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Introduction

Sepsis is a condition caused by microbial invasion from the local infectious source in the bloodstream that results to signs of the systemic illness in the remote organs. Additionally, severe sepsis and sepsis are the leading causes of fatality in the U.S. Researchers have discovered that half of the patients who have symptoms and signs of sepsis have positive blood culture or additional microbiological proof of the infectious focus. The blood streams are essential concerns to the physicians due to the high levels of antimicrobial resistance. However, (PCT) procalcitonin can help healthcare providers with early goal-directed therapy of sepsis. Procalcitonin is a prohormone of calcitonin, which is released by parenchyma cells, including liver cells, kidney cells, muscle cells, and adipocytes in response to the bacterial toxins resulting to an elevated serum level (Mayr, Yende & Angus, 2013). The PCT levels have been exercised to guide the empirical bacterial treatment of patients with severe exacerbations of chronic bronchitis, sepsis, and community-acquired pneumonia. More importantly, PCT level along with other standard clinical parameters will aid in determining whether the patient’s pragmatic antibacterial therapy is efficient (Wang et al., 2012).

 

Outcome Description

Patient Reported Outcome Measure (PROM) will be employed to achieve efficient outcome and development. The result of the will be disease specific, and the outcome I wish to measure is the effectiveness of PCT in detecting bacterial infection such as sepsis. Moreover, PCT has been identified to differentiate between systematic inflammatory response syndrome and sepsis of noninfectious origin. The values of PCT have to be further assessed according to the several sites of infection, pathogens, and hosts. A recent meta-analysis revealed that PCT is a helpful marker for the early identification of sepsis in gravely ill patients with high specificity and sensitivity (Mayr, Yende & Angus, 2013). Moreover, the PCT level were elevated after cardiogenic shock, surgery, heat shock, and immunotherapy. Sepsis manifests in distinctive spectra of harshness depending on the time beyond since the first manifestation. After sepsis evolves to dysfunction in one or more organs, it is referred to as severe sepsis. The patient will be invited to fill the PROM questionnaires. Filling them will aid in improving and measuring the quality of PCT. The physicians will understand the efficiency of PCT in detecting the early stages of sepsis (Wang et al., 2012). The prohormone will assist in solving most of the bacterial infections such as sepsis, which is the leading cause of death among the U.S.

Description of Hypothetical Study Design

Studies indicate that sepsis is one of the leading causes of death in the United States of America. Nevertheless, physicians are struggling to find the best solution to determine the physical diagnosis of the condition beforehand in order to come up with preventive measures and hopefully save more lives. In light of the statistics and the severity of the condition, this study seeks to measure the effectiveness of PCT in determining sepsis beforehand. Essentially, PCT levels are elevated in patients with bacterial infection. Hence, the study will seek to determine how effective PCT is in terms of helping healthcare providers with early goal directed therapy (Henriquez-Camacho & Losa, 2014).

The study is disease specific in that the application of PCT is projected to help in diagnosing sepsis at the early stages. It will be patient centered. In essence, the administration of the research procedure is that identified patients are administered with the PCT and their progress is monitored to review outcome and come up with probable inferences. The independent variable will be the PCT administered while the dependent variable will be the patients use for the purpose of the study. In other words, the sample used for the purpose of the research will comprise of both sepsis patients in their early stages and those in the severe stage. This variance will help in credibility and reliability of the data collected. The coordination of care will be another aspect to be taken into consideration because these patients will be monitored in order to apply the Patient Reported Outcome Measure (PROM). The utmost characteristics of the subjects of the research are probable diagnosis of sepsis or already identified severe sepsis case (Cho & Choi, 2014).

In order to understand the study design better, a review of the health outcome models is important. Kane, in his book, has discussed the various health outcome models. 

From the model above, the initial stage is the biological functioning of the measure taken to address the problem of the study. The second level of the model is the physical and mental health of the subjects of the study. The third level is the social and role functioning of the subjects as well. The final level of the model is the quality of life after the actualization of the PCT administered to the subjects of the study (Cho & Choi, 2014).

In reference to the current study, the administration of PCT will be subject to the first level based on the studies indicating that it is the most promising biomarker. Based on its credibility and reliability in projecting and determining early sepsis in the patients, it will be helpful in the determination of its biological functioning. In order to determine its outcome, the model will show the improvement of the subjects’ quality of life. Essentially, the model is progressive in that it allows the monitoring of the effectiveness of PCT as administered (León et al., 2013).

Quality and Assessment

It is significant for the PROM instrument to meet individual scaling, development, and psychometric standards when used to offer information. Particularly, the measures must have a sound hypothetical basis and be relevant to the patient’s group that is to be used. Additionally, they must be reliable, suitable, and composition of the scale must have been systematically tested with an appropriate methodology to justify the application of summary or scale scores. The standards should be maintained during each target language population (Cho & Choi, 2014). Hence, to guarantee the developmental standards are dependable in the translated accounts of PROM instrument. Therefore, the decoded device undergoes a procedure known as linguistic validation where the preliminary conversion is adapted to reflect the language and cultural differences between the various target populations. PROM implies that the questionnaire wraps issues of precise concern to the patient. The tool offers information about the patient on the effect of PCT in sepsis (Wang et al., 2012). The PRO information might be composed via self-administered questionnaires finished by patients themselves and via interviews.

