Abstract
Background:
Cone Beam Computed Tomography (CBCT), the focus of a number of radiotherapy fundraising campaigns in the mid-2000s, was introduced accompanied by a fanfare of newness and discourses of ‘hope’, ‘inspiring clinical confidence’ and ‘accuracy’. The CBCT system, used in the delivery of Radiotherapy treatment, was incorporated into strategic planning priorities across the United Kingdom based on a rationale of self-evidence. During this time, the way in which the new system was discussed with patients was variable.
Research objectives:
The purpose of this study was to uncover how experimental practices were embedded and enacted during the use of a new technological system, specifically relating to how patients were enrolled during introductory phases of technology adoption.
Research design and context:
Drawing on ethnographic work and interviews with staff members in one hospital, the study examines staff discussions prior to the introduction of the Cone-Beam CT imaging system in radiotherapy. It considers how staff views were at odds with practices that occurred during the ‘experimental’ stages of use and how these were shared with patients.
Ethical considerations:
Approval was obtained from the Local National Health Service Research Ethics Committee and National Health Service Main Research Ethics Committee (REC 07/Q1308/16) for the interview and ethnographic stages, respectively. All names have been changed and participants signed a consent form.
Findings:
Staff reported a lack of evidence, absence of proof and perturbing doubts with the X-ray volumetric imaging. Both patients’ and practitioners’ partial understanding about the risks and benefits of the system created incommensurable ideas regarding its use and what the patients’ role was during these introductory stages.
Conclusion:
Maintaining partial truth telling renders patients’ experiences of new treatment at odds with ‘experimental’ practice. This has wide-reaching implications for practice.
Introduction
Withholding truth from patients is a well-debated ethical concern within the medical profession. Tuckett 1 dates the rise of truth telling as a concept to the 1950s following the 1947 Nuremberg trial where it was established that the Hippocratic view of the doctor–patient relationship, centred on beneficence, was insufficient to protect individuals from medical abuses, indicating the need to consent prior to medical procedures. Gillon, 2 in a report to the BMJ, reported that it was Davidson, in 1957, who began the discussion regarding the likelihood of causing harm through prioritising honesty above information relating to a patient’s condition. Through these discussions, it was suggested that withholding the truth could be seen as a mode of evading awkward or unpleasant responsibility.
In the literature reviewed by Tuckett,
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the view that truth telling is essential because it is an intrinsic good was described along with the argument against truth telling based on the uncertainty principle. These arguments are well covered in the literature and are specifically used in debates over whether a patient would want to or should know the truth relating to diagnosis, usually terminal.
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The main arguments for deception or withholding information from patients are posited to be as follows: A doctor may add to a patient’s distress by telling them distressing news, thus adding to a patient’s problems; That the truth cannot be communicated because a doctor is rarely, or never, in a position to know the truth or because a patient would rarely, if ever, be in a position to understand the truth; That patients do not wish to be told the truth.
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Pergert and Lutzen 6 have discussed the relationship of hope and truth telling (again in the context of the diagnosis with severely sick patients or end-of-life care). The authors assert that ‘healthcare staff protect themselves and others by balancing truth telling with the aim of preserving hope’. However, when the truth is uncertainty, this balancing act is not specifically about preserving hope for the patient, rather it may be considered a mode of preserving and continuing practice without disruption. Balancing the level of disclosure, particularly within uncertain practices, can thus be considered partial truth telling.
Yet, ‘truth’ is a culturally constructed artefact. It is not a static object awaiting neutral discovery or delivery by a doctor to a patient.
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Pergert and Lutzen
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define truth, in the context of truth telling, as … the subjective truth; that is, what healthcare staff, out of their qualified judgement believe to and are convinced to be true.
One problem, of many problems, related to situated practices of truth telling occurs when there is uncertainty over practice, where risks are not ‘facts’, rather they are ‘perturbing doubts’. Telling the truth on uncertain territory can lead to a lack of confidence in practice or the need for overburdening of patients (and practitioners) with details, likelihoods, outcomes, alternatives and also speculation.
