New Pain Management Protocol for Neonates

Research Versus Evidence-based Practice

Research and evidence-based practice (EBP) each have a different focus.
Research is used to generate evidence for clinical practice. Research has the primary goal
to eliminate bias while comparing effectiveness of clinical practices (Maguire, 2016).
EBP methods are used to implement strong evidence in a clinical practice, amongst every
appropriate patient. EBP methods increase the efficiency of incorporating research into
clinical practice. While EBP is concern with context and local factors, research is
interested in generalizability (Melnyk & Fineout-Overholt, 2015).
Research has rigorous methodologies focused on reporting unbiased outcomes for
potential clinical practice. However, hoping research is published is considered an
inherent bias. This bias may be associated with monetary benefits, such as continued
grants. During research, planned differences exist for patient care, as experienced by
intervention group versus control group. Unplanned differences in care can be minimized
by techniques such as randomization and blind assignment (Melnyk & Fineout-Overholt,
2015). Research likely involves risks, weighed against the benefits of proposed research
by an Institutional Review Board (IRB). One risk is that a control group may be delayed
in receiving a beneficial intervention (Guido, 2014). Likewise, a new clinical practice
may be researched and found to have a negative outcome. The ethical considerations
present in research lead to the requirement of informed consent by a patient or guardian
to opt out of research. Not all research is approved by IRB despite the notion informed
consent.
EBP is supported by research and any risk to patients is low and already
identified, unless an already researched clinical practice is misinterpreted thus misapplied
(Melnyk & Fineout-Overholt, 2015). Patient preference is included in EBP. Since patients
reasonably expect that a health care service should result in the most modern
understanding of greatest health benefit, informed consent is not necessary for EBP
implementation. However, the clinician must still have correctly generalized EBP to an
appropriate patient population. Instead of having a monetary benefit, EBP approaches are
entirely patient-centered and tailored towards improving patient outcomes (Melnyk &
Fineout-Overholt, 2015). Ethically, it may be difficult to support withholding care that
has been researched and determined to promote better health (Melnyk & FineoutOverholt, 2015). Actually, the very measures, such as vital signs, that are used to
determine better health after given interventions may itself be considered evidence-based
practice (Guido, 2014). Not all patients receive every measure, calculation, and
diagnostic test under the sun, nor can such care be warranted. While EBP
implementation should be tracked by quality improvement (QI), this differs from research
by specifically targeting faithful implementation of practice and resources for verifiably
improved outcomes. EBP has already been researched. Inherent bias only exists in EBP
and QI if there is a lack of rigor in application (Maguire, 2016). However, QI can
effectively eliminate the danger of becoming research by focusing on quality assurance
and auditing (Melnyk & Fineout-Overholt, 2015). To determine if a new clinical practice
is working as predicted, it must be evaluated. Adjustments can then be made to more
faithfully follow EBP in practical application.
Ethical Considerations

With a vulnerable population, such as neonates, ethical considerations are more

strictly defined. Nurses must implement clinical practices by beneficence (doing good for
patients), nonmaleficence (not harming to patients), justice (distributing resources fairly
amongst patients), and fidelity (loyalty to the patients goals and stated intentions of
care). To guide any healthcare practice, EBP is inherently patient-centered, unlike
research. With the new pain management protocols, all established evidence is transferred
into the care setting for improving the outcome of each individual patient. Using
beneficence, the nurses must determine that pain management appears to be benefitting
the patient. Benefits to the patient may be determined by decreased negative outcomes,
such as reductions of opiate-induced respiratory depression. Associated benefits of
successful pain management may be seen by increased length of feedings, stability of
vital signs, reduced colic diagnoses, etcetera. Using nonmaleficence, the nurse must
ensure the infant and parent should not be caused greater distress by the new pain
management protocol, as well as not being over-medicated. The nurses understanding of
the new pain management protocol is essential to correct implementation that does not
cause harm. Interventions that are intended to improve care may be ineffective or lower
the quality of care (Melnyk & Fineout-Overholt, 2015). Using justice, the nurse must
ensure that all patients under care have the same available resources for assessment and
treatment. No patient should be caused inadvertent harm by diversion of resources
(Melnyk & Fineout-Overholt, 2015). Especially with pain management, the United States
health care system has found widespread biases against timely administration of pain
medication for minority patients (Truglilo-Londrigan & Lewenson, 2013). Resources that
appear to be skewed against any patient population must be audited. Using autonomy,
EBP practice is included in the general consent to care by the guardian. However, parents
may be informed that a new procedure has recently been implemented throughout the
department for pain management. Nurses may work with the parents to determine their
advocacy for increased or decreased pain management. Post-hospitalization surveys can
usually be performed without IRB approval (Melnyk & Fineout-Overholt, 2015). Using
fidelity, a nurse should be loyal to a vulnerable patients presumed goal of limiting pain,
especially pain that would interfere with eating and sleeping.
Informed Consent for Pain Management
Informed consent with evidence-based practice is not necessary in this case. Informed
consent is only required when the most effective practice is unknown, which often
involves risks (Melnyk & Fineout-Overholt, 2015). The new pain management protocol
allegedly gathers already researched methodologies that compare favorably to research of
abandoned old methodology. The goal of EBP is to provide greatest beneficence to the
patient (Guido, 2014). Neonates are vulnerable patients and invariably there will be some
parents that will opt out of any new method of care that is discussed for individual
informed consent. Allowing informed consent often creates a depleted pool of patients
that does not allow for effective evaluation of the new pain management protocol
(Melnyk & Fineout-Overholt, 2015). Also, the benefits of the researched care would be
withheld from vulnerable patients unable to evaluate for informed consent, therefore it is
not ethical to allow parent removal. The parent is not experiencing the pain. If an
intervention has no additional risk beyond the risk introduced in the research studies
reviewed in order to form the protocol, then EBP should not be treated as clinical

