Numerous factors go into writing an effective clinical paper. In this slide presentation, the elements are listed in a simple, graphically-rich manner. An illustrative paper is dissected to show the components of a good clinical paper.

1. Dr Arjun Rajagopalan
Writing a
paper

2. Dr Arjun Rajagopalan

3. Dr Arjun Rajagopalan

4. Dr Arjun Rajagopalan

5. Dr Arjun Rajagopalan

6. Dr Arjun Rajagopalan

7. Dr Arjun Rajagopalan
STEP 1
The need

8. Dr Arjun Rajagopalan

9. Dr Arjun Rajagopalan
"If$you$don't$have$0me$to$
read,$you$don't$have$the$
0me$4$or$the$tools$4$to$
write.$Simple$as$that."$
Stephen$King

10. Dr Arjun Rajagopalan
With%reference%to%Problem%“X”%the%unresolved%
issue(s)%at%stake%is:%Lorem%ipsum%dolor%sit%amet,%
consectetur%adipiscing%elit%…
The%grand%unifying%
model%of%
introduc,ons
Knowledge spectrum
Ignorance Clarity
We%are%
now%here
Our%study%will%shiQ%
this%posi,on%….

11. Dr Arjun Rajagopalan
STEP 2
Asking an
answerable question

12. Dr Arjun Rajagopalan

13. Dr Arjun Rajagopalan
The%4%part%ques,on
Popula,on
Indicator%variable
Outcome%variable
Comparison

14. An0bio0c$prophylaxis$at$urinary$catheter$removal$prevents$
urinary$tract$infec0ons%
Annals&of&Surgery&2009;&249:573–575
Popula0on Pa0ents$undergoing$elec0ve$abdominal$surgery$
at$a$single$centre$with$planned$periopera0ve$
urethral$catheteriza0on$
Indicator$
variable
Three$doses$of$trimethoprim4sulfamethoxazole$
at$urinary$catheter$removal.
Outcome$
variable
Primary:$occurrence$of$urinary$tract$infec0on$
aGer$catheter$removal.$Secondary:$occurrence$
of$asymptoma0c$bacteruria.$
Comparison No$an0bio0c$prophylaxis.

15. Dr Arjun Rajagopalan
The%prac,ce%of%
Medicine
Tag%the%ar,cle
$
$$
Observa,on
MeasurementInterven,on
Outcome
Cure%%%%%%%%%Death

16. Dr Arjun Rajagopalan
Tag%the%ar,cle
$
$$
Observa,onal
PATTERNS%
Causa,on%
Epidemiology
Diagnos,c%efficacy%
Decision%making%in%states%of%
uncertainty
Interven,onal
Alter%outcome
DIFFERENCES$
Odds/%risk/%associa,on%
Clinical%trials

17. TITLE TYPE/%TAG
Readmission%aQer%colectomy%for%cancer%
predicts%one>year%mortality
An,bio,c%prophylaxis%at%urinary%catheter%
removal%prevents%urinary%tract%infec,ons
CA19>9%serum%levels%in%obstruc,ve%
jaundice:%clinical%value%in%benign%and%
malignant%condi,ons
Observa,onal
Interven,onal
Diagnosis
Be%wary%of%ar,cles%that%a6empt%to%be%%
more%than%one%of%the%three%types

18. Dr Arjun Rajagopalan
STEP 3
Materials & Method

19. Dr Arjun Rajagopalan
The%prac,ce%of%
Medicine
$
$$
Observa,on%
(Popula,on)
MeasurementInterven,on
Outcome
Cure%%%%%%%%%Death

20. Dr Arjun Rajagopalan
STEP 3 A
Materials & Method
POPULATION
(The sample)

21. Dr Arjun Rajagopalan
Clearly%state%this%
dis,nc,on
Random
Epidemiological$
studies
Non>random
Clinical%studies

22. Dr Arjun Rajagopalan
The%value%chain
Non>random
Type Choice%of%individuals%from%available%
candidates
Consecu,ve All$available
Convenience Easily$available
Judgmental Hand$picked
Where%do%you%lie%in%
this%chain%of%value?

