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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…[continue]
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