Evidence “principles of evaluation and research methodologies which enable

Evidence
based medicine, entails the process of accumulating, interpretation, and
implementing independent research judgements in an aim to improve clinical
practice or patient outcomes.  Evidence based practice has the potential to
revolutionise pre-hospital care, Learning to advance patient care, abolishing
obsolete practices or ineffective practice. The promise of constant learning,
builds evidence based-knowledge to allow individual development towards
becoming an autonomous practitioner. This paper will aim to critically appraise
a published primary research article, in a quantitative field of research. The
utilisation of a suitable critical appraisal framework; Critical
Appraisal Skills Programme (CASP), (2014) randomised controlled
trial checklist to allow structure to this appraisal. A critical discussion
based from the findings of the critical appraisal framework will be included. A
further discussion of the applicability and implementation, of the research
findings into clinical practice. Quantitative research comprises of information
articulated in the form of number, variables and percentages. Seeking to
authenticate that all challenges, predicaments and hypotheses in the clinical
field, have comprehensible, evident and objective solutions which can be
expressed in a numerical format. The primary research article this appraisal is
focused on is the; “Permissive
Hyperthermia through Avoidance of Acetaminophen in Known or Suspected Infection
in the Intensive Care Unit (HEAT) trial” a randomised controlled trial published by (Young et al., 2015). Griffiths and Mooney,
(2012) discusses the importance of paramedics being ‘research
minded’ to consciously be asking questions, questions that can be
answered through evidence based research. The HCPC standards of proficiency
state in section 13 a paramedic must
“understand the key concepts of the
knowledge base relevant to their profession” (Health
and Care Professions Council (HCPC), 2014) subsection 13.11 “principles of
evaluation and research methodologies which enable the integration of
theoretical perspectives and research evidence into the design and
implementation of effective paramedic practice” (Health
and Care Professions Council (HCPC), 2014). Adhering to these standards of proficiency allows for professional,
high quality and advanced patient care to be delivered. Practice of these
sections can be carried out through actively seeking and reviewing published
papers, or reviewing studies presented within guidelines such as the National
Institute of Health and Clinical Excellence (NICE) or from the Joint Royal
Collages Ambulance Liaison Committee (JRCALC).  It is widely
acknowledged that various research designs, have more influence in their
ability in solving research questions, surrounding the efficacy of clinical
interventions than others. A “hierarchy of evidence” concept (see appendix one)
was developed, providing framework in ranking evidence (Akobeng, 2005).
The randomised
controlled trial (RCT) is regarded as providing the most dependable evidence on intervention effectiveness. Trial design;
the population of this RCT covered 700 patients, with an initial inclusion
criteria of 3601 patients, yet after exclusion criteria the sample size was
reduced to 700 patients who underwent randomisation, 690 were involved within
the final analysis. This trial took place across 23 adult medical-surgical ICUs
in Australia and New Zealand. Sedgwick, (2015)
discusses the importance of sample size in RCT researchers must calculate
optimal sample size. Too small a sample size a trial will lack power in
demonstrating the smallest effect of clinical significance, if detectable in a
population. Too large a sample size, would be recruiting beyond the number of
participants than necessary, this may cause a trial to become time consuming,
costly and potentially unethical. The
intervention given was acetaminophen also known as paracetamol through
intravenous route; 1g repeat doses every six hours, and the comparator was a
placebo; IV infusion 5% dextrose; 100mls repeat doses every 6 hours. The
primary outcome measured (see appendix two), was ICU-free days up to day 28. Days
not requiring ICU support, without the need for mechanical ventilation,
vasopressors or inotropes and free from renal replacement therapy. A patient
was required to be free from such supports until ICU discharge. Secondary outcomes,
within a 90-day follow up, (number of days alive) from randomization until day
90. Ray and Schulman, (2015) review the two basic
areas of thought, the first being the suppression of fever is beneficial
because the metabolic requirements outweigh its potential physiological benefit
in an already homeostatic compromised patient. The second is fever is an innate
protective mechanism, and should be permitted to run its course of natural
defence. This trial aimed to answer a clinically significant question with the
potential to be practice changing, in the way critically ill patients are
pharmacologically managed.  The trial
clearly states it conducted an investigator-initiated, blinded, prospective,
randomized controlled trial to evaluate their study. Block randomisation
consisting of a block size of six which was stratified according to
participating centre. Randomization as a method averts the selection bias and
protects against accidental bias, producing comparable study groups,
eliminating the bias source in treatment assignments (Suresh, 2011).
Block randomization method is aimed to randomize patients into groups,
resulting in equal sample sizes. 3601 patients met the
inclusion criteria, 1674 of these patients met the exclusion criteria, which
consisted of; liver dysfunction, acute brain
disorder, and post cardiac arrest requiring therapeutic hypothermia, pregnancy
and rhabdomyolysis amongst other conditions full table (see appendix three).700
patients underwent randomisation, Only 10 patients, 1.4% loss to follow up; 6
patients withdrew consent in the acetaminophen group and 4 were lost to
withdrawal of consent in the placebo group. Farrokhyar, et al., (2010) reviews the implications of inclusion and exclusion
criteria, these aspect of an RCT require high levels of time and attention.
Inclusion criteria essentially defines the population of which the
research question is focused upon. The exclusion criteria, defines the
populations of patients who are unaccommodating towards the research study or
may be harmed through study interventions.  Allocation concealment and study drugs were
concealed by being packed in undifferentiated 100ml glass bottles,
Investigators were unaware of the randomization block size. Clinical trials