23. Dr Arjun Rajagopalan
Points%of%error%in%the%
sampling%process
The%“universe”$
Rarely%accessible
Accessible%popula,on
Demographical$
Socio>economic$
Temporal
Recruitm
ent
Intended%popula,on
Inclusion$
Exclusion
Study%popula,on
Drop%outs$
(>15%%=%invalid)

24. Tranexamic$Acid$Treatment$for$Heavy$Menstrual$Bleed$
Lukes$AS,$Moore$KA,$Muse$KN,$et$al$
Obstet$Gynecol$2010;116:865–75
?%Target% Accessible
Intended
Study
711
196
123 73
115 72
An%example

25. Dr Arjun Rajagopalan
THIS%STUDY
With%
prophylaxis
Without%
prophylaxis
TARGET%POPULATION ?
ACCESSIBLE%POPULATION ?%PATIENTS
INTENDED%POPULATION 119 120
STUDY%POPULATION 103 102

26. Dr Arjun Rajagopalan
How%much%is%
enough?
The%“power”%of%a%
sample
A%priori%sample%size%
determina,on
Postulated%size%of%difference%between%groups
Power%of%the%test%to%detect%this%difference%–%as%%%>%(usually%
80>90%)
Acceptable%margin%of%error%(as%a%decimal)
An0bio0c$Prophylaxis$at$Urinary$Catheter$Removal$Prevents$Urinary$Tract$Infec0ons$$
Pfefferkorn$U,$$Lea$$S,$MD,$$Moldenhauer$J,$et$al$
Ann$Surg$2009;249:$573–575$
The$sample$size$was$determined$assuming$a$rate$of$urinary$
tract$infec0ons$of$5%$in$the$group$with$an0bio0c$
prophylaxis$and$of$15%$in$the$group$without$prophylaxis.$
To$detect$a$10%$difference$with$a$significance$level$of$0.05$
and$sta0s0cal$power$of$80%,$a$total$of$220$pa0ents$were$
required.

27. Dr Arjun Rajagopalan
STEP 3 B
Materials & Method
INTERVENTION
& COMPARISON

28. Dr Arjun Rajagopalan
Apples%vs%...?
The%act%of%
comparing
Design%of%interven,onal%trials
Interven,on%“A”
Outcome%“A”
Interven,on%“B”
Outcome%“B”
Conclusion:%“There%is%a%difference%between%“A”%and%“B”

29. Dr Arjun Rajagopalan
2%cri,cal%ques,ons%in%interven,onal%trials
?
Is%there%a%
comparison?$
Study%vs%control
Is%the%
comparison%fair?
Prospec,ve Retrospec,ve
Randomized%controlled$
trial%(RCT)
%>%Case>controlled$
>%Case%series

30. Assuring%comparable%groups:%$
The%randomized%controlled%trial%(RCT)
Inclusion$
Exclusion
Accessible$
popula,on
Intended$
popula,on
Random%
alloca,on
Control$
group
Study$
group
Outcome Outcome
“There%is/%isn’t%a%difference

31. Dr Arjun Rajagopalan

32. Dr Arjun Rajagopalan
Comparable%groups
An0bio0c$Prophylaxis$at$
Urinary$Catheter$Removal$
Prevents$Urinary$Tract$
Infec0ons$$
Pfefferkorn$U,$$Lea$$S,$MD,$$
Moldenhauer$J,$et$al$
Ann$Surg$2009;249:$573–575

33. Assembling%comparable%groups:%$
The%case>controlled%trial
Inclusion$
Exclusion
Accessible$
popula,on
Intended$
popula,on
Control$
group
Study$
group
Outcome Outcome
“There%is/%isn’t%a%difference
One>to>one%(n)%
match%except%
for%indicator%
variable

