PHARMACY INFORMATICS LEC - Unit 3.1: Introduction to Evidence-Based Medicine

Evidence-Based Medicine

• “The conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients”

• The use of relevant and timely evidence in clinical practice

• “The integration of best research evidence with clinical expertise and patient values.”

Evidence

Findings from clinical research, especially from patient-centered research, that are relevant to patient care.

Clinical Expertise

• Involves using clinical skills and previous experience to evaluate evidence and the patient’s health status and preferences.

• We develop insight and intuition to better apply and understand the evidence

Patient Values and Preferences

The “collection of goals, expectations, predispositions, and beliefs that individuals have for certain decisions and their potential outcomes.”

Steps in Evidence-Based Medicine (EBM)

1. Asking an appropriate and answerable questions

2. Finding evidence

3. Appraising evidence

4. Applying evidence to practice

Diagnosis

Clinical Question Type:

• How to select and interpret diagnostic tests

Therapy

Clinical Question Type:

• How to select treatments that do more good than harm and that are worth the efforts and cause of using them

Prognosis

Clinical Question Type:

• How to estimate the patient’s likely clinical course over time and anticipate likely complications of the disease

Harm/Etiology

Clinical Question Type:

• How to identify causes for disease

• Risk factors and causal factors of disease

Therapy

Identify the type of clinical question:

Among children with HPV, how effective is isoniazid prophylaxis in preventing tuberculosis?

Prognosis

Identify the type of clinical question:

Among patients with prostate cancer, by how much does lumbar metastasis increase 5-year mortality?

Diagnosis

Identify the type of clinical question:

Among patients with acute chest pain, how accurate is an electrocardiogram in diagnosing acute myocardial infarction?

Harm/Etiology

Identify the type of clinical question:

Among healthy males, how much does smoking contribute to the causation of lung cancer?

Patient, Population, Program, or Problem

The group the clinician is interested in – patient characteristics or population with a certain disease state

ex. Elderly patients with Type-II Diabetes

Intervention/Exposure

Drug, non-drug treatments, diagnostic tests, other interventions

ex. Metformin and Immunization

Comparison

Standard (active) treatment or placebo

ex. Insulin

Outcome

Death, hospitalization, major illness, quality of life

ex. Risk of heart attacks, strokes, peripheral arterial disease

Finding Evidence

• Searching published literature through bibliographic databases (e.g., PubMed)

• Manually skimming through reference lists in relevant studies

• Cochrane Database of Systematic Reviews and Meta Analysis

• Catalogs of critically appraised topics from schools and organizations

Appraising Evidence

A part of EBM rather than its entirety

Internal Validity

• Degree to which a study establishes a cause-and-effect relationship between the intervention/ exposure and the outcome

• Function of the design and execution of the study

• How well the study was conducted

Hierarchy of Evidence

Ranking of various types of evidence based on freedom from bias, scientific reliability, and clinical usefulness

Bias

Weakness of study

External Validity

• Degree to which the results of the study can be generalized beyond the specific context of the study to other populations, settings, times, and variables.

• Critical in determining whether the results of the study can be applied to the individual patient

• Can be determined by looking at the scope and limitations of the study

• Can I apply the study result to the patient?

• Can I apply the study beyond?

• Is the study generalizable?

Clinical Significance

• Based on clinician’s judgment

• Results of the research are important enough that they should be considered when making decisions about patient care

• Not the same as statistical significance (which is determined by p- values)

Shared Decision-Making

3 components:

1. Dialogue should exist between the patient and the healthcare professional

2. Dialogue should include discussions about various options and likely outcomes

3. Patient and healthcare professional should come to a consensus about what action is most appropriate

Applying Evidence

Most difficult step

EBM Advantages

• Attempts to increase the likelihood of receiving interventions that are efficacious and safe

• Allows clinicians to better keep up with new literature and developments

• Increases critical thinking skills

EBM Disadvantages

• Does not address why (mechanism) an intervention does or does not work

• Requires specialized knowledge and skills to practice effectively

• May be perceived as “cookbook medicine”

• Many questions lack available evidence

General Format of a Scientific Article

• Title

• Abstract

• Introduction

• Methodology

• Results

• Discussion

• Conclusion

• Recommendations

• Acknowledgement

Abstract

• First part of the publication

• Summarize, in a limited number of words, the aims of the research, the methods used to conduct the study, the results, and study conclusion

• Last part written

• Can’t be use for clinical decision as it does not provide complete assessment

Introduction

• Includes pertinent background information to justify why the research was done and what is already known about the topic to date

• Also discussed here the research gaps

• Also found are the research objectives and questions

Methods

• Blueprint of how the study was conducted

• Describes the researcher’s process for how the experiment/ observational study was conducted

• Details should be adequate for the research to be reproduced

• Important in assessing the internal validity of the study

Results

• Reports research findings

• Presents facts and data without interpretation

• Statistical significance is reported along with the results in the form of text, tables, and figures

Discussion

• Allows researcher to interpret research findings

• Focuses on the findings related to the objective/s

• Possible explanations for consistencies/ inconsistencies from previous research is provided

References

• Listed at the end of a research article

• Typically are listed in the order in which they occur

Peer Review

• An important way to reduce erroneous or misleading research from reaching the healthcare community

  • Filtering-out poor-quality studies

• Critical evaluation of a manuscript that has been submitted for publication, performed by a content expert who serves as a neutral party between the publisher and manuscript author

• Does not always prevent publication of articles with deficiencies; readers should still assess the quality of each published article

Peer Review Process

1. Submission of Manuscript (draft)

2. Screening of Manuscript

3. Peer-Review Proper

4. Submission of comments to author (revision)

Characteristics of the Peer Reviewer

1. Expert related to the main topic of the manuscript, or the methodology

2. Neither an employee of the publisher nor affiliated with the manuscript author

3. Usually a volunteer; does not receive financial compensation for performing a review

Being a peer reviewer comes with prestige

Blinded

Peer Reviewer in not aware of the author’s details

Open

Peer Reviewer knows the author’s details

Prepublication

Peer Review is done before publication

Post-Publication

Peer Review is done after publication

Predatory Journals

Entities that prioritize self-interest at the expense of scholarship

• Characterized by:

  • False or misleading information

  • Deviation from best editorial and publication practices

  • Lack of transparency

  • Use of aggressive and indiscriminate solicitation practices