Reconciling the principle of patient autonomy with the practice of informed consent: decision‐making about prognostication in uveal melanoma

Abstract

Background  Influential views on how to protect patient autonomy in clinical care have been greatly shaped by rational and deliberative models of decision‐making.

Objective  Our aim was to understand how the general principle of respecting autonomy can be reconciled with the local reality of obtaining consent in a clinical situation that precludes extended deliberation.

Method  We interviewed 22 patients with intraocular melanoma who had been offered cytogenetic tumour typing to indicate whether the tumour was likely to shorten life considerably. They were interviewed before and/or up to 36 months after receiving cytogenetic results. Patients described their decision‐making about the test and how they anticipated and used the results. Their accounts were analysed qualitatively, using inconsistencies at a descriptive level to guide interpretative analysis.

Results  Patients did not see a decision to be made. For those who accepted testing, their choice reflected trust of what the clinicians offered them. Patients anticipated that a good prognosis would be reassuring, but this response was not evident. Although they anticipated that a poor prognosis would enable end‐of‐life planning, adverse results were interpreted hopefully. In general, the meaning of the test for patients was not separable from ongoing care.

Conclusion  Models of decision‐making and associated consent procedures that emphasize patients’ active consideration of isolated decision‐making opportunities are invalid for clinical situations such as this. Hence, responsibility for ensuring that a procedure protects patients’ interests rests with practitioners who offer it and cannot be delegated to patients.

Introduction

Respect for patients’ autonomy is widely regarded as a defining principle of humane care. Conceptualizations of autonomy in medicine have usually been individualistic, relying on patients’ self‐determination to protect their interests in the face of practitioners’ power. Influential models of decision‐making therefore emphasize the importance of patients’ participation in information transfer, reflection and deliberation. ¹ , ² , ³ , ⁴ , ⁵ , ⁶ Similarly, the current practice of informed consent, widely regarded as underpinning self‐determination and patient protection, emphasizes the need for patients to have information upon which to reflect, and options upon which to deliberate, before deciding whether to accept interventions. ⁷ , ⁸ , ⁹ This approach to implementing autonomy has been debated theoretically, because autonomy has broader interpretations than self‐determination, and clinically, because many patients do not want to take responsibility for decision‐making or lack the knowledge or are too impaired by illness to do so. ² , ¹⁰ , ¹¹ , ¹² , ¹³ , ¹⁴ , ¹⁵ , ¹⁶ , ¹⁷

Theory and practice recommendations that are ethically and clinically sound should be based on understanding how general principles can be reconciled with local realities. This insight, in turn, can be gained from studying how practitioners and patients resolve ethical dilemmas in routine practice. ¹⁸ In this study, we therefore analysed patients’ accounts of decision‐making in a clinical situation precluding extended deliberation. These were patients with newly diagnosed intraocular melanoma who were offered prognostic tests to indicate whether their tumour was likely to be fatal. We reasoned that this could be particularly informative about how autonomy is preserved or threatened in situations that are incompatible with reflective and deliberative decision‐making.

Intraocular (uveal) melanomas are rare, with annual incidence of about six per million. Almost 50% of patients ¹⁹ develop metastatic disease, usually involving the liver and always fatal. Metastatic death occurs almost exclusively in patients whose melanoma shows partial or complete loss of chromosome 3 on cytogenetic testing. ²⁰ , ²¹ In patients with a lethal melanoma, the dimensions of the ocular tumour and the histological grade of malignancy indicate likely survival time. Cytogenetic testing of tissue samples taken at the time of primary ocular treatment therefore indicates prognosis for survival: patients with disomy 3 can be reassured that life‐expectancy is not significantly worsened by their tumour whereas those with monosomy 3 will almost certainly die of their disease within a few years. Although testing currently offers no appreciable survival benefit, virtually all patients accept it when it is offered. ²² This finding is consistent with a recent report which concludes that patients with choroidal melanoma desire such prognostic information ²³ and with a previous report on colorectal cancer. ²⁴ However, there are concerns that technologies that provide prognostic information without improving survival might harm patients. ²⁰

At the time of the study, patients offered cytogenetic testing at our centre had little opportunity to reflect on their decision: a fresh sample of tumour tissue was required and needed to be collected at the time of treatment, which was usually the day after diagnosis. We designed the study to answer two broad questions. How do patients decide whether to accept testing and what factors do they consider in doing so? How do they evaluate their decision subsequently and, in particular, how do they respond to and use the information that the test provides?

