ArticlePDF Available

Conducting Clinical Trials to Support Evidence-Based Clinical Nursing Practice: Challenges and Recommendations

Authors:

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.
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
2
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
3
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
4
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.
REFERENCES
[1]. Burns, P. B., Rohrich, R. J., & Chung, K. C. (2011). The
levels of evidence and their role in evidence-based
medicine. Plastic and reconstructive surgery, 128(1), 305.
[2]. Butcher, Howard K., et al. Nursing Interventions
classification (NIC)-E-Book. Elsevier Health Sciences,
2018.
[3]. Chaibi, A., Benth, J. Š., Tuchin, P. J., & Russell, M. B.
(2017). Chiropractic spinal manipulative therapy for
migraine: a three‐armed, single‐blinded, placebo,
randomized controlled trial. European journal of
neurology, 24(1), 143-153.
[4]. McMahon, M. A., & Dluhy, N. M. (2017). Ambiguity
within nursing practice: An evolutionary concept analysis.
Research and theory for nursing practice, 31(1), 56-74.
[5]. Clinicaltrials.gov. (2018). Home - ClinicalTrials.gov.
[online] Available at: https://clinicaltrials.gov/ [Accessed 6
Aug. 2018].
[6]. Crawford, G., Burns, S. K., Chih, H. J., Hunt, K., Tilley, P.
M., Hallett, J., ... & Smith, S. (2015). Mental health first
aid training for nursing students: a protocol for a pragmatic
randomised controlled trial in a large university. BMC
psychiatry, 15(1), 26.
[7]. Hakkaart-van Roijen, L., Bakker, T. J., Al, M., van der
Lee, J., Duivenvoorden, H. J., Ribbe, M. W., & Huijsman,
R. (2013). Economic evaluation alongside a single RCT of
an integrative psychotherapeutic nursing home programme.
BMC health services research, 13(1), 370.
[8]. Hale, C., & Griffiths, P. (2015). Ensuring the reporting
quality of publications in nursing journals: A shared
responsibility?. International journal of nursing studies,
52(6), 1025-1028.
[9]. Hsieh, L. Y., Chen, Y. R., & Lu, M. C. (2017). Efficacy of
cold application on pain during chest tube removal: a
randomized controlled trial: A CONSORT-compliant
article. Medicine, 96(46).
[10]. JNC.gov.jo. (2016). [online] Available at:
http://www.jnc.gov.jo [Accessed 6 Aug. 2018].
[11]. Légaré, F., Brière, N., Stacey, D., Bourassa, H., Desroches,
S., Dumont, S& Roy, L. (2015). Improving Decision
making On Location of Care with the frail Elderly and their
caregivers (the DOLCE study): study protocol for a cluster
randomized controlled trial. Trials, 16(1), 50.
[12]. Lillibridge, J., Axford, R., & Rowley, G. (2000). The
contribution of nurses' perceptions and actions in defining
scope and stabilising professional boundaries of nursing
practice. Collegian, 7(4), 35-39.
[13]. McCutcheon, H. H., & Pincombe, J. (2001). Intuition: an
important tool in the practice of nursing. Journal of
advanced nursing, 35(3), 342-348.
[14]. Nursing.uiowa.edu. (2018). CNC | College of Nursing |
The University of Iowa. [online] Available at:
https://nursing.uiowa.edu/cncce/nursing-interventions-
classification-overview [Accessed 6 Aug. 2018].
[15]. Peterson, M. H., Barnason, S., Donnelly, B., Hill, K.,
Miley, H., Riggs, L., & Whiteman, K. (2014). Choosing
the best evidence to guide clinical practice: Application of
AACN levels of evidence. Critical Care Nurse, 34(2), 58-
68.
[16]. Stilos, K., Moura, S. L., & Flint, F. (2007). Building
comfort with ambiguity in nursing practice. Clinical
Journal of Oncology Nursing, 11(2).
[17]. Turan, N., Kaya, H., Özsaban, A., & Aydın, G. Ö.
Intuition: An Important Tool in the Practice of Nursing.
Physiology, 4, 11-13.
[18]. US National Institutes of Health. (2012). ClinicalTrials.
gov.
[19]. Umscheid, C. A., Margolis, D. J., & Grossman, C. E.
(2011). Key concepts of clinical trials: a narrative
review. Postgraduate medicine, 123(5), 194-204.
... Nursing intervention is defined as "any care based on the judgment and clinical knowledge that a nurse makes to improve patient/ client outcomes" (9). Although this definition sufficiently broad enough to acknowledge many of the activities performed by nurses, it does not clearly delineate the boundary between nursing and non-nursing practice (10). Harkening back to the often-idealized images of Nurse Nightingale as ensuring an environment conducive to healing (e.g., opening windows for fresh air etc.), nurses often recognize the totality of factors impacting the holistic wellbeing of the client. ...
