Q: How can I fulfill my journal's requirement of a "Patient and public involvement" section in my protocol article?

Detailed Question -

I submitted a protocol article to BMJ Open. However, I got the following feedback from the journal about the format:

  • Kindly re-upload additional file 1 in PDF format.
  • Please ensure that your MANUSCRIPT’S TITLE in your main document and ScholarOne submission system are the same.
  • Please write a correct format of abstract for protocol paper (max. 300 words) including the following headings (please note that for RCTs there is a specific CONSORT extension for abstracts).

I am able to understand and incorporate the above comments; however, there is one detailed comment that I cannot understand. It says:

  • Patient and Public Involvement: Authors must include a statement in the METHODS section of the manuscript under the sub-heading 'Patient and Public Involvement'.

This should provide a brief response to the following questions:

  1. How were the development of the research question and outcome measures informed by patients’ priorities, experience, and preferences?
  2. How did you involve patients in the design of this study? Were patients involved in the recruitment to and conduct of the study?
  3. How will the results be disseminated to study participants?
  4. For randomised controlled trials, was the burden of the intervention assessed by patients themselves?
  5. Patient advisers should also be thanked in the contributorship statement/acknowledgements.
  6. If patients and or public were not involved please state this.

I cannot find any guideline about protocol article. I tried to find a sample article, but couldn't. I have no idea how can I respond to the above feedback. 

1 Answer to this question

BMJ Open is a reputed journal publishing medical research from all disciplines and therapeutic areas. From your question, it is clea that you want to submit a protocol article. Please see the author guidelines here: https://bmjopen.bmj.com/pages/authors/ . You can find author guidelines to present ‘Study Protocol’ articles in this section. The word count for such article types is 4000 words. Also, your protocol needs to follow the SPTRIT guidelines (http://www.spirit-statement.org/) as per the journal guidelines.  In case your protocol is based on a clinical trial, please ensure that your study is registered with registries enlisted under International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/network/primary/en/). All these are best practices both in research as well as academic publication.

Coming to the next part of your question as to how you need to answer the query from the journal related to 'Patient and Public Involvement,' please understand that a full disclosure of the informed consent of the participant is mandatory in any study involving human beings.

I am not sure what type of protocol you wish to publish and what it is based on – but, if it involves any human participation (either patients or the general public), please state explicitly what role they played in the experiment protocol. You must also mention the inclusion and exclusion criteria for recruiting the study participants.

The journal also advises you to add the names of people who have been involved in patient counselling, if any, in the Acknowledgements section.

If your study did not involve any human participation, please explicitly state that in the manuscript.

It would be difficult for us to advise anything more without knowing the type of protocol article that you will be submitting. However, for your reference, please go through the following different types of protocol articles from BMJ Open and review their contents for a better understanding of the journal’s expectations:

  1. STANDING Collaboration: a study protocol for developing clinical standards (2016) https://bmjopen.bmj.com/content/7/10/e014048
  2. AspiriN To Inhibit SEPSIS (ANTISEPSIS) randomised controlled trial protocol (2016) https://bmjopen.bmj.com/content/7/1/e013636
  3. Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol (2016) https://bmjopen.bmj.com/content/7/1/e011437
  4. Acupuncture for stable angina pectoris: a systematic review protocol (2017) https://bmjopen.bmj.com/content/8/4/e019798
  5. Metformin for endometrial hyperplasia: a Cochrane protocol (2016) https://bmjopen.bmj.com/content/6/8/e013385

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