Title: Exploring approaches to patient safety: The case of spinal manipulation therapy

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1 Reviewer s report Title: Exploring approaches to patient safety: The case of spinal manipulation therapy Version: 0 Date: 15 Feb 2016 Reviewer: Duncan Reid Reviewer's report: BCAM-D Re-thinking approaches to patient safety: The case of spinal manipulation therapy Thank you for the opportunity to review the above paper. The topic is of interest as the issue of spinal manual therapy (SMT) and risks are of great importance to those professions that use this as a treatment modality. Therefore I feel the topic will appeal to the readers. General comments. My main issue with this paper is that I feel the title does not really reflect the content. The researchers have done a good job seeking the views of a wide range of relevant health professionals that use SMT to manage neck pain. These qualitative interviews have captured the essence of the issues around intra and inter professional disagreement over safe practice, philosophical dogma as to the use of SMT, who is practising in the safest way and the conflict between business models and safe practice. The researchers have also indicated that much of the opinion is based on anecdote rather than facts about what each profession is actually doing in this space.

2 The title of the paper Rethinking approaches to patient safety- the case of spinal manipulation therapy, implies that the paper may offer some new insights on how these problems may be managed going forward. I feel they have identified the issues, but no solutions have been offered? What is the rethinking that has gone on here, the paper just describes what the current views and issues are. Based on the comments of the participants interviewed I feel the researchers could offer some quite strong recommendations such as; these professions need to talk and share best practice, should there be more generic training, should there be some combined professional work to develop a risk register, even if this is a challenge. To state in the conclusion that new approaches are needed, in my view is too soft a conclusion, what should these new approaches look like?? Given all this perhaps a better title for the paper would be "attitudes and beliefs towards patient safety in health professionals that use SMT". Understanding and listening to these attitudes and beliefs (many of which are not based on fact) is important for these professions to hear. None of these professions own SMT and this needs to be stated. If the paper was reframed with way then much of the data would still fit but the messages would be a little different. I think it would also be good for the authors to refer to one key piece of work by the International Federation of Orthopaedic Manipulative Therapists (IFOMPT) that has tried to get a worldwide consensus on cervical screening and safety. The following link and paper should be referred to in the document. Rushton A, Rivett D, Carlesso L, Flynn T, Hing W, Kerry R. International framework for examination of the cervical region for potential of cervical arterial dysfunction prior to orthopaedic manual therapy intervention. Manual Therapy 2014;19: Whilst these are physiotherapy focussed documents this group has tried to provide leadership to the profession over this issue. This is the type of approach the researchers in this paper may have recommended going forward.

3 Specific comments Abstract The opening statement of the abstract states "The purpose of this study was to gain insight into the current safety culture around the use of spinal manipulation therapy (SMT) by regulated health professionals in Canada and to explore the potential for implementing formal mechanisms for tracking associated adverse events." I feel the insights have been gained but no exploration or formal tracking is offered so this statement needs rewording. I have commented on the conclusion above and this needs to be strengthened both here and in the overall conclusion of the paper. Background Line 86, I feel the IFOMPT guidelines and the Rushton paper stated above could be referred to here as reference 16 is not sufficient to support that statement. The reference to the Reason model and other health care safety models is interesting but could be shortened. As the authors have stated these models do not apply so easily to primary care, therefore there is a need for less text, currently I feel the amount to text here detracts from the purpose. There needs to be a clearer purpose for the study and if the title is changed the purpose needs to reflect this.

4 Results Line 239 I think it would be useful to describe what the old model is, is this the subluxation theory?? Discussion Given my overall comments above I think the discussion could be strengthened if there was comment about how to change all the issues found in the interviews. This would make the paper stronger and more useful to the potential future directions. Are the methods appropriate and well described? If not, please specify what is required in your comments to the authors. Yes Does the work include the necessary controls? If not, please specify which controls are required in your comments to the authors. Unable to assess Are the conclusions drawn adequately supported by the data shown? If not, please explain in your comments to the authors. No Are you able to assess any statistics in the manuscript or would you recommend an additional statistical review? If an additional statistical review is recommended, please specify what aspects require further assessment in your comments to the editors. Not relevant to this manuscript Quality of written English Please indicate the quality of language in the manuscript: Acceptable Declaration of competing interests Please complete a declaration of competing interests, considering the following questions:

5 1. Have you in the past five years received reimbursements, fees, funding, or salary from an organisation that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? 2. Do you hold any stocks or shares in an organisation that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? 3. Do you hold or are you currently applying for any patents relating to the content of the manuscript? 4. Have you received reimbursements, fees, funding, or salary from an organization that holds or has applied for patents relating to the content of the manuscript? 5. Do you have any other financial competing interests? 6. Do you have any non-financial competing interests in relation to this paper? If you can answer no to all of the above, write 'I declare that I have no competing interests' below. If your reply is yes to any, please give details below. I declare I have no competing interests I agree to the open peer review policy of the journal. I understand that my name will be included on my report to the authors and, if the manuscript is accepted for publication, my named report including any attachments I upload will be posted on the website along with the authors' responses. I agree for my report to be made available under an Open Access Creative Commons CC-BY license ( I understand that any comments which I do not wish to be included in my named report can be included as confidential comments to the editors, which will not be published. I agree to the open peer review policy of the journal

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