Quality Evidence From Rickard, C.M., et al. (2012)

The objective of this study is to critically appraise quality evidence in the work of Richard, et al. (2012) which focuses on routine vs. clinically indicated replacement of peripheral intravenous catheters: A Randomized Controlled Equivalence Trial. The focus of the critique will be on the methodology, results, implications for clinical practice and further research.

Schultz et al. (2010) reports that randomized controlled trials “when they are appropriate designed, conducted, and reported, represent the gold standard in evaluating health care interventions.” (p.1) However, the absence of methodological rigor results in biased results in randomized trials. In order for a trial to be accurately assessed, there must be clear and transparent information presented in the study’s methodology and findings. Due to the absence of adequacy in the reporting of studies, the Consolidated Standards of Reporting Trials (CONSORT) was developed in 1996 and revised in 2001. The 2001 statement was updated by a CONSORT Group meeting in 2010, referred to hereinafter as ‘CONSORT 2010’. Schultz et al. (2010) states that when authors adhere diligently to the items in the checklist clarity is facilitated, “completeness, and transparency of reporting. Explicit descriptions, not ambiguity, or omission, best serve the interests of all readers.” (p.1) Schulz et al. (2010) presents a flow-diagram of the progression of a randomized controlled trial study, which has been adapted for this study and shown in the following illustration labeled Figure 1.

Figure 1

Randomized Controlled Trial Flow-Diagram

Source: Schultz et al. (2010)

Included among these steps are the assessment for eligibility following by the randomization. The next step is the allocation to intervention, the received allocated interventions, or no receipt of the allocated intervention next followed by the follow-up, then the analysis.

I. Title, Abstract, and Introduction

Rikard, et al. (2012) presents a study in the work entitled ‘Routine vs. clinically indicated replacement of peripheral intravenous catheters: a randomized controlled equivalence trial’ published in the Lancet Journal. There is a complete absence of an abstract or a title page. The ‘Introduction’ to the study is information and relates that as many as 70% of patients in “acute care hospitals need a short peripheral intravenous catheter, about 200 million are used each year in the U.S.A. alone.” (p.1066) The information is related that intravenous catheters “frequently fail before the end of treatment “because of the irritation of the vein (phlebitis) with symptoms including pain, swelling, redness, occlusion, and a palpable venous cord.” (Rikard, et al., 2012, p.1066) It is related that infection may occur in the bloodstream that is related to the peripheral intravenous catheter although this is an infrequent occurrence is a complication of a serious nature and noted to occur “in about 0-1% of intravenous catheters at 0-5 per 1000 catheter days.” (Rikard, at al, 2012, p. 1066)

It is reported that the current recommendation for replacement of intravenous catheters is “no more frequently than 72 to 96 hours” as stated by the U.S. Centers for Disease Control and Prevention (CDC) for adult patients however, for children the U.S. CDC states recommendations that the intravenous catheters should not be replaced since this fails to prevent infection. It is reported that modern intravenous catheters are comprised of “low-irritant materials” and therefore, may not require replacement. In fact, reported is that observational studies with sound designs have demonstrated that “longer dwell time increases daily phlebitis risk in a linear rather than exponential manner” or in other words more intravenous catheter days overall increases risk, but later days of cannulation are not higher risk than earlier days.” (Rikard, et al., 2012, p.1061)

Rikard et al. (2012) report the study’s aim as being focused on understanding “…the effect of extension of intravenous catheter dwell time beyond 3 days with replacement of catheters only for clinical reasons.” (Rikard, et al., 2012, p. 1061) Rikard et al. hypothesizes that “patients who had intravenous catheters replaced when clinically indicated would have equivalent rates of phlebitis, and no difference in other complications, compared with patients with catheters removed every third day.” (Rikard, et al., 2012, p.1061) This section of the study reported presents clearly the scientific background and the rationale for the study of this complicating and serious condition.

