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‫والردي‬ ‫الجيد‬ ‫بين‬ ‫المنشور‬ ‫العلمي‬ ‫البحث‬‫ء‬
‫العقيل‬ ‫المحسن‬ ‫عبد‬ ‫سيناء‬
‫االكلينكية‬ ‫الصيدلة‬ ‫بقسم‬ ‫مشارك‬ ‫استاذ‬
‫الصيدلة‬ ‫كلية‬
Salageel@ksu.edu.sa @alaqeels
Voting
www.Menti.com
Code: 349874
Peer Review Process
William Whewell, peer-review pioneer
Source: N AT U R E, VO L 5 3 2 . 2 0 1 6
Critical appraisal tools to evaluate the quality
of published research
0 5 10 15 20 25 30 35 40 45 50
Experimental studies
Systematic reviews
Observational studies
Diagnostic studies
Qualitative studies
Experimental and observational studies
All studies designs
Source:BMC Med Res Methodol. 2004; 4: 22.. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC521688/
NEWCAS TLE - O TTAW A Q UALITY ASS ESS MENT SCALE
CO HORT S TUDIES
Note: A study can be awarded a ma ximum of one star for each numbered item within the Selection and
Outcome categories. A maximum of two stars can be given for Comparability
Selection
1) Representativeness of the exposed cohort
a) truly representative of the average _______________ (describe) in the community 
b) somewhat representative of the average ______________ in the community 
c) selected group of users eg nurses, volunteers
d) no description of the derivation of the cohort
2) Selection of the non exposed cohort
a) drawn from the same community as the exposed cohort 
b) drawn from a different source
c) no description of the derivation of the non exposed cohort
3) Ascertainment of exposure
a) secure record (eg surgical records) 
b) structured interview 
c) written self report
d) no description
4) Demonstration that outcome of interest was not present at start of study
a) yes 
b) no
Compara bility
1) Comparability of cohorts on the basis of the design or analysis
a) study controls for _____________ (select the most important factor) 
b) study controls for any additional factor  (This criteria could be modified to indicate specific
control for a second important factor.)
Outcome
1) Assessment of outcome
a) independent blind assessment 
b) record linkage 
c) self report
d) no description
2) Was follow-up long enough for outcomes to occur
a) yes (select an adequate follow up period for outcome of interest) 
b) no
3) Adequacy of follow up of cohorts
a) complete follow up - all subjects accounted for 
b) subjects lost to follow up unlikely to introduce bias - small number lost - > ____ % (select an
adequate %) follow up, or description provided of those lost) 
c) follow up rate < ____% (select an adequate %) and no description of those lost
d) no statement
Critical
appraisal
tools
example
NEWCASTLE - O TTAW A Q UALITY ASSESSMENT SCALE
CASE CONTRO L STUDIES
Note: A study can be awarded a ma ximum of one star for each numbered item within the Selection and
Exposure categories. A maximum of two stars can be given for Comparability.
Selection
1) Is the case definition adequate?
a) yes, with independent validation 
b) yes, eg record linkage or based on self reports
c) no description
2) Representativeness of the cases
a) consecutive or obviously representative series of cases 
b) potential for selection biases or not stated
3) Selection of Controls
a) community controls 
b) hospital controls
c) no description
4) Definition of Controls
a) no history of disease (endpoint) 
b) no description of source
Compara bility
1) Comparability of cases and controls on the basis of the design or analysis
a) study controls for _______________ (Select the most important factor.) 
b) study controls for any additional factor  (This criteria could be modified to indicate specific
control for a second important factor.)
