Chapter 1: Intro to nursing research Nursing research: a scientific process that validates and refines existing knowledge and generates new knowledge that directly and indirectly affects nursing practice. The key to building EBP for the profession. Goal is to generate knowledge about nursing education, nursing administration, healthcare services, characteristics of nurses, and nurse roles. Evidence based practice (EBP): an integration of best research evidence, nurse’s clinical expertise, with the pt circumstances and values to produce quality, safe, costeffective outcomes. Acquiring knowledge in nursing through: -traditions: include “truths” or beliefs based on customs and trends. (nursing’s body of knowledge needs to be more research-based than traditional) -authority: person with expertise and power who can influence opinion and behavior. -borrowing: 2 ways-nursing borrows information from other disciplines without integration within unique focus of nursing; integrates info from other disciplines with the focus on nursing(better) -trial and error -personal experience -role modeling: learning by imitating behavior of an expert -intuition: insight into or understanding of situation as a whole that cannot be explained logically (hunch or gut feeling) -reasoning: inductive reasoning (specific to general) vs deductive (general to specific) Types of research methods Quantitative- formal, objective, systematic process in which numerical data are used to obtain info about the world- emerged from logical positivism (philosophical branch that focuses on strict rules of logic, truth, laws, and prediction). *Truth as absolute. Methods include scales, questionnaires, physiological measures. Data are numbers, analyzed w statistical techniques. -Descriptive research: conducted to test theory by describing variables -Correlational research: examines relationships among variables -Quasi-experimental and experimental research: determines cause and effect interactions between variables. Qualitative- systematic subjective approach used to describe life experiences and situations that give them meaning. The philosophic base is interpretive, humanistic, and naturalistic, concerned with understanding the meaning of social interactions. *Truth as being complex and dynamic. Data are in the form of words collected through interviews, observations, focus groups and analyzed for meaning. -Phenomenological research: inductive holistic approach used to describe an experience as it is lived by individuals (ie lived experience of losing a child) -Grounded theory research: inductive research technique used to formulate, test, and refined theory about a particular phenomenon. -Ethnographic research: developed by anthropology for investing cultures through in-depth study of members of culture (ie health practices specific to culture) -Exploratory-descriptive qualitative research: conducted to address an issue in need of a solution/understanding. Mixed methods research combines quantitative and qualitative research. Outcomes research: (in nursing) focuses on examining results of care and determining changes in health status for pt and family. (ie pt response to interventions, functional maintenance or improvement of physical/mental/social functioning for pt; financial outcomes achieved w provision of healthcare services;pt satisfaction w health outcomes, care received, and healthcare providers) -nursing-sensitive outcome: individual, family, or community state, behavior, or perception that is measured along continuum in response to nursing interventions. Uses the Nursing Outcomes Classification (NOC) to standardize terminology. Strategies to synthesize research evidence: -Systematic review: structured, comprehensive synthesis of literature to determine the best research evidence available to address a healthcare question. -Meta-analysis: conducted to combine or pool results from previous quantitative studies into a single statistical analysis that provides strong evidence about an intervention’s efficacy. *Cannot include qualitative studies bc their findings are not statistical. -Qualitative research synthesis: process and product of systematically reviewing and formally integrating findings from qualitative studies. -Meta-synthesis: systematic compilation and integration of qualitative study results (focused on interpretation rather than on combining study results, like in quantitative research synthesis) -Mixed-methods systematic review Levels of research evidence- presented in a pyramid that shows a continuum, with the highest quality at the top (Level 1) and weakest research evidence at the base (Level VII). Evidence-based guidelines: rigorous and explicit guidelines that have been developed based on the best research evidence available in that area. These are the gold standard for pt care- nurses and providers are encouraged to incorporate these into their practice. Chapter 4- Examining ethics in nursing research Unethical research examples throughout history: -Nazi medical experiments: conducted on prisoners of war (ie Jews in concentration camps). Exposed them to high altitudes, freezing temps, poisons, infection, untested drugs, and surgery w/o anesthesia. -Tuskegee syphilis study: study started in 1932 of natural history of syphilis in black men in Tuskegee, Alabama. Many subjects weren’t even aware they were subjects in a study! The evidence clearly showed the group with syphilis had developed more complications than the control group. 