Clasificación y supuestas autonomías de los daños

What is the patient perspective of the recruitment process in a challenging

surgical trial, when the best current advice as well as innovative approaches to the principles of patient participation are integrated?

A qualitative study was designed (Chapter 3.3) and analysis was performed of significant and emerging themes concerning patients invited to participate in a national multicentre trauma RCT comparing operative versus non-

operative treatment (Chapter 6.1). Emerging data indicated similar patterns of response to the invitation to take part in the trial, which prompted typological analysis of patients’ attitudes in the decision making process about trial participation (Chapter 6.2).

The feedback obtained from patients during the three years of the UK HeFT was illuminating. It provided evidence that could be valuable for the design of similar trials in the future.

At the present time, clinical research is not usually expected by patients to be an integral part of clinical care (Robinson, Kerr et al. 2005). Yet trialists assume an informed rational approach from subjects to the decision about committing to a research process, in particular random allocation to an intervention group. Possibly, this stems from the ethical responsibility to provide all important information about the compared interventions and the research process, in order to ensure informed consent or refusal to

This study confirms previous reports that most patients struggle to understand and retain trial information, especially in the hospital

environment, where they may be affected by medication and have difficulty coping with change in their condition (Chapter 6.1). Although some of them are happy to consider all possible information about a treatment choice, most found the sheer volume and type of information provided overwhelming. In particular, patients are very uncomfortable with

uncertainty about a treatment choice, as presented in current RCT designs. In a pragmatic clinical consultation scenario, a clinician is expected to provide an individual assessment and expert advice, which needs to balance carefully the advantages, risks and availability of alternative treatments. Patients with newly diagnosed conditions or injuries, often in pain and distress, request some psychological support and reassurance of the best clinical care as part of good standard clinical practice. It appears that the current trial recruitment process interferes with, and may even exclude, this clinical decision making process, by the application of fixed eligibility criteria. Even patients who agreed to take part in the UK HeFT mostly did it due to a sense of social responsibility, rather than being comfortably in equipoise about a treatment choice.

A surprising alternative suggestion to reduce research process interference in the clinical care process was uncovered. This came up spontaneously from several interviewees from the UK HeFT (Chapter 6.1.2). Patients were rather uncomfortable with the idea of accepting two very different

interventions as being equally good, yet not knowing which one they were going to have. They were desperate for some form of guidance and reassurance from their surgeon that one or another treatment was a good choice for them, even where there was no evidence to support which one was better.

This is suggestive of pre-randomisation (Chapter 1.4), where an eligible patient is randomly allocated to one of the compared treatments before being approached for potential recruitment (Zelen 1990). This technique was used successfully (83% recruitment rate) in a previous significant large trial of calcaneal fractures in Canada (Buckley, Tough et al. 2002). Pre- randomisation was considered for the UK HeFT, but later dropped because a patient is randomised without a consent, which is difficult to justify

ethically.

The typological analysis (Chapter 6.2) highlighted the different approaches patients adopted to deal with this additional stress. While some were passive or even intimidated by the clinical and research data provided, others

pro-actively took charge of the clinical decision making process. Using available external sources of information and their own judgement, they usually preferred and chose one treatment or the other. The treatment preference was the main reason for non-participation in the UK HeFT, despite most of the participants being positive towards clinical research. However, this undoubtedly subjective and biased approach produced evenly

split and similar patient groups (146 preferred operative and 144 non- operative care, Fig. 3.1), closely resembling those obtained from random treatment allocation. These groups represent a significant number of patients (83% of 351 who refused to take part in the UK HeFT) who are committed to the best treatment outcome, yet are ignored by researchers, unless an inclusive trial design is used (Torgerson and Sibbald 1998). In addition, most of those excluded from the research analysis due to treatment preference appear to have a specific psychological profile. They are pro-active about the decisions leading to their treatment choice and committed to the best possible outcome for the chosen treatment. These subgroups of patients (Fig. 6.2) can be seen in the light of a new theory of patient attitudes in the surgical trial. This highlights that certain types of patients are not and cannot be included within the current recruitment approach, affecting the generalizability of the results. This may be viewed as a selection bias secondary to, or even caused by, current methodological approaches to patient recruitment. In turn, this may contribute to failure to spot a difference between treatment outcomes, or indeed even to erroneous inferences for the whole trial.

7.3.1 Concerns and areas for future research/development

A major limitation of this work is that the above results concern a single trial centre in a single orthopaedic trauma RCT, albeit a multi-centre study. This was my first experience of qualitative research, although I had support and guidance from senior qualitative researchers. In order to make stronger and wider inferences, the results would need to be replicated in the setting of other challenging surgical RCTs.