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Nursing and Midwifery, Vol 2 No 3March 2022
Nursing and Midwifery
Homepage: http://nursing-midwifery.com/index.php/nm
1
Conducting Clinical Trials to Support Evidence-Based Clinical Nursing Practice:
Challenges and Recommendations
Tareq Afaneh, Maha Mihdawi
RN, MSN, PhD, CPHQ, Nurse Manager, Risk Management and Data Management, King Hamad University Hospital, Bahrain
RN, MSN, Nursing Research& EBP Coordinator, King Hamad University Hospital, Bahrain
ABSTRACT:
Clinical trials are important for the development of health professions including nursing profession. Much of what health care
providers practice in clinical settings is derived from evidence rooted in clinical trials. Despite nursing researchers employed
clinical trials to generate evidence that can support nursing practice for many years, the significance of generated evidence is
influenced by two key factors. First, the relevance of the studied topic to nursing profession. Second, the adherence of the study
design to standards of clinical trials. This paper aims to discuss feasibility of generating evidence to support nursing practice based
on clinical trials. The paper also presents recommendations to support the utilization of clinical trials in nursing research.
KEY WORDS: Nursing research, clinical trials, evidence-based practice, nursing intervention, scope of practice, study design,
clinical practice, research method.
INTRODUCTION
This paper presents a discussion on the feasibility of
building nursing practices on evidence that is derived from
clinical trials. The discussion debates two main concepts,
the significance of the topics of the studies to nursing
profession (relevance), and adherence of these studies to
clinical trials guidelines (adherence).
Clinical trials are planned to observe the outcomes of the
study participants in the context of experimental conditions
controlled by researcher. This approach of scientific inquiry
that aims to establish causal relationships between variables
differ from descriptive research approach. In the latest,
researchers aim to identify, describe, or explain variables
and possible relationship among them without introducing
interventions to influence to study participants. Hierarchies
of evidence have always placed Clinical trial studies and
their systematic reviews in a superior level as compared to
other study methods. Clinical trials require randomization of
the participants into intervention and placebo groups,
thereby removing the selection bias that results from the
imbalance of unknown confounding variables.(Umscheid,
2011).
Health sciences owe much to the clinical research method of
randomized clinical trial (RCT), which plays a vital role in
modern research and is considered to provide the best level
of evidence-based practice due to reliability of results
(Peterson, 2014). In fact, journals and organizations have
endorsed several classification hierarchies for the level of
scientific evidence, i.e. Canadian Task Force on the Periodic
Health Examination’s Levels of Evidence developed 1979,
Levels of Evidence from Sackett in 1989, and Levels of
Evidence for Therapeutic Studies, have placed clinical trials
and their systematic reviews on the top of the scientific
evidence hierarchy models (Burns 2011).
Clinical trials are usually led by a medical doctor, and have
a research team that may include doctors, nurses, social
workers, and other health care professionals Interventions in
clinical trials may be in the form of medications medical
devices, and procedures. They also include changes to
participants' behavior like diet, exercise, or the model of
care. Reasons for conducting clinical trials include
evaluating interventions, finding ways to prevent the initial
development of a disease, examining methods for
identifying a condition or the risk factors for that condition,
and exploring ways to improve the comfort and quality of
life through supportive care for people with a chronic illness
(Clinicaltrials.gov, 2018).
Despite the importance of clinical trials in generating
evidence, nursing researchers should be vigilant when
selecting clinical trial as a study method for two reasons,
first, different study questions can be ideally answered by
utilizing different study methods, second, clinical trials have
rigorous guidelines that strict adherence to is imperative to
generating quality evidence.
NURSES’ INTERVENTION SAND OTHER
HEALTHCARE PROVIDERS’ INTERVENTIONS
The scope of practice for registered nurses is well-
documented in many international nursing associations.