Surbone
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states that one particular difficulty with telling the truth within an oncology context is ‘avoiding therapeutic misconceptions in early-phase clinical trials’;
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indeed, Lignou and Edwards
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describe how … intentionally manipulating information can protect and secure a subject’s rights and at the same time benefit society. Moreover, we claim that manipulation of information may also affect a person’s desires to take part in a research without modifying or altering their beliefs and thus that a definition of manipulation of information broader than that found in the literature should be adopted.
In this article, I aim to look at truth telling in experimental practices. For the purposes of this article, I am defining experimental practices as a practice under study or evaluation and an experimental subject as a person under study or evaluation. I use these terms over ‘research practice’ or ‘research subject’ as the categorisation of a practice as research initiates governance frameworks for regulation and safeguarding. In the present paper, I aim to consider how partial truth telling in such practices raises empirical ethical issues for practitioners, patients and researchers alike. I want to move away from truth telling and its associations with delivering diagnosis or prognosis and look at a much more applied, situated and empirical example of telling the truth to patients.
Drawing on Pol's definition of ‘empirical ethics’ the paper connects with the ‘goods’ that carers and patients strive for, the values and norms they inexplicitly or explicitly shape and the ‘bads’ they want to avoid. 14 In working through this empirical case study and exploring the practices as they took place, I aim to reveal embedded values and ideals as they manifest in practice.
Research aim and objectives
Through this case study, I aimed to look at situated ethics, ethical dilemmas that occur in practice, highlighting how contexts of uncertainty and accountability shape responsibilities in experimental practice. The questions I sought to answer were, ‘How do uncertain practices shape truth telling and disclosure?’ and ‘What is the relationship between uncertainty and responsibility?’
Research design
To answer these questions, I work through the case of Cone-Beam Computed Tomography (CBCT) imaging in radiotherapy. This article draws on two research projects at the Sieverts Hospital ii over a period of 3 years. Based in the United Kingdom, the Sieverts Hospital was installing its first CBCT system in 2007. The first research project, prior to the installation, involved interviews with staff members conducted shortly after the decision had been made to begin a fundraising campaign for the purchase of system. The second was an ethnographic, mostly observational, study including observations of the installation phases including what was being done by clinical and non-clinical staff working with it.
For the interviews, all staff in the department (52) were invited to take part in an interview, and 14 participants were selected from those returning an opt-in slip in order to achieve a cross-sectional sample, that is, in order to ensure all grades and levels of experience of participants were represented. The sampling method was, therefore, considered to be purposive.
In the second study, the ethnographic approach focussed on the mundane practices around installing and working with the CBCT technology, revealing the interplay between machine and human. In ‘following the thing’, a name given to the process developed by Marcus, 15 the material object of the system was traced through several different contexts. Therefore, alongside the observations of what was being done by clinical and non-clinical staff working with the machine, I attended staff meetings and training sessions, I joined the practitioners in coffee breaks and for lunch and I conducted presentations of my research for participants and held group discussions with those I had observed. In addition, I examined documents such as training manuals, protocols, patient information leaflets, newsletters, local press and minutes of meetings in order to explore the way that these materials shape, and are shaped by, the technologies they are associated with. I spent portions of my fieldwork observing the machine when no one was ‘doing’ anything with it, learning how it became part of the establishment through action and non-action. Physically observing the system revealed only a small aspect of the network; following paperwork in the planning department where future treatments were being calculated or discussing doctor–patient consent procedures allowed a deeper exploration.
Throughout the fieldwork observations I took detailed notes, including sketches, which were later transcribed in full. Analysis of these transcripts, alongside other sources of relevant fieldwork material, entailed an iterative reading and coding to identify conceptual themes of interest.
Ethical considerations
Ethical approval was obtained from the Local National Health Service (NHS) Research Ethics Committee to conduct initial, pre-installation interviews at the Sieverts Hospital. Approval was then obtained from the NHS Main Research Ethics Committee (REC 07/Q1308/16) for the ethnographic stages of the project (which took place on two sites, although it is just the Sieverts Hospital presented here). Approval was sought and granted from the local hospital trust Research and Development committees. Written consent was obtained from all staff participants for the interviews and from staff who were observed as part of the machine installation and early use. The names of staff members and the hospitals have been changed to preserve anonymity.
