Health statistics and research

Health statistics and research





Part A

Medical providers need a research protocol to enable them extend their reach as well as improve their efficiency and effectiveness while at the same time maintaining high quality care and attention to the patients safety. It also facilitates the health care decision makers to make more informed decisions and improve the quality of the health care services they offer to different patients with distinct illnesses. The research protocol also enables them to determine the patients’ capacity to understand the risks and benefits of taking part in any clinical research trial (Hash, 2005).

Research on any new treatment regarding a particular disease or illness involves carrying out research clinical trials. These are research studies exploring whether a given medical strategy, treatment or device intended to be used ensures safety and effective use on humans. They identify which medical approach works well for a certain cohort of patients.

Clinical trials are mainly conducted in four phases which are; phase I, II, III, and IV. Phase I involves small trials conducted on a sample of patients and may be open to people with any type of disease such as cancer. It is carried out with an aim of finding out;

The dose range that is safe to patients

The kind of side effects to be experienced by the patients

How the body cope with the drugs

Whether the treatment shrinks the disease after laboratory tests are done

When the administration of the drug yields positive results on the sample of the patients, the administration of the dosage is increased in the next group of patients (Friedman, Furberg, & DeMets, 2010). This is normally done as the researchers keenly monitor the effects of the drug until when the appropriate dose is attained. It mainly involves patients with an advanced type of, say, cancer disease on which all the treatments have been administered.

Phase II involves people with the same type of cancer or those suffering from several different types of cancer. Its objectives include finding out;

What type of cancer treatment works

More about the side effects and how to suppress them

The best dose to administer

It is normally larger compared to phase I because it involves almost hundred patients. In this phase, a new treatment is normally compared to another which is already in use. In the event that the results show that the treatment can be as good as the one already existing or even yield better results, it then advances to phase III.

Phase III normally involve comparison of the new treatment in relation to the best treatment currently existing or the standard treatment. This phase normally focuses on determining;

A completely new treatment using the standard one

A new means of administering radiotherapy with the standard way

Different doses of administering a standard treatment

It involves more patients with different issues than in the first two phases and the success rates are likely to be small. It may involve thousands of patients in several different hospitals or even across different countries (Sedgwik, 2011).

Phase IV is normally carried out when the drug has been used and proved to work effectively and a license has been given. Its objectives include;

To establish the side effects and safety of the drug to a greater depth.

To find out what the long term risks and benefits are.

To find out the effectiveness of the drug when used within wider geographical regions.

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 entails laws which require people to abide by clinical health security rules in order to ensure that they keep the health insurance, protect confidentiality and security of the healthcare information and help the health provider control the administrative costs (Wilson, 2006).It provides guidelines to be followed by both health care providers and clinical assistant’s failure to which there are consequences. The guidelines are followed by abiding by laws designed and passed primarily to modernize the health information flow. Health organizations and medical staff ensure that privacy and security of health information is provided through digital methods of health informatics as a way of following HIPAA guidelines (Solove, 2013).

The process of informed consent

The informed consent can be developed by information provision and sharing by the research team and with the participants and community leaders, that is, communal assent and agreement with the family community. Next, the discussion and interaction between researchers and potential participants takes place with true understanding. There there is also the part of acceptance or rejection of participation which consists of either agreement to participate or the end of contract. The agreement of participation can be in the form of verbal, written, witnessed or recorded form. The follow up becomes the last step of developing informed consent framework (Bhutta, 2004).

How ethics is addressed in clinical trials

Ethics are addressed in clinical trials through regulations, traditions or standard operating procedures which are used by specific health organization. This implies that every health organization must have its work tradition and operation procedures that defined the ethics of work. Bioethics committee in this case will have significant contribution of ethical dialogue that is strengthened by social analysis which include taking in to an account the context and non-policy use of power to govern genomics/biotechnology and to sustain social debate on enduring issues of ethics (Chan et al., 2013, Burgess, 2013).