II. Methods (Trial Design and Participants)

Rikard, et al. (2012) report a study that was a”…multicenter, non-blinded, randomized controlled equivalence trial” and which took place in three government hospitals in Queensland, Australia that were government-affiliated. The target sample was derived from the three hospitals in the study. Participants were identified through research nurse screening of medical and surgical units among patient at least 18 years of age who had an intravenous catheter in place and who was expected to receive treatment in excess of four days. Exclusion criteria is stated to include: (1) bloodstream infection; (2) planned surgical removal of intravenous catheter within 24 hours; or (3) intravenous catheter already in sit for more than 72 hours. (Rikard, et al., 2012, p.1061) Intravenous catheters that the ER had inserted were not eligible for the trial but could be inserted by any doctor or nurse or by the hospital insertion team. Written and informed consent was acquired from all participants prior to the study.

III. Interventions (Randomization & Procedures)

Patients were assigned through randomization to one of two treatment groups. The random group allocations were generated by computer on a hand-held device for the first and all following intravenous catheters. Blinded data were reviewed by an independent data and safety monitoring committee “at two a-prior defined intervals” and it was recommended by the committee that the trial continue on. Stopping rules stated by the committee was at a “greater than 2;1 ratio in either group for phlebitis or catheter related bloom stream infection.” ( ) The primary outcome is reported to have been “phlebitis during catheterization or within 48 hours after removal.” ( 1062) Phlebitis was identified by two or more of the following symptoms: (1) patient-reported pain or tenderness rated more than 2 on a 1 to 10 scale; (2) erythema extending at least 1 centimeter from the site of insertion; (3) swelling that extended at least 1 centimeter from the site of insertion; (4) purulent discharge; or (5) palpable venous cord beyond the intravenous catheter tip. (Rikard, et al., 2012, p. 1062)

The research nurse rated all items following patients reported tenderness or pain. Phlebitis measures are stated to have been reported on a daily basis and 48 hours after removal of the intravenous catheter. The inter-rater reliability was ensured by a structured outcome assessment form. Every month a study manager went to each site and conducted audits on study data checking accuracy and completeness and was responsible for overseeing compliance among research nurses. Progress reviews took place between research nurses, the study manager, and investigators which ensured consistency among the sites in the research study. Stated as secondary endpoints in the study were the following:

(1) catheter related bloodstream infection;

(2) all-cause bloodstream infections;

(3) local venous infection

(4) colonization of intravenous catheter tip;

(5) infusion failure;

(6) number of intravenous catheters needed per patient for the course of treatment;

(7) Overall duration of intravenous therapy; and (8) costs per patient for the course of intravenous therapy. (Rikard, et al., 2012, p. 1068)

Rikard et al. (2012) reports that a two-sided design was used to test the group equivalence and a sample of 3,000 participants determined including another 300 to allow for attrition. The report describes the clinically indicated and routine replacement of intravenous catheter and who inserted the intravenous catheter as well as the gauge of the intravenous catheter, the location of the insertion, the integrity of the participant’s skin, the quality of the vein at the site of insertion, which side the insertion was located on and the insertion site. In addition, the prescribed treatment options are reported. (paraphrased) Reported in the outcomes of the study is a per-protocol analysis analyzing the first intravenous catheter per patient remaining in situ on the third day that was treated in the study as a random allocation. It is reported that the rates per 1000 days in the analysis was comprised by “aggregated rate comparisons (incident rate ratios) instead of hazard ratios (HR).” (Rikard, et al., 2012, p. 1070) Patient-level costs and the number of peripheral intravenous catheters each patient used was calculated using an independent sample t test by bootstrapping with 1000 replications to “calculate 95% CI for costs.” (Rikard, 2012, p. 1070) It is reported that the overall treatment time was compared between groups “with the median, quartile, range, and Mann-Whitey test” and p values deemed less than 0-05 to be significant. (Rikard, 2012, p. 1071)

