Re: Assessment of changes to screening programmes: why randomisation is important
Many might agree, as I do, with Bell et al [1], who argue that the best way to assess the changes that occur within screening programmes as new technologies and treatments become available is through randomised trials within the programmes. Indeed, some have lamented that this was not done earlier so that fewer uncertainties would have remained now!
I am, however, disquieted by their approach in particular with respect to its failure, as far as I can determine, to include as yet any non-health-professional citizens in this preliminary proposal stage; their question about use of information-provision; their view of consent as something provided by the participant rather than collaboratively achieved [2]; and generally to convey the notion that their proposal is one that should be considered solely by health professionals. Surely it is a matter for all citizens to be involved with from the start of deliberation of these questions for research? Overall, if citizens were to be involved, this proposal would provide a wonderful opportunity to educate the public whilst they are well about all the uncertainties that obtain in screening and in the research process generally. Testing Treatments could be used to explain randomisation, for example, or to learn about screening in Chapter 4 `Earlier is not necessarily better`, and to consider uncertainties. [3]
Australia is in the forefront for exploring how Society might become better engaged in such matters. For example, a Screening Symposium in Sydney in 2011 [4], posited on the belief that `epidemiological evidence of benefits and harms is not enough to inform screening policy`, set out to `find ways to engage communities in identifying the gaps in the existing evidence and facilitate evidence-informed deliberations among community representatives about what is important to them`. The BMJ itself has recognised the importance of patient and citizen involvement in the whole research process in its recent policies. Furthermore, screening is a public health matter that concerns all citizens, be they health-professional or not, utilising public funds in its implementation. Provision of adequate information for potential screening participants has been the subject of intense debate in the pages of the BMJ (and elsewhere) over many years, and is now accepted as an essential human right. The strongest available evidence has been used and debated when considering one of the BMJ`s recent campaigns of `Preventing Overdiagnosis`, with input from non-health-professionals.
In their opening paragraph, Bell et al, when advocating randomised controlled trials, suggest that one of the specific components where uncertainties may remain is: “Should potential participants be given an information booklet?” And when considering any obstacles that need to be overcome, the authors suggest that
“It may be argued that randomisation within screening programmes does not have sufficient benefit for participants and may confuse invitees, leading to low participation and limited health benefits.”
Why no mention of harms avoided? Might not `low properly informed participation` be preferable to achieving `high under- or ill-informed participation`? Is `high participation` a proper goal? Would not all citizens be beneficiaries of a well conducted screening trial? Currently, under-informed citizens can be subjected unknowingly to harm. Consenting invitees might legitimately give their consent for a variety of reasons, aside from their degree of possible confusion. Participants agree to participate in trials for many different reasons, including altruism, with varying degrees of `understanding`/`misunderstanding` (confusion). [5]
I find it disturbing that there seems to be little recognition of the current inclusive approach that respects citizens and their rights, or gives them opportunity to exercise their responsibilities.
[1] Bell KJL, Bossuyt P, Glasziou P, Irwig L. Assessment of changes to screening programmes: why randomisation is important. BMJ 2015;350:h1566
[3] Evans I, Thornton H, Chalmers I, Glasziou P. Testing treatments: better research for better healthcare – Second Edition. Pinter and Martin, London. 2011. ISBN 978-1-905177-48-6 Free download from www.testingtreatments.org/the-book/
[4] Screening Symposium, School of Public Health, University of Sydney, 8 December 2011 “What do the community want from screening?”
[5] Dixon-Woods, M, Ashcroft RE, Jackson CJ, Tobin MD, Kivits J, et al. Beyond “misunderstanding”: Written information and decision about taking part in a genetic epidemiology study. Social Science and Medicine. 2007;65:11:2212-2222
Competing interests:
No competing interests
01 April 2015
Hazel Thornton
Honorary Visiting Fellow, Department of Health Sciences
Rapid Response:
Re: Assessment of changes to screening programmes: why randomisation is important
Many might agree, as I do, with Bell et al [1], who argue that the best way to assess the changes that occur within screening programmes as new technologies and treatments become available is through randomised trials within the programmes. Indeed, some have lamented that this was not done earlier so that fewer uncertainties would have remained now!
