Outcomes research, medical effectiveness appropriateness criteria, and clinical practice guidelines are words and concepts long familiar to the health services research community. They have more recently entered the vocabulary of a wide variety of groups concerned with health care, including members of Congress, health industry officials ranging from the insurance sector to drug and medical device companies, major employers and consumer groups. This Module is designed to explain what these terms mean, why they are important, and how health outcomes research can lead to improvements in the health care system and ultimately to health of Americans. In this Module, we will also review important factors to be considered when evaluating conclusions and interpretative findings from a research study.
Most nursing studies deal primarily with human subjects. There is a concern for protecting individuals from any harmful effects that might result from participation in the study. As nurses engage in various research activities, it is important that the profession operate from the sound ethical knowledge base. This Module includes a discussion of the accountability of researchers in maintaining ethical standards at all phases of the research process.
Outcomes research studies the end results of medical care, hence, the effect of the health care process on the health and well-being of patients and populations. It spans a broad spectrum of issues, from studies evaluating the effectiveness of a particular medical or surgical procedure, to examinations of the impact of insurance status or reimbursement policies on the outcomes of care. It also ranges from the development and use of tools to measure health status, to analyses of the best ways in which to disseminate the results of outcomes research to physicians or consumers to encourage behavior change.
The field of outcomes research emerged from a growing concern about which medical treatments work best and for whom. In large part because of its potential to address the interrelated issues of cost and quality of health care, public and private sector interest in outcomes research has grown dramatically in the past several years. Insurance companies, employers, state and federal governments and consumers are all looking to outcomes research for information that will help them make better decisions about what kind of medical care is appropriate (and should be reimbursed), for whom, and when.
The broad ranging issues encompassed by outcomes research can be viewed as a complex puzzle that together will help improve the operation of the health care system and ultimately the health of Americans.
A hallmark of outcomes research is the breadth of issues it addresses. Outcomes research touches all aspects of health care delivery, from the clinical encounter itself to questions of the organization, financing and regulation of the health care system. Each of these factors plays a role in the outcome of care, or the ultimate health status of the patient. Understanding how they interact requires collaboration among a broad range of health services researchers, such as physicians and advanced practice nurses, economists, sociologists, political scientists, operations researchers, biostatisticians and epidemiologists.
Outcomes research evaluates the results of the health care process in the real-life world of the doctor’s office, hospital, health clinic and even the home. This contrasts with traditional randomized controlled studies, funded mainly through the National Institutes of Health (NIH), which test the success of treatments in controlled environments. These are called efficacy studies. Research in real-life settings is called effectiveness research.
The field of outcomes research is broad and complex. It touches on all aspects of the health care process and has implications for every aspect of the health care system, including how care is organized, financed and delivered.
The nation is spending over $800 billion dollars on health care, yet very little is known about what that $800 billion is buying. Outcomes research is one of the most important tools policymakers, clinicians, managers and payers have to learn more about the most effective and efficient ways to provide high quality health care. While much has been learned from this field, many questions remain unanswered. With the debate over national health care reform intensifying, the need to make appropriate investments in outcomes research becomes even more crucial.
Once research data have been collected and analyzed, the researcher perceives to interpret the results/outcomes. Interpreted results or outcomes become findings for others to evaluate. Interpreting research findings involves organizing and explaining the meaning of data. Interpretation of findings is usually found toward the end of a research report, under the heading of results, conclusions, or discussion. Interpreting the research results includes: examining the meaning of the results, considering the significance of the findings, generalizing the findings, drawing, conclusions, and suggesting implications for practice and/or further study (Burns, Grove, & Gray, 2013).
In quantitative studies, outcomes of statistical tests are included to show or support the statement of results. Although the inclusion of calculated values, degrees of freedom, and the significance level is important, the narrative portion of the results section should emphasize the variables of interest rather than just statistics. The researcher should provide meaning when reporting the results. Research findings are to be reported as objectively as possible.
Another important factor to consider when interpreting research findings is clinical significance. Research findings that have meaning for patient care in the absence or presence of statistical significance are called clinically significant. Achieving statistical significance, however, does not automatically mean that the study has value for the discipline of nursing. Statistical significance indicates that the findings from analyses are unlikely to be the result of chance. Interpretation of findings must make logical sense.