Empirical sections
CBCT
CBCT has been introduced into radiotherapy treatments in order to improve the positioning of radiation beams during targeted cancer treatment in a process called Image Guided Radiotherapy (IGRT). In the context of the system described in this article, installation involves adapting a radiotherapy treatment machine, or linac, so that the machine can take a computed tomography (CT) scan of a patient prior to delivering a daily dose of radiotherapy. The CBCT scan images are then assessed prior to the patient receiving their treatment to ensure that the treatment radiation will be delivered to the correct location within the patient body, avoiding unnecessary treatment of healthy tissue.
Knowing about risks
In interviews with staff at the Sieverts Hospital held prior to the introduction of the CBCT technology, practitioners at the centre of the technological change discussed a lack of evidence, absence of proof, a lack of compatibility with existing systems in use, the politics of decision-making processes and perturbing doubts.
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Fuelled by a lack of evidence for the procedure (and an introduction based on axiomatic certainty),
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this sceptical perspective was maintained by some during the installation phases of the equipment. This is evidenced by the following conversation between Jo and Samantha (two senior members of staff in the department): Jo is asking Samantha about how they are going to use the system once it has been installed. Sam answers but says that they are thinking in a very theoretical way ‘because we don’t know’ … Jo says ‘Then in 20 years we’ll be treating all the secondaries [secondary cancers] from the kV imaging!’ Sam says she’ll have retired by then and Jo jokes about how the secondary cancers will be Sam’s ‘parting shot’. (From field notes, 8 October 2008, p. 2)
It may be the case that those faced with the prospect of treatment might choose the benefit of increased life expectancy and accept the risk of a secondary malignancy, a risk suggested by Jo and Sam. However, as this is not brought into the discussion with patients, they are denied the opportunity to address this choice.
Experimental subjects
Throughout observations at the Sieverts Hospital, it became apparent that the introduction of CBCT scanning into the treatment of patients with prostate cancer was experimental, with no real consistency or evidence base for the practice. I use the term ‘experimental’ here to denote the untried or untested way in which patients were exposed to the new procedures with little or no knowledge of outcomes (on both the part of the patients and the practitioners), rather than an alternative reading which would suggest patients were part of a controlled experiment or ‘trial’ to improve treatment outcomes. Therefore, through the following account, I highlight how patients were performed as experimental subjects during the introductory stages of the CBCT system. Through the following detailed description of the experimental patient, including how this role is later derided, I highlight how these practices, while being accounted for, create incommensurable ideas regarding the use of the system.
When the Sieverts Hospital began to use the equipment on patients, this was described to me by one of the radiographers, Louise, as having ‘not started using it clinically yet’. Despite this ‘non-clinical’ use, 10 patients were having weekly CBCT scans, and weekly, additional, electronic portal images (EPI) were taken. These EPI images are the traditional images used to verify a patient’s position which, at the Sieverts Hospital, involves additional radiation, as an area larger than the treatment field is used to acquire the images. On this occasion, the rationale for taking these additional EPI images at the same time as CBCT scans was to determine whether the displacement of treatment position, acquired from the CBCT, was the same as the displacement observed using the traditional system. This kind of testing appeared to be reiterating the mechanical quality assurance tests, performed on the equipment daily without exposing a ‘real’ patient, used to confirm that the CBCT images and the EPI images are congruent.
Frequently, staff in the department told me that they were not going to look at these additional images, that they were not being ‘actioned’. Therefore, despite the images being taken prior to the radiotherapy treatment being given, no one was examining them until all the images for each patient had been taken, by which time the patients could have finished their course of 30 plus treatments over a 6- or 7-week period. This was contrary to the purported benefits of using the system where daily CBCT scans are taken and reviewed prior to patients’ treatment enabling corrections to be made. Due to the circumstances of patients receiving additional radiation doses from these additional images being taken, I discussed this with radiographers in the department: We acquired CBCTs and EPIs on ten prostate patients. The results were analysed in conjunction with Seb (physicist) and then presented to the clinicians at a protocol review meeting. The results were basically used to confirm the bone match results were comparable to … EPI’s which provided a level of confidence in a new system and also, provided radiographers with experience using the system. (Personal Communication with Louise, 11 April 2011)
Louise describes the ‘trial’ as providing a level of confidence in the new system and providing experience for practitioners in using it. However, it was not described to the patients in this way. This can be seen in the patient discourse used when discussing their treatment, as described below.
