Infection Risk with Nitrofurazone Impregnated Urinary Catheters in Trauma Patients - Research Paper Example

 A Critical Appraisal A Randomized Control Trial Infection Risk with Nitrofurazone-Impregnated Urinary Catheters in Trauma Patients Article Citation Stensballe, J., Tvede, M., Looms D. et.al. (2007) Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients. Annals of Internal Medicine. 147. 285-293. Background Critical appraisal is usually the third step in formulating an evidence based protocol. It follows asking the clinical question or PICO and searching for evidence. When appraising a study the cause and effect mechanism must be supported and there are three criteria which determine that. They are the independent variable or the intervention, a strong relationship between the dependent and the independent variable, and other variables do not explain the outcome. Along with that there are three characteristics of an RCT that lend themselves to appraisal. Those characteristics are and experimental group that receives the experimental intervention or treatment, a control or comparison group who receives what is considered the standard care or no care, and random assignment of the participants (Melnyk & Overholt, 2005). There are three very important questions that must be gotten at when doing a critical appraisal and those are: Are the study findings valid? What are the results of the study and are they important? And Will the results help me in caring for my patients? Randomized control trials are considered by many to be the most appropriate research design to be used for determining how effective a particular intervention might be. It is considered when appropriately done to be the highest level of evidence so it works well for determining evidence based practice guidelines. Published RCT's have been through the peer review process but this does not relieve the reader from assuring that the quality of the publication is good and also whether the results will apply to their patients (Mittlbock, 2008). Appraising an article before hand prevents the use of articles that are not valid in an important study. Urinary tract infection is one of the most likely nosocomial infections to occur when a patient is admitted to the hospital. It increases in likelihood when a when a urinary catheter is placed. Today, however, with present on admission criteria being used to prevent payment for complications, everyone needs to be aware as well as using evidence based research in an attempt to prevent these infections. This paper will be a review of the Stensballe article on impregnated urinary catheters for prevention. This is a double blind, randomized control trial. The study was approved by the local ethics committee and the Danish Data Protection Agency. This appraisal will be looking for validity, results and relevance. Are the results of the study valid? Were the patients assigned to treatment randomly? The study included all adults above the age of 18 who entered the emergency room as a trauma victim and needed a urinary catheter, during a twenty four month period. Planned exclusions were HIV infection, preinjury treatment with corticosteroids, pregnancy, primary brain injury, and inability to give informed consent. Two types of catheters were used, regular silicone catheters and nitrofuazone impregnated catheters. The nurses opened sealed and consecutive catheter envelopes for use. Both kinds of catheters were new to the hospital and were not identifiable by the nurses. Whoever the next patient was got the next catheter which made the whole assignment completely at random. The patients were registered into the program by the lead trauma nurse and they were randomized but only the statistician knew which group the patient fell into. The statistician was a person who did not work for the same organization and was totally independent of the study. Were all the patients who entered the trial properly accounted for and attributed at its conclusion? Was the follow-up complete? The patients who entered this study were very well accounted for. There were 1367 patients assessed for entrance while 1155 were excluded so 212 were randomly assigned. 106 were assigned to the group with the treated catheters and 106 were assigned as the regular catheter group. In the standard silicone catheter side, 1 found out she was pregnant, 2 were under 18, 8 had the catheter removed within 24 hours, and 11 died within 24 hours. 1 had an adverse reaction. That was a total of 29 patients dropped from the study. The intention to treat was n-106 and the analyzed per protocol was n=77. This did decrease the sample size but the data was kept on each of these patients and merged into the final data up to the time period when they were lost from the study. Those patients that were in the treated catheter group, 1 found out she was pregnant, 1 could not sign the consent, 14 had catheters removed within 24 hours, 1 was referred to another hospital, 1 catheter was exchanged for a temperature sensing catheter and 4 had adverse events. This left 28 patients excluded with an intention to treat 106 and analyzed per protocol 77. Intentions to treat patients of 106 in each case were included in the study throughout the final results. 