Method

Participants

Patients were referred from across the British Isles for assessment and treatment of uveal melanoma at a national specialist centre for adult ocular tumours, which was the first, internationally, to offer patients cytogenetic testing. Its protocol for offering the test to patients begins after initial clinical assessment, when the ocular oncologist informs the patient about the diagnosis, prognosis and treatment options. If planned treatment is enucleation or local resection, the patient is given the option for cytogenetic testing to determine whether the tumour is ‘life threatening’. Patients are told that a bad result would lead to consultation with an oncologist, who would offer 6‐monthly liver scans in the hope of detecting metastatic disease before symptom onset. Patients are warned that screening rarely prolongs life so the main benefits would be reassurance or ‘life‐planning’. After opportunity for questions patients are asked whether they would like the test. Where they are uncertain, the ocular oncologist reassures them that most patients who have had the test were pleased to have done so. Patients receive an audio‐recording of the consultation. A specialist nurse then reviews what has been said and provides written information about treatment and the test. Next, a specialist registrar seeks written consent from each patient, at the same time requesting permission to use any tissues, data and images for research, teaching and quality control studies. While some patients return to their local hospital for enucleation, most are treated at the specialist centre, usually within 24 h.

Cytogenetic studies and histological investigations are described elsewhere. ²⁰ Prognosis was estimated according to cytogenetic type, histological grade of malignancy and clinical stage of tumour growth. ²⁵ Patients with good prognosis (life expectancy not significantly reduced) received a letter, copied to their GP and local opthalmologist, explaining that their life‐expectancy was almost normal and inviting them to discuss the result with the specialist nurse by telephone. Patients with poor prognosis (disease likely to be fatal) were invited for consultation with a medical oncologist, who explained the result and its significance and offered 6‐monthly screening (biochemical liver function tests and magnetic resonance imaging). Patients unable to return to the centre were referred to an oncologist near their home. Patients developing metastatic disease were investigated and referred to a surgeon for potential resection of liver metastases or offered entry into ongoing chemotherapy trials. Details of clinical management are reported elsewhere. ²⁰ , ²⁵

Patient selection and recruitment

After ethical approval, patients were sampled in two ways (Fig. 1). Thirty‐four previous patients were selected from clinical records who: had been treated by enucleation or local resection for uveal melanoma: had been offered cytogenetic testing; and lived within 60 miles of the study centre. Sampling was purposive to ensure inclusion of males and females across the age‐range for this population and, because we anticipated that patients’ perspective on the test might evolve as they adjusted to the results and the screening programme, to include patients who had received their results up to 3 years previously. As potentially critical cases, we selected all those (n = 2) who had declined the test. After contacting the GP or oncologist to exclude patients experiencing any illness‐related crisis, we wrote to 25 patients requesting consent to interview; 15 consented and were interviewed 4–44 months after primary ocular treatment (0–36 months after receiving results). As the study progressed, we preferentially recruited patients with poor prognosis to test and develop our understanding of apparent contradictions in their accounts.

Figure 1.

 Patient selection and recruitment.

To examine explicitly whether and how patients’ views changed over time, in particular from before to after receiving test results, we selected nine additional current patients for sequential interviews. They were identified 1–2 days after initial ocular treatment and asked for consent for up to three interviews over the following 2 years. Seven consented; all were interviewed before receiving their cytogenetic results; six were re‐interviewed 1–4 months after receiving their results (one could not be contacted after the first interview); four provided a third interview approximately 1 year later (one died of metastases before this and one withdrew). In all, 22 patients (15 previous and seven current) participated in 32 interviews.

