Equipoise

The development of the consensus statement was underpinned by a five-year research project funded by the Canadian Institutes of Health Research [14] (link). The project used a mixed methods approach incorporating both empirical work and ethical analysis. The empirical work included interviews with key informants, review of published CRTs [15] (link), a survey of trialists, and a survey of REC chairs. Based on the empirical work, as well as the practical experiences of research team members, the team identified six questions specific to CRTs in need of further analysis: How should research participants be identified? From whom, how, and when must informed consent be obtained? Does clinical equipoise apply? How does one determine if the benefits outweigh the risks? Who are gatekeepers, and what are their responsibilities? How ought vulnerable groups be protected [16] (link)? The research team conducted an ethical analysis of each issue, which led to a series of discussion papers laying out principles, policy options, and rationales for proposed ethics guidelines [17] (link)–[20] (link). The research team posted these papers on a wiki (http://crtethics.wikispaces.com) and publicized the wiki in the discussion papers and surveys.
To develop the consensus statement from this process, the research team organized a two-and-a-half-day meeting of a multidisciplinary expert panel that took place in Ottawa, Canada, in November 2011. The research team identified the constituencies and perspectives that needed to be represented within the expert panel, including ethicists, cluster trialists, consumer representatives, RECs, policy makers, funding agencies, and journal editors. Potential expert panel members were identified by consultation with colleagues, via searches of the relevant literature and the Internet, and from respondents in the key informant interviews, trialist survey, and REC chair survey. In addition to six of the members of the research team, 26 external individuals were approached, of whom 13 agreed to participate. (See Text S2 for a list of the 19-member expert panel.) External members were invited as individuals rather than as representatives of their home organizations.
The research team made the discussion papers available to the expert panel in advance of the meeting. The first day of the consensus process was an open meeting with a simultaneous webcast, attended by individuals from the same constituencies and sources used to identify the expert panel. Eighty people participated in person, and a further 20 participated by webcast. The research team presented the results of the empirical studies and the ethical analyses of the six questions, and three expert discussants and the audience commented on the presentations. The open meeting served to further familiarize the expert panel with the content of the materials developed by the research team, and allowed them to hear issues raised about the materials by the broader audience. Video of the open portion of the consensus meeting is available via YouTube (http://www.youtube.com/user/mtaljaard55).
Over the next one and a half days the members of the expert panel met in closed session to discuss the identified issues and to develop recommendations. The expert panel was chaired by Professor Martin Eccles, an experienced small group leader with expertise in chairing guideline development groups. Initial discussions established the “rules of engagement” for the expert panel process. The expert panel agreed about how debate should be conducted and how they wanted the chair to run the process. The expert panel agreed to achieve consensus, where possible, through discussion and would document disagreements; they did not wish to use a majority voting system. Draft recommendations based upon the background papers were presented to the expert panel, and members were asked to identify issues in need of clarification and discussion. Full discussion of these issues was facilitated by the chair with the aim of achieving consensus on the underlying principles, but not necessarily specific wording. All expert panel members actively participated in the discussion. Some draft recommendations were substantially revised during the process. There were no substantive disagreements requiring presentation of dissenting views.
A writing group, consisting of seven members of the research team, then reviewed the results of the meeting and produced a first draft of the consensus statement. The writing group circulated the draft to the expert panel in December 2011 and asked for comments on both the principles and specific wording of the recommendations. Responses were received from all participants, and a point-by-point response to all comments (available on request) was produced and the draft consensus statement revised accordingly. In February 2012, the writing group posted the revised consensus statement on the wiki and invited the expert panel, participants of the open meeting, respondents in the key informant interviews, trialist survey, and REC chair survey, and other contacts of the research team to comment. Again, the writing group produced a point-by-point response to all comments (available on request) and revised the consensus statement. In June 2012, the final draft of the consensus statement was sent to the expert panel for approval, which was given by all members with no dissention.

The patients were subjected to CCUS plus ABG based algorithm in which we collected information about LUS patterns , TTE (Trans-thoracic Echocardiography), IVC along with ABG on admission to ICU. On the basis of the findings as described in Figure 1 the patients were classified into one of the described pathophysiological domains. The bedside CCUS plus ABG based diagnosis was made by one of the three intensivists, who was present at the time of admission (all with equipoise training in CCUS) . The diagnosis was noted on data collection sheet and then put in a sealed envelope. Once the Chest X-ray was done, the image was sent to two independent physicians not directly related to patient care , who made the diagnosis on the basis of Chest X ray based algorithm as described in Figure 2 and diagnosis was noted on data collection sheet and then put in a sealed envelope. The team analysing the two algorithms were different. The composite diagnosis is the final diagnosis made by two critical care consultants at the end of 48 hours after carefully interpreting clinical and investigational data which included CT scan, Echocardiography and blood investigations. Once the study was completed , the sealed envelopes were opened and correlation of the CCUS plus ABG based algorithm vs Composite diagnosis, CxR algorithm vs Composite diagnosis and CCUS vs CxR was done for each of the pathophysiologic condition. We collected information about patient demographics (age, gender), primary admission source, severity of illness (SOFA), need for intubation, form of mechanical ventilation, vasopressor need , ICU outcome and length of ICU stay. We calculated the diagnostic test properties of each of these algorithms with composite diagnosis, percent agreement and percent agreement beyond chance for each of these algorithms and final correlation of these algorithms for each of the five defined pathophysiological diagnosis (Figure 1).

Interviews were conducted by MJ (a female final year BSc honours undergraduate student with prior research internship experience and who first undertook a training module in qualitative research) and JP (a female paediatric occupational therapist with many years of research experience including experience of qualitative interviewing, and an MPhil). Interviewees did not have a prior working relationship with those interviewed but introductions were made at the start of the interview process. Participants were made aware of the goals of the research at the start of the interview. In terms of reflexivity, JP had led on the course development but was keenly aware of the need to avoid bias towards a favourable outcome in her questioning and interpretation. MJ had not been involved in development of the course and had no prior detailed knowledge of the research field; she was therefore in a position of equipoise.
Interviews took place either face to face in a quiet office setting or by telephone, at the convenience of the interviewee. They were held on a 1:1 basis, with no observers or other non-participants present. No repeat interviews were undertaken.
Interview content was shaped by a topic guide; this was not formally pilot tested but was reviewed by research team members prior to implementation. Interviews began with discussion about the participants’ professional background and prior knowledge of the subject area. This was followed by consideration of what the participant had gained from the training and how it had influenced, or could influence, their practice. The course structure and content were also discussed. Interviews were audio recorded, transcribed verbatim and pseudonymised prior to analysis. Due to the straightforward nature of the interviews, separate field notes were not undertaken and transcripts/findings were not returned to participants for comment.