). One report of potential for reduced postoperative narcotic requirement (level 4). No evidence for improved quality of life measures or a more rapid return to work/ activities (data absent).
Surgical measures
Functional outcomes
tional, and recovery outcome measures [1–5,13–16]. Of note, all current reports represent single-institution cases series and thereby represent Oxford level evidence of 4 (range 1 ⫽ best to 5 ⫽ worst) [6]. A summary of robotic cystectomy literature-based outcomes is shown in Table 1.
3. Results Of the 50 Google sites, 23 were surgeon/provider sites, 18 links to articles, 4 news stories, 3 patient support sites, 1 meeting program, and 1 was the Intuitive Corporation site. Of the 50 Yahoo sites, 38 were surgeon/provider sites, 5 links to articles, 4 news stories, 2 meeting programs, and 1 was the Intuitive site. Analysis of all 61 provider sites showed that 64% were academic-affiliated and 36% were private practice sites. With regard to information on bladder cancer itself, 13% of the provider sites contained factual information, 7% had both factual and erroneous data, and 80% had no information. (No site had purely erroneous bladder cancer information.) Information taken directly from the Intuitive site was found in 33% sites (9 academic and 11 private). Ten (16%) of the provider sites had a direct link to the Intuitive site. Only 4 provider sites (7%) listed any references, and the remainder (93%) had no literature-based references. Regarding provider-based information, Table 2 demonstrates the findings of the site analysis related to robotic
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Table 2 Analysis of provider Internet sites based on accuracy of purported surgical/oncologic, functional, and recovery outcomes Surgical/oncologic
ALL (n ⫽ 61) Google (n ⫽ 23) Yahoo (n ⫽ 38)
Functional
Recovery
Unsub
Both
Factual
Absent
Unsub
Both
Factual
Absent
Unsub
Both
Factual
Absent
39% 35% 42%
15% 30% 5%
5% 4% 5%
41% 31% 48%
26% 30% 24%
0% 0% 0%
0% 0% 0%
74% 70% 76%
26% 39% 18%
21% 22% 21%
13% 22% 8%
40% 17% 53%
Unsub ⫽ unsubstantiated data/claims (not present in peer-reviewed literature); Factual ⫽ data/claims that have basis in peer-reviewed literature; Both ⫽ having data/claims that are both unsubstantiated and factual; Absent ⫽ no data/claims made.
cystectomy outcomes for the entire group and stratified by search engine used. With regard to information on surgical/ oncologic outcomes, 24 sites (39%) had solely unsubstantiated claims, 9 (15%) had both evidence-based and unsubstantiated information, 25 (41%) had no information, and only 3 (5%) had purely evidence-based data. Information on functional (sexual, urinary) were unsubstantiated in 16 (26%) sites, and absent in 45 (74%) sites. Regarding procedural/physical recovery, 16 (26%) of sites had only unsubstantiated information, 13 (21%) contained both unsubstantiated and evidenced-based information, 24 (40%) had absent information, and only 8 (13%) had evidenced-based data. In summary, a significant number of the sites had nonevidence-based claims with regard surgical/oncologic aspects (54%), functional recovery (26%), and surgical recovery (47%). Table 3 provides some examples of nonevidence-based claims reported on some provider sites.
