Webster et al. 2007) is effective because it clearly identifies the purpose and nature of the study in the trial itself. The CONSORT criteria specifically state that the randomized nature of the trial must be indicated in the title, which is evident in the case of the present study. Randomized trials are necessary for health care studies because they help to maintain the homogeneity of the samples (Jadad & Enkin, 2007). It also eliminates selection bias (Piantadosi, 2005). Hence, it may be said that the title is effective because it states that the study was based on a randomized trial.
It is necessary for an effective abstract to have a structured summary of the research design, methods, results, and conclusion. The abstract provides a concise, clear and well-structured summary for the reader. The information has been organized separately to facilitate comprehension. The abstract describes the background, objective, design, setting, participants, interventions, main outcome measures, results and the conclusion of the study. In this way the abstract covers all the information that is required by the CONSORT checklist.
The introduction to a research article must present an explanation of the scientific background and the rationale for the study. It must identify some weakness in the existing research that makes the current study necessary. After establishing the need for the study, the article should clearly state the specific objectives of the study and articulate the hypotheses that embody the research objectives and specify the questions that will be answered in the study.
The current study satisfies both these criteria by presenting a clear statement of what is already known about the subject and what the current study adds to the body of research. Next, in the introduction, the study introduces the widespread use of intravenous catheters in modern medical care and the responsibility of the registered nurse in administering it effectively. The need for the current study is established by stating the current practice of re-siting the catheter every three days as opposed to when clinically indicated, such as when phlebitis is observed. The introduction also signifies the need for research into the current practice because of the lack of any relevant research for the last fifteen years. The researchers of the current study opine that such short dwell times may not be necessary when longer dwell times may reduce hospital costs without increasing the risk of infection or other complications. Specifying the hypothesis in the introduction is important because a hypothesis states the generalization whose validity is to be tested (Kumar, 2008). The two hypotheses of the study are also specified in the introduction: that more unplanned cannula re-sites will take place in the control group following the current 3-day practice than in the group where cannula is re-sited only when clinically indicated; and that the cost of IV cannulation will be greater in the control group than in the intervention group.
The section on the methods of the research contains explicit information about the trial design and the allocation ratio. The patient flow through the trial is explained clearly with the help of the CONSORT flow diagram, which shows the number of participants that were selected for the study and the reasons for omitting any from the study.
The eligibility criteria for participants are described in the study. In addition, the setting of the study and location from where data was collected for the study are also described. The participants had to be inpatients at the Royal Brisbane and Royal Women’s Hospital. Participants would be observed at these locations and data would be collected through observation and reporting from nurses. They also had to be at least eighteen years of age and should have been expected to require in IV catheter for at last four days during the course of the study. Patients who had bloodstream infection or who were being given immunosuppressive treatment were excluded from the study. Only those participants were eligible who were being administered an IV catheter by a registered nurse from the IV Therapy Team of the hospital.
The interventions administered to the experimental group as well as the control group are discussed under the heading of Procedures in the given study. The interventions are described in sufficient detail to allow for the study to be replicated by other researchers in a different setting. The interventions involved replacing the peripheral catheter for the intervention group only when clinically indicated and every three days for the participants in the control group. The interventions were administered by the member of the IV Therapy Team. Risk factors for each participant were accounted for. The observations were adjusted for any irritability on a scale of 1 to 4 that was experienced due to any medication received by the patient during the study. This scale was developed in consultation with the pharmacist. With the help of the IV team member, observations were also adjusted for the vein quality on a six-point scale. These observations are fairly clear and specific to meet the criteria specified by the CONSORT checklist.
The study clearly describes the primary and secondary outcomes that were measured by the researchers. Primary outcomes should be measured without any bias (Kirch, 2008). The primary outcomes included the comparison of unplanned cannula removal in the experimental and the control group. The unplanned cannula removal was defined as a composite of two or more of the following occurrences: leakage, infiltration, erythema, local infection, phlebitis and catheter-related infection of the bloodstream. The secondary outcome measure was cost which was calculated separately for patients requiring intermittent IV medication from those requiring a continuous infusion. The cost included the cost of the catheter, tap, syringe, dressing, disinfection, and anesthetic as well as the cost of nursing time. The cost for the first group was $14.26 per insertion and $21.26 for continuous infusion which also included the cost of replacement intravenous set and a bottle of saline solution.
