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HOW TO CRITIQUE
SCIENTIFIC ARTICLES
     HANI ALMOALLIM
WHAT INFORMATION WOULD I REQUIRE
   TO ACCEPT THE CONCLUSION?




  Fisher’s assertability question
KIPLING 6 HONEST SERVING MEN

•   I keep six honest serving men
•   They taught me all I know
•   Their names are ;
•    what, why and when
•   How, where and who

R. Kipling 1902
THE PLAN

• Over view on article structure

• What's considered to be the gold stranded of
  research?

• Hands-on evaluation of medical articles
SCIENTIFIC PAPER

The council of biology editor define scientific paper
  as , an acceptable primary scientific publication
  must be the first disclosure containing information to
  enable peers :

• 1- to assess observation
• 2- to repeat experiment
• 3- to evaluate intellectual process
SCIENTIFIC PAPER

• New

• True

• Important

• comprehensible
Why : study design

How : study methodology

Who : study population

What: intervention and outcomes

How many: statistic

What else/
TITLE

• Has to be informative, concise and graceful!

• Attract the reader!

• Tell what the study about!



• Why the study was done?
• What get studied is what get funded!
AUTHORS

• Are they known in the field?



• What's their specialty?



• Citation index.
DATE OF SUBMISSION/ ACCEPTANCE

• Long delay may indicate that referee found serious
  issues in the initial version
ABSTRACT

•   Why the study was done
•   What was done
•   What was found
•   What was concluded
•   It helps to answer Fisher’s assertability question
IT S NOT HOW THE DATA WERE ANALYZED
    IT HOW THE DATA WERE COLLECTED
INTRODUCTION

• How important is the study and what’s new

• Is there clear statement to justify the study?

• Is there a clear statement of the study hypothesis?
WHY: STUDY QUESTION

• The study design , population to be studied, the
  method to be used, all depends on the purpose of
  the study

• Is the hypothesis stated in advance or arose by the
  data
• “ fishing expedition”: exploring their data for
  association then reporting the significant one!
Is It Efficacy Or Effectiveness

• Therapeutic studies
Efficacy :
• whether the intervention will work ; very controlled
  population and experimental conditions( ideal ).
  Short term goals

Effectiveness :
• intervention will cause more good than harm, under
  normal clinical condition, long term goals
Bypass Surgery In Patients With Coronary
             Heart Disease

         efficacy                      effectiveness
• Patient with clearly          • Policy: intent to treat
  documented coronary             principle”
  stenosis
                                • Long term
• Increased myocardial            survival, quality of life
  flow or relief of symptoms

• Any one was allocated to      • Any one allocated but
  TX but did not receive it,      did not receive the
  will not be included in the     surgery will be included
  study                           in the study
Nicotine patch therapy in adolescent smokers
   Smith etal 1996




What information would I require to
accept the conclusion
WHY

Is sufficient evidence presented to justify the study?

Is there a clear statement of the purpose of the study?

Is there a clear statement of study hypothesis?

Is it clearly outlined in the study if its
Efficacy
effectiveness
HOW: STUDY DESIGN

          observational                              experimental

    Comparison group

                                             randomized
                                                           Non randomized
    yes                      no

  Analytical               descriptive




cohort      Case control
                               Cross sectional
Comparison Group

Almost all studies has comparison :
• dose left handed subjects live longer than right
  handed?
• Are women more more likely to have periodontal
  disease than men

• Comparison to be fair
EXAMPLE 2:          Cancer And Vitamin C

• observational study of Vitamin C as a treatment for
  advanced cancer.
• For each patient, ten matched controls were
  selected with the same age, gender, cancer
  site, and histological tumor type.
• Patients receiving Vitamin C survived four times
  longer than the controls (p < 0.0001).
• Cameron and Pauling 1976
• Ten years later, the Mayo Clinic conducted a
  randomized experiment which showed no
  statistically significant effect of Vitamin C. Moertel
 1989
• Why did the Camoeron and Pauling study differ from
  the Mayo study?