present with the risk that perceptions regarding the specific advantages of a
single treatment over the alternative might manipulate study outcomes, leading
to a biased result. When participants and data collectors (health
care professionals, investigators) are uniformed of the treatment assigned, it
is given the term ”double blind”. Allocation
concealment is a technique used in preventing selection bias through
concealment of the allocation sequence from those allocating participants to
intervention groups, until the moment of assignment. This method avoids
researchers from consciously or unconsciously swaying which participants are
allocated to a given intervention group (Akobeng, 2005).  As Torgerson and Torgerson, (2003) have advocated, the results
of a hypothesised RCT with compromised randomisations for example by, poor
allocation concealment may be more negative than an explicitly un-randomised
study. Schulz, (1995) illustrated in trials without
allocation concealment, estimations of treatment effect were exaggerated by
approximately 41% in comparison with those who reported adequate allocation
concealment.  Baseline demographics comparable with no major
difference in key aspects such as age, sex, weight, pre-existing co morbidities,
respectable
baseline equilibrium with comparable peak temperatures, in the twelve hours
prior to randomisation T38.8C ± 0.6°C and T38.7C ± 0.6°C (see appendix
four). Patients groups appear to of
been treated equally, same treatment, drug measurements, and dosage intervals.
Similar demographics allow for more accurate study results.  The treatments primary outcome,
measured a median of Intensive care unit (ICU) free days (alive and discharged
from the ICU), up to day 28; results showing no significant difference (0 to 1; P
= 0.07), 23 days in the acetaminophen group and
22 days in the placebo group. Secondary outcome, comparison of patient’s
acetaminophen group and placebo group, no significant difference in ICU free day’s
28- or 90- day mortality. Paracetamol correlated with; reduced ICU stay length
in survivors (3.5 days IQR, 1.9 to 6.9 vs. 4.3 days IQR, 2.1 to 8.9,
P = 0.01). Lengthier ICU stay in the non-survivor subgroup (10.4 days IQR, 4.1
to 16.9 vs. 4.0 days IQR, 1.7 to 9.4, P 0.05. Patients not facilitating
the need for mechanical ventilation: 27 vs 26 P=0.14. Patients not requiring
pharmacological interventions from Inotropes or vasopressors: 27 vs 27 P=0.36.
Patients who did need support from renal replacement therapy: 28 vs 28 P=0.53. Protocol
deviations were high, open label acetaminophen used in both groups; paracetamol
group 30% and placebo group 28% this could have attenuated treatment effect.
There is no information stated from the study table (see appendix one) on the utilisation of paracetamol prior to
randomisation, or post ICU discharge. However there was an 80% power
in detecting difference of 2.2 ICU-free days in the 28 days post randomisation,
at an alpha level of 0.05 The
confidence limits show consistency throughout the paper, Confidence intervals
CI can be calculated, surrounding the point estimate of the result providing
value range within which true value is guaranteed to exist with a level of
given confidence. The wider the CI suggests inaccurate result indicating that
results should be interpreted with caution irrespective of statistical
significance. CI are commonly calculated at a CL of 95%, typically if observed
results are statistically significance, P-0.05, the null hypothesis should not
fall within 95% CI (Tseng and Flechner, 2011). Implementing
the HEAT trials study findings, into clinical practice warranted a response
that was not addressed in the study journal itself. Young, (2016)
considers the HEAT trial to be ‘practice-informing’ alternatively to being
considered ‘practice-changing’ as it was only intended to provide preliminary
data. The HEAT trial failed in evaluating patient wellbeing, in the sense of
whether the administration of acetaminophen in treating fever actually made
patients feel like they were recovering. Understandably there are elements of
the trial that would have made assessing patient wellbeing difficult, such as
the use of sedation and mechanical ventilation in the ICU setting. Under JRCALC 2016 REF REQUIRED As pre-hospital clinicians we
are not indicated to administer IV paracetamol to manage pyrexia, this study
proved nor disproved that it has any significant difference in improving the
patient’s condition long term. In the brief moments we have with a patient
before they are handed over to the receiving definitive care centre, knowledge
as to if it makes the patient more comfortable would be very insightful into a
potential benefit of administering acetaminophen in a pre-hospital environment.
Are the
benefits worth the harms and costs? The clinical perception of “fever” has been
at the forefront of medical focus for centuries, and although present day
aptitude to identify and manage fever has progressed, debate continues over the
best practices with regard to the treatment of this homeostatic physiologic
derangement. However again in Young, (2016) response,
evolution may have advanced in the recognition and treatment of pyrexia this
may be inapt in the ICU setting. Only critically ill patients are sent to ICU,
without an ICU treatment these specific patients will die. ICU support allows
patients to surpass normally physiological parameters of healing, without
further studies confirming if temperature control is beneficial and has a
positive result the use of anti-pyretic may only be prolonging life (fragment consider revision). Consideration of the cost of
pyrexia is multifactorial, pyrexia has a considerable metabolic cost. Cooling
of a patient with fever decreases oxygen consumption by approximately 10 % per
°C, any possible advantage of a febrile response, needs to be evaluated against
the substantial metabolic cost (Young and Saxena, 2014).

As of current
this study does not prompt pre-hospital clinicians to step out of national JRCALC
guidance, as there is no clinical significant outcome which show true benefit
to patients in an acute setting. Clinically the effect of paracetamol appears
acceptable and well tolerated by patients, this trial has provided comfort in
knowing that it does not appear detrimental to the patient’s condition.
However, Paracetamol remains an effect analgesic with patients who present with
pain in conjunction with a fever. This paper aimed to critically appraise a
primary research article, focused on the use of acetaminophen in critically ill
patients in an attempt to re-evaluate the goldilocks hypothesis too hot or too
cold? With association to practice in the pre-hospital setting. 

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