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Critical Evaluation of Biomedical

Literature

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Introduction
There are more than 20,000 biomedical
journals available worldwide
Approximately 9000
published everyday

articles

are

being

Updating scientific knowledge is an


Herculean
task
for
the
healthcare
professionals
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Introduction
Majority of biomedical literature conforms to the
Vancouver guidelines
[Editors of English language biomedical journals met in Vancouver and came up with guidelines]

Over 500
guidelines

journals

recommend

Vancouver

It is the uniform technical requirements for


manuscripts to be submitted for publication
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Introduction
The Vancouver guidelines format include

Format of abstract
Text
Tables/graphs
Reference
Permissible abbreviations and symbols
Authorship recommendation
Acknowledgements
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Introduction
Although majority of biomedical literature
confirms to the Vancouver guidelines, the content
and quality of scientific publication vary
enormously
Thus drug information pharmacist requires the
skills to be able to critically evaluate and interpret
the literature prior to formulating answers and
making recommendations
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When evaluating the literature various


aspects should be considered

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The journal
Reputation of journal
Is the journal reputed?

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The journal
Reputed journal usually demonstrate
The editorial policy specifying types and format of
articles
Publishes results of well-conducted research
Articles undergo peer review
Texts exceeds pages of advertising /promotional
material
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The journal
Choice of journal
Is the journal specific to particular research?

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Researchers and facilities


Are
researchers
have
appropriate
qualification and or experience in the field of
research?
Has a statistician been included?

Authors have any connection


pharmaceutical company?
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with

Researchers and facilities


Are the authors from the same research
facility or is the study multicentre study?
Appropriateness of medical facility

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Sponsorship
What was the source of financial support for
the research?

Independent support is preferred, financial support


from Pharmaceutical company doesn't increase
good quality research
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The manuscript
Includes:
title
abstract/summary
introduction
objectives
methods
results and data analysis
discussion/ conclusion
references
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Title
Is the title indicative of content?
(May not reflect the content always)

Look for any positive or negative title

Should be succinct description of research and / or


results of study
Should not relay on title alone to determine if the
paper is worth reviewing
or discarding
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Abstract
Does the abstract provide an accurate synopsis of
the paper?
-- - ---

It should outline purpose of study


Brief methodology
Important/ major results
Authors conclusion [based on study findings]
Should not be used alone to evaluate the study
as it does not provide full description
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Abstract
Abstracts should comply with the standard
format recommended by the Ad Hoc
working group for critical appraisal of the
medical literature

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Abstract
This format includes:
Objectives - Clear and succinct
Design - study design, duration and follow up
Setting - location, facilities and patient populations
Patients - nature of patients, no. of patients enrolled, no.
of patients completed the study

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Abstract
Intervention - synopsis of interventions

(example: drug dose, method of administration)

Results - methods used to determine the outcome,


statistical methods

Conclusion - the authors' conclusions based on


study result

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Introduction
Does the introduction provide background
and rationale for the study?

Should provide background information and


reasons for conducting the study
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Study design and methods


Is the study design appropriate for the
question being assessed?
Look for

Power of the study Based on sample size


[power of the study is its ability to detect the worthwhile differences
between two treatment groups]

Patients selection
demographic data, inclusion & exclusion criteria,
settings of patient
selection [ in-patient / out patient, research institution or general practice
settings]
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Study design and methods


Study design - Should be clearly stated and described

Controlled, placebo controlled, single blind, double blind,


open study, randomised study, retrospective, prospective
study, case report, case-controlled, co-hort studies,
crossover, DUE etc

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Study design and methods


Some methods to achieve control and ensure
equivalence in patient groups are:

-- Stringent adherence to inclusion & exclusion


-----

criteria
Matching with respect to variability
Randomization in selection
Blinding
Cross over control studies
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Study methods and measurements


Are the methods employed in the study
appropriate?

When evaluating a study one should consider drug


therapy, measurement of therapeutic outcome or
adverse effects
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Study methods and measurements


Drug therapy
Were appropriate doses and regimens used?
Was the length of the study adequate?
Was the length of wash out period adequate?
Was patient compliance ensured?
Were the effects of concurrent medication observed?
Did the study medication affect the blinding?
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Study methods and measurements


Measurement of therapeutic outcome or adverse
effects
Is the methods used for measurement of therapeutic
outcome appropriate?
Is the methods used to measure adverse effects
appropriate?
Is the effect measured or assessed by appropriate
persons?
Were variations in observations controlled? (E.g. In
multicentre study)

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Study results and analysis


i) Data presentation

-Table/graph/chart format

-Data should be presented clearly


- All the data collected should be presented

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Study results and analysis


(ii) Patient drop out and data collection
Reasons for patient dropout quoted?
- In case of ADR event and incidence should be
quoted
-Errors in patients should be mentioned
- Ineligible patient, decrease sample size and
protocol deviation
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Adverse events
Is nature and incidence were specified?
Methods used for detection of safety
appropriate?

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Statistical evaluation
Are appropriate
employed?

statistical

methods

Use of inappropriate test will results in misleading


conclusion
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Economic evaluation
Is appropriate pharmacoeconomic method
employed?

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Discussion and conclusion


Interpretation of results should be presented
Should address the results with previous
studies
Should demonstrate how the results answer
the study hypothesis
Conclusion should be based on study results
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References
Are appropriate and adequate references are used in
the study?
Are references quoted appropriately?

Vancouver style is more commonly used


Lawrence RC, Helmick CG, Arnett FC, et al. Estimates
of the prevalence of arthritis and selected
musculoskeletal disorders in the United States. Arthritis
Rheum 1998;41:778 -799
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