Interviews

Interviews were in patients’ homes or in a private area of the oncology clinic and were semi‐structured according to a guide. The researcher prompted previous patients to talk about experiences and expectations in six areas: (i) recollections of being offered the test and how they decided; (ii) understanding of its purpose or value; (iii) reasons for wanting prognostication and concerns about it; (iv) understanding of their risk of metastatic death; (v) understanding of their own test results; and (vi) how they had responded to the results. In their first interview, current patients were prompted to talk about areas i–iv, their experience of awaiting results and their anticipation of how results might affect them. At their second and third interviews, they were asked about how they had received their results and (iv–vi) above. Particular attention was paid to comparing experiences with expectations.

The researcher adopted a conversational style, avoiding closed questions in favour of prompts and reflections to facilitate patients’ talk. Patients therefore determined the pace and sequencing of interviews, which lasted 22–65 min and were audio‐recorded and transcribed verbatim (except for anonymization).

Data analysis

Analysis, led by SC, proceeded in parallel with the interviews and was inductive in that no categories were specified in advance. Transcripts were read and discussed by SC and PS to identify recurrent patterns so as to build a thematic framework incrementally. This was tested and modified by constant comparison, ‘cycling’ between sets of data and the developing account of them, searching for disconfirmatory cases and by discussion amongst the wider team. We first analysed patients’ accounts descriptively. However, inconsistencies – in particular, describing different reasons for valuing the test at different times – led to more interpretive analysis. We therefore became concerned with the need to distinguish patients’ explanations of their behaviour from their justifications. Analysis was finalized when no further changes emerged from this process and when all the relevant text could be accommodated by it. In our final analysis, most elements were defined by commonality of meaning across data from several patients. In addition, we report two cases whose atypical experience was particularly informative about factors that were relevant generally. Standards by which we assessed the developing analysis included coherence and ‘theoretical validity’ whereby conclusions should connect with theoretical ideas beyond the present study. ²⁶ We were also concerned with ‘catalytic validity’; ²⁷ that is, findings should have the potential to change theory or practice.

In reporting the analysis, we present transcript to illustrate the meaning of each category of the analysis. Data extracts are labelled according to the patient; for patients interviewed sequentially, the number of the interview in the sequence is indicated (e.g. P16/1 is the first interview of patient P16). The ellipsis indicates omitted speech.

Findings

Sample characteristics

The sample included nine men and 13 women aged 39–79 years (Table 1). One had declined testing and most had poor prognosis. One had developed resectable liver metastases and one had been diagnosed with incurable metastases at the time of interview.

Table 1.

 Details of patients

Patient ID	Age at first interview (Int)	Gender	Months since treatment			Months since received results			Prognosis
			Int 1	Int 2	Int 3	Int 1	Int 2	Int 3
P1	60–69	F	34			31			Poor
P2	60–69	F	30			21			Poor
P3	50–59	M	33			30			Poor
P4	60–69	M	23			21			Poor*
P5	70–79	F	28			23			Poor
P6	50–59	F	44						Declined test
P7	70–79	F	14			12			Good
P8	60–69	F	18			16			Good
P9	70–79	M	22			19			Good
P10	70–79	M	20			17			Good
P11	70–79	F	11			6			Poor
P12	60–69	M	22			17			Poor
P13	70–79	F	43			36			Poor
P14	60–69	F	4			0			Poor
P15	70–79	M	41			36			Poor
P16	50–59	M	1	8	†		4	†	Poor
P17	40–49	F	3	‡	‡		‡	‡	Good
P18	60–69	F	3	7	19		2	14	Poor
P19	60–69	M	1	6	18		3	15	Poor
P20	60–69	M	2	5	16		1	12	Poor
P21	30–39	F	1	6	18		2	14	Poor
P22	40–49	F	1	4	§		2	§	Good

*Patient had resectable liver metastases before interview.

‡Patient could not be contacted.

†Patient died before interview.

§Patient withdrew.

Patients’ accounts

Most patients were positive about having the test; only one (P20) criticized its management and only one (P6) regretted her decision (these atypical cases are described further below). There was striking consistency in patients’ accounts of deciding about the test and in how they evaluated their decision and described using the results.

All except one consented to the test. When asked about their decision, those who had accepted were all enthusiastic as P1, with a poor prognosis result, illustrated when asked if she would have preferred not to know: ‘I’m glad I had it, I was really glad I had it’(P1). The only patient who declined ‘wished I’d had it…I would advise people to have it, because they will always think “No, I should have done it”’(P6).