American Nursing Association (ANA), for example, issued
ANA’s Nursing Scope and Standards of Practice. Canadian
Nursing Association issued framework for the practice of
registered nurses in Canada 2015 and so forth in many
countries. In addition, ANA has adopted Nursing
Intervention Classification (NIC), which is gaining growing
international recognition as an approach to nursing clinical
documentation, communication of care across health
settings, effectiveness research, and productivity
Tareq Afaneh, et,al, Nursing and Midwifery, 02 (03) March, 2022
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measurement(Nursing.uiowa.edu, 2018).Based on this
classification, nursing intervention is defined as “any
treatment, based upon clinical judgment and knowledge, that
a nurse performs to enhance patient/client outcomes”
(Butcher, et al 2018).Although the definition is appealing, it
is broad enough to embrace many activities performed by
nurses and does not set a cross line between nursing practice
and non-nursing practice.
There are some factors that define the implementation of
scope of practice including complexity of health care
organization, multidisciplinary approach of care
complexities, emergence of global health care emergencies,
expectations of the patients, and expectations of the
employers (McMahon, & Dluhy, 2017)(Stilos, et al 2007).In
actual nursing clinical settings, a “grey zone” of practice
arises in which nurses may find themselves welcomed to
perform tasks that they may not be competent to perform, or
wish to perform advanced or specialized tasks that they were
not licensed or trained to perform at the general nurse
level(Lillibridgeet al, 2000). These situation of
indistinctness of nursing roles are usually elaborated at the
organizational level through organizational scope of nursing
practice, nursing competencies, and nursing policies and
procedures. This organization level definition of nursing
scope of practice led to inter-organization inconsistencies of
what constitute nursing interventions. A nursing intervention
may be indorsed to be practiced by nurses in one hospital,
while the same intervention is not allowed to be performed
by the same level nurses in a neighboring hospital. Nursing
scope of practice and related nursing interventions can be
described as contextual and negotiable.
Nursing researchers should be vigilant when deciding to
conduct studies using clinical trials design. The focus should
beareas of nursing practice were quality evidence is lacking.
Failing to do so, nursing researchers usually end up
investing resources in studies that will not add quality
evidence to nursing profession.
Feasibility of conducting clinical trials to establish
evidence for clinical nursing practice:
The aim of nursing research process is to bring best possible
evidence to improve health by improving nursing clinical
practice. As the clinical practice is not limited to drugs or
devices, all aspects of clinical practice can, and should be
subject to be researched using appropriate research
methodologies. In nursing profession, some clinical
practices gained the credit as result of nurses’ intuition,
opinion, or expertise without being adequately tested
through rigorous scientific research(Turan, 2016). This
approach of developing nursing practice puts nursing
researchers before a crucial responsibility of bringing
scientific evidence to adopt, modify, or abandon these
practices.
Although there is an increased number of therapeutic
clinical trials published in nursing journals, their
methodological rigor and quality of reporting remain
questionable(Hale & Griffiths, 2015).Chunhu (2014)
reviewed methodological reporting of randomized trials in
five leading Chinese nursing journals and concluded that the
overall reporting was poor. Despite clinical trials reporting
guidelines are gaining more popularity as tools that help
both researchers and reviewers to improve the quality of
conducting and reporting clinical trials, their utilization in
nursing clinical trials is not up to the required standard. In
fact, some nursing journals that review and publish clinical
trials do not specifically support clinical trials guidelines,
which potentially contribute to poor methodological quality
ofclinical trials.(Hale& Griffiths, 2015).
Some researchers conduct non-pharmacological clinical
trials using methodological standards of the
pharmacological clinical trials. Chaibi(2015)argued the
feasibility of establishing a manipulative-therapy RCT with
concealing the placebo intervention and maintaining the
blinding throughout the study is impossible to achieve.
The same methodological challenges are observed in other
clinical trials. Hsieh, et al, (2017) for example studied
efficacy of cold application on pain during chest tube
removal. Despite the research topic explicitly stated that it is
“a randomized controlled trial conducted using CONSORT
guidelines”, the blinding for both participants was not
achieved.
Clinical trials conducted by nurses are not limited clinical
interventions; it is established that some trials were
conducted to test modalities of care (Légaré et al,
2015),nursing education and training methods (Crawford et
al, 2015), and even economic evaluations(hakkaart, 2013).
Nursing clinical trials relevance to nursing profession and
adherence to clinical trials standards:
It is the responsibility of all nursing research stakeholders to
assess the need for conducting a clinical trial based on the
“relevance to nursing profession” from one side, and on the
“possibility of adhering to clinical trials guidelines” on the
other side.