106 patients were included in each set of statistical studies. Were patients, their clinicians and study personnel blind to treatment? This study is a double blind study. The patients who were assigned to the groups did not know which one they were in. The nurses who put the catheters in did not know which one of the catheters they were putting in and the evaluators did not know which patients had which catheters. A separate independent biostatician was the only one aware. The trauma team leader entered the patient in the study but the randomization took place separate from his knowledge also. The lab personnel that received the labs for study were also blinded to which patients had which kind of catheter. Were the groups similar at the start of the trial? It is important that the groups are similar or as much alike as possible. If they are not, we do not know for sure that it was not the differences that created the results. That is the beauty of true randomization as it creates a situation in which all patients have the same chance of having either treatment. These groups were very similar throughout the course of the study and they were treated similarly throughout the study. Those that had special things happen such as a need to replace the catheter with a temperature sensing or became ill enough to transfer, were kept track of but removed from the rest of the study. The eventual results included the parts of their study that were completed. There was a random mix of male and female patients and the patients ranged between the ages of 18 and 59. They were all in a traumatic accident. Were the participants followed up and data collected in the same way? Yes, the participants were followed through the whole program and data was collected in the same way. Even the lab who received the urine specimens did not know which patient was using which catheter. The only time the study stopped is when the catheter was discontinued because of no longer needing it, discharge, or some other reason such as switching to a temperature sensing catheter. The data was all collected by the independent statistician who verified and distributed the reports. Aside from the experimental intervention, were the groups treated equally? The two groups were treated equally. All trauma patients who entered the hospital and had a catheter placed and who were not excluded because of prior criteria had the same urinalysis done on a daily basis and tracking done. No one knew who these patients were until the end of the study. They could not be treated differently because no one knew who they were. What are the results? How large was the treatment effort? The statistical analysis for this study had an expected 20% infection in trauma patients. This was an 80% power ratio to detect a 65% reduction in the incidence with the treated catheters which according to the study would give them a P less than 0.05 and would require a sample size of at least 200 which they met in their final sample size. There was a reduction in overall urinary tract infections in the first 30 days with the treated catheters which continued throughout the study period. A total of 1190 urine cultures were obtained, covering 1001 catheter days. There were no urinary tract related bacteremias that were seen during this study. The nitrofurazone group had 7/77 cases which was 9.1% while the non-treated catheter patients had 19/77 or 24.7%. The incidence of CABF per 1000 catheter days was 13.8 in the nitrofurazone group and 38.6 in the silicone group. This gives a treatment difference of 13.8% which is significant in treatment levels. The results also showed that for those patients that had the treated catheter, and got an infection, the infection took longer to happen. Will the results help in caring for my patients? Can the results be applied to my patient care? The result of this study is important to patient care for several reasons. This particular study was done on trauma patients who need a urinary catheter longer than the average patient. The work shows that the trauma patients who got a urinary tract infection took longer to get one, in fact on the average up to 30 days. This would indicate that the average patient might not get a urinary tract infection at all when needing a catheter for 3-5 days. However, since this determination is supposed to be made with patients that are similar to those in the study, it would be somewhat limited in scope and may need to be studied with patients that had a shorter term hospitalization. There would, of course need to be a cost study done as well. The average patient would certainly be considered a sub group. Costs are also not often reported in a trials but become important when evaluating whether or not to use a treatment in an evidence based protocol. If a treatment only gives a small health gain, it may not be worth making the switch. In this case the health gain is large. The study did seem to take into account all of the clinically important questions such as reduction in antibiotic use and reduced length of stay. This would decrease the numbers of complications for a patient that is already very ill which again would be a good side result for the regular patient. There were very few harmful effects noted throughout the study, in fact, the total was four which makes the risks very low. The cost of this catheter has got to be higher but when compared to the overall cost of extended length of stay and patient complications that are no longer reimbursed by Medicare; the cost benefit ratio has got to be on the side of the treated catheter. Clinically important outcomes were all addressed by the study including reduced antibiotic use and earlier discontinuation of catheter use. It is important to know, once we are sure that the study is valid, whether or not the study is applicable. It is important to know whether there are important differences