Accepting the test was the only thing to do

Whether to have the test was typically presented as an ‘automatic’ decision; no patient recalled consciously weighing the decision or considering an alternative to the one made. When specifically asked to recall the decision, a typical response was that: ‘I never thought about it…I never asked, I’ve never thought about it to be honest, I just know that it’s done and … I feel great’(P2). One patient was explicit that ‘I really can’t say that I thought rationally about it at all’(P13), but several others explained that the shock of diagnosis precluded hearing, understanding and appraising information about the test (Box 1). Indeed, a few patients at the start of the interview did not even recall being offered the test. Of those who did, none recalled considering how they might respond to the prognostic information, and patients interviewed before receiving results were still unable to think about how they might react as P17 illustrated:

Table Box 1.

 The impossibility of a reasoned decision

Patients described several reasons why they were unable to assimilate information about the test:

Being too shocked to take in what they were told

Whether I realised what I was saying when I signed that consent form I don’t know, because it was just sort of a whirr, my husband wasn’t very well at the time, we were both shocked… It was just I don’t, like a bad dream really … So I really can’t say I thought rationally about it at all. (P13)

Denying the seriousness of the diagnosis

All the telling me what it was and all that, just didn’t register with me at all …It didn’t hit me’ til weeks later … You only pick up on certain things don’t you when they say um, you just shut off don’t you. (P8)

Being too anxious or upset

Well I think I signed some consent forms for tests and things like that if I remember rightly... To be honest with you, I was in a bit of a, how should I put it, I were in a bit of a, I was a little bit afraid. I didn’t notice a lot, to be honest. (P10)

P17: ‘I can’t answer that [how I will react]… I can’t because until I actually, like, get the results, I don’t know, do I, how I am going to feel or, I mean, if it’s a good result, I’m going to be happy. But if it’s not, obviously I’m going to be down and I can’t answer that until I actually get the results…’

Interviewer: ‘I just wondered whether it was something you had thought ahead to or not?’

P17: ‘…No, I haven’t, not at the minute, no. I’m just taking every day as it comes’.

As another patient interviewed before receiving her results explained: ‘It’s too frightening to think of the worst case scenario, it really, really is’(P21/1). Patients’ emotional state therefore precluded considered decisions. Similarly, the one patient who declined the test attributed this explicitly to emotional factors, recounting several family problems: ‘I didn’t want to find out if there was anything… I was scared… I had too much going on’(P6).

Furthermore, recurring language in patients’ accounts implied that, rather than actively choosing, they were ‘going along with’ with an expectation to have the test: for example in describing having ‘agreed straight away really, that I would like to know’(P16/1) or being ‘happy with’ (P3) having the test. They saw it as natural continuation of treatment stating, for example, that: ‘I thought it was done automatically, you know. You do any operation, you automatically investigate what you have done, so I really didn’t query or think anything untoward about it.’(P3). Therefore, it seemed that the key influence on patients accepting the test was that they were offered it.

Accepting the test was the ‘right’ thing to do

There were three ways in which patients presented accepting the test as the correct response. First, their language reflected normative views of the value of being informed; for example that: ‘you have got to take it [test]…You have got to look at life sensibly’ (P20/1). Similarly, four patients referred to not having the test as putting one’s ‘head in the sand’, and P21 described her incredulous response to realising, after signing the consent form, that it was optional: ‘I obviously think the penny had dropped that I signed for these tests... I turned to my husband and said why would you not want them tests doing, why would you say no I don’t want them’(P21/1). In this way, patients presented the test as the obvious response to threat of further disease.

Secondly, patients interviewed before receiving results described the difficulty of living with uncertainty about prognosis. A typical response was that: ‘It isn’t sometimes what you know, it’s the things that you don’t know that can be worse’(P16/1). They therefore described anticipating that the test results would enable them to ‘move on’, and that even results indicating poor prognosis would help: ‘For me, whether it be good news or bad news, it’s sort of, it’s bringing your life back into your control’(P21/1). Being able to plan was central: ‘I think the more information you have got and the more prepared you are for it then it helps really. It’s not such a frightening experience then … [The result would] enable you then to plan everything out yourself financially and health‐wise and whatever’(P16/1).