• The treatment group represented patients newly
  diagnosed with terminal cancer. They received
  Vitamin C and followed prospectively.
• The control group was selected from death
  certificate records The control group represented a
  retrospective chart review.
Be Cautious When A Study Compares
Prospective Data To Retrospective
               data
Did The Author Created The Groups?
• Experimental study
• Observational study

• Who did the choosing ?:
• Author decided who get the intervention :
  experimental
• Patients / doctors decided/group were intact prior
  to study : observational
EXAMPLE

121 children with moderate-to-severe asthma were
"randomly assigned to receive subcutaneous
injections of either a mixture of seven aeroallergen
extracts or a placebo.” Adkinson (1997),
an experimental design.
EXAMPLE
"80 severe recidivist alcoholics received acupuncture
either at points specific for the treatment of substance
abuse (treatment group) or at nonspecific points
(control group).” Bullock (1989),

Since the researchers controlled the nature of the
acupuncture, this is an experimental design.
EXAMPLE


33 health care workers who became seropositive to HIV
after percutaneous exposure to HIV-infected blood
were compared to 665 health care workers with similar
exposure who did not become seropositive. Cardo (1997)


Since the researchers did not control who became
seropositive, this is an observational study.
EXAMPLE

• 80,082 women between the ages of 34 and 59
  years were followed for 14 years to look for
  instances of non-fatal myocardial infarction or
  death from coronary heart disease. These women
  were divided into low, intermediate, and high
  groups on the basis of their consumption of dietary
  fat. Hu (1997),

• Since the women themselves controlled their diets,
  rather than having a diet imposed on them by the
  researchers, this represents an observational design
• information from Experimental designs is
  considered more authoritative than information
  from observational designs
HOW: STUDY DESIGN

What is the study design?

Was it randomize?

Was it blinded?

Was prognostic stratification used?
HOW : STUDY DESIGN

• Controlled trial

• Before- and after

• Prospective analytic

• Cross sectional

• Retrospective

• Case series
Was The Assignment Randomized?

• assurance that the two groups are comparable in every
  way except for the therapy received.

• use of a random device, such as a coin flip or a table of
  random numbers.

• Be alert to “ quasi-random allocation” patient allocated
  on the basis of seemingly random process ( BD, chart #..
  Etc)
• If randomization was not followed :
• could any bias have occurred from the allocation of
  patients?
Why Randomization Is Important?

• Groups are more comparable for known and
  unknown variables ( measurable and un
  measurable)

• Eliminate selection bias

• Some statistical analysis prerequisite randomization

• Its difficult to have blinding in a trial which is not
  based on random allocation
What Type Of Blinding Was Used

• Knowledge of group membership, either before or
  during the data collection can bias the study

• At the start of the study, did the patients know
  which group they were going to be placed in?

• During the study, did the patients know which group
  they were in?
BLINDING


•   Single blind
•   Double blind
•   Triple blind
•   Surgical trials : at least who performs the outcome
    assessment.

• If the study was not blinded… how does lack of
  blinding might have affected the result?
BLINDING

• Studies without blinding show an average biase of
  11-17 % Schulz 1996, Coldiz 1989

• Comparing Unblinded study to a blinded one : an
  overestimation of treatment effect by 11-17 %
Why Blinding Is Important?

• Prevent bias form allocating the patient to experimental
  /control: i.e.; very sick patient.

• Minimize difference of how pt are treated during care.

• Prevent losing patient from trial.

• Prevent placebo Positive effects of a treatment.

• Greater validity of result : more like to report side effect.

• Minimize expectation bias for subjective outcomes, i.e
  pain.
WHO
            STUDY POPULATION
• Is the population from which the sample clearly
  described?



• Did they represent a full spectrum of disease of
  certain subset?
WHO:    STUDY POPULATION

•   Clear and replicable inclusion and exclusion criteria
•   Did the criteria match the goal of the study?
•   Who was excluded at the start of the study?
•   Who dropped out during the study?
•   Was there any effort to minimize drop out?
•   Where the authors able to characterizes the
    demographic of the drop out?
WHAT : Intervention And Outcomes

• What is the intervention? Is it Cleary stated

• Were there enough subjects?

• Did the research have a narrow focus?

• Did the authors deviate from the plan?

• Did the authors discard outliers?
Were There Enough Subjects?


• Small sample size lead to lack of power ; negative
  study
• Half of the articles reporting non significant
  difference between therapies, a 50% improvement
  in performance could be easily missed
• Type II error and small sample size are ubiquitous to
  medical lit Freiman etal

• Predetermine the needed size!
Did The Research Have A Narrow Focus?


