Nursing Research Evidence Levels

Levels of Evidence

• The strongest level of evidence is a meta-analysis of randomized control trials (RCTs)
• The weakest level of evidence is expert opinions.
• The acronym "Most Random Questions Need More Quality Evidence" helps remember the ranking of levels of evidence:
  • Meta-analysis of RCTs
  • Randomized control trials
  • Quasi-experimental
  • Non experimental/observational study
  • Meta synthesis of qualitative studies
  • Qualitative study/descriptive study
  • Expert options

Meta-analysis vs. meta-synthesis

• Meta-analysis uses statistical methods to synthesize findings from quantitative research studies on a single topic.
• Meta-synthesis is a synthesis of several qualitative research studies.

Florence Nightingale's Contributions to Nursing Research

• Florence Nightingale was a pioneer in nursing research.
• She was the first nurse to use statistics to support her hypotheses and is known as the first epidemiological nurse.
• She set a standard for optimal patient outcomes.

Nuremberg Code

• The Nuremberg Code defines voluntary consent, legal capacity, sufficient understanding, and enlightened decision-making.
• The code established ethical standards for research following unethical experiments conducted by Nazi Germany on concentration camp members.

Belmont Report

• The Belmont Report outlines three fundamental ethical principles for research involving human subjects:
  • Respect for persons: Individuals should be treated autonomously with the freedom to participate or not, and those with reduced autonomy should be protected.
  • Beneficence: Research should maximize benefits and minimize harm to participants.
  • Justice: The costs and benefits of research should be distributed fairly.

Tuskegee Experiment

• The Tuskegee Experiment, a syphilis study conducted by the US Public Health Service in Alabama from 1932 to 1973, involved two groups of poor Black male sharecroppers.
• One group was left untreated for syphilis, while the other was free of the disease.
• The researchers withheld treatment from the individuals with syphilis to study the untreated disease process.

Principles of Informed Consent

• Informed consent is built on 16 ethical principles of respect and related to self-determination.

Basic Ethical Principles

• Respect for persons: Individuals should be treated autonomously with the freedom to participate or not, and those with reduced autonomy should be protected.
• Beneficence: Research should maximize benefits and minimize harm to participants.
• Justice: The costs and benefits of research should be distributed fairly.

Informed Consent vs. Assent

• Informed consent is provided by an individual who is legally capable of making decisions.
• Assent is given by children between 7 and 18 years old.
• Assent is required in addition to parental permission and should include:
  • Information about what the child will be expected to do and what will be done during the research.
  • A basic understanding of the research's purpose.
  • The ability for the child to express their preference about participation.

Protecting Basic Human Rights: Vulnerable Groups

• Vulnerable groups, those with diminished autonomy, may require extra precautions to protect their rights.
• Consult agencies like the Institutional Review Board (IRB) for the latest federal and state regulations and guidelines regarding research involving vulnerable groups.

Institutional Review Boards (IRBs)

• IRBs review studies to ensure ethical standards are met and the rights of human subjects are protected.
• They are responsible for:
  • Protecting subjects from undue risk and loss of personal rights and dignity.
  • Assessing the risk/benefit ratio of research.
  • Approving, modifying, or disapproving research studies.

Types of Theories in Nursing Research

• Grand nursing theories are also known as conceptual models.
• These theories aim to describe the broader discipline of nursing as a whole.
• An example is Jean Watson's Theory of Caring.
• Middle range theories focus on a limited aspect of reality and contain a limited number of concepts.
• An example is the Theory of Unpleasant Symptoms.
• Situation-specific nursing theories are developed for a specific situation or context.

Levels of Evidence

• A hierarchy of evidence categories, ranked from strongest (level 1) to weakest (level 7) evidence
• Level 1 - Meta-analysis of randomized controlled trials (RCTs)
• Level 2 - Randomized controlled trials (RCTs)
• Level 3 - Quasi-experimental studies
• Level 4 - Non-experimental/observational studies
• Level 5 - Meta-synthesis of qualitative studies
• Level 6 - Qualitative study/descriptive study
• Level 7 - Expert opinions

Meta-analysis vs. Meta-synthesis

• Meta-analysis focuses on a single topic/question, using quantitative methods and statistical analysis to synthesize findings.
• Meta-synthesis is a synthesis of several qualitative studies, involving qualitative methods.

Florence Nightingale’s Contributions to Nursing Research

• First to utilize statistics to support her hypothesis.
• Groundbreaking nurse known for setting the standard for optimal patient outcomes.
• Her work positioned her as a pioneering epidemiologist.

Nuremberg Code

• A set of ethical research guidelines developed after World War II, in response to Nazi human experimentation atrocities.
• Established principles like voluntary participation, legal capacity, and informed consent, which have shaped ethical standards in research.

Belmont Report

• A document outlining the ethical principles for human subject research.
• Three fundamental principles:
  • Respect for Persons:
    • Recognizing individual autonomy (freedom to participate or not)
    • Protecting individuals with reduced autonomy
  • Beneficence:
    • Maximizing benefits and minimizing harm to participants
  • Justice:
    • Ensuring equitable distribution of research benefits and costs.

Tuskegee Experiment

• A controversial syphilis study conducted in Alabama from 1932 to 1973.
• Involved two groups of poor black male sharecroppers.
• The untreated group was deliberately left without treatment for syphilis, with the aim of observing the disease's progression.

Informed Consent vs. Assent

• Informed consent is a process where individuals voluntarily agree to participate in research after understanding the potential risks and benefits.
• Assent is obtained from children aged 7-18 years old for research participation.
• Assent requires parental permission and includes explanations about the study, its purpose, and the child's role.

Protecting Basic Human Rights: Vulnerable Groups

• Research involving vulnerable groups, like children, pregnant women, or prisoners, requires extra precautions to ensure their rights are protected.
• Consult with Institutional Review Boards for the most recent guidelines and federal and state regulations.

Institutional Review Boards (IRBs)

• Committees responsible for ethical review of research involving human subjects
• Assess whether ethical standards are met in terms of subject protection, minimizing risk, and maximizing benefits.
• Have the authority to approve research, require modifications or disapprove the study.

Types of Nursing Theories

• Grand Nursing Theory:
  • Also known as conceptual models.
  • Broad, overarching theories encompassing the entirety of the nursing discipline.
  • Example: Jean Watson's theory of caring.
• Middle-range Theory:
  • Limited number of concepts focusing on a specific aspect of reality.
  • Example: Theory of unpleasant symptoms in healthcare.
• Situation Specific Nursing Theory:
  • Narrowly focused, developed for a particular setting or situation.
  • Example: A theory on pain management for elderly patients.