IV. Outcomes

Rikard et al. (2012) report that 5907 intravenous catheters and 17-412 catheter days were studied. Protocol adherence is reported at 85% among 3379 patients who were eligible and 3282 enrolled with no patient withdrawing consent. Hospital protocol adherence is reported at 85% with 248 blinded paired observations revealing 98% agreement with the Cohen’s ? Of 0-33. It is reported that in the study’s primary analysis and in both groups that “…7% of patients had phlebitis with an absolute risk difference (ARD) of 0-41% (95% CI — 1-33 to 2-15), which was within the predefined equivalence margin of 3%.” (Rikard, et al., 2012, p. 1071) It is reported that the equivalence hypothesis was accepted and that “…all comparisons of phlebitis occurrence between study groups were equivalent including per patient (p=0-64, table 3) and per 1000 catheter days (p=0-67, table 3), and on survival analysis (p=0-96). The per-protocol analysis (n=2537) had consistent results with the primary analysis with ARD 0-70% (95% CI — 0-88 to 2-28, table 3); this comparison had 90% power (p=0-05) to detect equivalence (margin 3%) at the recorded occurrence of phlebitis of 5-5%.” (Rikard, et al., 2012, p. 1072)

The study findings report that none of the patients had a venous infection and groups were reported as being “…equivalent for all-cause bloodstream infections, and catheter colonization.” (Rikard, et al., 2012, p. 1072) It is reported that only one patient in the study had a “…catheter-related bloodstream infection and this patient was in the routine replacement group.” (Rikard, et al., 2012, p.1072) Rikard et al. (2012) report that there were 15 blood cultures that were positive from 13 patients and that all blood stream infections in the clinically indicated group were “Gram positive organisms, whereas Gram positive organisms were similarly represented within the routine replacement group.” (p. 1072) It is reported that in the substudy the intravenous catheter colonization rates showed no difference between groups. The study reports that the clinically-indicated group “required significantly fewer intravenous catheters per patient, with significantly reduced hospital costs” and no adverse events were reported to have been related to the trial intervention. (Rikard, et al., 2012, p. 1073)

V. Implications for Clinical Practice

Phlebitis is reported to have occurred in 7% of patients when there was removal of intravenous catheters on the basis of clinical indication and when this was done every three days. There was only a small absolute difference stated at 0-41% and this is stated to have been within the prestated 3% equivalence margin. The study reports that there is no indication that clinically indicated replacement increased the risk of infection in the bloodstream of the patients. This is reported to be primary evidence that “routine removal is not warranted.” (Rikard, et al., 2012, p. 1075) The study reports confirming the “low occurrence of catheter-related bloodstream infections in peripheral intravenous catheters identified in previous prospective studies of none in 2088,17 none in 1054,13 and none in 6538 intra-venous catheters.” (Rikard, et al., 2012, p. 1075) The pathogenesis of catheter-related bloodstream infection is reported to be likely to assist in the comprehension of the results of the study presented in the work of Rikard (2012). It is reported that these type of infections are typically related “to the insertion procedure ( (poor hand hygiene or skin preparation) with later infections caused by colonization along the skin tract, or contaminated hubs or fluids.” (Rikard, et al., 2012, p. 1075) It is stated that the replacement of intravenous catheters theoretically speaking is likely to reduce infections occurring later however, due to the exposure to the risk of contamination, this effect is diminished. Rikard et al. (2012) reports that the substudy rate stated at 5% of tip colonization with no bloodstream infections being associated is consistent with previous study results that demonstrated that colonization as being “a poor predictor of infection.” (Rikard, et al., 2012, p. 1076)

VI. Further Research

Further research should be focused on the replication of the results of this particular study since clinically indicated intravenous catheter replacement offers a solution for not only reducing infection among those who have intravenous catheters but as well in reducing costs associated with the schedule required on replacing intravenous catheters. Recommended is future research studies geared toward replicating the study reported in the work of Rikard et al. (2012).

References

Rikard, CM, et al. (2012) Routine vs. clinically indicated replacement of peripheral intravenous catheters: a randomized controlled equivalence trial. The Lancet. Vol. 380. 22 Sept. 2012.

Schulz, KF et al. (2010) CONSORT 2010 Statement: Updated Guidelines For Reporting Parallel Group Randomized Trials. Open Medicine 2010;4(1);E60.