• A good research study has limited objectives that
  are specified in advance. Failure to limit the scope
  of a study leads to problems with multiple testing.

• A large number of comparisons limits the amount of
  evidence that you can place on any single
  conclusion.
• Fishing
• “If you torture your data long enough,
  it will confess to something."
Be aware of Multiple comparison
problems:
Increase in type I error
Were Statistical Tests Applied
               Appropriately?
• Knowledge of bio statistic
• Greenhalgh T. statistic for the non – statistion. Part I:
  British medical journal 1997
• Greenhalgh T. statistic for the non – statistion. Part II:
  significant relations and pitfalls. British medical
  journal 1997
•   Withdrawals; patients removed by investigators
•   Dropout: patients leave the study on their well
•   Crossover: patients change arm of the study
•   Poor compliers
•   Intent to treat : subjects are analyzed according to
    the treatment to which they were randomized to
SO WHAT

• If difference was detected …is it clinically
  significant?



• For a difference to be a difference it has to make a
  difference"
SO WHAT

• Were the patient entered and analyzed sufficiently
  representative that the results can be generalized?



• Can intervention as performed be generalized to
  other sitting?
HOW
Study design
Allocation of subjects randomized
Control group
Blindness

                WHO
Population Cleary described
Inclusion and exclusion criteria
Volunteers
Sample size
              WHAT
  What intervention
  Compliance
  Dropout
  Narrow focus
  Change of plan
  Alternative hypotheses
Why : study design

How : study methodology

Who : study population

What: intervention and outcomes

How many: statistic

What else/
WHAT DOES IT TAKE TO CONVINCE
ME THAT THIS EVIDENCE IS TRUE?
THANK YOU
How many: statistical significant and
sample size

Was statistical significant considered?

Was test applied appropriately?

Did they consider the sample size prior to
start?

