Quality improvement research: Can it be published?

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Quality assurance in maternity care is a valuable activity; it frequently leads to changes in the way health care in provided so that women and their families experience a better maternity service and/or better health outcomes. The term ‘quality assurance’ encompasses activities such as ‘peer review’, ‘root cause analysis’ ‘quality improvement’ and ‘audits;’ including chart and data base audits. An increasing number of quality assurance papers are being submitted for possible publication in Women and Birth. This has raised questions and concerns among editors and reviewers.¹ The question for me as editor in chief then is, under what circumstances is quality improvement research of sufficient ethical and scientific quality to allow it to be published in this journal?

In order to be published in this journal quality assurance research must either have formal ethical approval or meet the NHMRC guidelines for the ethical conduct of quality assurance.¹ Some potential authors seek to publish quality assurance research that has not been subjected to formal ethical approval by committee. Occasionally, I have been told that the reason the project did not have ethical approval is that the chair of the ethics committee said that formal ethical approval was not needed simply because it was a quality assurance project; this is not true. The question potential authors need to answer is: “When does quality assurance in health care require independent ethical review?” This very question is the title of an NHMRC publication which provides guidelines for ethics committees, researchers and editors about the circumstances under which quality assurance research does, and does not, require formal ethics approval.

According to the NHMRC guidelines, an important matter to consider when deciding if formal ethical approval is needed concerns issues of consent and confidentiality. Consent and confidentiality refer, not just for patients but to others who may be at risk of being defamed if the quality assurance research is published; this includes individual health professionals and health care organisations. Another major consideration is in a situation where the researchers are considering not obtaining informed consent is the National Privacy Principle 2.1. It states, in part that:

“An organisation must not use or disclose personal information about an individual for a purpose (the secondary purpose) other than the primary purpose of collection unless both of the following apply:

For example, quality assurance research concerning chart audits, for women and babies who experienced emergency caesarean sections, may not need formal ethical approval because the secondary purpose (quality assurance related to the causes of emergency caesarean) is directly related to the primary purpose for collecting the information. This assumes that the researchers who examined the charts were members of the relevant clinical team where the audit was conducted. When a member of the quality assurance team is not normally a member of the clinical team, then that research requires formal ethical approval (See NHMRC guidelines for more details).¹

When seeking to publish quality assurance research where ethical approval has been granted this should be noted in the methods section of the paper. Do not name the ethics committee in the paper: instead include the name of the committee in the covering letter. When seeking to publish quality assurance research that has been conducted without formal ethics approval a statement such as the following must be included in the Methods section of the submitted paper: “As this research conforms with the ethical standards established by the NHMRC for quality assurance research ethical approval was not sought”.¹

Some people believe that quality assurance research will not, or should not be published because it is a ‘lesser’ form of research. I do not necessarily agree with such a belief; there are examples of both poor and good quality scientific research. Indeed, the difference between quality assurance research and scientific research is not easy to define: the NHMRC committee of experts failed to distinguish between ‘research’ and ‘quality assurance’.¹ That may be because the term ‘research’ is used colloquially to mean something like reading and gathering information. What is meant by scientific research, however, is much more specific. The following definition of scientific research is based on a well respected dictionary of philosophy.³

Science is a branch of study which is concerned with a connected body of truth claims usually based on observations in the world. These truth claims and observations are systematically classified and integrated into theories, models and general principles. Science includes trustworthy methods for the discovery of new knowledge. The methods for the discovery of new and better claims to truth are called ‘research methods’ and are subject to methodological scrutiny by peers during the project development and reporting phases of research.

Thus, based on this definition of scientific research, some quality assurance research may be considered good scientific research, depending upon how well the research was conceptualised and conducted in line with established methodological standards.

In order to be published in Women and Birth quality assurance research must meet the same scientific research standards as for any other research. The criteria used to evaluate research quality can be read at: http://www.ees.elsevier.com/wombi/img/ReviewCriteria.doc. Researchers should note that without an appropriate review of related research, a quality assurance research paper would not be publishable. This is in line with one of the criteria for research review which requires “that the study is situated by an adequate and critical review of related literature?” In addition, in order to be considered worthy of publication, all research must have a clear potential to change current practice for the better. The meaning of the term ‘practice’ here includes clinical, educational, administration, policy and political practice as it applies to health care provision for childbearing women and their families.

In summary a quality assurance research paper may be accepted to this journal if the following conditions are met. Firstly, that either ethics approval was granted prior to the commencement of the study OR the study was conducted in line with the NHMRC guidelines.¹ Secondly the study was conceptualised and conducted in a scientific manner which includes demonstrating methodological rigor and linking new knowledge to previous knowledge via a critical literature review. Finally, like all good quality scientific research the study must have the demonstrated potential to change practice for the better.

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References 

1. NHMRC. When does quality assurance in health care require independent ethical review?; 2003. Available at: http://www.nhmrc.gov.au/publications/synopses/e46syn.htm [accessed 9 January 2009].
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2. Office of the Privacy Commissioner. Guidelines to the National Privacy Principles; 2001. Available at: http://www.privacy.gov.au/publications/nppgl_01.html [accessed 9 January 2009].
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3. Flew A, editor. A dictionary of philosophy. 2nd ed. London: MacMillan; 1983.
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