Exposure
1) Ascertainment of exposure
a) secure record (eg surgical records) 
b) structured interview where blind to case/control status 
c) interview not blinded to case/control status
d) written self report or medical record only
e) no description
2) Same method of ascertainment for cases and controls
a) yes 
b) no
3) Non-Response rate
a) same rate for both groups 
b) non respondents described
c) rate different and no designation
Critical
appraisal
tools
example
Critical
appraisal
tools
example
Valid and reliable research
Picture Source: http://businessoverbroadway.com/validity-cem-program
Implementation
Reporting biasAttrition (drop out) bias
Performance biasSelection bias
Recruitment/Allocation
Publication bias
Analysis/Publication
Channeling bias Confirmation bias
Research Misconduct
Detection bias
Threats to
validity
Selection bias: the classic example
Selection bias: the classic example
Concealment
Blinding
Time
Randomisation
Performance bias
Selection bias
Detection bias
Source: http://en.testingtreatments.org/wp-content/uploads/sites/3/2015/12/6.3.3-Unbiased-prospective-allocationp73-74x.pdf
The inadequate or unclear allocation concealment
and biased estimates of intervention effects
BMJ 2008;336:601
The lack of blinding and biased intervention
effects
BMJ 2008;336:601
Methods to
Establish
Blinding in
RCTs
PLOS Medicine 3(10): e425. https://doi.org/10.1371/journal.pmed.0030425
Methods of
Blinded
Outcome
Assessment
PLOS Medicine 3(10): e425. https://doi.org/10.1371/journal.pmed.0030425
Reporting bias
Publication Bias
Journal of Evaluation in Clinical Practice
Volume 20, Issue 6, pages 908-914, 12 MAY 2014 DOI: 10.1111/jep.12147
Publication bias and Selective outcome
reporting
. (Illustration: Margaret Shear, Public Library of Science)
PLOS Medicine 2(5): e138. https://doi.org/10.1371/journal.pmed.0020138
Medical Journals Are an
Extension of the Marketing Arm
of Pharmaceutical Companies.
Publication Bias and selective reporting: the Tamiflu
Experience
Source: Tamiflu capsules. Photograph: Per Lindgren/REX via The Guardian Tom Jefferson
An estimated $200 billion —85% of global spending on research — is
routinely wasted on poorly designed and redundant studies.
Lancet 2009; 374: 86–89
Research Misconduct
Falsification
Fabrication
Plagiarism
Source: https://ori.hhs.gov/definition-misconduct
Research Misconduct
Andrew Wakefield
Research Misconduct
Research Misconduct
Joachim Boldt
Research Misconduct
Anil Potti
Justifications
for retraction
stated in the
notices
consulted,
which
accounted
for 4,232
retracted
articles.
PLOS ONE 7(10): e44118. https://doi.org/10.1371/journal.pone.0044118
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0044118
Research Misconduct
Grigori Perelman
Self-regulation?
Source: http://blog.minitab.com/blog/adventures-in-statistics-2/why-anecdotal-evidence-is-unreliable
‫والرديء‬ ‫الجيد‬ ‫بين‬ ‫المنشور‬ ‫العلمي‬ ‫البحث‬
Voting
www.Menti.com
Code: 349874
‫شكرا‬
‫العقيل‬ ‫المحسن‬ ‫عبد‬ ‫سيناء‬
‫االكلينكية‬ ‫الصيدلة‬ ‫بقسم‬ ‫مشارك‬ ‫استاذ‬
‫الصيدلة‬ ‫كلية‬
Salageel@ksu.edu.sa @alaqeels

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البحث العلمي المنشور بين الجيد والرديء د. سيناء العقيل

  • 1. ‫والردي‬ ‫الجيد‬ ‫بين‬ ‫المنشور‬ ‫العلمي‬ ‫البحث‬‫ء‬ ‫العقيل‬ ‫المحسن‬ ‫عبد‬ ‫سيناء‬ ‫االكلينكية‬ ‫الصيدلة‬ ‫بقسم‬ ‫مشارك‬ ‫استاذ‬ ‫الصيدلة‬ ‫كلية‬ Salageel@ksu.edu.sa @alaqeels
  • 3.
  • 4.
  • 5.
  • 6. Peer Review Process William Whewell, peer-review pioneer Source: N AT U R E, VO L 5 3 2 . 2 0 1 6
  • 7.