The installation of the CBCT equipment at the Sieverts Hospital was publicised by the Charity responsible for raising funds for its purchase. During the launch of the system, in a local newspaper, a patient who was told he would be receiving image-guided radiotherapy (IGRT), the CBCT scans, was interviewed. The text from the newspaper read, Mr George, 77, of [town] near [district] is one of the first patients to be treated. Mr George is being treated for prostate cancer. He said: ‘My doctor told me that surgery was too dangerous at my age, so I have just started this treatment. It is brilliant to know that I am one of the first patients to be having the newest cancer fighting treatment and that the radiation will just beat the cancer without damaging healthy cells. (Taken (and adapted) from the local newspaper, 3 April 2009
i
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However, Mr George is one of the 10 patients in the trial of the CBCT system who is not receiving any alteration to his treatment. As such, there is an obvious discrepancy between the rhetoric of ‘not being clinical’ indicated by Louise and ‘having the newest cancer fighting treatment’ as understood by Mr George.
Later into Mr George’s treatment, this contradiction manifests once more. Mr George and Mr Fox, both receiving radiotherapy treatment for prostate cancer at the Sieverts Hospital, were routinely having their treatment on the CBCT-adapted linear accelerator, LA1. The two men were both in the ‘trial’ of the system. One day, when LA1 had broken down, it transpired that these two patients chose not to have their treatment on a machine that did not have a CBCT attachment, LA3. This decision was informed by their belief that they were being treated with the ‘newest’ technology.
When I was being told about the patients choosing to have their treatment on LA1 rather than LA3, I asked the radiographers working on the LA1 machine whether the patients were aware the scans were not being examined, as the newspaper report suggested Mr George believed otherwise: She [Nikki, a junior radiographer] says most of the patients, like this one (on the bed at the moment, not having a scan today) are ‘just like yeah whatever, do what you want’ but there are two which ‘don’t stop going on about it’ [Mr. George, quoted above, was one of these patients]. Nikki says they sit in the waiting room telling everyone they are having the best treatment. She says that last week LA1 broke and they were on LA3 [without the CBCT capabilities] … but they knew they would get LA1 back by 5:30. Nikki says that these two patients said they would wait until 5:30 so they could get the best treatment. I ask Nikki if the patients know that no one is actually looking at the scans and she says ‘yeah, they know everything’. (Monday, 11 May 2009, p. 4)
The framing of the ‘trial’ as a way of ensuring staff are familiar with the machine, rather than a research trial, positioned the patients as experimental subjects, rather than research subjects. Had this framing of been otherwise and the patients were ‘research subjects’, then the Declaration of Helsinki would apply. 20 This framing raises important questions regarding the validity of consent. The patients consented to the treatment procedure (although there is no specific consent for nested procedures within the radiotherapy treatment), yet the purpose of the experimental scans was not discussed with them, an example of partial truth telling. Another radiographer in that department told me she thought that this trial was ‘wrong’; yet, this conversation took place well after the event and was never publicly voiced. There were risks involved in additional scans (as the conversation between Jo and Sam demonstrates); however, in routine practice, it is assumed that this risk outweighs the benefits of the advances in treatment. Yet, if there is no advancement of treatment for these patients, should they not have been informed about the risks? The governance requirements of experimental practice and research practice are different and, as such, create differing levels of explanation for the patients. Furthermore, the direct patient benefit of experimental (staff training) practice versus ‘new’ treatment also differs. The scans taken during the experimental practice were no longer a nested treatment procedure for these patients with a therapeutic benefit. Rather they can be seen as a research project that ought to have been consented independently of the treatment.
Discussion
These events are situated in an in-between space: the space between patient and practitioner and the temporal space between machine installation and routine practice. Through taking a praxiographic approach to ethics and truth telling – that is one that studies things and people in their relations 14 – it is possible to problematise ‘truth telling’ in these contexts and consider how patients’ experiences of ‘new’ treatment can be at odds with ‘experimental’ practices.
