Invited Editorial
Eleven questions regarding cervical cancer prevention in India During the 1970s and 1980s, numerous scientific studies established cervical screening to be an archetypal preventive health intervention. [1] Nevertheless, since 1998, three separate randomized trials in India funded by the US National Cancer Institute (NCI) and the Bill and Melinda Gates Foundation have compared, in aggregate, cervical cancer death rates among 224,929 women offered cervical screening to cervical cancer death rates among 138,624 women offered no screening whatsoever. To date, at least 254 women in unscreened control groups have died from cervical cancer.[2‑4] The US Office for Human Research Protections (OHRP) provides leadership in the protection of human subjects involved in research conducted or supported by the US Department of Health and Human Services. The OHRP has no authority to investigate research funded by the Gates Foundation, but determined in 2012 that the NCI‑funded study in India was unethical because study subjects had not been given adequate information to provide informed consent.[5] The lack of equipoise embedded in the defective scientific design of these US‑funded studies required inadequate informed consent, and, predictably, nothing was learned from the deaths of women in these studies that was not already known.[2] Conversations regarding the science and ethics of the iconic Tuskegee Syphilis Study, to which the US‑funded India screening studies have been compared,[4] have continued for decades following the halt of that tragic debacle in 1972. The injustice of the US‑funded India screening studies will be compounded if past[2‑4] and future conversations regarding those studies needlessly redirect intellectual resources required to address India’s current challenges into contemplations of an immutable past. Real‑world obstacles to successful cervical cancer prevention involve people far more than technology, and success requires sustained, coordinated effort among stakeholders with shared interests but competing incentives.[6] For example, although
all stakeholders share an interest in improving health outcomes by preventing cervical cancer, some stakeholders aim to improve outcomes while enhancing corporate profit, while others aim to improve outcomes while enhancing research funding and academic advancement, and still others aim to improve outcomes while enhancing professional reimbursement.[6] The definitive goal of all public health efforts, including cervical cancer prevention, is to improve health outcomes as rapidly as possible among as many people as possible. However, as exemplified by the tragic US‑funded India screening studies, influential global health organizations are currently incentivising research and commercial interests at the expense of that definitive goal.[2] The time is past due for a shift in conversational agendas, away from those which primarily benefit research and commercial interests, toward those which primarily benefit the common good. Productive conversations regarding the most effective routes toward the definitive goal of public health should be encouraged.
Eric J. Suba Director of Clinical Laboratories, Kaiser Permanente Medical Center, 350 Saint Joseph Avenue, San Francisco, California, USA For correspondence: Dr. Eric J. Suba, The Viet/American Cervical Cancer Prevention Project, 2295 Vallejo Street, Suite 508, San Francisco, California - 94123, USA. E-mail: eric.suba@ gmail.com
THE DELPHI METHOD: A CONVERSATIONAL TOOL The Delphi method is a tool for structuring conversation in manners that allow diverse (and at times contentious) groups of individuals to deal with complex problems without necessarily having to meet face‑to‑face.[7] The Delphi method was originally developed at the RAND Corporation during the Cold War to forecast the impact of technology on warfare, and is characterized by anonymity of participants and structured information flow. These characteristics help avoid certain negative attributes of face‑to‑face conversation (such as groupthink, bandwagon effect, halo effect, and personality conflict) that tend to cause poor decision‑making. The Delphi method allows participants to more freely express their opinions, openly critique the opinions of others, admit error, and revise judgments. With the Delphi method, participants maintain anonymity, sometimes even after final reports are issued.