34. Assembling%comparable%groups:%$
Retrospec,ve%(historical)%controls
Inclusion$
Exclusion
Accessible$
popula,on
Intended$
popula,on
Control$
group
Study$
group
Outcome Outcome
“There%is/%isn’t%a%difference
Retrospec,ve$
Not%matched

35. Dr Arjun Rajagopalan
Variability%in%
the%
interven,on
Standardizing%
interven,ons
Protocols
Training
Skill stratification
Blinding

36. Dr Arjun Rajagopalan
STEP 3 C
Materials & Method
MEASUREMENT

37. Dr Arjun Rajagopalan
Measurement%error
Measurement$
error
OBSERVER%ERROR DEVICE%ERROR

38. Dr Arjun Rajagopalan
Keeping%it%
down
Protocols
Training
Repetition
Multiple observers
Blinding
Minimizing$observer$error
OBSERVER%ERROR

39. Dr Arjun Rajagopalan
Measuring%
observer%error
Intra>observer Inter>observer
Kappa$
Value$
(0%–%1)

40. Dr Arjun Rajagopalan
Keeping%it%
down
DEVICE%ERROR
Minimizing$device$error
Protocols
Repetition
Appropriateness
“Gold standard”
comparisons

41. Dr Arjun Rajagopalan
STEP 4
Results

42. Dr Arjun Rajagopalan

43. Dr Arjun Rajagopalan

44. Dr Arjun Rajagopalan

45. Dr Arjun Rajagopalan

46. Dr Arjun Rajagopalan

47. Dr Arjun Rajagopalan
STEP 5
Statistical analysis

48. Dr Arjun Rajagopalan
Is%this%difference%real%or%due%to%chance?
Chances%are%...

49. Dr Arjun Rajagopalan
Chances%are%...
Familiarity with medical statistics
leads inevitably to the conclusion
that common sense is not
enough… Many people are not
capable of using common sense
in the handling and interpretation
of numerical data until they have
been instructed
Sir Austin Bradford Hill

50. Dr Arjun Rajagopalan
Biosta,s,cs%
demys,fied:%two%
keys%to%
understanding%
the%mystery
“Black%box”%
Biosta,s,cal%mumbo>jumbo
2%es,mates%of%chance
95%%(CI)$
(confidence%interval) ‘p’%value
Is%it%true?%
Yes/No
Where%is%the%truth?%
Show%me%the%money

51. Dr Arjun Rajagopalan
STEP 6
Conclusion

52. Dr Arjun Rajagopalan
The%4%part%ques,on
Popula,on
Indicator%variable
Outcome%variable
Comparison

53. Dr Arjun Rajagopalan
STEP 7
Discussion

54. Dr Arjun Rajagopalan
With%reference%to%Problem%“X”%the%unresolved%
issue(s)%at%stake%is:%Lorem%ipsum%dolor%sit%amet,%
consectetur%adipiscing%elit%…
Knowledge spectrum
Ignorance Clarity
We%are%
now%here
Our%study%will%shiQ%
this%posi,on%….
Drawbacks%
Strengths%
Contribu,on

55. Dr Arjun Rajagopalan

56. Dr Arjun Rajagopalan

57. Dr Arjun Rajagopalan

58. Dr Arjun Rajagopalan
STEP 8
The manuscript

59. Dr Arjun Rajagopalan

60. Dr Arjun Rajagopalan
INSTRUCTIONS
TO
AUTHORS

61. Dr Arjun Rajagopalan

62. Dr Arjun Rajagopalan
First
language
5%
Fluent
speakers
4%
Non-English
Speakers 91%

63. Dr Arjun Rajagopalan

64. Dr Arjun Rajagopalan

65. Dr Arjun Rajagopalan
Evidence Based
Medicine
The Evidence
Pyramid
Abilityto
controlbiasand
dem
onstrate
cause
and
effect

66. Dr Arjun Rajagopalan
THANK%YOU