Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales

Objective To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds). Design A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales. Setting NHS trusts in England and health boards in Wales, UK. Participants Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review. Results From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure’s novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon’s experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included. Conclusions Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients’ and clinicians’ views is required to address variability around information provision/consent for innovative procedures.

The study methods need to be better defined and described to increase the replicability of the work. It's stated that 'methods derived from' content analysis and thematic synthesis are used, which suggests that the authors used some innovative method, but it is not stated what this is. In general the methods need to be more fully described. It seems that this study could neatly be described as a (qualitative) documentary analysis but this terminology is not used nor is recognition shown of this method or its place in the literature.
More detail is needed also on the approach to qualitative analysis. For example, 'To ensure this framework fully encapsulated the data, it was piloted on a sample of policies (15%), by two analysts (JZ and JM) before being independently applied to the full dataset. Data within each theme were reviewed to investigate variations between policy statements on consent.' This suggests that the analysis led to the development of a framework, which was then used to analyse the data further and generate themes. So an iterative approach is suggested but not fully described. I couldn't understand the sentence 'data within each theme were reviewed to investigate...' so I think more should be done to clarify this and the other aspects of the analysis process.
Further to that, the manuscript makes frequent mention of the HSC guidance from 2003. It would be good to know if the thematic analysis derived themes from this guidance as a gold standard (directed analysis?) or if themes were derived independently of this. The authors could include some appraisal of this guidance or comment on whether this is the standard to which they think trusts and health boards should be aiming. Currently it is unclear whether the themes were generated by reference to this standard or exclusively from the data (e.g. a conventional analysis or Grounded Theory approach). Without this description of how themes were generated it is hard to see how the analysis could be repeated.
I was surprised to see a STROBE statement included given that until this point in the manuscript, the study was not described as observational. Again this points to more information being required with regard to study methods and design.
It would also be an improvement to give context to the manuscript with regard to the philosophical and ethical aspects of information and consent. Some ethical works are cited, but the Beauchamp and Childress reference does not appear until very near the end. More work could be done to show the importance and usefulness of the study's findings by discussing them with reference to the ethical context rather than just existing guidelines like those from NICE, the RCS, and so on.
While I do not think it is a barrier to publication, there are some parts where proofreading could improve readability. For example, the phrase 'approvals for the delivery of new invasive procedures, which have not been evaluated or recommended by NICE' is ambiguous; it suggests the approvals should be evaluated, but really you mean the innovations, I think.

REVIEWER
Fleisher While the findings may be of use to a wider audience than just those interested in surgery, it should be made clearer in the abstract, and possibly in the title, that the focus of this study is on *surgical* interventions. The title should be made more informative with regard to the study type and the approach used.
We have included wording in the title to enhance clarity on the study type, approach and that the focus includes surgeries: A qualitative documentary review of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisation policies in England and Wales.
We have also included wording in the abstract to state that the focus is on invasive procedures including surgeries as well as to highlight that this is a documentary analysis:

Design-A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.
The study methods need to be better defined and described to increase the replicability of the work. It's stated that 'methods derived from' content analysis and thematic synthesis are used, which suggests that the authors used some innovative method, but it is not stated what this is. In general the methods need to be more fully described. It seems that this study could neatly be described as a (qualitative) documentary analysis but this terminology is not used nor is recognition shown of this method or its place in the literature.

Thank you, agreed, this was a qualitative documentary analysis and text has been added in the methods section to clarify this and to explain that it facilitated both a thematic analysis to permit rich description and content analysis to allow for quantification of the findings:
A comprehensive qualitative documentary review of guidance on information provision and consent within NHS organisations' policies for the introduction of IP/Ds was undertaken. More detail is needed also on the approach to qualitative analysis. For example, 'To ensure this framework fully encapsulated the data, it was piloted on a sample of policies (15%), by two analysts (JZ and JM) before being independently applied to the full dataset. Data within each theme were reviewed to investigate variations between policy statements on consent.' This suggests that the analysis led to the development of a framework, which was then used to analyse the data further and generate themes. So an iterative approach is suggested but not fully described. I couldn't understand the sentence 'data within each theme were reviewed to investigate...' so I think more should be done to clarify this and the other aspects of the analysis process.