in the patients in the trail and the patients or population of patients that are about to be treated. It is also important to weigh present procedures that are used against those that are being considered from these trials. Applicability Urinary tract infection can be a major issue for patients who already need a great deal of care or are immundeficient based on previous disease or problems. This includes those patients that are trauma victims as well as those that are critically ill. Prevention is the key to safety for the patient as well as earlier discharge and better healthcare reimbursement. There is also a reduction in cost when one considers a shorter length of stay. The results of this study showed a decrease in the number of infections that occurred up to the 30 day period of use. Urinary tract infections are second only to respiratory infections as complications for patients who are already ill. These infections often lead to bactueriuria, symptomatic or asymptomatic infections cystitis and pyelonephritis, not to mention that they also cause more debilitation of the patient, creating an issue with healing and recovery. They may cause renal damage. There is an increased likely hood of these infections when the patient is extremely debilitated or has a neutrogenic or autoimmune disorder. There are, also patients that are predisposed to getting these infections. The use of antibiotics also causes many side effects in patients, especially if it is over a longer term of care. Patients become immune to their effects, develop diarrhea and many other GI symptoms and may develop a secondary infection due to the use of some of these antibiotics. A third issue is the fact that the government, shortly to be followed by most insurance companies has a present on admission policy at this time. This means that if you come in with a urinary tract infection, the extra money that infection costs will be included in the diagnosis but if you develop an infection after admission, the funds for that cost will be carved out and not paid for those infections. This is a very costly side effect of developing a complication in the hospital. These reasons make this study very applicable to the general care of patients who are admitted to the hospital and need a urinary catheter as the results show that the use of this type of catheter will reduce these infections. There are also four other studies available at this time using this particular catheter and the results coincide with the results noted in this study. There are some differences in these patients that might affect the outcomes that would be achieved in a different group of patients such as mine. That includes the fact that these were trauma victims who were severely debilitated. These catheters prevented infection in their case which might mean one of two things, my patients would do even better or it could affect my patients in a different way and the results would not be as good. It is difficult to tell when there have been no studies with the regular patients. There is also a cost, reimbursement issue. This is obviously more expensive though we do not know how much more expensive. A trauma patient pays at a high DRG and the cost ratio may be low under those circumstances but will it be cost effective for patients with lower paying DRG's such as congestive failure or pneumonia? Conclusion When one is reading any research it is important to keep in mind the things that have been learned here. This is true, be it a systematic review, a RCT, an economic evaluation or some other study design. It is important to remember that the three things we always want to know are is it valid, what are the results, and is it relevant. This process will ensure that poor quality studies are not being used to achieve evidence based protocols. The objective of this appraisal was to determine validity, results, and relevance. This has been done through the appraisal process. The study shows good validity as their randomizing was well blinded to create a lack of bias in determining results. All of the patients were treated the same according to protocol as no one knew which patients were which and urine specimens were done on all of this group of patients daily. The results were quite positive for the use of the treated catheter in this case. There was a large reduction in the numbers of infections with its use. It also took longer for those that did get an infection with the use of this catheter to get a one. The relevance of the study to the patients we normally care for is debatable and probably requires more study. These were all trauma victim and our patients are not. Would it work as well with the average patient? One would guess that the answer is that it would work even better but we do not know that answer for sure and we do not know what the cost benefit looks like. References Dullum, Ciliska, Haynes, and Marks (2008). Evidence Based Nursing. Lippincott: Boston. Melnyk, B & Overholt, E. (2005). Rapid critical appraisal of RCTs; an essential skill. Evidence Based Practice. 50. Mittlbock, M. (2008). Critical appraisal of randomized clinical trials; can we have faith in the conclusion? Breast Care. 3. 341-346. Stensballe J., Tvede M., Looms D., et.al. (2007). Infection risk with nitrofurazone- impregnated urinary catheters in trauma patients. Annuls of Internal Medicine. 147. 285-293. Taylor R., Reeves B., Ewings P. et.al. (2004). Critical appraisal skills training for health care professionals; a randomized controlled trial. Biomedical Control Medical Education. 4(30) Read More