Article
Full-text available
The Article Abstract is not available.
Article
Full-text available
Background: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain. Methods: A prospective, randomized, single-blind, sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600-g ice packs 15 minutes before CTR, whereas subjects in the sham group (n = 30) received tap water packs. Numerical rating scale was used to measure pain intensity before, immediately after, and 10 minutes after CTR. Results: The generalized linear estimating equation (GEE) model, adjusted for other factors, both the groups demonstrated a trend toward decreased pain during CTR over time (P < .001), but no significant differences between the 2 groups (P = .65), even stratifying by gender. If we fixed experimental group, women significant reduced pain score of 2.7 on immediately after CTR compared with before CTR (P < .0001) and reduced pain score of 2.05 on 10 minutes after CTR compared with before CTR (P < .0001). The sham group had no similar performance as the experimental group. In the male subgroup, both experimental and sham groups, men significantly reduced pain score on immediately after CTR and 10 minutes after CTR compared with before CTR (P < .0001). Conclusion: The results indicate that cold application is not more effective than sham treatment in decreasing pain during CTR, even among gender. Although statistically non-significant, clinically important differences of decreased pain score were observed with cold application among women (Clinical Trial Registration: clinicaltrials.gov identifier NCT03307239).
Article
Full-text available
BACKGROUND AND PURPOSE: To investigate the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs. METHODS: This was a prospective three-armed, single-blinded, placebo, randomized controlled trial (RCT) of 17 months duration including 104 migraineurs with at least one migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1-month run-in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow-up. The primary end-point was the number of migraine days per month, whereas secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption. RESULTS: Migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo group at all follow-up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (P > 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow-up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT. CONCLUSIONS: It is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.
Article
Full-text available
One of the toughest decisions faced by elderly people is whether to stay at home or move to a care facility. This study seeks to evaluate the impact of training interprofessional home-care teams in shared decision making combined with a decision aid on the proportion of elderly people who report being active in the decision-making process regarding whether to stay at home or move to a care facility. We propose a multicenter cluster randomized trial conducted with home-care interprofessional teams in the Province of Quebec with 2 data collection phases: before and after the intervention. Units of randomization will be centers for primary healthcare and social services. We will enroll 16 of these and ask each to provide one home-care interprofessional team involved in decisions and care planning with eligible clients. Clients will be included if they i) are aged ≥65; ii) are receiving care from the participating home-care interprofessional team; iii) have faced the decision about staying at home or moving to a care facility in the past 3 to 6 months; iv) are able to read, understand and write French or English; and v) are able to give informed consent. If clients are unable to provide informed consent, their primary caregiver who was involved in the decision-making process will be eligible to participate. The intervention arm will receive training in shared decision making and use of a decision aid. The control arm will receive 'usual care'. The primary outcome of interest is the assumed role in the decision-making process as assessed in clients or caregivers with a modified version of the Control Preferences Scale. Multilevel modeling will be used to take the hierarchical structure of the data into account. The study has obtained full ethical approval. The trial will comply with CONSORT guidelines adapted for cluster randomized trials. Home care is a rapidly growing sector and this study will lay the foundations of a national strategy to ensure that IP home-care teams provide the highest quality of care for seriously ill elderly people and support for their families. ClinicalTrials.gov NCT02244359 (registered 18 September 2014).
Article
Full-text available
The impact of mental health problems and disorders in Australia is significant. Mental health problems often start early and disproportionately affect young people. Poor adolescent mental health can predict educational achievement at school and educational and occupational attainment in adulthood. Many young people attend higher education and have been found to experience a range of mental health issues. The university setting therefore presents a unique opportunity to trial interventions to reduce the burden of mental health problems. Mental Health First Aid (MHFA) aims to train participants to recognise symptoms of mental health problems and assist an individual who may be experiencing a mental health crisis. Training nursing students in MHFA may increase mental health literacy and decrease stigma in the student population. This paper presents a protocol for a trial to examine the efficacy of the MHFA training for students studying nursing at a large university in Perth, Western Australia. This randomised controlled trial will follow the CONSORT guidelines. Participants will be randomly allocated to the intervention group (receiving a MHFA training course comprising two face to face 6.5 hour sessions run over two days during the intervention period) or a waitlisted control group (not receiving MHFA training during the study). The source population will be undergraduate nursing students at a large university located in Perth, Western Australia. Efficacy of the MHFA training will be assessed by following the intention-to-treat principle and repeated measures analysis. Given the known burden of mental health disorders among student populations, it is important universities consider effective strategies to address mental health issues. Providing MHFA training to students offers the advantage of increasing mental health literacy, among the student population. Further, students trained in MHFA are likely to utilise these skills in the broader community, when they graduate to the workforce. It is anticipated that this trial will demonstrate the scalability of MHFA in the university environment for pre-service nurses and that implementation of MHFA courses, with comprehensive evaluation, could yield positive improvements in the mental health literacy amongst this target group as well as other tertiary student groups. Australian New Zealand Clinical Trials Registry ACTRN12614000861651 .