Statistical significance can be achieved if there is an adequate sample size. However, is it a clinically significant difference? The word “significance” should be used when reporting statistical results and clarified when describing clinical results. Likewise, a study that is clinically significant does not need to be statistically significant. Clinical significance refers to findings that have meaning for patient care in the absence or presence of statistical significance. The reader of research must not only base evaluation of a study on its rigor, but also on its clinical significance.
An essential feature of results of a study is generalizability, the extent to which research findings can be generalized beyond that, given research situation to other settings and subjects. This is also termed external validity. When interpreting the findings of a study, the researcher examines risks to validity that may have been introduced at various stages of the research process, one of which involved selecting the sample. The researcher needs to consider whether the sample size was too small to allow generalization of findings.
Conclusions are derived from research findings. In order to draw conclusions, the researcher must interpret the results within the context of the study. It is important to remember that research never proves anything, but instead offers support for a position (Burns, Grove, & Gray, 2013).
Limitations are aspects of the study that are potentially confounding to the main study variables. Sample deficiencies, design problems, weakness and data collection procedures, and use of unreliable measures are common limitations cited. Limitations are generally reported in the Discussion section of an article so that the interpretation of results is made with knowledge of the potential impact on the limiting factors.
The research process is built on a foundation of trust. Researchers trust that the results reported by others are valid. Society trusts that the results of research are honest and that they describe the world accurately and without bias. Therefore, persons conducting research must devote themselves to the values of ethical conduct. The primary concern of the investigator should be the safety of the research participant. Some important ethical issues in research are the protection of human rights, the right to privacy of the participants, informed consent, and assurance that the information collected is not misused.
In order for informed consent to be ethical, the document used for this purpose must give assurance that all participants agreed voluntarily to participate in the study, that each participant has been given essential information about the study and understands that information, and that participants are aware of the risks and benefits involved in participating in the study. Key elements of informed consent are (1) providing potential subjects with sufficient information about participating in a research study and (2) assuring them that participation is voluntary and can be withdrawn at any time without negative consequences. The language is simple (8th grade level) to make sure that all subjects understand the meaning of informed consent.
Three important ethical principles of research are discussed in the Belmont Report, written by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. These principles are autonomy, which refers to the obligation of the investigator to respect each participant as a person capable of making an informed decision regarding participation in the research study, beneficence, which refers to the obligation on the part of the investigator to attempt to maximize benefits for participants, while minimizing the risk of harm, and justice, which requires that the selection of participants is fair and not coercive.
An institutional review board (IRB) is a committee whose approval is required when human subjects are used for the purpose of research. These boards are governed by federal regulations and exist in academic institutions, healthcare facilities, and federal agencies. The purpose of an IRB review is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Researchers present their research proposal to the appropriate IRB prior starting the research project. The IRB carefully reviews the proposal and either offers suggestions for change or approve the proposal. Once the researcher has obtained IRB approval they are ready to conduct their study.
Upon completing this Module students will:
• Define outcomes research.
• Identify the differences between outcomes research and other types of research.
• Describe how outcomes research provides answers for policymakers, clinicians, managers and payers.
• Identify the best ways to incorporate the results of outcomes research into the health care process.
• Identify funding sources for outcomes research.
• Distinguish between statistical and clinical significance.
• Understand human rights as it applies to undertaking research involving human subjects.
• Define informed consent and its key elements.
• Explain the role of institutional review boards in safeguarding the rights of subjects participating in a study.
• Gray, Grove, & Sutherland (2017)– Chapters 9, 13, & 26
• Melnyk & Fineout-Overholt (2015) – Chapter 10 & 22
• The Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Post your initial response by Wednesday at midnight. Respond to two students by Sunday at midnight. All responses should be a minimum of 300 words, scholarly written, APA formatted, and referenced. A minimum of 2 references are required (other than your text). Refer to the Grading Rubric for Online Discussion in the Course Resource section.
This question does not require additional posting to students or references.
Module VI – Discussion 1
Discussion 2 Develop the informed consent for your proposed scholarly project at an 8th grade level. Include as an attachment in the discussion post.
Run your consent form through the Flesh-Kincaid and provide a screen shot as an attachment to the discussion post. Interpret the meaning.
In your response to peers, discuss any difficulty you had in trying to get the reading level down to 8th grade. Indicate what reading level you began and what level you ended.
Module VI – Discussion 2
Discussion posts should follow criteria for the Rubric for Online Discussions.