Thirdly, almost all indicated that accepting the test was also ‘right’ in as much as it met expectations of others, particularly hospital staff, and fulfilled perceived obligations to them, to other patients and to their own families (Box 2). However, given the instantaneous decisions that patients described and the absence of conscious deliberation, these reasons why having the test was ‘right’ are likely to be post hoc justifications rather than explanations of the decision.

Table Box 2.

 Accepting the test was ‘right’ because it helped others

Patients described having the test as the ‘right’ decision because it fulfilled obligations to other people.

Some saw it as fulfilling obligations to the hospital

In as much as everybody had been so helpful there, so really I needed to do my bit … Everybody at the hospital had done their part so, really, I thought that would be some contribution from myself. (P16/1)

Or as helping other patients

Well they’d find things out wouldn’t they, you know, different things, not only just for me, for the future, isn’t that the way they do it, like, they find things out so... because you know they can do tests and find out can’t they. Perhaps they could find something out from that that they didn’t know about, and it would help someone else. (P1)

Two patients described the decision as fulfilling obligations to family

Maybe because of my children, you know, cos I’ve got five children, and just maybe, just probably because of them, I don’t think it [choosing the test] was anything to do with myself, [I] think it was like more my husband and my children I was more worried about. You know, in case like anything did happen to me, they’d be left. (P17/1)

Meaning of results depended on the care context

Once patients had received a poor prognosis, their reasons for valuing the test changed. None referred spontaneously to the increased likelihood of metastases or death, and none described using the information for end‐of‐life‐planning. Instead, most were explicit that, as P3 explained, they were ‘not going to worry about the future’, and they described focusing on reestablishing normal routines. P16 illustrated this divergence between anticipation and experience of poor prognosis results. When prompted about his previous reference to life planning (quoted above), he emphasized a return to normality and described a future structured by the 6‐month interval between screenings: ‘Well I think it allows you to move on, but you don’t quite move on in a straight line really... I’m moving on by saying I need to get back to work …I don’t suppose you will ever know 100%…but every 6 months you can sort of say well, things are OK, and it’s another 6 months you can sort of forget really isn’t it.’(P16/2)

Despite poor prognosis, and no objective relief from uncertainty, patients described how the test allowed them to feel hopeful (Box 3). First, it maximized chances of survival because it instigated screening that would enable early detection of metastases, which they perceived as key to curative treatment. Secondly, receiving the ‘all clear’ after screening provided intervals of perceived safety. That is, the screening helped patients to define a ‘future’ which was sufficiently short for them to feel safe in it; without it, the future still felt intolerable (Box 4). Finally, regular screening provided a continued sense of security in being cared for. Uncertainty continued to trouble the patient who declined testing and therefore received no follow‐up screening or care:

Table Box 3.

 Using poor‐prognosis results to build hope and security

Patients described three ways in which poor‐prognosis results and continuing clinical oversight allowed them to feel hopeful or secure.

1. ‘Catching it early’ is the key to cure.

Many patients explicitly linked early detection with successful treatment

I mean you go in twice a year, you know. Within 6 months if you’ve got anything though you’ll be diagnosed and they can treat it. (P20/3)

For others, early detection at least provided a sense of having done what is possible

You know you feel as though, at least the scan, whether it does it’s job or not, at least you’ve sort of tried to keep an eye on everything and monitor what’s happening (P16/2)

2. Patients described looking into the future only as far as their next screening scan

At least that way you can sort of say ‘Things are OK’ and it’s another 6 months you can sort of forget really isn’t it. (P16/2)

The ‘all‐clear’ allowed them to feel safe in the present

I do feel great when I’ve been because I know I’m alright. (P2)

and for the next 6 months

You get the ‘all clear’ and that’s great. Then you carry on as normal for 6 months until the next scan. Hopefully that will be all clear too. (P19/2)

3. The continued clinical oversight directly provided a sense of security

You feel like you’re being looked after. In other words, you know, you’re not just put on one side. (P11)

Table Box 4.

 A deviant case: when poor‐prognosis results were given without the offer of monitoring

Unusually, patient P20 learned his poor‐prognosis results from a routine ophthalmology clinic, and learned of the 6‐monthly screening later.