  • 8. Critical appraisal tools to evaluate the quality of published research 0 5 10 15 20 25 30 35 40 45 50 Experimental studies Systematic reviews Observational studies Diagnostic studies Qualitative studies Experimental and observational studies All studies designs Source:BMC Med Res Methodol. 2004; 4: 22.. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC521688/
  • 9. NEWCAS TLE - O TTAW A Q UALITY ASS ESS MENT SCALE CO HORT S TUDIES Note: A study can be awarded a ma ximum of one star for each numbered item within the Selection and Outcome categories. A maximum of two stars can be given for Comparability Selection 1) Representativeness of the exposed cohort a) truly representative of the average _______________ (describe) in the community  b) somewhat representative of the average ______________ in the community  c) selected group of users eg nurses, volunteers d) no description of the derivation of the cohort 2) Selection of the non exposed cohort a) drawn from the same community as the exposed cohort  b) drawn from a different source c) no description of the derivation of the non exposed cohort 3) Ascertainment of exposure a) secure record (eg surgical records)  b) structured interview  c) written self report d) no description 4) Demonstration that outcome of interest was not present at start of study a) yes  b) no Compara bility 1) Comparability of cohorts on the basis of the design or analysis a) study controls for _____________ (select the most important factor)  b) study controls for any additional factor  (This criteria could be modified to indicate specific control for a second important factor.) Outcome 1) Assessment of outcome a) independent blind assessment  b) record linkage  c) self report d) no description 2) Was follow-up long enough for outcomes to occur a) yes (select an adequate follow up period for outcome of interest)  b) no 3) Adequacy of follow up of cohorts a) complete follow up - all subjects accounted for  b) subjects lost to follow up unlikely to introduce bias - small number lost - > ____ % (select an adequate %) follow up, or description provided of those lost)  c) follow up rate < ____% (select an adequate %) and no description of those lost d) no statement Critical appraisal tools example
  • 10. NEWCASTLE - O TTAW A Q UALITY ASSESSMENT SCALE CASE CONTRO L STUDIES Note: A study can be awarded a ma ximum of one star for each numbered item within the Selection and Exposure categories. A maximum of two stars can be given for Comparability. Selection 1) Is the case definition adequate? a) yes, with independent validation  b) yes, eg record linkage or based on self reports c) no description 2) Representativeness of the cases a) consecutive or obviously representative series of cases  b) potential for selection biases or not stated 3) Selection of Controls a) community controls  b) hospital controls c) no description 4) Definition of Controls a) no history of disease (endpoint)  b) no description of source Compara bility 1) Comparability of cases and controls on the basis of the design or analysis a) study controls for _______________ (Select the most important factor.)  b) study controls for any additional factor  (This criteria could be modified to indicate specific control for a second important factor.) Exposure 1) Ascertainment of exposure a) secure record (eg surgical records)  b) structured interview where blind to case/control status  c) interview not blinded to case/control status d) written self report or medical record only e) no description 2) Same method of ascertainment for cases and controls a) yes  b) no 3) Non-Response rate a) same rate for both groups  b) non respondents described c) rate different and no designation Critical appraisal tools example
  • 12.
  • 13.
  • 14. Valid and reliable research Picture Source: http://businessoverbroadway.com/validity-cem-program
  • 15. Implementation Reporting biasAttrition (drop out) bias Performance biasSelection bias Recruitment/Allocation Publication bias Analysis/Publication Channeling bias Confirmation bias Research Misconduct Detection bias Threats to validity
  • 16. Selection bias: the classic example
  • 17. Selection bias: the classic example
  • 20. The inadequate or unclear allocation concealment and biased estimates of intervention effects BMJ 2008;336:601
  • 21. The lack of blinding and biased intervention effects BMJ 2008;336:601
  • 22. Methods to Establish Blinding in RCTs PLOS Medicine 3(10): e425. https://doi.org/10.1371/journal.pmed.0030425
  • 23. Methods of Blinded Outcome Assessment PLOS Medicine 3(10): e425. https://doi.org/10.1371/journal.pmed.0030425
  • 25. Publication Bias Journal of Evaluation in Clinical Practice Volume 20, Issue 6, pages 908-914, 12 MAY 2014 DOI: 10.1111/jep.12147
  • 26. Publication bias and Selective outcome reporting
  • 27. . (Illustration: Margaret Shear, Public Library of Science) PLOS Medicine 2(5): e138. https://doi.org/10.1371/journal.pmed.0020138 Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies.
  • 28.
  • 29. Publication Bias and selective reporting: the Tamiflu Experience Source: Tamiflu capsules. Photograph: Per Lindgren/REX via The Guardian Tom Jefferson
  • 30. An estimated $200 billion —85% of global spending on research — is routinely wasted on poorly designed and redundant studies. Lancet 2009; 374: 86–89
  • 36. Justifications for retraction stated in the notices consulted, which accounted for 4,232 retracted articles. PLOS ONE 7(10): e44118. https://doi.org/10.1371/journal.pone.0044118 http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0044118
  • 38.
  • 39.
  • 40.
  • 43. ‫والرديء‬ ‫الجيد‬ ‫بين‬ ‫المنشور‬ ‫العلمي‬ ‫البحث‬
  • 45. ‫شكرا‬ ‫العقيل‬ ‫المحسن‬ ‫عبد‬ ‫سيناء‬ ‫االكلينكية‬ ‫الصيدلة‬ ‫بقسم‬ ‫مشارك‬ ‫استاذ‬ ‫الصيدلة‬ ‫كلية‬ Salageel@ksu.edu.sa @alaqeels