Critical Appraisal of Randomised

Critique
Critical Appraisal Report
On
A Randomized controlled trial to investigate the effect of skin-glue application along with
standardized catheter care in minimizing the ED inserted PIVC (Peripheral intra-venous
catheters) failure rate (Budgen, 2016)
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Critique
Critical Evaluation Tool template (Quantitative Study)
Introduction
PICO Complete this table
What is the
problem/population?
Increased failure rate of PIVC inserted in the emergency department
What is the
intervention?
Skin glue application (cyanoacrylate) at the PIVC insertion site and hub
of PIVC along with standard PIVC care
What is the
Comparator?
Group that received standard PIVC care
What is the primary
outcome?
PIVC failure rate at 48 hours (regardless of cause).
What is the secondary
outcome/s?
The individualized modes of PIVC’s failure as catheter- dislodgement,
infection, phlebitis or line-occlusion
What was the Length
of Time of the
intervention?
48 hours or more after enrolment
Critical Appraisal models
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Critique
Critical appraisal involves systematic evaluation of a research study to determine
the extent to which the study findings are trust-worthy, appropriate as well as relevant
(Merriam-Webster, 2015). This report scrutinizes both the merits and demerits of the
study methods with its applicability in healthcare practice. According to Baker (2014),
various critical evaluation models can be used to critique a study and evaluate a
quantitative research-study that includes critical appraisal-skill program (CASP),
CONSORT, Polit tools, JADAD score, Parahoo and Rees model.
Journal
The given study was published in Annals which is an international, peer-
reviewed journal that is released by American College of Emergency Physicians; with a
credit of being the largest circulating emergency medicine journal with over 33,000
subscribers. Annals that are published in United-States has highest impact-factor:
5.008, journal-rank:1.942 with highest citation-years (9.6 years) than immediate
competitor (5.1 years) (Callaham, 2017). They publish original articles, research-reports
and facts in emergency medicine. These informations suggest that Annals are highly
regarded journal that assures me to utilize the study-evidences in my clinical practice
confidently to provide quality patient-care.
Authors
The authors Bugden, Scott, Clark, Johnstone & Shean are well experienced in
emergency medicine in Caboolture hospital, Queensland with first four from the applied
health-related economics centre and Menzies’s health institute, Griffith University.
Author Mihala has published 29 research-articles, 101 study-citations; Fraser with 462
research-articles, 3,697 study-citations while Rickard with 191 research-articles and
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Critique
2,231 study-citations. This study was conducted in the Caboolture hospital,
Queensland. The author informations give me enough confidence to utilize these study
findings in my practical area to minimize PIVC failure.
Title, Abstract and Literature Review
The researchers have given a clear, concise, accurate title that is consistent with
the text. It stimulates an appropriate perception about the study’s basic nature (Boswell,
n. d.). Their objective as ‘to investigate the effect of applying skin-glue with regular
PIVC-care in minimizing the PIVC failure-rate’ is clear, adequate as well as achievable.
The abstract condenses the study-problem, objectives, study-methodology, sample-
descriptions, findings, conclusions and recommendations, as suggested by Iverson
(2014). They have given recent, relevant, comprehensive and well-organized literature-
review. They have only quoted studies to show the effect of skin-glue in minimizing
infection but not for PIVC-occlusion and other causes. Few studies comparing the effect
of skin-glue and other methods could have been included.
Research Design
They have used Randomized-Controlled Trial (RCT) which is a true experimental
quantitative design that is characterized with manipulation (skin-glue application with
standardized PIVC-care), control group (receiving only standardized PIVC-care) and
randomization (random assigning) (THS, 2015). This design helps to compare 2 or
more interventional measures and also assists in drawing causal inferences between
variables and renders strongest evidence (Polit, 2016). They have given one research
question (purpose-statement) as ‘Does the application of skin-glue to adhere PIVC-line
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Critique
improve PIVC failure-rates as compared to standardized securement?’, which is clearly
stated (Boswell, n. d.).
According to Limm (2013), at-least 80% of the patients admitted in hospital
requires PIVC insertion with majority in EDs in which 33%- 69% fails prematurely due to
inadequate PIVC fixation causing dislodgement, micro-motion or site-infection (Marsh,
2015). PIVC failure can interfere with IV and medication therapy which may increase
cost and patient discomfort. Hence, this large trail in ED setting can rule-out the effect of
skin-glue with standard-securement rather than current best-practice.
They have given an appropriate hypothesis to translate the study question into
an expected outcome as ‘the skin-glue application can minimize the failure of PIVC at
48 hours’, which is scientific hypothesis that tests the relationship between skin-glue
and PIVC failure-rate (Polit, 2016). They utilized single-sited, 2-armed, RCT to select
360 patients having 380 PIVC-insertions with the help of randomizer software for
clinical-trial and were randomly allocated into control and experimental groups in 1:1
ratio (unblocked/unmasked). The control group received standardized PIVC-securement
while the experimental group received single drop of cyanoacrylate skin-glue at PIVC’s
hub and insertion-site to stick the PIVC in patient’s arm along with standardized PIVC-
care with tape and dressing based on the Queensland’s guidelines (2015) and were
analyzed for primary & secondary outcomes.