We have edited the methods section and included further description to make the steps of analysis clearer:
This stage is often termed the reflective interpretation stage in qualitative documentary analysis. 35 36 This approach allowed for a thematic synthesis to explore the thematic patterns and depth of information while also permitting quantification of their frequencies through content analysis. 33 The extracted data were iteratively read to ensure familiarisation. Following this, coding categories were inductively formulated from reviewing the policies including the HSC document. These coding categories were collated into a thematic framework.
To ensure this framework fully encapsulated the data, it was piloted on a sample of policies (15%), by two analysts (JZ and JM) independently before being applied to the full dataset. To promote rigor in the data analysis, frequent discussions were held with the team to discuss and refine the initial findings with reference to the raw data. Once the framework had been populated with all the data, it was possible to have a clear overview of each policy's data and analysis results on information provision and consent. This served as case description 35 from each policy, while also providing numerical frequencies of the policies that contained each theme in the framework. The completed framework also permitted the comparative analysis 35 between different policies highlighting similarities and differences among the policies.
Further to that, the manuscript makes frequent mention of the HSC guidance from 2003. It would be good to know if the thematic analysis derived themes from this guidance as a gold standard (directed analysis?) or if themes were derived independently of this. The authors could include some appraisal of this guidance or comment on whether this is the standard to which they think trusts and health boards should be aiming. Currently it is unclear whether the themes were generated by reference to this standard or exclusively from the data (e.g. a conventional analysis or Grounded Theory approach). Without this description of how themes were generated it is hard to see how the analysis could be repeated.
We apologise for the lack of clarity in our description of the analysis. The analysis was done inductively and codes and themes were formulated from reviewing the policies including the HSC document. This has now been clarified in the methods section.
Following this, coding categories were inductively formulated from reviewing the policies including the HSC document as in a grounded theory approach. 35 The discovery that many of the policies had similar wording to the HSC guidance document was a finding from the analysis and points to the intertextuality as added in the discussion section. Rather than proposing the HSC guidance as a standard, we aimed to show that guidance shared through the Health Service Circular seemed to be replicated in the local policies. I was surprised to see a STROBE statement included given that until this point in the manuscript, the study was not described as observational. Again this points to more information being required with regard to study methods and design.

On further reflection, we have decided that the SRQR checklist for reporting is more suited to this study because it is specifically intended to guide the reporting of qualitative studies including qualitative document reviews. A completed SRQR checklist has been uploaded alongside the revised transcript.
It would also be an improvement to give context to the manuscript with regard to the philosophical and ethical aspects of information and consent. Some ethical works are cited, but the Beauchamp and Childress reference does not appear until very near the end. More work could be done to show the importance and usefulness of the study's findings by discussing them with reference to the ethical context rather than just existing guidelines like those from NICE, the RCS, and so on.

Thank you for the suggestion, we have now added text to give context on the philosophical and ethical aspects of informed consent in the introduction:
Patient autonomy is considered a cornerstone of modern healthcare provision, 18 philosophically it is argued that respecting personal autonomy stems from acknowledging that each person has inherent worth and the ability to choose their own destiny. 19 Beauchamp and Childress 19 further explain that for one to exercise personal autonomy, they need to be intentional, done with understanding and be free from controlling influences of others. Respecting this autonomy hence promotes a person's right to hold views and make their own choices as well as supporting their capacity to make these decisions. 19 Informed consent can be seen as a process that fosters patient-centred decisionmaking by respecting their right to self-determination. 22 In the context of surgical innovation, in terms of ethics, informed consent is complicated by trying to communicate challenging aspects like the inherent uncertainties within the innovation, surgeon's lack of experience, lack of robust evidence for the procedure and cost implications. 23 More has also been added in the discussion section: Fundamentally, informed consent should be an exercise of patient autonomy by ensuring that patients understand the procedure and its implications as well as being free of any controlling influences. 19 The inability to exercise informed consent philosophically contravenes the autonomy of the patient and in so doing impacts on their power and positioning within the clinical decision-making process. 19

This is also reiterated in the NICE guidelines for shared decision making, outlining that clinicians should openly discuss the risks, benefits and consequences of treatment choices with patients 36 as has debates in other clinical forums. 23
While I do not think it is a barrier to publication, there are some parts where proofreading could improve readability. For example, the phrase 'approvals for the delivery of new invasive procedures, which have not been evaluated or recommended by NICE' is ambiguous; it suggests the approvals should be evaluated, but really you mean the innovations, I think.

Thank you, we have included a paragraph discussing the definition of surgical innovation in the introduction:
A singular definition of surgical innovation is challenging as it can be contextualised to different aspects of a procedure 1 . This may include an entirely novel or modified anatomical approach, differences in the use of devices and technology or changes to a patient group 2 . The degree of modification from standard procedures that constitutes an innovation is also often debated with implications on the governance required for the procedure 2 .
We have included sentences explaining that while the national guidance state that patients need to be informed by qualified clinicians, the clinicians are not mandated to tell patients about their own experience with the procedure although this is advised by professional bodies: Both the RCS and GMC guidance state that the patient should be informed by a clinician who is trained and qualified to provide the treatment, and the RCS advises that clinicians should tell patients their experience with the procedure. 4 24 25 .

Method: Please define innovative in the policies. Are there any national standards for informed consent for international readers?
This is an important point and thanks for raising it. One of the aims of the broader part of this study is to examine how innovative is defined within policies. We have found that there are inconsistencies (paper under review BJS). As part of the broader project we examined policies for how innovation was defined. This is reported elsewhere (paper under review BJS).

We found inconsistency between policies in the definition of innovation:
Whilst NHS organisations were asked for their policies and guidance documents for innovative, new and modified procedures, we did not give them a definition of what these involved because of the lack of an agreed national definition.
We have now included text describing the national standards for informed consent in the introduction: The Royal College of Surgeons (RCS) guidance state that as part of the consent process for treatment, patients need to be told of their diagnosis and prognosis, options for treatment including no treatment, the purpose, expected benefits and risks of the procedure, likelihood of success and potential further treatment as well as the clinicians that will be involved in the procedure 23

GENERAL COMMENTS
Thank you for your careful and robust considerations of our suggestions.