This illustration of situated ethics highlights the way in which practitioners inhabited the ‘technological frontier’ of the ‘risk society’. 21 In the process of stabilising a technology into practice, the uncertainty and diversity of possible futures became forgotten, or ‘black boxed’, as demonstrated by the absence of talk about risk or dose, once CBCT scanning was fixed in treatment routines. Whether the practitioners accepted the risks associated with these technologies or they choose to overlook them is unclear. However, what resulted was an absence of truth telling within practices of acquiescence to the purported value of the installation.
The case of introducing IGRT technologies into practice could be considered a site where potential uses of the technology have taken precedence over knowledge about their associated risks. This decadent technology 22 was promoted as the latest and best system for improving the accuracy of radiotherapy treatment. Despite the lack of knowledge about the increased dose from additional CBCT scans, the risk was classified as inevitable or, at least, someone else’s responsibility. Doubts were neither formalised nor well researched, and as such, there were no ‘facts’ on risk to share with patients.
When it comes to applying the CBCT system into practice, it appears that those actors developing techniques for usage and advancing technological practice, stop thinking in terms of risk and prioritise application. When practice takes over, the act of using the system took precedence. Issues such as protocol development, accidental injury and case load management were considered relevant and hence became associated with the technology, leaving those initial risky decisions considered closed and hence not up for discussion with the patient.
We see from the presentation of this ethnographic material that the actions of the patients were at odds with the ‘experimental’ nature of the new system. In positively connecting with the trial and their treatment with the CBCT system, the patients provided practitioners with an opportunity to reaffirm their accountability. The choice of Mr George and Mr Fox to wait for their treatment involving the CBCT scan validated the actions of practitioners in performing the scan through displaying their choice to receive the ‘newest’ treatment.
In this sense, as Charis Cussins suggests, the patients maintain influence on their healthcare treatments by making decisions about them, resulting in patients being neither a victim nor helpless in this process. 23 Contrary to Cussins’ work on fertility treatment, however, the patients in this research, those invoking the right to be treated on what they perceive as superior machinery, are making decisions situated in the context of ‘life-saving treatment’ and, as such, the context of different life goals than those of fertility treatment. Furthermore, these decisions were founded on incomplete knowledge.
It seemed absurd to Nikki that the patients would wait to have their treatment on the LA1 machine, but, for Mr George, it could be interpreted as a means through which he maintained control of his treatment and his cancer. Through applying his partial and constructed knowledge of the benefits of the ‘new’ treatment, he was able to make a decision about his treatment. The performances of the patient – those who, according to Nikki, were passive in letting the radiographers do what they want or those who actively participated in the decisions about their treatment – were influenced by their interpretation of the (partial) information regarding the CBCT scans. Their capacity for action was therefore located within the confines of the knowledge they have received from the radiographers and various other sources, for example, the charity funding the machine installation. Patient actions were therefore shaped by the level of understanding they were enabled to obtain, and practitioners directed the actions of patients through maintaining these partial levels of understanding. Such partial truth telling created order and justification for practitioners’ own practices. By not correcting what aspects of ‘new’ treatment they were getting, practitioners ensured the patients remained engaged while being protected from any suggestion that what they were doing was questionable. The radiographers also made an implicit deferral to the authority of the patient’s consultant as, under the regulatory framework of exposing patients to radiation, 24 responsibility for obtaining informed consent for the radiotherapy procedure and responsibility for the patient’s exposure, ultimately lies with the consultant.
The patients had no formal sources of information regarding this trial. They consented for radiotherapy treatment, the risks of which were explained by the consultant, and they were told they were being treated on the machine with the new ‘life-saving’ technology. Through the process of partial truth telling relating to the potential benefits of the system, Mr George was transformed into a patient who wanted to be treated on that system. In not receiving information about the nature of the scans, he maintained this position (although that is not necessarily to say he would decide not to receive the scans should he be informed differently). Following Lignou and Edwards, 8 ‘the fact that a researcher has manipulated a potential subject’s decision does not in and of itself make it morally problematic’. However, as they elaborate, what is of moral concern is what the researcher intends to achieve by manipulating the information presented to a patient. While there may be no legal issues with the validity of the consent for radiotherapy treatment, there is, in this case, a moral question regarding the validity of consent for nested procedures, for example, the IGRT process.