The Sample
Target population is an entire population set in which the researcher is interested
in proposing the study and in generalizing the research-findings (THS, 2015). Here, thay
have selected the adult-patients being admitted in the Emergency department (ED) of
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Critique
Caboolture Hospital having PIVC-insertion as target population. Their setting was
Caboolture Hospital, a Community hospital; 50km away from Brisbane’s north receiving
52,000 ED patients/ year. The samples that are the subset of population were recruited
by 3 ED-research nurses for 16 hours/day in a week, as given by Polit (2016). They
included participants aged 18/above years, having patent upper-limb PIVC, inserted by
ED-nurses/clinicians and those consented. The samples allergic to adhesives, phlebitis,
infection and/or thrombosis in PIVC-insertion, unwilling, anxious and non-English
speaking were excluded. They have randomly allotted 174 PIVC-patients in both
standard-care and skin-glue group by Randomizer-software.
Ethics are the set of rules that governs the degree to which the ethical, moral,
legal and/or professional values are followed in a study (Polit, 2016). They got a pproval
from the ethics-committee of the hospital’s human-research and have registered the trial
in the Clinical-Trial registry of Australia & New-Zealand. The text suggests that they
have got written consent from all the participants, which assures confidentiality and
patient’s rights (DH, 2014).
Data collection
Fink (2013) stated that data collection is a phenomenon by which the data is
collected to address the study-problem. They have gathered the demographic and
confounder details at the time of enrollment by a self-structured questionnaire with
variables as age, gender, medication-history, PIVC-insertion (site, limb, person-inserted
& gauge size), hours from PIVC-insertion to intervention and follow-up.
They have evaluated their primary study-outcome of measuring the PIVC failure
within 48 hrs of insertion (regardless of cause) by direct-visualization (hospitalized-
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Critique
patients) or telephoning (discharged PIVC-patients) with gathering data about the
experiencing features of PIVC-failure at 48 hrs or more. They have investigated their
secondary study-outcomes by evaluating the individual modes of PIVC failure as site-
infection, phlebitis, PIVC-occlusion, and/or PIVC-dislodgement through direct-
observation, chart-review as well as structured-questionnaire. One of the three research
nurses, well experienced in ED has collected data by these means appropriately.
Bugden et al (2016) has explained only about the data collecting method but not
about the method of measuring data. They have stated that they have analysed the site-
infection, PIVC-occlusion, phlebitis and PIVC-dislodgment variables but they failed to
mention their method of grading these variables. The measurement instrument used
should be valid as well as reliable to avoid bias (Fink, 2013). They haven’t mentioned
the instrument’s validity and study-reliability assessment anywhere in the text. Though,
the questionnaires were referenced from the study by Rickard (2012), the lack of
measurement validity and reliability undermines the study-findings.
Bias is defined as any influence that distorts the study’s results and undermines
study-validity (Fink, 2013). Blinding/masking helps to control bias in which the
participants were prevented from reaching the information of study-participants,
interventional aspects and/or researchers/observers (Polit, 2016). The text suggests
that they have not blinded the participants as well as research ED-nurses after their
allocation because of their intervention’s nature with subtle skin-glue color and
appearance that are exhibited at the interventional & follow-up period which is
acceptable.
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Critique
Data Analysis
The data analysis that involves organizing and analysing the gathered
information by using statistical measures as descriptive and inferential methods is
applied in this study (Polit, 2016). They have done an in-depth data analysis as per their
study-outcomes as well as tested the study-hypothesis. Descriptive analysis that
includes mean and percentages were used to describe and summarize data while
inferential statistics that includes p-value and point- estimation was used to draw
inferences between variables (Newcombe, 2012). Absolute differences between
outcome PIVC failure-rates (primary & secondary) were drawn at the confidence
intervals of 95% by point estimation and they have declared the statistical significance
at p<0.05. They have efficiently managed the follow up sample loss (0.83%) by
excluding them from data analysis to eliminate bias.
Results
The results were expected and have completely presented their findings based
on objectives (Polit, 2016). Their primary analysis indicates that the failure of PIVC was
statistically (10%) lowered in experimental (17%) as compared to control (27%) group
signifying a statistical-difference (CI95%:–18% to –2%; p=0.02) which is less than
p<0.05 and so the statistical study-hypothesis was accepted. Their secondary analysis
indicates that the PIVC-dislodgement was significantly (7%) lowered in experimental
(7%) than control (14%) group at CI95%:–13% to 0%, p=0.04 that is less than p<0.05
and hence the hypothesis was accepted as supported by HospiMedica (2016). The rate
of phlebitis (CI95%:–5% to 3%) and occlusions (CI95%:–8 to 4%) in experimental was
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Critique
lower than control group but wasn’t statistically-significant while no site infection was
noted in both groups and hence statistical-hypothesis was partially rejected.