4. Discussion According to NielsenNet ratings, a recent Harris Poll, approximately 80% of Americans have access to the Internet in their home [17,18]. Furthermore, pursuit of healthrelated information represents the third most common reason for accessing the Internet by users, with a rising trend over the last 5 years [19]. These findings appear to be particularly applicable for the cancer patients in whom access to the Internet may fulfill natural desires to further educate themselves about their disease, with the benefits of convenience and anonymity [8]. (Indeed, a large percentage of oncology patients have reported that they seek such additional knowledge due to the feelings that the information provided by their physician is deemed deficient) [20]. To this point, a recent study by the National Trend Survey demonstrated that whereas cancer patients desire and appreciate information received from their physician, the majority utilized the Internet as an important (and often initial) source of information [21]. Approximately 70% of these information seekers have stated that such information influenced decisions related to their care [19]. Moreover, the Internet sometimes provides the only mechanism through which a patient may obtain information that is otherwise more difficult to encounter, including novel or nontradi-
tional approaches [9]. In the present case, minimally invasive approaches to bladder cancer, including robotic-assisted laparoscopic surgery, may be considered novel and, to some degree, untested, at least by the highest levels of clinical evidence. Despite the tremendous potential for information and education that the Internet provides and given the desire for and reliance on such information by patients, it is clear from a variety of studies that health information found on the Internet is patently deficient, and this has even been shown for bladder cancer in particular [7–9,22,23]. The “anarchic” nature of the Internet in its current state leads to unverified and often faulty information; making therapeutic decisions Table 3 Examples of non-evidenced based claims from provider sites with regard to surgical, oncologic, functional, and recovery outcomes [28 –30] “Not so long ago at all, cystectomy was performed using a traditional open surgical procedure; and therefore usually involved notable tissue and nerve damage, significant blood loss and carried a greater risk of post-operative infections and complications. By comparison, the robotic-assisted laparoscopic cystectomy may seem a bit like a kind of state-of-the-art miracle” [28]. “In reality, the robotic cystectomy is simply a newer and more effectual minimally invasive bladder cancer surgical method. It that makes use of the Da Vinci Robotic Surgical System and imitates a surgeon’s movements—it offers bladder cancer patients the prospect of a more effective surgical and less problematic post-surgical outcome. It is fast becoming the favored surgical answer to cancer of the bladder” [28]. “The magnification offered by the robotic system grants our surgeons better precision during the procedure, thus, sparing vital delicate nerves and muscle tissue. The benefits of robotic cystectomy: spares vital muscle and delicate nerve tissue, shorter hospital stay, faster return to normal activity, minimal blood loss, minimized chances of postoperative incontinence or impotence, minimized chances of complications commonly associated with cystectomy, minimal postoperative pain” [29]. “Da Vinci Robotic Cystectomy (also known as Robotic Assisted Cystectomy) is the most advanced method of performing Cystectomy . . . decreases risk and speeds recovery” [30]. “Before you decide on which course of action would be right for you, it may help you to know that open surgery patients can experience five times the loss of blood, have four times the risk of other complications, a high chance of infection, incontinence or impotence and are forced to spend roughly three times as much time in the hospital as patients who opt for robotic-assisted surgery. Roboticassisted cystectomy also offers patients a cancer removal rate that is 14% higher” [28].
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based on such information may be potentially harmful, particularly for life-threatening illnesses such as cancer [22]. There have been several attempts to establish “codes of conduct” for Internet sites, for example, by the Health on the Net Foundation (HON), by the European Union (EU), and more recently by the Health Summit Working Group [24 –26]. Despite these efforts, it is clear that information provided in the vast majority of sites remains deficient. Whereas there exist significant shortcomings of Internetderived information, it is interesting that the majority of patients utilizing the Internet for health-related reasons remain enthusiastic about its use, with the vast majority (80% to 93%) deeming the information to be trustworthy [7,19,20,27]. In the present study, one of the most important outcome measures was in regard to reports of surgical resection and oncologic efficacy. At this point in the urologic literature, there is simply no evidence to support that robotic approaches offer a more oncologically complete or efficacious operation [1–5,13–16]. Furthermore, despite claims of improved magnification, instrument dexterity, and other purported benefits of robotic approaches, there exists no evidence to suggest that robotic cystectomy is an inherently technically superior operation compared with the open approach. Indeed, the only operative variable that has been demonstrated in several case series to be potentially beneficial in a robotic approach is the potential for reduced blood loss [1–5,13–16]. Despite the absence of evidence-based information, over 50% of the sites described surgical and oncologic benefits or robotic cystectomy that have no scientific rationale based on the current literature. Of note, 20% of the sites did report some validated benefits, and these were all related to the potential for lower