Part B: Survey for distribution to medical providers

This survey will involve the following questions to gather appropriate responses:-

What are the academic qualifications and experience for you as a medical staff provider?

What clinical protocols do employ to improve the efficiency of medical care?

How do you select patients for clinical trials as a medical staff provider?

Are there some medical ethics or guidelines you do follow in the clinical trial process? If yes, state some of them.

What significant role does the ethics stated above play in the clinical process?

What are your duties or responsibilities as a medical staff in the clinical trial process?

Have you ever participated in any clinical research training as a medical staff?

How is clinical research important in supporting your clinical process as a medical staff?

Cover letter to accompany the survey

Dear respondent,

As a health informatics professional for a physician owned multispecialty group organization, that provides outpatient services at seven distinct sites, I would like to carry out research concerning the progress and quality of clinical trial process undertaken by various medical staff at different levels.

The survey questions enclosed or attached to this letter are meant to gather information from various medical staff who takes part in clinical trial process. You are requested to respond to all questions accordingly. The information gathered is meant to be used in research analysis concerning the progress of medical services offered at various levels to different patients in terms of quality of service. The information gathered for this case will be kept confidential and therefore you need not to reveal your name while responding to the attached questions. You should feel free as a medical staff respondent to elaborate more on the respective questions given. In addition, the respondent is allowed to include any other additional comment that he/she thinks is relevant as far as the scope of the given questions are concerned.

The medical staff respondents are also requested to email back the completed response to the respective questions by using the provided email address. I would also like to request the respondents to submit their responses within a period of at most seven days. I also take this opportunity to thank all the concerned medical staff respondents in advance for their cooperation with me while trying to gather relevant information from them.


Health informatics officer,

For: Physician-owned Multispecialty Group Organization

Statistical analysis to use for evaluating the survey results

Correlation statistical analysis will be used to analyze the relationship that exist between medical education training for cancer research and the success of clinical trial process in terms of quality of medical health care. The analysis will also be used to show the relationship that exists between medical research and awareness of health security guidelines. The analysis thus to be carried through qualitative research.

Suitability of using interviews in the process

Interview in this case will not be the best method to employ in information gathering since it is not convenient as such. It is not convenient in the sense that I as the interviewer will have to spend a lot of time and money to find and interview each respondent. This also makes interview a very expensive process. In addition, there is no guarantee of finding all the relevant staff in a given health organization and interview them by interrupting their daily work activities. As a result, survey questions remain the best option which will reduce the total cost of research by just sending questions to respondents via email.

How the clinical trials team uses the Internet for information on trials

The internet in this case is used for medical research for more information about the clinical trial process. During research, the clinical trial team collects data samples through online surveys where the participants consist of other medical staff. They also use internet for the publication of several clinical trials of both pharmacological and phycological treatments for internet addiction (King et al., 2011).


Hash, J. (2005). An introductory resource guide for implementing the health insurance portability and accountability act (HIPAA) security rule (Doctoral dissertation, National Institute of Standards and Technology).

Friedman, L. M., Furberg, C., & DeMets, D. L. (2010). Fundamentals of clinical trials (Vol. 4). New York: Springer.

Sedgwick, P. (2011). Phases of clinical trials. BMJ, 343.Wilson, J. F. (2006). Health Insurance Portability and Accountability Act privacy rule causes ongoing concerns among clinicians and researchers. Annals of internal medicine, 145(4), 313-316.

Solove, D. J. (2013). HIPAA turns 10. J AHIMA, 84(4), 22-8.

Bhutta, Z. A. (2004). Beyond informed consent. Bulletin of the World Health Organization, 82, 771-777.

Chan, A. W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., GÃ, P. C., Krleža-JeriÄ, K., … & Moher, D. (2013). SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine, 158(3), 200-207.

Burgess, M. (2013). Biomedical Ethics.King, D. L., Delfabbro, P. H., Griffiths, M. D., & Gradisar, M. (2011). Assessing clinical trials of Internet addiction treatment: A systematic review and CONSORT evaluation. Clinical psychology review, 31(7), 1110-1116.