I am, however, disquieted by their approach in particular with respect to its failure, as far as I can determine, to include as yet any non-health-professional citizens in this preliminary proposal stage; their question about use of information-provision; their view of consent as something provided by the participant rather than collaboratively achieved [2]; and generally to convey the notion that their proposal is one that should be considered solely by health professionals. Surely it is a matter for all citizens to be involved with from the start of deliberation of these questions for research? Overall, if citizens were to be involved, this proposal would provide a wonderful opportunity to educate the public whilst they are well about all the uncertainties that obtain in screening and in the research process generally. Testing Treatments could be used to explain randomisation, for example, or to learn about screening in Chapter 4 `Earlier is not necessarily better`, and to consider uncertainties. [3]
Australia is in the forefront for exploring how Society might become better engaged in such matters. For example, a Screening Symposium in Sydney in 2011 [4], posited on the belief that `epidemiological evidence of benefits and harms is not enough to inform screening policy`, set out to `find ways to engage communities in identifying the gaps in the existing evidence and facilitate evidence-informed deliberations among community representatives about what is important to them`. The BMJ itself has recognised the importance of patient and citizen involvement in the whole research process in its recent policies. Furthermore, screening is a public health matter that concerns all citizens, be they health-professional or not, utilising public funds in its implementation. Provision of adequate information for potential screening participants has been the subject of intense debate in the pages of the BMJ (and elsewhere) over many years, and is now accepted as an essential human right. The strongest available evidence has been used and debated when considering one of the BMJ`s recent campaigns of `Preventing Overdiagnosis`, with input from non-health-professionals.
In their opening paragraph, Bell et al, when advocating randomised controlled trials, suggest that one of the specific components where uncertainties may remain is: “Should potential participants be given an information booklet?” And when considering any obstacles that need to be overcome, the authors suggest that
“It may be argued that randomisation within screening programmes does not have sufficient benefit for participants and may confuse invitees, leading to low participation and limited health benefits.”
Why no mention of harms avoided? Might not `low properly informed participation` be preferable to achieving `high under- or ill-informed participation`? Is `high participation` a proper goal? Would not all citizens be beneficiaries of a well conducted screening trial? Currently, under-informed citizens can be subjected unknowingly to harm. Consenting invitees might legitimately give their consent for a variety of reasons, aside from their degree of possible confusion. Participants agree to participate in trials for many different reasons, including altruism, with varying degrees of `understanding`/`misunderstanding` (confusion). [5]
I find it disturbing that there seems to be little recognition of the current inclusive approach that respects citizens and their rights, or gives them opportunity to exercise their responsibilities.
[1] Bell KJL, Bossuyt P, Glasziou P, Irwig L. Assessment of changes to screening programmes: why randomisation is important. BMJ 2015;350:h1566
[2] Sutton AG. New rules of consent. BJM rapid response 1st April 2015. http://www.bmj.com/content/350/bmj.h1534/rr-8
[3] Evans I, Thornton H, Chalmers I, Glasziou P. Testing treatments: better research for better healthcare – Second Edition. Pinter and Martin, London. 2011. ISBN 978-1-905177-48-6 Free download from www.testingtreatments.org/the-book/
[4] Screening Symposium, School of Public Health, University of Sydney, 8 December 2011 “What do the community want from screening?”
[5] Dixon-Woods, M, Ashcroft RE, Jackson CJ, Tobin MD, Kivits J, et al. Beyond “misunderstanding”: Written information and decision about taking part in a genetic epidemiology study. Social Science and Medicine. 2007;65:11:2212-2222
Competing interests: No competing interests