Critical Evaluation of Biomedical

Literature
By

Mr.B.R.Jaidev Kumar
M. Pharm,

Lecturer
Department of Pharmacy Practice
JSS College of Pharmacy, Mysore - 15
 Introduction
There are more than 20,000 biomedical
journals available worldwide

Approximately 9000 articles are being

published everyday

Updating scientific knowledge is an

Herculean task for the healthcare
professionals
 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 journals recommend Vancouver

guidelines

It is the uniform technical requirements for

manuscripts to be submitted for publication
 Introduction
The Vancouver guidelines format include
 
 Format of abstract
 Text
 Tables/graphs
 Reference
 Permissible abbreviations and symbols
 Authorship recommendation   
 Acknowledgements
 Introduction
Although majority of biomedical literature
conforms 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
When evaluating the literature various
aspects should be considered
 The journal

Reputation of journal
 
    Is the journal reputed?
 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   
 The journal

Choice of journal
 
Is the journal specific to particular research?
 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 with
pharmaceutical company?
 Researchers and facilities

Are the authors from the same research

facility or is the study multicentre study?
 
   Appropriateness of medical facility
 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
 The manuscript
Includes:
title
abstract/summary
introduction
objectives
methods
results and data analysis
discussion/ conclusion
references
 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
 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
 Abstract

Abstracts should comply with the standard

format recommended by the Ad Hoc
working group for critical appraisal of the
medical literature
 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
 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
 
 Introduction
Does the introduction provide background
and rationale for the study?
 
 

Should provide background information and

reasons for conducting the study
 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]
 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
 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
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
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?
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)
 Study results and analysis

i) Data presentation
    

- Table/graph/chart format
    - Data should be presented clearly

  - All the data collected should be presented

 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
 Adverse events

  Is nature and incidence were specified?

Methods used for detection of safety

appropriate?
 Statistical evaluation
Are appropriate statistical methods
employed?

Use of inappropriate test will results in misleading

conclusion
 Economic evaluation

Is appropriate pharmacoeconomic method

employed?
 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

 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