In the case study I have presented here, partial truth telling to patients created multiple patient positions, exemplified by both those who let the radiographers ‘do what they want’ and those who ‘don’t stop going on about it’, and thus also facilitated support for the use of the CBCT system. This legitimated the actions of the radiographers involved in the trial of the system with the 10 patients. Nikki stated, ‘Yeah, they know everything’, suggesting that the patients were given all possible information and therefore made an informed decision, justifying the radiographers’ practices in this instance.
Through the multiple actions from patients, radiographers and the CBCT system, the role of the technology as ‘innovative’ and ‘best’ was accounted for. However, in the case of these patients, there was no therapeutic benefit, and hence the involvement of the charity, and associated rhetoric, heightened the therapeutic potential of the system being introduced. It may be that these patients were fully informed about the trial of the technology; however, the statement in the newspaper and their actions regarding waiting for treatment on the ‘newest’ machine suggest otherwise. The case study presents a case where ‘informed consent’ was invalid as, in essence, the subjects have been deceived. The fact that the patients appeared to fully agree to the study does not actually grant the practitioners authority to perform the intervention.
Surbone 7 argues that a preoccupation with autonomy and partnership leads to the application of rules of reciprocity that do not capture the essence of the patient–practitioner partnership: a dynamic, asymmetrical relation with unequal knowledge and power. The patient looks to the practitioner, they invest in medical authority as a result of the consent to treatment and all that it involves. At the same time, in order to deliver the radiotherapy in line with the CBCT imaging protocols, the practitioner accepts that someone, if not them, has evaluated the risk and it is acceptable.
Author’s reflection
Uncovering the circumstances of the experimental practice and the partial understanding of the patients placed me in a very difficult situation. It was not plausible to consider discussing this with the patients involved, and therefore all I could do was, to the best of my ability, raise this with other practitioners in the department, asking questions such as ‘do the patients know?’ and ‘what do you think about …?’ As I have indicated in the main text, my position was either refuted, ‘They know everything’, or it was confirmed but only in private.
Conclusion
In this article, I have presented the case of experimental subjects during the introduction of CBCT imaging in radiotherapy treatment practices. The aim of the article was to look at situated ethics to highlight how contexts of uncertainty and accountability shape responsibilities in experimental practice to answer the questions: how do uncertain practices shape truth telling and disclosure, and what is the relationship between uncertainty and responsibility?
As the case demonstrates, truth telling in experimental practices is not a reiteration of well-established debates concerning informed consent for treatment. Rather it is an example of practitioners legitimising action with new technological systems through managing their uncertainty. Routinely, there would be no informed consent for the procedure of localisation or imaging nested within the wider context of radiotherapy treatment. However, in the experimental practice described, the ethical obligation of disclosure was marginalised. The case shows how the dynamic and interactive process of truth telling was destabilised by uncertainty. The practitioners removed themselves from taking responsibility for telling the truth to patients in order to work with, or ‘park’, any uncertainty relating to their duties and, therefore, continue to practice.
The patients’ partial understanding of the practices they were being exposed to and the practitioners’ partial understanding relating to the risks of the system, created incommensurable ideas regarding the use of the system. By maintaining partial truth telling and not clarifying exactly what the degree of knowledge the patient had about the system, for example, ‘the patients know what is happening’, practitioners worked to account for their actions and formed boundaries around their actions in order for those actions to make sense to them. As such, patients’ experiences of ‘new’ treatment can be considered at odds with ‘experimental’ practice. This has wide-reaching implications for practice. By making uncertainty visible and present in discussions with patients, a more open and responsible practice would surely follow. Ongoing, forward- and backward-looking reflection would shape services in a way which would be accountable to those who will be affected by outcomes.
An inherent weakness with the project was the lack of patient voice in the data collection. Further research should aim to include the patient while remaining sensitive to how uncertainty is discussed and hence revealed.
Footnotes
Conflict of interest
The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The research was funded by an interdisciplinary PhD studentship awarded by the Economic and Social Research Council.