Diagram one presented below proposes model to assess
nursing clinical trials against the two dimensions: relevance
to nursing profession and adherence to clinical trials
standards. According to this model, clinical trials can be put
into four categories (quadrants), where the implication of
clinical trials can be assessed against which quadrant
clinical trials in nursing fall in.
Tareq Afaneh, et,al, Nursing and Midwifery, 02 (03) March, 2022
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Diagram 1. A proposed model for assessing clinical trials based on relevance to the priorities of nursing profession, and adherence to clinical trial
guidelines.
Quadrant one represents clinical trials that are of no or low
relevance to nursing profession, at the same time they show
low possibility of adherence to clinical trials guidelines.This
type of trials should be neither planned by nursing
researchers nor endorsed by nursing journals. The
implication maintaining this category of clinical trials may
be harmful to the development of nursing
profession.Clinical trials that fallunder quadrant two are
studies that despite their ability to comply with clinical trials
guidelines, they are of low or no relevance to nursing
profession. These clinical trials may be conducted as
interdisciplinary approach under “health research”domain,
rather than, “nursing research” domain, as they can
contribute to improving health outcomes. Clinical trials that
fall in quadrant three are trials have the priority to be studied
by nursing researchers; yet, they have low chance to adhere
to clinical trials guidelines. In this category of clinical trials,
researcher must deliberately take the decision not to use
clinical trials methodology to research the topic as they
usually end up generating findingsthat lack methodological
rigor necessary to produce quality evidence.Despite the
efforts that is invested in these type researches, the quality
of generated evidence is questionable.
The fourth quadrant represents clinical trials that retain true
methodological design and are relevant to nursing
profession research priority.This category of clinical trials
should be adopted and promoted by nursing researchers and
nursing policy makers. Implication for utilizing clinical
trials under this category would be of great significance to
bring quality evidence to nursing practice and to refinethe
scope of nursing profession.
Recommendations for improving quality of evidence
generated from clinical trials in nursing:
Generating evidence from researchin general and from
clinical trials in specific is not an easy mission.Although
most of the responsibility of conducting quality clinical
trials goes to the researcher, all stakeholders should assume
this responsibility.Generating quality evidence from
research requires research stakeholders to deliberately
coordinate their efforts to improve the quality of evidence
generated from clinical trials(Hale& Griffiths, 2015).
Recommendations to improve the quality of clinical trials
are presented below.
Nursing journals:
1. Nursing Journals shouldexplicitly endorse specific
clinical trials reporting guidelines.It is not recommended
that journals accept to review clinical trial studies that
are not explicitly based on a clinical reporting guideline
endorsed by the journal.
2. Journals should encourage reviewers to use clinical trials
guidelines when reviewing the submitted researches.
Nursing journals reviewers:
1. Journals reviewers should strictly adhere to clinical trials
guidelines endorsed by the journal.
2. Journal reviewers can improve researchers’ capacity in
compliance with clinical trials guidelines through
feedback process.
Nursing researchers:
1. Purposefully choose not to conduct clinical trials when
the topic is of no or little relevance to nursing profession,
or when clinical trial is not the optimal design for
conducting the study.
2. When researchers decide to conduct a clinical
trial,theyshould take all necessary measures to adhere to
the clinical trials guidelines, starting from planning
phase.
Readers (research users):
1. Readers, are responsible for assessing the quality of
research evidence.
Tareq Afaneh, et,al, Nursing and Midwifery, 02 (03) March, 2022
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2. Readers need to build their capacity for assessing clinical
trials and critiquing their method.
CONCLUSION
This paper presented a brief discussion on feasibility of
building nursing practices on evidence derived from nursing
clinical trials. It is obvious that in real practice there is no
clear cut between nursing and non-nursing interventions,
which is reflected on lacking of clear cut between nursing
and non-nursing clinical trials. The discussion focused on
the methodological challenges of using clinical trials in
studying nursing interventions There is a gap between
clinical trial reporting guidelines requirements from one side
and the actual clinical trial reports published in nursing
journals from the other side. Implication for using clinical
trials in nursing was discussed based on two criteria:
relevance to nursing profession, and congruence with
clinical trial design. Finally, a group of recommendations
were proposed to improve quality of evidence generated
from clinical trials.
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