The criteria and procedure for determining the sample size is discussed clearly in the research article. The sample size was determined on the basis of the assumption that there would be a 40% rate of unplanned cannula removals. This was a reliable assumption because it was obtained from a member of the IV Therapy Team. The number of participants in each of the intervention and control groups was determined to be 105 because this would help the researchers to determine a 50% decrease in the number of unplanned cannula removals in both the groups. However, the article does not contain any information about any interim analysis and stopping guidelines. There is, however, reasoning provided for excluding participants from the sample because of death or altered mental state. This helps to clarify the situations when the research on any particular participants of the study may have been required to be stopped. The procedures had previously been approved by the Human Research Ethics Committee.
Randomization and Allocation
The researchers use a computer generated list to allocate the participants equally to the intervention and control groups. This has been stated clearly in the research paper. Furthermore, the list was stratified according to oncology status to distribute the participants to the two groups more fairly. The participants were allocated to the respective groups by phoning an independent and neutral person. This shows that the research article effectively meets the criteria for effective randomization made clear in the CONSORT checklist.
Blinding is necessary for ensuring that bias does not creep into the results of the study. For the purpose of the current study, the participants were blinded for the study but the nurse administering the IV catheter was not. However, according to the researchers, this did not affect the outcome of the study because the person was not associated with the interpretation of the results. The person did perform the re-siting of the cannula on the participants of both the groups and helped the researchers to make observations but did not interpret or process the results for them. In this way, not blinding the IV team member helped the researchers perform their study without compromising on the integrity of their results.
The researchers do suggest that the person diagnosing the IV related complication should have been blinded to the study group of the participant, which would have enabled the researchers to arrive at a more fair and unbiased outcome for their research. On the basis of the above discussion, it cone be said that the study does not follow all the necessary criteria for ensuring an absence of bias through appropriate blinding of research participants and investigators. There was similarity in the interventions administered to the participants. They were monitored up to 48 hours after the re-siting of the cannula for any observations. The observations were made with the help of the IV team member which helped to add credibility to the observations.
The statistical analysis of the data findings was based on an initial intention to treat analysis. The researchers used the 2-sided Fisher’s Exact test to analyze the primary outcome, i.e. The number of unplanned re-siting instances in both the intervention and the control groups. This test is used to determine if two populations are different from one another in participant proportion that appear in one of the two variable classifications (Osborne, 2006). Data was processed within a 95% confidence interval which explains the behavior of most of the data. Often, a tradeoff between precision and sample size is required (Sharma, 2007). The secondary outcome, i.e. The costs of unplanned catheter re-siting in both the control and the intervention groups were analyzed by using the Student’s t-test comparison, the most common test for comparing two groups of continuous data (Shields et al. 2005). 2-tailed results were obtained for all statistical tests. The data were analyzed through the Statistical Processes for Social Sciences (SPSS) software which is the most widely used program for analyzing statistical data in medical and social sciences. The researchers also followed the CONSORT guidelines to adhere to their standards for research methodology and presentation. An analysis of the research article shows that the researchers employed effective and appropriate statistical processes for interpreting the data from their findings.
The research article meets the CONSORT guidelines for including all necessary results relating to the study. Figure 1 describes the patient flow through the trail and shows clearly the number of participants assigned to the trial, the number who received the intended treatment in each group, and the number of participants whose results were analyzed. The figure shows how many participants were excluded from the control group along with the reasons for their exclusion. The number of cases falling in each category is also specified. The criterion for ineligibility is also mentioned in the figure, such as a minimum age of 18 years. The number of patients who did not receive intended treatment in the intervention and control groups is given.
