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Informatics

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Lynette Evangelista
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120 views28 pages

Informatics

Uploaded by

Lynette Evangelista
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Consists of journals and other periodicals wherein medical

and clinical studies are published


Determine which studies are reliable and acceptable by certain
standards

✓ Use the wrong study design

✓ Use the right methods incorrectly

✓ Misinterpret their results

✓ Report their results selectively

✓ Reference other studies selectively or incorrectly

✓ Draw unjustified conclusions from their research


1. Safety and efficacy trials

2. Trials designed to evaluate:


1. Continuing education
2. Critically appraise or evaluate chemical studies
3. Develop skills in literature evaluation
4. Allows RPh to recognize which studies are important, reliable and
deserve attention
5. Used in other fields of pharmacy practice
A. Solving therapeutic dilemmas
B. Patient counselling and information interpretation
C. Other HCP contact RPh for opinions
D. Decisions on drug policy management
6. Not all biomedical literature pass the standards
Consolidated Standards of Reporting Trials

Provide standards, checklists, content suggestions for authors to


use when submitting manuscripts and medical journals

British Medical Journal

JAMA (Journal of American Medical Association)

Lancet

Annals of Internal Medicine

STARDS (Standards for Reporting of Diagnostic Accuracy)


I. Clinical Studies

A. N-of-1 Study

B. Stability or In-Vitro Study

C. Bioequivalence Study

D. Programmatic Research

II. Survey Research

III. Post-marketing Surveillance Study

IV. Overviews

V. Health Outcome Research

VI. Medical Studies


• Determine cause and effect relationship

• Researchers administer a drug or treatment and follow the subjects

forward in time to determine the effects of such treatment

❖ Prospective Study: watches for outcomes, such


as the development of a disease, during the study
period and relates this to other factors such as
suspected risk or protection factor/s.
Compare effects of the drug to the control during multiple
Researchers investigated whether paracetamol was as effective as
non-steroidal anti-inflammatory drugs
observation periods in a (NSAIDs) in the treatment of
single patient
pain and disability related to osteoarthritis of the hip or knee. A series
of double blind,Very effective“n
randomised in confirming causality
of 1” controlled trials was performed.
Each drug was taken for two weeks, administered for a maximum of
five cycles. Thirteen patients in primary care who had regularly been
using NSAIDS were selected. Patients received the same type of
NSAID and in the same dosage, if possible, as they were taking before
the start of the study. Outcome measures included severity of
complaints of pain, stiffness, and limitations in daily functioning,
together with satisfaction with drugs and side effects
Evaluate and determine the stability of drugs in various

preparations under various conditions


Assess the bioequivalency of two or more products

When are drugs considered bioequivalent?

If their rate and extent of systemic

absorption (in the body) “do not show a

significant difference” when administered

at the same dose by the same route and

under the same experimental conditions


Determine the impact of economic value of programs and

services provided by pharmacists in community and

institutional settings

Include an assessment of related research capacity and describe

how the proposed program will build on a strengthen that

capacity
Study the incidence, distribution and relationships of
sociological and psychological variables through the use of
questionnaires applied to various populations

Gathers information from a sample to generalize


findings to a larger, “target” population

❖ Pharmacy

❑ Determine how programs should be


implemented
❑ Understand the behavior of patient or members
of the profession
Evaluate use and adverse effects associated with newly approved

drug therapies
Review articles, analyze, assess and evaluate

previously conducted research studies

Narrative Reviews Qualitative Quantitative

“General Overview” Meta analyses

Nonsystematic Systematic Systematic

Subjective summary Qualitative and Results of conducted


of data from multiple objective summary of clinical trials are
studies data from multiple combined, statistically
studies where the evaluated and
results are not summarized
statistically combined
Medical Studies

Explanatory Descriptive

Observational Experimental Case Report Case Series

Case Control
Randomized
Cohort
CT/Experimental
Cross-Sectional
• Used to document and communicate experiences

• Investigator simply records data from observations made and

draws conclusions as to possible reasons for the events witnessed

• Describe unusual or new events

❖ Major Limitation: Do not provide definitive


explanations, determine causes or supply
evidence that one drug is superior to another
• Based on the observations of individual patients

• Describe and adverse event following the use of a particular drug

or group of drugs or to report a possible DI

• Frequently generate hypotheses to serve as the basis for more

rigorous studies
• Document observations from a group or series of patients

• Used to examine the prior histories of patients with the same

outcome in hopes of identify a possible cause and effect

relationship

• Useful for estimating the incidence of an adverse event of a

newly marketed drug when there is a limited information available

about the particular event

• Used to help ensure that a certain adverse event is

not associated with the use of a drug


More rigorous design to identify answers to questions that arise in

clinical medicine

Employed to determine the efficacy of medications or identify

whether there is a true relationship between the use of a drug

and the occurrence of an outcome


Investigators: Bystanders

Examine the natural course of health events, gather data about the

subjects included and classify & sort the data

Conducted when it is unethical or impossible to

perform clinical studies


“Trohoc Study”

Determines association between disease states and exposure to

various risk factors

Participants with a particular characteristic are

compared to a similar group of participants

without the characteristic to determine the risk

factors associated with the development of that

characteristic
“Follow-up Study”

Determine the association between various factors and disease


state development

A group of subject already exposed to a


certain factor are compared to an unexposed
group of subject and followed prospectively

Development of a disease state of interest is


observed during the study period
“Prevalence Study”

Identifies prevalence of characteristics of diseases in


populations, can be thought of as a “snapshot” because data is
collected and evaluated at a single point in time even if the
observations may cover a period of several months/years

Most ideally suited for generating, rather than


testing hypothesis

Surveys that evaluate opinions/situations


at a fixed point in time and studies focused
on description, diagnosis and mechanisms
of disease states
Prospective trials in which an attempt to regulate the variables

in a study occurs on the part of the investigators

Allows the investigator to help account for the

possible influence that other outside factors

could have on a study’s outcomes independent

of the drug being evaluated

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