01 Introduction to Clinical Research

What is Research?

What is Research?

1. Add new knowledge

2. Analyze existing knowledge and provide new perspective

3. Support existing knowledge

4. Explore knowledge that is not well known/does not yet have scientific evidence

THE SCIENTIFIC METHOD

• Associated by many people towards research

• A cyclical process with posing questions and reaching conclusions

• This process is an ongoing loop that pushes discovery and innovation forward

• Not limited to the sciences

Steps of the scientific method

1. Making observations and asking questions

2. Formulating hypotheses or educated guesses

3. Answering those questions and developing experiments to collect data and produce results

4. Form a conclusion with the help of the results

5. Sharing the results of the research with other scholars so that they can observe, verify, and ask their own questions

When to Research?

• there is something we want to clarify or add evidence to,

• explore a new treatment or body of knowledge,

• or if we have a discovery that contradicts an existing body of knowledge

EMPIRICAL RESEARCH

It is a methodological approach to problem solving. Decisions are based on the finding and conclusions that are established as a result of analyzing collective data about variables and the relationships that connect those variables

CLINICAL RESEARCH

It is a structured process of investigating facts and theories and exploring connections. It proceeds in a systematic way to examine clinical conditions and outcomes, to establish relationships among clinical phenomena, to generate evidence for decision making and to provide the impetus for improving methods of practice.

Importance of Research

• systematic

• Creative

• Challenges

Purpose of Research

• Review and synthesize existing knowledge

• Investigate existing situation or problem

• Provide solutions to problem

• Explore and analyze more general issues

• Construct or create new procedures

• Explain new phenomenon

• Generate new knowledge

Four Basic Characteristics of Research

• Logical

• Understandable

• Confirmable

• Useful

Logical

systematic nature that a researcher must proceed, articulating each thought and action throughout the research process .

Understandable

research process, study outcomes, and its conclusions need to be explicit, make sense, be precise, intelligible, and credible to the reader or research consumer.

Confirmable

claims by the researcher should be supported by evidence; research strategy should be accurate and credible within the stated boundaries of the study.

Useful

value of study and its usefulness become more widely accepted as the new knowledge as it increasingly stimulates further research, and promotes the testing and verification of new or existing theory and practice.

Criteria of a Good Research

• The analysis of data should be sufficiently adequate to reveal its significance and the methods of analysis used should be appropriate.

• The validity and reliability of the data should be checked carefully

• The purpose of the research should be clearly defined and common concepts be used

• The research procedure used should be described in sufficient detail to permit another researcher to repeat the research for further advancement, keeping the continuity of what has already been attained.

• The researcher should report with complete frankness, flaws in procedural design and estimate their effects upon the findings.

• Conclusions should be condoned to those justified by the data of the research and limited to those for which the data provide an adequate basis.

Validity

(as a tool or technique) should measure what it’s supposed to measure; (as a result) the result of the assessment tool is on par with the gold standard

Reliability

the result of the assessment is consistent

LIMITATIONS OF RESEARCH

• Limited access of information

• Unlimited time

• Conflict over biased views and personal issues

OUTCOME MEASURE TOOL

To quantify different aspects of a patient.

ISSUES OF OUTCOME MEASURE

• Issues of validity for outcome measures remain paramount, as researchers and clinicians must understand the conditions and situations for which these tests are appropriate.

• The interpretation of outcomes based on these tests must also be made with consideration of the constructs that are being measured.

• Clinical decisions based on such outcomes must account for the context of the scale used and its measurement properties.

SOURCE OF DATA

• The scientific method is the most rigorous process for acquiring new knowledge, incorporating elements of deduction and induction in a systematic and controlled analysis of phenomena.

• The scientific approach has been defined as a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena

Level of Evidence

Steps of Research

1. Identify the Research Question

2. Design of the Study

3. Methods

4. Data analysis

5. Communication

STEP 1: Identify the Research Question

• The first step of the research process involves delimiting the area of research and formulating a specific research question that provides an opportunity for scientific testing.

• During this stage, the researcher must define the type of individual to whom the results will be generalized.

• Rationale for the study, a justification of the need to investigate the problem, and a theoretical framework for interpreting results

• Research hypotheses are proposed.

STEP 2: Design of the Study

• Designs the study and plans methods of subject selection, testing, and measurement so that all procedures are clearly mapped out.

• The choice of research method reflects how the researcher conceptualizes the research question

STEP 3: Methods

• The researcher implements the plans designed in step 1 and 2

• Data collection

STEP 4: Data Analysis

• Involves analyzing, interpreting, and drawing valid conclusions about the obtained data.

• It is the pulling together of all the material relevant to the study, to apply them to a generalized or theoretical framework.

STEP 5: Communication

Researchers have a responsibility to share their finding with the appropriate audience so that others can apply the information either to clinical practice or to further research