Was the study large enough to detect
difference?
REFERENCE

 Critical thinking : understanding and evaluating dental
research. D Brunette

http://www.childrensmercy.org/stats/journal/jour2003
-07.htm

http://healtoronto.com/howto.html



                       Thank you

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How to critique articles

  • 1. HOW TO CRITIQUE SCIENTIFIC ARTICLES HANI ALMOALLIM
  • 2. WHAT INFORMATION WOULD I REQUIRE TO ACCEPT THE CONCLUSION? Fisher’s assertability question
  • 3. KIPLING 6 HONEST SERVING MEN • I keep six honest serving men • They taught me all I know • Their names are ; • what, why and when • How, where and who R. Kipling 1902
  • 4. THE PLAN • Over view on article structure • What's considered to be the gold stranded of research? • Hands-on evaluation of medical articles
  • 5. SCIENTIFIC PAPER The council of biology editor define scientific paper as , an acceptable primary scientific publication must be the first disclosure containing information to enable peers : • 1- to assess observation • 2- to repeat experiment • 3- to evaluate intellectual process
  • 6. SCIENTIFIC PAPER • New • True • Important • comprehensible
  • 7. Why : study design How : study methodology Who : study population What: intervention and outcomes How many: statistic What else/
  • 8. TITLE • Has to be informative, concise and graceful! • Attract the reader! • Tell what the study about! • Why the study was done? • What get studied is what get funded!
  • 9. AUTHORS • Are they known in the field? • What's their specialty? • Citation index.
  • 10. DATE OF SUBMISSION/ ACCEPTANCE • Long delay may indicate that referee found serious issues in the initial version
  • 11. ABSTRACT • Why the study was done • What was done • What was found • What was concluded • It helps to answer Fisher’s assertability question
  • 12. IT S NOT HOW THE DATA WERE ANALYZED IT HOW THE DATA WERE COLLECTED
  • 13. INTRODUCTION • How important is the study and what’s new • Is there clear statement to justify the study? • Is there a clear statement of the study hypothesis?
  • 14. WHY: STUDY QUESTION • The study design , population to be studied, the method to be used, all depends on the purpose of the study • Is the hypothesis stated in advance or arose by the data • “ fishing expedition”: exploring their data for association then reporting the significant one!
  • 15. Is It Efficacy Or Effectiveness • Therapeutic studies Efficacy : • whether the intervention will work ; very controlled population and experimental conditions( ideal ). Short term goals Effectiveness : • intervention will cause more good than harm, under normal clinical condition, long term goals
  • 16. Bypass Surgery In Patients With Coronary Heart Disease efficacy effectiveness • Patient with clearly • Policy: intent to treat documented coronary principle” stenosis • Long term • Increased myocardial survival, quality of life flow or relief of symptoms • Any one was allocated to • Any one allocated but TX but did not receive it, did not receive the will not be included in the surgery will be included study in the study
  • 17. Nicotine patch therapy in adolescent smokers Smith etal 1996 What information would I require to accept the conclusion
  • 18. WHY Is sufficient evidence presented to justify the study? Is there a clear statement of the purpose of the study? Is there a clear statement of study hypothesis? Is it clearly outlined in the study if its Efficacy effectiveness
  • 19. HOW: STUDY DESIGN observational experimental Comparison group randomized Non randomized yes no Analytical descriptive cohort Case control Cross sectional
  • 20. Comparison Group Almost all studies has comparison : • dose left handed subjects live longer than right handed? • Are women more more likely to have periodontal disease than men • Comparison to be fair
  • 21. EXAMPLE 2: Cancer And Vitamin C • observational study of Vitamin C as a treatment for advanced cancer. • For each patient, ten matched controls were selected with the same age, gender, cancer site, and histological tumor type. • Patients receiving Vitamin C survived four times longer than the controls (p < 0.0001). • Cameron and Pauling 1976
  • 22. • Ten years later, the Mayo Clinic conducted a randomized experiment which showed no statistically significant effect of Vitamin C. Moertel 1989 • Why did the Camoeron and Pauling study differ from the Mayo study? • The treatment group represented patients newly diagnosed with terminal cancer. They received Vitamin C and followed prospectively. • The control group was selected from death certificate records The control group represented a retrospective chart review.
  • 23. Be Cautious When A Study Compares Prospective Data To Retrospective data
  • 24. Did The Author Created The Groups? • Experimental study • Observational study • Who did the choosing ?: • Author decided who get the intervention : experimental • Patients / doctors decided/group were intact prior to study : observational
  • 25. EXAMPLE 121 children with moderate-to-severe asthma were "randomly assigned to receive subcutaneous injections of either a mixture of seven aeroallergen extracts or a placebo.” Adkinson (1997), an experimental design.
  • 26. EXAMPLE "80 severe recidivist alcoholics received acupuncture either at points specific for the treatment of substance abuse (treatment group) or at nonspecific points (control group).” Bullock (1989), Since the researchers controlled the nature of the acupuncture, this is an experimental design.
  • 27. EXAMPLE 33 health care workers who became seropositive to HIV after percutaneous exposure to HIV-infected blood were compared to 665 health care workers with similar exposure who did not become seropositive. Cardo (1997) Since the researchers did not control who became seropositive, this is an observational study.
  • 28. EXAMPLE • 80,082 women between the ages of 34 and 59 years were followed for 14 years to look for instances of non-fatal myocardial infarction or death from coronary heart disease. These women were divided into low, intermediate, and high groups on the basis of their consumption of dietary fat. Hu (1997), • Since the women themselves controlled their diets, rather than having a diet imposed on them by the researchers, this represents an observational design