Journal of Cancer Research and Therapeutics - July-September 2014 - Volume 10 - Issue 3
Access this article online Website: www.cancerjournal.net DOI: 10.4103/0973-1482.142746 PMID: *** Quick Response Code:
459
Suba: Cervical cancer prevention in India
For the past several years, the Papanicolaou Society of Cytopathology (an all‑volunteer US‑based non‑profit organization) has been organizing unmoderated Delphi conversations regarding cervical cancer prevention among stakeholders in Guatemala, Mexico, and Viet Nam. Individuals invited to volunteer as participants in these Delphi conversations have included the leaders of ministries of health, women’s groups, non‑governmental organizations, faith‑based organizations, midwives, private and public laboratories, medical universities, and professional medical societies, as well as global experts in cervical cancer prevention. These Delphi conversations have been conducted on a free, user‑friendly Delphi website hosted by the Wharton School of Business at the University of Pennsylvania.[8] ELEVEN QUESTIONS REGARDING CERVICAL CANCER PREVENTION
definitive public health goal of improving health outcomes as rapidly as possible among as many people as possible. All 11 questions were offered in English, Spanish, and Vietnamese. Responses could be in any language. Participants were responsible for translations of responses offered in languages other than their own. After all participants had submitted responses to the questions, the Delphi website allowed each participant to review responses from all of the other participants. Subsequently, all participants were invited to comment on responses from the other participants while once again submitting responses to the same 11 questions, to assess whether any revisions of viewpoint may have occurred. Face‑to‑face meetings to discuss the results of the Delphi conversation will be conducted in Guatemala, Mexico, and Viet Nam. All Delphi participants have the option of publishing the content of their conversations. CONCLUSIONS
The online Delphi conversations among stakeholders in Guatemala, Mexico, and Viet Nam have consisted of responses to these 11 questions: • Will the introduction of visual inspection with acetic acid (VIA), and/or human papillomavirus (HPV) vaccines, and/or HPV screening entirely eliminate requirements for gynecologic cytology? • Will the introduction of HPV screening accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will quality management for HPV screening be more effective than quality management for cytology screening? • Will the introduction of HPV screening accelerate or decelerate reductions in cervical cancer rates? • Will the introduction of liquid‑based cytology (LBC) accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will the introduction of LBC accelerate or decelerate reductions in cervical cancer rates? • Will the introduction of VIA screening accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will quality management for VIA screening be more effective than quality management for cytology screening? • Will the introduction of VIA screening accelerate or decelerate reductions in cervical cancer rates? • Will the introduction of HPV vaccines accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will the introduction of HPV vaccines accelerate or decelerate reductions in cervical cancer rates? The aim of structuring Delphi conversations around these questions is to use the Socratic method to facilitate conversation regarding the most effective routes to the
460
Indian women at high risk for death from cervical cancer may wish to consider whether their legitimate health interests are satisfactorily being served by US‑funded medical leaders.[2‑4] I will gladly assist any stakeholders interested in organizing an all‑volunteer Delphi conversation regarding cervical cancer prevention for India. REFERENCES 1. DeMay RM. The Pap Test. First Edition. American Society for Clinical Pathology Press: Chicago, Illinois, 2005.ISBN 0-89189-420-9. 2. Suba EJ. US‑funded measurements of cervical cancer death rates in India: Scientific and ethical concerns. Indian J Med Ethics 2014;11:167‑75. 3. Sankaranarayanan R, Nene BM, Shastri S, Esmy PE, Rajkumar R, Muwonge R, et al. Response to article titled “US‑funded measurements of cervical cancer death rates in India: Scientific and ethical concerns” by Eric J Suba. Indian J Med Ethics 2014;11:175‑8. 4. Suba EJ. Response by Eric Suba to Sankaranarayanan et al. Indian J Med Ethics 2014;11:178‑80. 5. U.S. Office for Human Research Protections. July 5, 2012 Letter of Determination. Available from: http://www.hhs.gov/ohrp/detrm_ letrs/YR12/jul12d.pdf [Last accessed on 2014 Aug 21]. 6. Suba EJ, Murphy SK, Donnelly AD, Furia LM, Huynh ML, Raab SS. On behalf of the Viet/American Cervical Cancer Prevention Project. Systems analysis of real‑world obstacles to successful cervical cancer prevention in developing countries. Am J Public Health 2006;96:480‑7. 7. RAND Corporation. The Delphi Method. Available from: http://www. rand.org/pardee/pubs/futures_method/delphi.html [Last accessed on 2014 Aug 21]. 8. Armstrong JS. Delphi Decision Aid. Available from: http:// armstrong.wharton.upenn.edu/delphi2/index.php [Last accessed on 2014 Aug 21]. Cite this article as: Suba EJ. Eleven questions regarding cervical cancer prevention in India. J Can Res Ther 2014;10:459-60.
Source of Support: Nil, Conflict of Interest: None declared.