No suggestions were found allowing others to propose similar study but they
have given their intention to propose cost-benefit study in the future. They recommend
nurses to apply skin-glue along with standard-care to reduce PIVC-failure as It is a
simple and quick method to be easily practiced in busy ED.
Conclusion
Bugden (2016) has concluded that the application of skin-glue adhesives with the
standardized PIVC-care as suggested by the PIVC guidelines of Queensland (2015)
can reduce the PIVC failure-rates in adult-patients particularly in busy emergency
settings. If the failure rates of PIVC are minimized, the ED-patient values will be
promoted by eliminating un-needed cost, time, material and man power expenses.
Applying the skin glue will enhance comfort of patient, promote their outcomes and will
minimize the admission numbers due to the complications of PIVC failure
(HospiMedica, 2016). They suggests that the use of adhesive skin glue will promote
attachment of PIVC-line with the patient’s skin, thus avoiding unnecessary
dislodgement, phlebitis, infection and occlusions which may interrupt the flow of
medications. According to Stuart (2013), about 0.1% of the patients who suffered with
PIVC failure may develop sepsis, which endangers the patient’s life adversely, which
can be avoided by using adhesive skin glue to PIVC-site.
Relevance to nursing practice
Nursing is all about providing essential care to all the patients irrespective of
caste, creed, race and colour in varied settings ranging from basic care to critical care
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Critique
(Douglas, 2012). It involves rendering basic front-line care to the clients specifically in
the busy emergency departments. Nurses should render quality nursing-care to the
client in-accordance with their own values, beliefs and ethics. According to Boswell (n.
d.), all the nurses should undertake critical appraisal of varied studies to evaluate its
applicability in practice, thus enhancing evidence based nursing-practice.
The nurses should render care within their ethical principles which is a set of
moral values what all the nurses are expected to follow (Douglas, 2012). The nursing
care rendered to the patients should not induce any harm to the patients or families and
should impose some form of benefit to the clients based on the ethical-principle of
beneficence (Polit, 2016). Nursing care should not inculcate any form of harm and/or
any pain/discomfort to the clients that includes physical harm or injuries, psychological
harm (stress, anxiety), social harm (lack of social support) as well as financial harm
(lack of financial support or loss of wages), which comes under the principle of
maleficience (Polit, 2016). The care rendered should not damage or hurt a person’s
self-dignity, which is based on the principle of justice. Hence, evidence based nursing
care is given with greater importance to protect the patient life.
The professional nurses must strive to render effective holistic-care to the
patients by preventing illness, improving and protecting the health of the people
(Douglas, 2012). It indicates that the nurses should take the responsibility to protect the
ED-patients from unnecessary harm of PIVC failure causing site-infections that includes
cellulitis/pus formation, phlebitis, vein irritation, pain/discomfort, swelling/ redness,
PIVC-occlusions with PIVC-dislodgements (fluid extravasations/accidental PIVC-
removal) (Aymes, 2016). The nurses should strive to propose more studies related to
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Critique
the effect of skin-glue adhesives in preventing PIVC failures to provide evidence-based
care.
The nurses in the ED have to insert PIVCs to save the patients by starting
treatment strategies. Studies suggests that majority of the ED patients requires IV-
infusions to initiate immediate life-saving measures but nearly 33% to 69% of these
insertions prematurely fail due to inadequate fixations causing pain, dislodgment,
extravasations, discomfort, etc that affects the patient’s value severely (Marsh, 2015). It
can influence the emotions of the ED-patients as it may necessitate increased expenses
of the insertion of PIVCs because of frequent PIVC-failures, unnecessary expenditure
due to repeated hospital admissions to manage the complications of premature PIVC-
failures as occlusions, dis-lodgments, phlebitis/others (Edwards, 2014). The PIVC-
failures can interfere with the management therapies as hydration, antibiotic and/or
analgesic therapies. This can affect the physical, emotional and societal values of
patient and the family-members as it may cause unnecessary hospital costs, fear and
depression.
Stuart (2013) has also supported that the PIVC-failure increases healthcare
expenditure as increased staff-time, more length of hospital-stay and adverse-event
management. Hence, practicing the skin-glue with standard-care in PIVC by nurses will
enhance patient’s comfort and also avoids patient harm within ethical principles, thereby
promoting quality-care (ACSQHC, 2013). This critique helps me to generate best
practices in PIVC-care so as to be utilized in my practical setting.
Reference
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Critique
ACSQHC- Australian Commission on Safety and Quality in Health Care. (2013).
Literature Review: Medication Safety in Australia. ACSQHC, Sydney.
Aymes, S. (2016). Skin Glue Reduces IV Failure Rate in the Emergency Department.
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(2016). Skin glue reduces the failure rate of emergency department-inserted
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Edwards, M. (2014). A pilot trial of bordered polyurethane dressings, tissue adhesive
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