Before receiving results

He worried that ‘every pain is a cancer’, and anticipated using poor‐prognosis results for life‐planning

If it’s [cancer] too far then I want to know that and all to live what I have got left …have to cram more in than I want to cram in just at present

After receiving the result

He felt neither informed nor reassured

The only thing I got was “there’s good ones, there’s bad ones and there’s medium ones” and I came up with the medium one… So I’m in limbo…I’m fit with a medium risk is that a good or bad chance? You don’t know do you?... I’m worried now that I’ve got it somewhere else, so every ache and pain in my body is cancer…so that’s not putting my mind at ease.

After learning of the screening programme

He felt no reduction in uncertainty

I understood that if they did this operation and sent it away for the test they’d be able to tell me whether it would go further, whether anything had broken away from it but that wasn’t the fact … Nobody could answer the question there.

Instead, he felt cared for

The follow‐up’s been fantastic …I’ll not say they are 100% perfect or what, they can’t promise anything but at least you know they’ve got their eye on it

This allowed him to avoid thinking of the future

I just put that [cancer] to one side and then just carry on … because that [monitoring] is my peace of mind. Without that I wouldn’t be doing half of what I’m doing … It’s gone more like back to normal.

P6: ‘I still regret it [declining the test]… If you get anything and it’s bad you automatically think you’ve gone back, you really do…It’s always there

Interviewer: ‘So you’ve still got that worry. That, that’s what you’re saying?’

P6: ‘Yeah, it’s always there, and I really think anyone who’s had it doing [enucleation because of intraocular melanoma] would worry about that’.

Of five patients with good prognosis, only one immediately recalled receiving her result (she had been interviewed sequentially, and the previous interview might have reminded her of the test). One other patient subsequently showed the interviewer his result letter and another later recalled the GP mentioning that the result was good. These patients said that they simply assumed ‘No news is good news’ or that: ‘When I left there and there was no further follow‐up…I just thought everything must be alright … because I would have been informed surely’(P7). However, the one patient who spontaneously recalled receiving a good prognosis was not completely reassured: ‘Initially I was made up, cos as they said, like, everything was fine, but I have got my little doubts because I think I proved them wrong last time’(P22/2).

Summary of findings

Patients could not make a considered decision because of the emotionality of the situation. They trusted the clinician and readily accepted what was offered; that is, they did not distinguish the test from ‘routine care’. Nevertheless, patients were committed to the decision to accept the test, justifying it using normative ideas including altruism and the importance of being ‘informed’ and ‘taking control’. Once received, the results’ meaning depended entirely on the context provided by other aspects of their care. The offer of continuing follow‐up allowed patients to invest poor prognosis results with hope, whereas the absence of continued clinical contact reduced the salience of a good prognosis.

Discussion

To our knowledge, this is the first detailed study of how patients with cancer decide about their care in a situation that precluded extended deliberation. The most important finding was that, from patients’ perspective, consenting to prognostic testing was not a discrete event. The test’s significance for patients was entirely contingent on other aspects of their care. Our findings therefore diverge from current principles and practice of informed consent.

Making the decision: the test was part of ongoing care

We approached the study assuming that the invitation to have the test was a significant event for patients but it proved not to be. Most patients did not see themselves as having a decision to make. Some did not recall the test and none described weighing potential consequences in considering it. Therefore, while models of shared decision‐making and ethical ideas of informed consent emphasize patients’ participation in information transfer, reflection and deliberation, ² , ⁵ , ⁷ , ⁸ , ⁹ , ²⁸ , ²⁹ , ³⁰ none of these was evident here. Patients were emotional rather than rational, being too shocked to assimilate information for an informed decision, and being unable to confront what poor prognosis would mean.