Article
Full-text available
There is an 80% prevalence of two or more psychiatric symptoms in psychogeriatric patients. Multiple psychiatric symptoms (MPS) have many negative effects on quality of life of the patient as well as on caregiver burden and competence. Irrespective of the effectiveness of an intervention programme, it is important to take into account its economic aspects. The economic evaluation was performed alongside a single open RCT and conducted between 2001 and 2006. The patients who met the selection criteria were asked to participate in the RCT. After the patient or his caregiver signed a written informed consent form, he was then randomly assigned to either IRR or UC.The costs and effects of IRR were compared to those of UC. We assessed the cost-utility of IRR as well as the cost-effectiveness of both conditions. Primary outcome variable: severity of MPS (NPI) of patients; secondary outcome variables: general caregiver burden (CB) and caregiver competence (CCL), quality of life (EQ5D) of the patient, and total medical costs per patient (TiC-P). Cost-utility was evaluated on the basis of differences in total medical costs). Cost-effectiveness was evaluated by comparing differences of total medical costs and effects on NPI, CB and CCL (Incremental Cost-Effectiveness Ratio: ICER). CEAC-analyses were performed for QALY and NPI-severity. All significant testing was fixed at p<0.05 (two-tailed). The data were analyzed according to the intention-to-treat (ITT)-principle. A complete cases approach (CC) was used. IRR turned out to be non-significantly, 10.5% more expensive than UC ([euro sign] 36 per day). The number of QALYs was 0.01 higher (non-significant) in IRR, resulting in [euro sign] 276,290 per QALY. According to the ICER-method, IRR was significantly more cost-effective on NPI-sum-severity of the patient (up to 34%), CB and CCL (up to 50%), with ICERs varying from [euro sign] 130 to [euro sign] 540 per additional point of improvement. No significant differences were found on QALYs. In IRR patients improved significantly more on severity of MPS, and caregivers on general burden and competence, with incremental costs varying from [euro sign] 130 to [euro sign] 540 per additional point of improvement. The surplus costs of IRR are considered acceptable, taking into account the high societal costs of suffering from MPS of psychogeriatric patients and the high burden of caregivers. The large discrepancy in economic evaluation between QALYs (based on EQ5D) and ICERs (based on clinically relevant outcomes) demands further research on the validity of EQ5D in psychogeriatric cost-utility studies. (Trial registration nr.: ISRCTN 38916563; December 2004).
Article
Purpose: To analyze the concept of ambiguity in a nursing context. Background: Ambiguity is inherent within nursing practice. As health care becomes increasingly complex, nurses must continue to successfully deal with greater amounts of clinical ambiguity. Although ambiguity is discussed in nursing, minimal concept refinement exists to capture the contextual intricacies from a nursing lens. Nurse perception of an ambiguous clinical event, in combination with nurse tolerance level for ambiguity, can impact nurse response. Yet, little is known about what constitutes ambiguity within nursing practice (AWNP). Method: Rodgers evolutionary method was used to explore AWNP, with emphasis on nurse thinking during ambiguous clinical situations. Literature searches across multiple databases yielded 38 articles for analysis. Results: Attributes of AWNP include (a) variations in cues/available information, (b) multiple interpretations, (c) novel/nonroutine presentations, and (d) unpredictable. Antecedents include (a) a context-specific, clinical situation with ambiguous features needing evaluation and (b) an individual to sense a knowledge gap or perceive ambiguity. Consequences include ranges of (a) emotional, (b) behavioral, and (c) cognitive clinician responses. Conclusion: Preliminary findings support AWNP as a distinct concept in which ambiguity perceived by the nurse likely affects judgment, decision making, and clinical interventions. AWNP is a clinically relevant concept requiring continued development.
Article
Evidence-based nursing care is informed by research findings, clinical expertise, and patients' values, and its use can improve patients' outcomes. Use of research evidence in clinical practice is an expected standard of practice for nurses and health care organizations, but numerous barriers exist that create a gap between new knowledge and implementation of that knowledge to improve patient care. To help close that gap, the American Association of Critical-Care Nurses has developed many resources for clinicians, including practice alerts and a hierarchal rating system for levels of evidence. Using the levels of evidence, nurses can determine the strength of research studies, assess the findings, and evaluate the evidence for potential implementation into best practice. Evidence-based nursing care is a lifelong approach to clinical decision making and excellence in practice.
Article
The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform.