Healthcare Statistics and Research
A research protocol is an official document or directive offering a systematic and definite
presented elaboration of a comprehensive research study procedures. Its principal elements that
are normally focused on are the research methodology, study objective, research design, protocol
summary, research question, as well as the project management that will be implemented. The
research protocol’s design is in such a manner that the ethic committee can evaluate the study in
a bid to ensure that it complies with the code requirements that ethics and the regulations
necessitate. There exists close connection between the practice of medical practitioners and the
research protocol; a research study that involves privacy protection of the patients and safety
consideration. Typically, patients are involved in research studies and there are high chances that
medical providers might misuse their data for personal gains (Angell, 2008). Hence, a research
protocol is a means of enhancing health care provision. It also acts as a control measure for
ensuring that all medical providers abide by the federal rules in addition to other rules and
standards that guard the confidentiality of patient data. In a nut shell, the research protocol saves
health providers from imprisonment, legal problems, and penalties. It also saves them from being
sued and ethical issues as it gives an affirmation of the study’s description, and this also involves
ethical considerations that involve patient treatment as well as the utilization of the health data
from patients. This affirmation is essential in that it leads the study investigator and staff in
complying with the HIPAA rules and guidelines of privacy, in addition to other ethical issues
The clinical trial phases guide researchers in enquiring and responding to questions that
results to reliable information regarding the drugs and patient protection. Phase I is basically
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about new drug administration, either orally or intravenously, in addition to how often the
administration should be. In Phase II, the drug safety, depending on certain diseases, as well as
working conditions is tested. In Phase III, novel drug combinations are tested compared to the
current standard. Phase IV comes after the drug has been marketed and approved. The phase
evaluates the risks, side effects, and benefits of the drug following use for some period.
The rules and regulations of HIPAA aim at guarding patient information that emerges
from a covered entity, in addition to the identifiable information concerning the patient.
Following the guidelines requires that information on patient sheets only has the name and time
so as to promote privacy. In a patient prefers remaining silent on admission, it is vital that
medical practitioners obey this.
An informed consent ensures that patients have adequate knowledge about their health
care. An informed consent is necessary since an individual has rights over what is done to his
body in response to ethics and law. In addition, medical practitioners have an ethical duty of
involving patients when providing healthcare. The informed consent indicates the decision the
patient took, the reasonable available alternatives, relevant risks, benefits, and that the patient
accepted the intervention. For it to be valid, the patient should be perfectly competent so as to
make the decisions, which should be wholly voluntary (Beecher, 2012).
In clinical trials, there is a need of ethics in the study design formulation and monitoring
in a bid to enhance the safety of patient data. It is as a result of ethics that informed consents
should be signed and in order. Monitoring involves following the provided protocol, appropriate
assessment of the unpleasant occurrences, and promotes integrity in researches. Clinical trials
should be based on benefits, justice, and respect for patients.
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The ethics committee should familiarize the hospital staff and community at large of the
ethical concerns that patient families and health care providers experience in clinical trials. The
committee is supposed to give guidance regarding the ethical issues. The internet is of great
significance to clinical trial teams for trials information. The team possesses a large database of
companies that deal with pharmaceutics. Here, all the information regarding upcoming studies
can be obtained from www.clinicaltrials.gov. The teams can access many research studies from
here for their use. In addition, assessing other institutions’ clinical trials can give teams insight
on future study suggestions.
What are clinical protocols?
How are patients selected for trials?
Why are ethics important in any clinical trial process?
How can patients in clinical trials adhere to HIPAA guidelines?
What are an informed consent’s elements? (Flory & Emanuel, 2011).
What are a valid informed consent’s eligibility requirements?
How are clinical trials useful to a health provider’s practice?
Define the various forms of clinical trials?
Being a health informatics professional in the clinic, I greatly admire the clinical research
department. There are five clinical associates that work with the III and IV phases with the
diabetic patients’ endocrinologist group as well as oncologists for cancer research studies.
Although there are no adequate funds for conducting the cancer research, ethical reasons have
made us progress with the research. Fortunately, there are enough funds for the diabetes
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research. Initiatives for ensuring that the clinical trials become more acceptable have been laid
down and this was promoted through ensuring that the involved medical staff were well
informed about the clinical trials at the clinic. The planned survey purposes at assessing the
extent to which medical practitioners are informed about the clinical trials. There are numerous
trials in internet medicine, cardiology, and pediatrics. The trials generate revenue and give hope
to critically ill patients (National Center for Health Statistics (US), 2009).
The statistical analysis to be used is random sampling. This will be essential in retrieving
the results of the survey as well as narrowing down data, leaving me with a few numbers of
physicians to be interviewed. An interview will be used for gathering information and I will be
able to acquire 1 st hand information based on the face-to-face interaction. In addition, the number
of physicians defaulting from the study will be less. The interview will also ensure that I control
the questions and reframe them where necessary. In addition, facial expressions will inform me
whether the physician is lying.
Many analyses have identified substantial quality challenges in the entire healthcare
system. Consistently, information technology has been identifies as a vital component of any
improvement approach. CPOE (Computerized Physician Order Entry) is presently a promising
technology which permits physicians to use computers to enter data as opposed to handwriting
them (Kuperman & Gibson, 2003). Based on the fact that CPOE fundamentally transforms the
ordering process, it has the potential of reducing the overuse, misuse, and underuse of healthcare
services substantially. According to studies, it has been documented that CPOE decreases costs,
reduces medical errors, shortens the length of stay, and betters compliance with a number of
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guidelines (Doolan & Bates, 2002). CPOE costs are substantial in terms of organizational and
technology process analysis as well as redesign, user support and training, and system
CPOE is a relatively novel technology and to date, there is no agreement on the most
appropriate approaches of addressing the numerous challenges it presents (Sittig & Stead, 1994).
The technology can bring about numerous vital benefits and is a significant platform for the
future healthcare system changes. It is important that organizational leaders advocate for CPOE
since it is a critical tool through which healthcare quality can be improved (Cutler, Feldman &
The barriers of CPOE result from the transformations needed in practice patterns,
teaching patterns, roles within the team, and institutional policies. For successful implementation
of CPOE, there is a need for system to be easy to use and fast; the user interface should behave
consistently regardless of the situation; the institution should have committed and broad direction
and involvement by the clinicians before being implemented; the organization’s top leadership
should be dedicated to the project; and several users and problem solvers should meet severally
so as to work out the procedural issues. Some of the variables that are impacted on directly by
CPOE include cost-effectiveness, safety, and quality of healthcare (Bukunt et al., 2005).
Needs assessment will begin by assessing the extent to which COPD was embraced by
physicians, the benefits the physicians associated with COPD, challenges in using it, as well as
the disadvantages it had. It will also be determined if the physicians preferred using COPD or
handwriting, and if every department has adequate COPD systems.
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Developing a hypothesis for the project and formulating the research questions will begin
by a preliminary existing literature review for the topic. The research question will be based on
the data to be collected, and it will pose the link between variables in terms of a question (Cutler,
Feldman & Horwitz, 2005). The research question will also reflect the where, what, how, and
when the data will be collected. The hypothesis will attempt predicting the link between
variables based on the statistical consideration.
The research will purpose to describe the medication prescribing errors’ epidemiology
that pharmacists avert and assessing the chances that the errors can be prevented by COPD.
Method: in a 700-bed institution, the staff pharmacists will save all orders having a
prescribing error for one week. Pharmacist investigators will then classify error type, drug class,
phase of hospitalization, proximal cause, and patient harm potential. Subsequently, the chance
that CPOE would have barred the prescribing inaccuracy will be rated.
An interview would be used to gather data and the face-to-face interaction will ensure
that the interviewers can assess the credibility of the information being given. Bivariate analysis
will be used to assess relationships. The conclusions would be drawn after the results’ data is
analyzed and discussed.
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Angell, M. (2008). Industry sponsored clinical research: a broken system. Journal of the
American Medical Association, 80: 899–904.
Beecher, H. K. (2012). Ethics and clinical research. N Engl J Med, 274: 1354–60.
Flory, J. & Emanuel, E. (2011). Interventions to improve research participants’ understanding in
informed consent for research: A systematic review. Journal of the American Medical
Association, 292: 1593–1601.
National Center for Health Statistics (US). (2009). Vital and Health Statistics: Analytical studies
(No. 14-19). US Department of Health, Education, and Welfare, Public Health Service.
Bukunt, S., Hunter, C., Perkins, S., Russell, D., & Domanico, L. (2005). El Camino Hospital:
using health information technology to promote patient safety. Jt Comm J Qual Patient
Cutler, D.M., Feldman, N.E., & Horwitz, J.R. (2005). U.S. adoption of computerized physician
order entry systems. Health Aff (Millwood), 24(6):1654-63.
Doolan, D.F., & Bates, D.W. (2002). Computerized physician order entry systems in hospitals:
mandates and incentives. Health Aff (Millwood), 21(4):180-8.
Kuperman, G. J., & Gibson, R. F. (2003). Computer physician order entry: benefits, costs, and
issues. Ann Intern Med., 139(1):31-9.
Sittig, D. F., & Stead, W. W. (1994). Computer-based physician order entry: The state of the art.
J Am Med Inform Assoc., 1:108–23.