Intro to Clinical Research Methods & Critical Appraisal

Evidence Based Practice/Medicine

the process of systematically finding, appraising and using contemporary research findings as the basis for clinical decisions

Why you need to know about research (3)

1. Pharmacists manage knowledge

2. knowledge changes over time

3. ongoing interpretation is required

Professional Competencies

integration of communicator, collaborator, leader-manager, health advocate and scholar knowledge, skills and behaviours enables graduates to provide care

Role as scholar (SC)

pharm graduates take responsibility for excellence by applying medication therapy expertise, learning continuously, creating new knowledge and disseminating knowledge when teaching others

Competencies of a scholar (3)

1. use systematic approaches in the search best available evidence

2. critically appraise health-related research and literature

3. provide effective education to others

Ways of knowing

1. Sensory experience

2. agreement with others (common knowledge)

3. expert opinion

4. logic (reasoning)

5. scientific method

Scientific method

1. Identify problem/question

2. clarify the problem

3. determine info needed and how to obtain it

• study what is already known

• carry out new research

4. organize the information

5. interpret the results

define clinical research

• clinical = patients (patient-oriented)

• systematic/formal technique

two approaches to clinical research

1. quantitative - deals with numbers

2. qualitative - deals with words

mixed methods research

combining numbers with words

how does quantitative differ from qualitative

differ in assumptions about the purpose of research itself, methods utilized by researchers, kinds of studies undertaken, role of researcher, and degree to which generalization is possible

The investigator assigned exposure

Experimental

no exposure assigned

observational

experimental and comparison made

controlled

experimental but no comparison

uncontrolled

experimental, comparison, controlled, with non-radomized

controlled clinical trial CCT

experimental, comparison, controlled, randomized

randomized controlled trial (RCT)*

Observational & a comparison is made

Analytic

Observational but no comparison

descriptive

Examples of descriptive studies

• qualitative

• survey

• case series

• surveillance

usually just describing what happened

3 directions of study Analytic studies may take

1. cohort

2. case control

3. cross-sectional

Cohort

exposure → outcome

case control

outcome → exposure

cross-sectional

exposure & outcome at the same time

phase I

small number of participants, usually volunteers (n = 20-80)

phase II

early studies in patients with a specific disease; preliminary safety and efficacy (n=100-300)

phase III

large-scale comparative studies (n=1000-3000) demonstrative of efficacy and safety

phase IV

surveillance and post-marketing studies - use of the therapy in practice with monitoring of its outcome; additional information

• studies that happen after drugs are marketed, can observe side effects after drug has been used by the masses

determination of study design

1. what was the objective → descriptive/analytic

2. if objective was analytic, was it an intervention or an exposure → experimental or observational

• if an intervention was it random

3. if observational analytic, when were outcomes determined → cohort, case-control, or cross-sectional