For most patients, their instantaneous choice simply meant going along with the ocular oncologist’s offer. That is, they followed an heuristic to trust what experts suggest. ³¹ As in previous studies of patients with cancer, they valued clinicians’ expertise; ³² , ³³ their consent amounted to trust. ³⁴ Therefore, from the patients’ perspective, accepting the test was no more a decision than were their ‘decisions’ to accept some other clinical procedures, such as anaesthesia. There is other evidence that, when offered decisions about predictive or diagnostic testing for serious disease, many people regard their response as requiring no decision‐making. ³⁵ , ³⁶ , ³⁷ Similarly, nearly half of patients surveyed after discharge from hospital care identified no clinical decision during their stay ³⁸ suggesting that they do not separate clinical decision‐making from the process of clinical care. Other aspects of care that communication researchers and teachers isolate as discrete events, such as ‘breaking bad news’, also seem to have meaning for patients only as part of ongoing care and clinical relationships. ³⁹

These patients’ experience of what communication experts regard as decision‐making opportunities can be understood from the perspective of Kukla’s ² critique of the emphasis in bioethics on regarding isolated decisions (‘punctate’ decisions) as the units of autonomy. Kukla ² suggested that autonomy should be sought in individuals’ overall engagement in care. Other ethical analyses as well as theoretical reformulations of decision‐making have emphasized the relational nature of autonomy and feelings of involvement. ¹ , ¹⁸ , ³⁷ , ⁴⁰ , ⁴¹ , ⁴² Empirically, if clinical relationships are good, patients trust practitioners’ recommendations ⁴³ and, as in the present study, find no tension between doing what they suggest and feeling involved. ³⁷ , ⁴⁴

Patients’ acceptance of the test cannot be described as mere compliance. They displayed what Kukla termed ‘conscientious autonomy’ in that they offered retrospective accounts of the decision that went beyond conformity and showed ownership of the decision, which is consistent with a recent report ²³ that patients are positive about prognostic information. In doing this, most presented it as serving others’ interests, particularly other patients’, but also practitioners’, for example by providing information to help research. That is, they drew on altruistic interpretations of their behaviour. ⁴⁵ , ⁴⁶ , ⁴⁷ Others indicated that accepting the test met normative expectations about being involved and informed. ³⁵ , ⁴⁸ , ⁴⁹ Therefore, most patients accounted for their decision morally rather than rationally. However, these accounts are best seen as justifications for having the test; the most likely explanation for accepting it without deliberation remains that the ocular oncologist, whom they trusted, offered it.

Using the results: their meaning was contingent on ongoing care

The way that patients used the results also depended on practitioners’ ongoing care. While awaiting results, patients envisaged using them to reduce uncertainty and, in some cases, plan their lives. After receiving results, however, the function changed, and life‐planning was unimportant. Beran et al. ²³ finding that, after receiving poor prognosis results, patients valued these for life‐planning emerged in responses to retrospective questionnaires which may be less sensitive to subtle changes in patients’ thinking than qualitative interviews. Patients with good prognosis did not recall the result as a salient event. Moreover, the single patient who explicitly recalled receiving a good prognosis did not trust it sufficiently for complete reassurance. It seems that practitioners’ behaviour was more salient than the results letter. That is, in the absence of a consultation where they were explicitly told of their prognosis, they gained more reassurance from not being called back.

Practitioner’s behaviour also explained why patients with poor prognosis results did see the test as reassuring. Instead of responding by life‐planning for a curtailed future as they had anticipated, the result led to patients feeling hopeful about the future. For most patients, this depended on the screening programme that poor prognosis results triggered. Patients derived hope from this programme in three ways. First, it provided a sense of continuing in a caring relationship, which is already known to provide hope. ⁵⁰ Secondly, it meant that early treatment would be available, and treatment also provides hope. ⁵¹ Finally, screening allowed patients to adopt a time‐scale, defined by intervals between screenings, within which they could feel safe. That is, whereas objectively screening describes what has occurred in the previous 6 months, patients interpreted the ‘all‐clear’ as providing safety for the subsequent 6 months until the next screening. In this way, patients used screening to redefine the future as a period for which they could achieve a feeling of safety and return to normality. A patient who, uniquely in this sample, received his results before the offer of screening showed how the objective uncertainty that remains after poor prognosis results remained intolerable without the promise of screening. He felt hopeful only after the offer of screening allowed him to constrain his view of the future. Therefore, while good prognosis results were isolated from clinical relationships and so meant little to patients, poor‐prognosis results were a source of hope because they were integrated into a programme of continuing care.