research (Melnyk & Fineout-Overholt, 2015). Also, there is no testing of hypotheses, nor
want to contribute to generalizable knowledge. Thus no informed consent is needed. In
order to effectively evaluate this new EBP intervention, it is best if consent is included
within generalized consent to treatment. However, an IRB should still review the protocol
under a more lenient basis (Melnyk & Fineout-Overholt, 2015). Indeed, there may be
increased risk to patients if the components of the studies used were gathered into an
overall protocol that was not previously studied.
PICOT and Ethics
In non-elderly adults diagnosed with hypertension (P) does a single
intervention consisting of a heart healthy diet or exercise (I) compared
to simultaneous interventions of exercise with a heart-healthy diet (C)
reduce resting systolic blood pressure levels (O) over four months (T)?
Relevant ethical principles include justice and providing the same
exercise and nutritional resources across all socioeconomic statuses.
Also, beneficence is important when feeding patients in the hospital
and providing a diet that is known to limit the risks involved with
hypertension, such as stroke, heart attack, and heart failure (Osborn,
Wraa, Watson, & Holleran, 2014). If a patient has already experienced
an adverse health event as a probable complication of hypertension,
then an immediate diet change may be beneficial to limiting repeated
events. Nonmaleficence is appropriate when considering which
supposedly heart-healthy diet to use for a patient. Using what is known
as the rice diet to lower blood pressure, a patient must use
supplementation to intake all essential nutrients (Osborn, Wraa,
Watson, & Holleran, 2014). Supplementation is not as effective to
absorb nutrients as consuming the same amount of a nutrient in food.
The rice diet also results in rapid weight loss for the first five weeks,
which can increase the risk of heart attack (Ziv et al., 2013).
References
Guido, G.W. (2014). Legal & Ethical Issues in Nursing. (6th Ed.). Boston, MA: Pearson
Education.
Maguire, D. (2016). Maintaining an Ethical Perspective in EBP [Educational Design and
Technology voice-over interactive slides]. Retrieved from
http://decade.it.usf.edu/nursing/NUR4169/module6/Ethical%20Perspective
%20output/story.html
Melnyk, B. M. & Fineout-Overholt, E. F. (2015). Evidence-based practice in nursing &
healthcare: A guide to best practice (3rd ed.). Philadelphia: Wolters
Kluwer/Lippincott, Williams & Wilkins.
Osborn, K., Wraa, C., Watson, A., Holleran, R. (Eds.). (2014). Medicalsurgical nursing:

preparation for practice (2nd ed.). Upper Saddle River, New

Jersey: Pearson.
Truglilo-Londrigan, M. & Lewenson, S. (2013). Public health nursing: Practicing
population-based care. Burlington, MA: Jones & Bartlett.
Ziv, A., Vogel, O., Keret, D., Pintov, S., Bodenstein, E., Wolkomir, K.,
Efrati, S. (2013).
Comprehensive approach to lower blood pressure: A randomized
controlled trial of a multifactorial lifestyle intervention. Journal of
Human Hypertension, 27(10), 594600. doi: 10.1038/jhh.2013.29