blood loss. What is perhaps most alarming is that one site (one of the highest ranking sites on both Google and Yahoo) claims “a cancer removal rate that is 14% higher” with the robotic approach. Certainly, a scientific basis for such a confusing statement is absent, and claims of a more thorough oncologic operation are simply unfounded. Next, the present study analyzed claims for superior functional outcomes, i.e., potency or continence in the case of orthotopic neobladders. Again, there exist no present literature reporting or comparing erectile function after robotic cystectomy and, thereby, any claims supporting its superiority did not have evidence-based justification in this procedure and patient population [1–5,13–16]. These same conclusions are also true for the potential for improved neobladder continence with robotic cystectomy. Despite this, over 25% of the evaluated sites reported the potential for improved functional outcomes with the robotic approach. We also evaluated the potential for improved postoperative recovery with a robotic-assisted approach. Although there is no randomized study evaluating outcomes compared with the open approach, several case series have suggested lower pain, faster recovery of bowel function, and
faster hospital discharge with robotic vs. open cystectomy by comparing to historical controls [1–5]. Whereas over one-third of the sites did report these evidence-based benefits of recovery, almost half of the provider sites reported advantages (i.e., faster return to work) that are not supported in peer-reviewed literature. It was also surprising to see the amount of information on provider sites that was extracted from the Intuitive Surgical site on robotic cystectomy. Although Intuitive Surgical may be attempting to provide clear and concise information on the potential of robotic cystectomy, there are inherent and potentially significant conflicts of interest that exist in their reporting of robotic cystectomy advantages. Therefore, information from their site, particularly information that is not referenced, cannot be considered a scientific and unbiased source of information. Nevertheless, many providers (33%) utilize this information verbatim on their own sites, and a significant percentage (16%) actually provided direct links back to the Intuitive site and that information. It is concerning that the majority of the URLs were provider sites, with 64% of the sites being university-related providers or institutions, and 36% of the sites not being affiliated with a university (i.e., “private”). Certainly, all physicians should provide information at the highest and unbiased levels of evidence. However, it is our opinion that it is incumbent upon academic institutions, whose charge often involves research and clinical excellence, to provide only scientifically rigorous information at levels that are expected in peer-reviewed literature. In either case (academic or private), all health care professionals should seek to deliver factual and evidence-based information to the public and not suggest untrue or unproven claims that seem to be the present case. As of December, 2008, there are 47 papers on robotic cystectomy that exist in the English literature. Although there are no prospective randomized controlled trials described, and none of the reports are of the highest levels of objective evidence, all of these represent single-institution experiences and case series, and only a few have comparisons to even historical open experiences. Despite these low levels of evidence, there presently exists some literature by which providers can resource and report on the potential benefits of the robotic approach, such as lower blood loss, less pain, faster return of bowel function, and even faster hospital discharge [1–5,13–16]. Indeed, our institution’s experience with this procedure has been favorable. In addition, some of these early case series also do not demonstrate any early inferiority with regard to pathologic outcomes vs. the open approach [1–5,13–16]. However, reporting oncologic or surgical superiority (apart from blood loss), significant functional benefits, and improved postsurgical recovery (beyond hospital discharge) hint of self-promotion, and are speculative or anecdotal at best. Given the fact that many patients utilize the Internet for health-related information, and since the majority of these individuals are
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enthusiastic about its use and deem the information to be trustworthy, such misleading reports by providers may have significant and potentially deleterious influences on a patient’s awareness and expectations about treatment. Ultimately, it is our patients who may be potentially harmed with misinformation, unsound decisions, and even eventually treatment regret. All of these concerns are particularly meaningful when one considers the life-threatening nature of cancer, specifically urothelial cancer.
5. Conclusions The majority of the information available on the internet with regard to robotic cystectomy is supplied by surgeons/ providers. This information is highly variable with much of the information provided being unsubstantiated with little or no evidence-based data. Reported results generally tended to overstate claims of the robotic approach, particularly with regard to surgical and oncologic ability, functional outcomes, and surgical recovery. Furthermore, information directly adapted from the Intuitive site was seen in a significant number of provider sites. These findings seem to show that providers are not presenting evidence-based information to patients and are often over-stating the claims and outcomes of the robotic approach. We feel that such findings should highlight the need for health care professionals to deliver factual and evidence-based information to the public, and not to suggest untrue or unproven claims that seem to be the present case for this potentially life-threatening disease.
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