10 years later, the death rate among those with syphilis was 2x the rate of that of the control group—however the subjects were not treated for their syphilis (even though penicillin was determined to be effective). Info about this effective treatment was withheld, and deliberate steps were taken to withhold treatment. The study continued for 40 years and was only stopped after publication about it caused public outrage. -Willowbrook study: From mid 1950s- early 1970s, Dr. Saul Krugman conducted research on hepatitis at an institution (called Willowbrook) for mentally retarded. The subjects were children who were deliberately infected with hepatitis. (During the length of the study, the institution was closed for new inmates due to overcrowding but admitted children only if their parents agreed to enroll them in the study.) Ethical standards for researchInternational standards: Nuremberg Code (1949) includes guidelines that help evaluate the consent process, protection of subjects from harm, and balance of benefits and risks in a study. The Nuremberg Code provided basis for the development of Declaration of Helsinki (1964)- majorly focused on clarifying the difference between therapeutic research and nontherapeutic research. Therapeutic research- provides patients with an opportunity to receive an experimental treatment that might have beneficial results. Nontherapeutic research is conducted to generate knowledge for science; results may help future patients but aren’t expected to benefit active participants. Standards in the US: The Belmont Report (1979) was formed in response to the public outcry when the Tuskegee Syphilis study was exposed. Identifies ethical principles to guide selecting subjects, informing them of risks and benefits of a study and documenting their consent. Also details differences between therapeutic and nontherapeutic research. President Obama issued an executive order creating the Presidential Commission for the Study of Bioethical Issues- diverse group of national leaders to advise government leaders on emerging ethical and social issues as a result of scientific advances (2009-2017). Federal regulations for protection of human subjectsCode of Federal Regulations (CFR) aka the Common rule- regulations for protecting human subjects, updated as needed. FDA regulations- requires patient consent to participate in clinical trials relating to new drugs and medical devices. Health Insurance Portability and Accountability Act (HIPAA)- aka privacy rule that focuses on protecting electronic storage and transfer of pt information. Defines protected health information (PHI) as data generated and collected for research that can be linked to an individual person. Application of ethical principles*the principle of respect for persons: people should be treated as autonomous agents with the right to choose whether or not to participate in study, or withdraw. - right to self-determination (violated through use of coercion, covert data collection, deception) *people with diminished autonomy (impaired decision making due to medication, mental illness or mental capacity- can be temporary or permanent) require additional protection bc of decreased ability to give informed consent. *the principle of beneficence: minimize risks, assure benefits. -right to protection from discomfort and harm- studies that have high certainty of causing permanent damage to study participants is highly questionable. *principle of justice: inclusion and exclusion criteria, consent and surveys translated -right to privacy: HIPAA privacy rule expanded the protection of a person’s privacy, specifically their identifiable private information (IPI). The Common Rule created a new type of consent called broad consent, when a potential subject gives researchers permission to store, maintain, and use IPI for other studies. -right to anonymity and confidentiality: complete anonymity is when researcher cannot link a subject’s identity with their individual responses. In most studies, researchers know identity of subjects and promise the subjects that their identity will be kept anonymous from others and data will be kept confidential. *in qualitative studies, breach of confidentiality is more likely because the researcher gathers data from fewer participants and reports long quotes made by them. -right to fair selection and treatment- subjects should be treated fairly and receive what they are owed, treated in a way that is equitable to treatment of others in the same situation.(no social, cultural, racial, sexual biases in selection) Ie injustices include research conducted on people deemed “less valuable”, like those living in poverty, prisoners, slaves, minority groups. Also, selecting subjects because they want them to receive benefits of study, or money/power. -Each study must include consent form describing researcher’s role and subject’s participation. Need to respect that agreement. Report must indicate the selection and treatment of subjects were fair. Inclusion criteria should reflect the research problem and study purpose. Exclusion criteria should be justified to protect potential subjects at higher risk for harm. Informed consent- providing information to a potential subject and the opportunity to participate in the study. Has 4 elements: 1- Disclosure: providing the information that a reasonable person would need to make a decision about participation (not necessarily every possible detail. 2- Comprehension-Prospective subjects need to not only receive the information, but comprehend it. Researcher must take time to teach them about study in detail. 3- Competence: Investigators must indicate the competence of the subjects. People with diminished autonomy bc of legal or mental incompetence of confinement to an institution are not legally competent to consent to participate. 4- Voluntary agreement. *all elements must be documented ina consent form. Institutional Review Board (IRB)- a committee that reviews research to ensure the investigator is conducting the research ethically. An IRB has authority to approve, require modifications, and disapprove studies it reviews. -Some types of studies are exempt from review, such as those that pose no apparent risk to research subjects. Some studies may meet criteria for expedited review if they carry some risks, but risks are minimal. -A study that carries greater than minimal risks must receive a full review by IRB. Whether a study is ethical or not depends on balance between the risks and benefits (benefit-risk ratio). Current issues in research ethics -Genomics research: using specimens without subject’s knowledge (even if research is groundbreaking).; ethical and legal dilemmas of Human Genome Project -Using animals in studies -Research misconduct: the fabrication, falsification, or plagiarism in processing, performing, or reviewing research, or in reporting research results.