Clinical Research in Quality Improvement: Complementary Approaches to Improving Neurosurgical Practice

Introduction

Practicing neurosurgeons should be involved in a continuous, ongoing process of improving the results of their clinical interactions with patients. For the individual surgeon, this might include a process for self-improvement, such as continuing education or maintenance of certification. The process of improving clinical care overall relies principally on functions that are more broadly applied. The predominant methods for doing this are clinical research and process improvement.

In clinical research, the results of diagnosing and treating patients are examined using a variety of research designs. This could be based on work with a single patient, a group at a single institution, or a larger scale trial. A variety of designs are used, including retrospective studies (such as a case report, a clinical series, or a study of a patient registry) or prospectively collected data, such as in a prospective trial. Appropriate analysis of the data is then done and conclusions are drawn about the population. In general, the goal is to design the study such that the results can be generalized to a larger population of patients with a given disease, disorder, or intervention. The results will be shared with other neurosurgeons, their institutions, and ultimately the patient families by means of peer-reviewed publications.

In the process improvement scenario, the neurosurgeon or a group of neurosurgeons in a single institution decide to analyze a single aspect of their practice, develop a formal protocol, and then initiate it. Data are collected before and after initiation of change in protocol is made and a conclusion then drawn as to whether the protocol-driven change improved the outcome. This is typically an iterative process, with another change being made and then studied, to see if it has a further impact on the process, shown as an improved outcome.

The many trial design techniques to isolate the effect of a particular intervention are not used because the goal is to improve outcome, not to validate a particular technique. Therefore, it is often impossible to tell which of many aspects of the protocol are truly important.

It is also unnecessary to use the many forms of trial design that control for bias. Since the objective is to apply the results solely to the local situation, the patient population involved in the process improvement project is not considered to be a sample but the entire universe of patients who will be affected.

A common model for this iterative process, which becomes cyclical when repeated, is the Plan-Do-Study-Act model (PDSA). Although this was developed in industrial and other quality control settings, this has been adapted extensively in healthcare processes (see http://www.ihi.org/knowledge/Pages/HowtoImprove/ScienceofImprovementHowtoImprove.aspx ). The results are usually only applied within the originating institution and are not intended to be generalizable. A consequence of this is that the results are also not intended for publication.

The situation is not always quite this clear. An individual neurosurgeon may feel that their excellent clinical results are important and contain object lessons for others, and so should be shared in publication. The error here is in failing to recognize that these results are not clinical research, but are a result of process improvement. If the collection of data required IRB (Institutional Review Board) approval, the misinterpretation of this as research is furthered. Similarly, publication of the process results in a peer-reviewed journal further contributes to this confusion.

In the example that follows, a question of how to improve a clinical process was first studied via a small retrospective study. This in turn resulted in the opportunity to pursue a change in process, which can then be followed and nuanced in an iterative fashion.