Journal of Cancer Research and Therapeutics - July-September 2014 - Volume 10 - Issue 3
Copyright of Journal of Cancer Research & Therapeutics is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Eleven questions regarding cervical cancer prevention in India During the 1970s and 1980s, numerous scientific studies established cervical screening to be an archetypal preventive health intervention. [1] Nevertheless, since 1998, three separate randomized trials in India funded by the US National Cancer Institute (NCI) and the Bill and Melinda Gates Foundation have compared, in aggregate, cervical cancer death rates among 224,929 women offered cervical screening to cervical cancer death rates among 138,624 women offered no screening whatsoever. To date, at least 254 women in unscreened control groups have died from cervical cancer.[2‑4] The US Office for Human Research Protections (OHRP) provides leadership in the protection of human subjects involved in research conducted or supported by the US Department of Health and Human Services. The OHRP has no authority to investigate research funded by the Gates Foundation, but determined in 2012 that the NCI‑funded study in India was unethical because study subjects had not been given adequate information to provide informed consent.[5] The lack of equipoise embedded in the defective scientific design of these US‑funded studies required inadequate informed consent, and, predictably, nothing was learned from the deaths of women in these studies that was not already known.[2] Conversations regarding the science and ethics of the iconic Tuskegee Syphilis Study, to which the US‑funded India screening studies have been compared,[4] have continued for decades following the halt of that tragic debacle in 1972. The injustice of the US‑funded India screening studies will be compounded if past[2‑4] and future conversations regarding those studies needlessly redirect intellectual resources required to address India’s current challenges into contemplations of an immutable past. Real‑world obstacles to successful cervical cancer prevention involve people far more than technology, and success requires sustained, coordinated effort among stakeholders with shared interests but competing incentives.[6] For example, although
all stakeholders share an interest in improving health outcomes by preventing cervical cancer, some stakeholders aim to improve outcomes while enhancing corporate profit, while others aim to improve outcomes while enhancing research funding and academic advancement, and still others aim to improve outcomes while enhancing professional reimbursement.[6] The definitive goal of all public health efforts, including cervical cancer prevention, is to improve health outcomes as rapidly as possible among as many people as possible. However, as exemplified by the tragic US‑funded India screening studies, influential global health organizations are currently incentivising research and commercial interests at the expense of that definitive goal.[2] The time is past due for a shift in conversational agendas, away from those which primarily benefit research and commercial interests, toward those which primarily benefit the common good. Productive conversations regarding the most effective routes toward the definitive goal of public health should be encouraged.
Eric J. Suba Director of Clinical Laboratories, Kaiser Permanente Medical Center, 350 Saint Joseph Avenue, San Francisco, California, USA For correspondence: Dr. Eric J. Suba, The Viet/American Cervical Cancer Prevention Project, 2295 Vallejo Street, Suite 508, San Francisco, California - 94123, USA. E-mail: eric.suba@ gmail.com
THE DELPHI METHOD: A CONVERSATIONAL TOOL The Delphi method is a tool for structuring conversation in manners that allow diverse (and at times contentious) groups of individuals to deal with complex problems without necessarily having to meet face‑to‑face.[7] The Delphi method was originally developed at the RAND Corporation during the Cold War to forecast the impact of technology on warfare, and is characterized by anonymity of participants and structured information flow. These characteristics help avoid certain negative attributes of face‑to‑face conversation (such as groupthink, bandwagon effect, halo effect, and personality conflict) that tend to cause poor decision‑making. The Delphi method allows participants to more freely express their opinions, openly critique the opinions of others, admit error, and revise judgments. With the Delphi method, participants maintain anonymity, sometimes even after final reports are issued.