Economic Impact

The proposed tool/measurement is the use of Patient Reported Outcome Measurements (PROMs). These are tools used to gain insight from the patient's perspective into how aspects of his or her health and the disease's impact and treatment are seen to be having on the patient's lifestyle and quality of life. They are self-completed questionnaires which the patient completes about himself or herself. Thus, a PRO is a report of the patient's health status that comes directly from the patient without a clinician's interpretation of the response of the patient (Cho & Choi, 2014).

Use of PROMs in sepsis is important as it allows for the measurement of various types of outcomes such as the psychological well-being of the patient, cognitive functioning, patient’s physical functions, symptoms, satisfaction with care, role activities, and the patient’s adherence to medical regimens. Thus, in sepsis, the use of PROs is cost effective as a patient’s eligibility clinical trials can be easily determined. This, therefore, reduces the costs used in repeated trials to establish the eligibility of the patient for the tests (Cho & Choi, 2014). Additionally, PROs aid in confirmation of the measures thus reducing costs of repeated trials. Another significance of the use of PROs is in the determination of the patient's compliance or reasons for non-compliance. Through this, the severity of side effects to certain medicine that are used in the treatment of sepsis can be determined, and this will enable clinicians to know the right medicines to be purchased for the patient.

The types of PRO instruments include generic, disease-specific, population-specific, dimension-specific, individualized, utility measures and summary items. With the generic PROM, comparisons between treatments for different groups of patients with sepsis can be done so as to assess the comparative effectiveness (Cho & Choi, 2014). Additionally, normative data can be generated from healthy populations and comparison can be made with sepsis patients, thus, the unexpected negative or positive effects of sepsis intervention can be determined. In case individualized instruments are used, the individual patients can be addressed, rather than the imposition of an external standard that may not be adequately relevant. Through this, costs of treatment can be minimized since clinicians will know exactly what to address as they have first-hand information from the patient as to how the disease affects them. In the use of disease-specific instruments, clinically significant changes resulting from the treatment of sepsis will be determined, and this will enable a cost-benefit analysis to be done regarding the kind of treatment to be put in place (Henriquez-Camacho & Losa, 2014).

In general, the patient reported outcome measures are significant as they provide a baseline assessment of the sepsis status, the quality of life, and well-being of the patient. Besides, the data derived from these measures will guide a clinician in making sound decisions about the different clinical inputs thus saving on costs. Thus to ensure the cost-effectiveness of a PRO instrument used and ensure maximum benefits are derived in the treatment of sepsis, clinicians should check for the validity, reliability, and instrument's ability to detect change. From the information provided by the patient without the influence of a clinician, PROMs become useful tools in treatment as essential information will be obtained which will aid in providing the right kind of treatment for sepsis (Cho & Choi, 2014). Through this, costs of treatment will be minimized and will allow for the classification of outcomes on clinical, humanistic and economic bases.

Ethics

The study will not include all citizens but only those who will be selected. Particularly, it will include patients with symptoms that show potential sepsis and those with severe sepsis. The measurement could change policy in terms of the determination of people with symptoms of sepsis. To avoid any ethical issues, the researcher must observe all the ethical code stipulations. Most importantly, the patients should sign a consent form to ensure that everything is done with their complete consent.

Most institutions, professions, and disciplines have standards for behavior, which suit the particular goals and aims (Henriquez-Camacho & Losa, 2014). They assist the members of the various disciplines to coordinate their activities, actions and establish trust. Therefore, in this research, the ethical norms serve the goals and aims of the study and apply to individuals carrying out scientific research. Adhering to the moral standard will promote the objectives of the research such as avoidance of error, knowledge, and truth. For instance, it prohibits against falsifying, misrepresenting research information, advocating for the truth, and fabricating to avoid error.

Additionally, since the study will often involve a great deal of coordination and cooperation among various individuals in institutions and disciplines. Furthermore, the ethical standards endorse the values, which are significant to collaborative work like accountability, trust, fairness, and mutual respect. Most of the moral norms will assist to ensure that the researchers will be held accountable to the community. Moreover, the moral standards will aid in helping build the support for the study. Individuals are more likely to fund research they can believe the integrity and quality of research. Lastly, some of the norms in the research will promote the variety of other essential social and moral values such as compliance with the law, safety, health, human rights, and social responsibility. Thus, when the research follows the ethical standards discussed, the effect in PCT in identifying the early stages of sepsis or any other bacterial infection in the blood will relay reliable results (Henriquez-Camacho & Losa, 2014).

The code of voluntary participation needs to apply to the patients in the study. They have free will to participate in the program with an informed consent. Here, the participant of the study must be fully informed about the risks and procedures involved in the investigation and should give the consent to participate. For the research to be conducted, the researcher must ensure that they do not risk harm when they participate. Anonymity and confidentiality should be practiced when to carry out the research. The research will change the perspective of the public towards the treatment of diseases and screening. The most severe patient suffering sepsis may die in the process. Some of the patients may fail to understand the significance of the research in improving health care.

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