Abstract
Quality improvement and clinical research differ significantly, even though either may result in publication in medical literature. In the former, a single aspect of clinical practice is studied, a protocol to improve process is then developed, and the results are studied. In general, the results are locally applicable and not necessarily generalizable. Clinical research, by contrast, involves retrospective or prospective collection and analysis of patient data, often with an intent to publish the results. Sometimes, the distinction is not clear. This chapter seeks to explore the similarities and differences between the two methods, using an example from pediatric neurosurgical practice.
Keywords
Clinical research, Process improvement, Noise vs bias, PDSA cycles, Study designs, Implant infections, Intrathecal baclofen therapy
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.
An Example From Clinical Practice
Rationale for Study
It is becoming more common for patients, or their parents/guardians, to request combining elective surgeries whenever possible. The reasons cited for this include patient and family convenience, financial concerns, and (particularly in the case of a younger patient) concerns that multiple episodes of anesthesia or sedation have potentially deleterious effects on neurodevelopmental outcomes. In the case of implant surgery, surgeons may be hesitant to combine procedures because of a perceived increased risk of implant infection, although there is virtually no literature to support this fear.
This example involves the care of patients with cerebral palsy and spasticity in a specialty care hospital setting. During the care of such patients, whose spasticity is managed with intrathecal baclofen (ITB) therapy, pumps are often inserted or revised on an elective basis. Elective revisions are most often because of end of battery life. In our institution, the group of pediatric neurosurgeons who perform pump surgery have differing views of the risk of pump infection when combined with other surgery. This prompted the question of whether ITB pump surgery combined with another surgical procedure has historically resulted in a higher infection risk. The null hypothesis in this study is that there is no difference in infection rates between patients who undergo pump surgery alone versus those who underwent pump surgery combined with other procedures.
Method
After obtaining IRB approval for a retrospective study, surgical logs were used to create a database of all ITB pump surgery at a single hospital, which has a large population of children and young adults with cerebral palsy. This study was restricted to a 5-year period (2006–10) with a minimum of 1-year follow-up. During this period of time, the decision to allow a combined procedure at the time of ITB pump surgery was by surgeon’s choice. No surgeon agreed to combine ITB surgery with a contaminated case, or any case in which there was a high expectation of bacteremia (i.e., only clean surgeries with low risk of contamination were included). ITB pump insertions and revisions were included, but explants were not. Procedures were then grouped according to whether they were pump surgeries only vs those combined with other procedures. Other procedures included were orthopedic (nonspine) procedures, orthopedic spine procedures (including those in which the ITB procedure was a catheter revision necessitated by the spine surgery), and injection therapies (botulinum toxin or phenol injections). Infection rates were then calculated for each group. Statistical analysis was done using chi-square tests or unpaired t -tests where appropriate.
Results
During the study period, all patients received perioperative antibiotics according to a standardized institutional protocol. This included intravenous vancomycin (15 mg/kg) before induction and for 24 h postoperatively. Each patient also received mupirocin to each naris for a 4-day period, starting preoperatively, for control of staphylococcal carrier states. For those patients with surgical ostomies of any kind, or who were diapered, an aminoglycoside course was also added for the 24-h perioperative period, using either gentamicin or tobramycin at a dose of 2 mg/kg per dose. At our institution, patients are either children or young adults, with the vast majority of them (> 86%) having a primary diagnosis of spastic cerebral palsy. Nearly 60% of patients reviewed here were males; no significant differences among gender, age, or diagnosis were observed between patients who had an isolated pump procedure vs combined procedures.
A total of 504 procedures were included, of which 422 (83.7%) were isolated pump procedures and 82 (16.3%) were combined procedures. The infection rate for the isolated pump surgeries was 16/422 (3.79%), with Staphylococcus aureus as the most common causative organism. Infection rates in the combined procedures were also established. There were two pump infections in the 34 extremity surgeries (5.88%). Both were associated with plate removal and the organisms were Staphylococcal species. In those cases which involved spine surgery, three pump infections occurred out of 29 cases (10.3%). The organisms were a Staphylococcal species, a Klebsiella species, and one unidentified species. In all three of these cases that resulted in pump infections, the catheter surgery was unplanned, that is, the ITB catheter was dislodged during primary surgery in two cases and in the third (a pseudoarthrosis repair) the catheter surgery was unanticipated. One pump infection was identified among 19 cases with combined injection therapy (5.3%, a Staphylococcal infection following a botulinum toxin injection).
Statistical analysis between groups showed that although infection rates for combined surgeries were higher, this trend was not significant. The infection rate for pump surgery alone was 16/422 (3.79%) and that for all combined surgeries taken together was 6/82 (7.31%) ( P = .15 by chi-squared test). The risk of infection in combined surgery compared to pump surgery alone had OR = 2.323 (95% CI 0.73–7.39, Peto method). The infection rates in each subgroup of combined surgery were also not significantly different from the rate for pump surgery alone, although the small sizes of these groups limit the usefulness of this statistical testing.
Discussion and Follow-Up
In light of the finding that no significant difference in infection rates was observed in a short retrospective review at a single center, surgeons were given the option of combining pump surgery with another procedure when appropriate. The hospital quality and infection control departments continue to monitor the overall rate of ITB pump surgery infections. An unanticipated benefit of this review was the recognition that spine surgery in a patient with a previously implanted ITB pump carries a risk of infection of the catheter, even though the rate of ITB infections in spine surgery patients was not significantly increased. The observation of a trend toward higher infection rate led to the recommendation that the perioperative antibiotic management of such patients be adjusted to use the same protocol as is used for ITB pump surgery alone. Although not a part of this specific hospital measure, the infection rates for spine surgery overall have subsequently improved.
In this example, a small quality study was performed, starting with retrospective data, to see if selected second procedures could be added to ITB surgery. Finding no significant difference in a small pilot study, the practice of combing surgeries was allowed to continue. An unexpected benefit of this was the decision to adjust the perioperative antibiotics used in spine surgery if an ITB pump was present. As is typical of process improvement work, the hospital continues to monitor the infection rates in ITB implant surgery. However, these results would not be considered to be generalizable, and while they may be reported and shared, they are not considered “research” with results that can be expected to be reproducible elsewhere.
Related posts:
On Developing the Tools and Metrics for a Neurosurgical Quality Program
The Physician Handoff and Its Role in Quality and Safety
Improving Operating Room Safety
Improving Performance by Improving Education
Quality of Care and Outcomes in Pediatric Neurosurgery: Incorporating Evidence-Based Practice
Use of Risk Model for Assessment of Resident Perception of Surgical Complexity and Evaluation of Procedural Competence
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