The period during which the research was conducted is also specified (April to November 2004). Table 1 in the article presents the baseline demographic and clinical characteristics of the participants by sex, reason for admission, past medical history and other relevant factors. The results also specify the number of participants that were assessed in each group. The results have been interpreted in sufficient detail. The researches have clearly stated where the result findings have been statistically significant. They have also used relevant numbers wherever results have been expressed in percentage form. The precision of the results has also been expressed. For instance, findings have been expressed with a 95% confidence interval.
Another important outcome is that there was a very low correlation observed between the cannula administering and the rate of phlebitis among the participants. The existing research on the subjects and the standards of the Intravenous Nurses Society Standards of Practice require no more than 5% rate of infection. However, in the current study, the correlation was only 1.5%.
The results are discussed positively indicating success in attaining the study outcomes. The article presents a discussion in the light of previous relevant research that both supports as well as contradicts the research findings. Research that supports the assertion that the risk of contracting phlebitis decreases with time, thus making it less necessary to re-site the cannula during a certain period. They also refer to the results of a study that conflict with their findings. However, the flaws of the study referred to are also pointed out, thereby lending greater credibility to the current research. Throughout the discussion, the authors have used percentages and numbers simultaneously making it easy for the reader to form valid and reliable evaluations.
The authors have also discussed the limitations of their research. One is a failure on the part of the researchers to assess the effect on the research results of excluding the participants whose cannula would have to remain in situ for more than three days. In hindsight, the researchers feel that including those participants in the research would not have affected their findings. Therefore, they suggest that in further studies, participants should not be excluded on these grounds. A second weakness of the study is that the person diagnosing the IV related complications was not blinded to the study, which might have presented some room for bias.
Conclusion and Implications for Professionals and Researchers
The article meets the criteria specified in the CONSORT guidelines and follows the CONORT Statement 2010 Flow Diagram. The study makes an important contribution to the topic because it has helped to renew research on the topic after nearly fifteen years. And while doing so, it helps to break certain myths about the appropriate time for re-siting of cannulas in patients. The findings that replacing cannulas after every three days does not have a better effect on patient health than when re-sited only when clinically indicated has positive implications for patient health and hospital costs. The re-siting of cannulas is an uncomfortable process for patients, especially those who have to stay long at the hospital. Frequent re-siting can be disturbing and painful to them. Hence, re-siting the cannula only when clinically indicated can help to increase the comfort level of patients and help to avoid unnecessary distress. A second important implication is that hospital costs can be significantly reduced by implementing this minor change. This means that hospitals will be able to run more efficiently given the constant pressure on administrative and financial resources. Combined with greater patient comfort, both these benefits reflect significant positive implications of this study for the stakeholders. Similarly, there are positive implications for researchers and professional bodies that set standards for medical and nursing practices. They need to revisit their standards that prescribe re-siting the cannula every three days. A more rigorous analysis of their claims is necessary. Similarly, nursing practitioners will need to monitor patients for frequently for clinical indications for re-siting the cannula instead of making a visit to the patient only on the third day.
Jadad, A.R., & Enkin, M.W. (2008). Randomized controlled trials. (2nd ed., p. 5). Blackwell Publishing.
Kirch, W. (2008). Encyclopedia of public health. (p. 414). Springer Science.
Kumar, R. (2008). Research methodology. (p. 25). APH Publishing Corporation.
Osborn, C.E. (2006). Statistical applications for health information management. (2nd ed., p. 261). Jones & Bartlett.
Piantadosi, S. (2005). Clinical trials: A methodological perspective. (p. 350). John Wiley & Sons.
Sharma, J.K. (2007). Business statistics. (2nd ed., p. 315). Pearson Education.
Shields, T.W., Locicero III, J., Ponn, R.B., & Rusch, V.W. (2005). General thoracic surgery. (6th ed., Vol. 1, p. 1410). Lippincott Williams & Wilkins.
Webster, J., Lloyd, S., Hopkins, T., Osborne, S., & Yaxley, M. (2007). Developing a research base for intravenous peripheral cannula re-sites (DRIP trial): A randomised controlled trial of hospital in-patients. International journal of nursing studies, 44(5), 664-671. doi:S0020-7489(06)00065-4 [pii]
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