Therefore, the functions that patients ascribed to the test changed over time. In this respect also, the findings are hard to reconcile with current models of consent and decision‐making: patients cannot be regarded as providing deliberated, informed consent if the meaning to them of what they are consenting to changes after they consent.

Limitations of the study

When people are interviewed about decisions that they have made or accepted, their responses might be products of cognitive dissonance, whereby they retrospectively find plausible justifications for their own behaviour, ⁵² or such justifications might be constructed for self‐presentation in the interview. Neither is likely here. Patients described functions, particularly hope, that are supported by previous literature on responses to life‐threatening illness. Moreover, neither cognitive dissonance nor self‐presentation explains why the patient who declined the test described her decision negatively. By interviewing a subset of patients sequentially, we confirmed that the functions they ascribed to the test changed after they received results, which is also hard to attribute to cognitive dissonance or to attempts to provide plausible justifications to the interviewer. The sample was limited: we were able to interview only one patient who declined the test; relatively few patients with good prognosis were included; and we had little information from patients who had developed metastases. Furthermore, it is not clear how the protocol for offering the test was implemented in practice and to what degree it may have varied between patients. Further research with a larger sample encompassing all these sources of variability and incorporating direct observation of how the test was offered to participants is needed. As a qualitative study, the findings cannot automatically be generalized. Instead, their importance is to challenge existing assumptions in literature on decision‐making and consent and to suggest the need for a new conceptual approach where patients do not see decisions to be made.

Implications of the findings

We have described what occurred in practice. In considering what should occur, the conventional principles and procedures of informed consent and shared decision‐making are unhelpful. Stronger procedures to ensure that the decision is ‘informed’, such as requiring lengthier or more strenuous consent procedures, would introduce ‘rituals of consent’ ¹³ that would be unlikely to change the structure of relationships and expectations that determine patients’ near‐unanimous acceptance of the test. ² Similarly, seeking complete equipoise in presenting the test is implausible. Merely offering it probably suggests in this context that it has value. Moreover, the offer creates the uncertainty that only the test can then resolve, ³⁵ and evokes the culturally‐based obligation to ‘be informed’ that only the test can then meet. ³⁵ , ⁴⁸ , ⁴⁹ Therefore, the offer of the test unavoidably influenced the patient’s attitudes about it and was inevitably the main determinant of the patient accepting it.

From this perspective, protecting patients’ autonomy requires two questions to be addressed. If the offer of the test is the key influence on patients’ acceptance it is necessary, first, for clinicians to have evidence that patients will be helped, and not harmed, by the test. That is, the responsibility to protect patients’ interests remains with clinicians and cannot be devolved to the patient by the consent procedure. The practitioners’ role as patients’‘agents’ ⁵³ is therefore inescapable. If the test is to be offered, the next question is how to respect patients’ autonomy while acknowledging their trust in the clinician. ¹⁵ We suggest that this is a question about how to allow patients to have a sense of ownership of their decision, rather than how to ensure that they take responsibility for it. ² Where patients are distressed and vulnerable, such as in the present study, the clinical relationship needs to emphasize authority and trust, ⁵⁴ and ownership is consistent with guidance from the clinician in the absence of detailed information and deliberation. Where patients are less vulnerable or more confident or authoritative, or for patients who find it hard to trust their practitioners, the relationship will need explicitly to address feelings of autonomy, even to the point of detailed information and overt consent with the possibility that patients will reject an intervention that might help them.

The clinical model that we studied was very specific, but there are probably other similar situations in clinical care where an expert clinician’s suggestion or offer of an intervention is the critical factor in patients accepting it. For example, in cancer care, patients will accept chemotherapy even without appreciable survival benefit. ⁵⁵ , ⁵⁶ The general principle that the present study points to is to dissociate clinicians’ responsibility for ensuring that proffered interventions are in patients’ interests from their need to integrate the offer into the type of relationship that the patient needs. Patients in this study who accepted the test felt ownership over the decision to do so and were positive about it. Therefore, one direction for future research is to study how clinicians such as those in the study centre negotiate these ethical and clinical dilemmas in practice in order to guide patients’ consent while supporting their sense of ownership and autonomy. ¹⁷