Journal of Cancer Research and Therapeutics - July-September 2014 - Volume 10 - Issue 3
Access this article online Website: www.cancerjournal.net DOI: 10.4103/0973-1482.142746 PMID: *** Quick Response Code:
459
Suba: Cervical cancer prevention in India
For the past several years, the Papanicolaou Society of Cytopathology (an all‑volunteer US‑based non‑profit organization) has been organizing unmoderated Delphi conversations regarding cervical cancer prevention among stakeholders in Guatemala, Mexico, and Viet Nam. Individuals invited to volunteer as participants in these Delphi conversations have included the leaders of ministries of health, women’s groups, non‑governmental organizations, faith‑based organizations, midwives, private and public laboratories, medical universities, and professional medical societies, as well as global experts in cervical cancer prevention. These Delphi conversations have been conducted on a free, user‑friendly Delphi website hosted by the Wharton School of Business at the University of Pennsylvania.[8] ELEVEN QUESTIONS REGARDING CERVICAL CANCER PREVENTION
definitive public health goal of improving health outcomes as rapidly as possible among as many people as possible. All 11 questions were offered in English, Spanish, and Vietnamese. Responses could be in any language. Participants were responsible for translations of responses offered in languages other than their own. After all participants had submitted responses to the questions, the Delphi website allowed each participant to review responses from all of the other participants. Subsequently, all participants were invited to comment on responses from the other participants while once again submitting responses to the same 11 questions, to assess whether any revisions of viewpoint may have occurred. Face‑to‑face meetings to discuss the results of the Delphi conversation will be conducted in Guatemala, Mexico, and Viet Nam. All Delphi participants have the option of publishing the content of their conversations. CONCLUSIONS
The online Delphi conversations among stakeholders in Guatemala, Mexico, and Viet Nam have consisted of responses to these 11 questions: • Will the introduction of visual inspection with acetic acid (VIA), and/or human papillomavirus (HPV) vaccines, and/or HPV screening entirely eliminate requirements for gynecologic cytology? • Will the introduction of HPV screening accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will quality management for HPV screening be more effective than quality management for cytology screening? • Will the introduction of HPV screening accelerate or decelerate reductions in cervical cancer rates? • Will the introduction of liquid‑based cytology (LBC) accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will the introduction of LBC accelerate or decelerate reductions in cervical cancer rates? • Will the introduction of VIA screening accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will quality management for VIA screening be more effective than quality management for cytology screening? • Will the introduction of VIA screening accelerate or decelerate reductions in cervical cancer rates? • Will the introduction of HPV vaccines accelerate or decelerate coverage of target demographic groups by cervical‑screening services? • Will the introduction of HPV vaccines accelerate or decelerate reductions in cervical cancer rates? The aim of structuring Delphi conversations around these questions is to use the Socratic method to facilitate conversation regarding the most effective routes to the
460
Indian women at high risk for death from cervical cancer may wish to consider whether their legitimate health interests are satisfactorily being served by US‑funded medical leaders.[2‑4] I will gladly assist any stakeholders interested in organizing an all‑volunteer Delphi conversation regarding cervical cancer prevention for India. REFERENCES 1. DeMay RM. The Pap Test. First Edition. American Society for Clinical Pathology Press: Chicago, Illinois, 2005.ISBN 0-89189-420-9. 2. Suba EJ. US‑funded measurements of cervical cancer death rates in India: Scientific and ethical concerns. Indian J Med Ethics 2014;11:167‑75. 3. Sankaranarayanan R, Nene BM, Shastri S, Esmy PE, Rajkumar R, Muwonge R, et al. Response to article titled “US‑funded measurements of cervical cancer death rates in India: Scientific and ethical concerns” by Eric J Suba. Indian J Med Ethics 2014;11:175‑8. 4. Suba EJ. Response by Eric Suba to Sankaranarayanan et al. Indian J Med Ethics 2014;11:178‑80. 5. U.S. Office for Human Research Protections. July 5, 2012 Letter of Determination. Available from: http://www.hhs.gov/ohrp/detrm_ letrs/YR12/jul12d.pdf [Last accessed on 2014 Aug 21]. 6. Suba EJ, Murphy SK, Donnelly AD, Furia LM, Huynh ML, Raab SS. On behalf of the Viet/American Cervical Cancer Prevention Project. Systems analysis of real‑world obstacles to successful cervical cancer prevention in developing countries. Am J Public Health 2006;96:480‑7. 7. RAND Corporation. The Delphi Method. Available from: http://www. rand.org/pardee/pubs/futures_method/delphi.html [Last accessed on 2014 Aug 21]. 8. Armstrong JS. Delphi Decision Aid. Available from: http:// armstrong.wharton.upenn.edu/delphi2/index.php [Last accessed on 2014 Aug 21]. Cite this article as: Suba EJ. Eleven questions regarding cervical cancer prevention in India. J Can Res Ther 2014;10:459-60.
Source of Support: Nil, Conflict of Interest: None declared.
Journal of Cancer Research and Therapeutics - July-September 2014 - Volume 10 - Issue 3
Copyright of Journal of Cancer Research & Therapeutics is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