  • 29. • information from Experimental designs is considered more authoritative than information from observational designs
  • 30. HOW: STUDY DESIGN What is the study design? Was it randomize? Was it blinded? Was prognostic stratification used?
  • 31. HOW : STUDY DESIGN • Controlled trial • Before- and after • Prospective analytic • Cross sectional • Retrospective • Case series
  • 32. Was The Assignment Randomized? • assurance that the two groups are comparable in every way except for the therapy received. • use of a random device, such as a coin flip or a table of random numbers. • Be alert to “ quasi-random allocation” patient allocated on the basis of seemingly random process ( BD, chart #.. Etc) • If randomization was not followed : • could any bias have occurred from the allocation of patients?
  • 33. Why Randomization Is Important? • Groups are more comparable for known and unknown variables ( measurable and un measurable) • Eliminate selection bias • Some statistical analysis prerequisite randomization • Its difficult to have blinding in a trial which is not based on random allocation
  • 34. What Type Of Blinding Was Used • Knowledge of group membership, either before or during the data collection can bias the study • At the start of the study, did the patients know which group they were going to be placed in? • During the study, did the patients know which group they were in?
  • 35. BLINDING • Single blind • Double blind • Triple blind • Surgical trials : at least who performs the outcome assessment. • If the study was not blinded… how does lack of blinding might have affected the result?
  • 36. BLINDING • Studies without blinding show an average biase of 11-17 % Schulz 1996, Coldiz 1989 • Comparing Unblinded study to a blinded one : an overestimation of treatment effect by 11-17 %
  • 37. Why Blinding Is Important? • Prevent bias form allocating the patient to experimental /control: i.e.; very sick patient. • Minimize difference of how pt are treated during care. • Prevent losing patient from trial. • Prevent placebo Positive effects of a treatment. • Greater validity of result : more like to report side effect. • Minimize expectation bias for subjective outcomes, i.e pain.
  • 38. WHO STUDY POPULATION • Is the population from which the sample clearly described? • Did they represent a full spectrum of disease of certain subset?
  • 39. WHO: STUDY POPULATION • Clear and replicable inclusion and exclusion criteria • Did the criteria match the goal of the study? • Who was excluded at the start of the study? • Who dropped out during the study? • Was there any effort to minimize drop out? • Where the authors able to characterizes the demographic of the drop out?
  • 40.
  • 41. WHAT : Intervention And Outcomes • What is the intervention? Is it Cleary stated • Were there enough subjects? • Did the research have a narrow focus? • Did the authors deviate from the plan? • Did the authors discard outliers?
  • 42. Were There Enough Subjects? • Small sample size lead to lack of power ; negative study • Half of the articles reporting non significant difference between therapies, a 50% improvement in performance could be easily missed • Type II error and small sample size are ubiquitous to medical lit Freiman etal • Predetermine the needed size!
  • 43. Did The Research Have A Narrow Focus? • A good research study has limited objectives that are specified in advance. Failure to limit the scope of a study leads to problems with multiple testing. • A large number of comparisons limits the amount of evidence that you can place on any single conclusion. • Fishing
  • 44. • “If you torture your data long enough, it will confess to something."
  • 45. Be aware of Multiple comparison problems: Increase in type I error
  • 46. Were Statistical Tests Applied Appropriately? • Knowledge of bio statistic • Greenhalgh T. statistic for the non – statistion. Part I: British medical journal 1997 • Greenhalgh T. statistic for the non – statistion. Part II: significant relations and pitfalls. British medical journal 1997
  • 47. Withdrawals; patients removed by investigators • Dropout: patients leave the study on their well • Crossover: patients change arm of the study • Poor compliers • Intent to treat : subjects are analyzed according to the treatment to which they were randomized to
  • 48. SO WHAT • If difference was detected …is it clinically significant? • For a difference to be a difference it has to make a difference"
  • 49. SO WHAT • Were the patient entered and analyzed sufficiently representative that the results can be generalized? • Can intervention as performed be generalized to other sitting?
  • 50. HOW Study design Allocation of subjects randomized Control group Blindness WHO Population Cleary described Inclusion and exclusion criteria Volunteers Sample size WHAT What intervention Compliance Dropout Narrow focus Change of plan Alternative hypotheses
  • 51. Why : study design How : study methodology Who : study population What: intervention and outcomes How many: statistic What else/
  • 52. WHAT DOES IT TAKE TO CONVINCE ME THAT THIS EVIDENCE IS TRUE?
  • 54. How many: statistical significant and sample size Was statistical significant considered? Was test applied appropriately? Did they consider the sample size prior to start? Was the study large enough to detect difference?
  • 55. REFERENCE Critical thinking : understanding and evaluating dental research. D Brunette http://www.childrensmercy.org/stats/journal/jour2003 -07.htm http://healtoronto.com/howto.html Thank you

Editor's Notes

  1. Its not as important how data is analysied … what is important is how data is collected
  2. As critical apprasial you should consider the resones for the study and determin is ther enough evidance presented o justfy
  3. Randomization insures that both measurable and unmeasurable factors are balanced out across both the standard and the new therapy, assuring a fair comparison. It also guarantees that no conscious or subconscious efforts were used to allocate subjects in a biased way.
  4. . Nevertheless, for any deviation or modification to the protocol, you can ask whether this change would have made sense to include in the protocol if it had been thought of before data collection began.