What to write
Ethical aspects of implementing and studying the intervention(s) and how they were addressed, including, but not limited to, formal ethics review and potential conflict(s) of interest.
Explanation
SQUIRE 2.0 provides guidance to authors of improvement activities in reporting on the ethical implications of their work. Those reading published improvement reports should be assured that potential ethics issues have been considered in the design, implementation and dissemination of the activity. The example given highlights key ethical issues that may be reported by authors, including whether or not independent review occurred, and any potential conflicts of interest.1 These issues are directly described in the quoted sections.
Expectations for the ethical review of research and improvement work vary between countries2 and may also vary between institutions. At some institutions, both quality improvement and human subject research are reviewed using the same mechanism. Other institutions designate separate review mechanisms for human subject research and quality improvement work.3 In the example below, from the UK, Hands et al4 report that the improvement activity described was reviewed and approved by a regional research ethics committee. In another example, from the USA, the authors of a report describing a hospital-wide improvement activity to increase the rate of influenza vaccinations indicate that their work was reviewed by the facility’s quality management office.5
Avoiding potential conflict of interest is as important in improvement work as it is in research. The authors in the example paper indicate the presence or absence of potential conflicts of interests, under the heading, ‘Competing Interests.’ Here, the authors provide the reader with clear and detailed information concerning any potential conflict of information.
Both the original and SQUIRE 2.0 guidelines stipulate that reports of interventions to improve the safety, value or quality of healthcare should explicitly describe how potential ethical concerns were reviewed and addressed in development and implementation of the intervention. This is an essential step for ensuring the integrity of efforts to improve healthcare, and should therefore be explicitly described in published reports.
Example
Close monitoring of (vital) signs increases the chance of early detection of patient deterioration, and when followed by prompt action has the potential to reduce mortality, morbidity, hospital length of stay and costs. Despite this, the frequency of vital signs monitoring in hospital often appears to be inadequate…Therefore we used our hospital’s large vital signs database to study the pattern of the recording of vital signs observations throughout the day and examine its relationship with the monitoring frequency component of the clinical escalation protocol…The large study demonstrates that the pattern of recorded vital signs observations in the study hospital was not uniform across a 24 h period…(the study led to) identification of the failure of our staff in our study to follow a clinical vital signs monitoring protocol…
Acknowledgements The authors would like to acknowledge the cooperation of the nursing and medical staff in the study hospital.
Competing interests VitalPAC is a collaborative development of The Learning Clinic Ltd (TLC) and Portsmouth Hospitals NHS Trust (PHT). PHT has a royalty agreement with TLC to pay for the use of PHT intellectual property within the VitalPAC product. Professor Prytherch and Drs Schmidt, Featherstone and Meredith are employed by PHT. Professor Smith was an employee of PHT until 31 March 2011. Dr Schmidt and the wives of Professors Smith and Prytherch are shareholders in TLC. Professors Smith and Prytherch and Dr Schmidt are unpaid research advisors to TLC. Professors Smith and Prytherch have received reimbursement of travel expenses from TLC for attending symposia in the UK.
Ethics approval Local research ethics committee approval was obtained for this study from the Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee (study ref. 08/02/1394).”4
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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