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Research methodology
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.
1.
,
() (Evidence Based Medicine)
)
[1] )
[2].
,
, ,
.
,
.
.
.
, () . ,
( ). ,
( ). ,
.
2.
.
,
.
Feinstein [3]
2
. (
, , -
) .
(
)
(
,
). ,
.
( 1)
, , ,
.
(,
, , )
( randomized
controlled trials) [4].
-.
( 2)
1:
-
( , ,
..)
3
2:
,
- (screening)
,
- /
2.1 (Observational Studies)
.
:
.
2.1.1 (Ecological Studies):
(association)
(aggregate) (individual).
' ' [1],
.
Lewis . [5]
(Standardised Mortality Rate -
SMR) .
.
.
.
( . )
4
.
.
2.1.2 (Cross-sectional surveys):
('' '
' - outcome) ('' ' '
- exposure) .
( - )
-
. ,
() .
,
.
1.
Skapinakis . [6].
10000
+
-
+ -
a b
c d
: = a/a+c
b/b+d
odds ratio (ad/bc)
1:
5
.
,
.
,
,
.
2.1.3 (Case control studies):
, .
'
,
.
d
c
b
a
: Odds Ratio = ad/bc
2: -
6
(odds ratios).
2. ,
, .. .
, (.
).
. , Kendell . [7]
-
.
. ,
[8]
, .
,
.
.
7
2.1.4 (Cohort Studies Longitudinal studies):
,
(..
) (..
).
. (..
) .
(relative risks),
(
).
3. -
. ,
.
.
. ,
-
+
-
+ (a)
- (b)
+ (c)
- (d)
: a/a+b c/c+d
3:
-
8
,
.
[4]. (
, )
.
, .
-
,
. Doll
Hill .
Framingham [10].
2.2. (Experimental studies)
,
4:
9
.
(randomized controlled trials
RCTs).
[11].
o
(
confounding ).
, .
[11].
RCTs (
)
.
RCT , ..
. ,
RCT.
:
.
4 RCTs.
( )
.
.
(concealment)
RCT [12].
.
10
. RCTs ,
.
.
RCTs
.
.
. ,
,
.
RCT
.
,
(intention to treat analysis).
, ,
(..
).
,
.
,
, .
RCTs
,
. [13]:
) : RCTs
( ,
11
...),
[14],
) :
, .
,
) RCTs:
RCTs
.
,
.
2.3
, , , ,
, ,
- [15]. ,
.
( )
-,
.
-
,
.
3.
(publication bias)
,
12
(
) [16].
(funnel plot).
3: :
(
)
, .
[17,18].
.
Cochrane (Cochrane
Collaboration)
-.
Archie Cochrane,
Cardiff ,
. Cochrane
. 1993
77 11 Cochrane.
RCTs
1948
13
.
Internet Cochrane Library (www.cochrane.org
,
).
3.
3.1
(population)
, ..
50-70 .
(sample) , .
. ,
(random) (representative)
.
100
(50% , 50% ),
55 44 .
.
(). (sampling variation).
,
.
!
3.2
:
;
14
,
,
:
, H0,
, H1
.
p (p-
value). p
, .
p, .. 0,05,
,
. , p
. , p
0,05 ( 5%).
0,05 ,
( , ..
, p).
3.3
,
:
-
. 5%,
5%
.
.
-
. ,
p
.
.
15
(. )
.
3.4
(power)
.
.
: ) ( 5%),
)
) .
.
,
.
80%.
5%.
3.5
5%
5%.
4% 6%.
20 p
.
.
3.6
(.. ,
..) .
,
, .. , .
16
.
(standard error)
.
,
(standard deviation)
. ,
.
:
95% = (1,96* SE)
, = SE= .
,
p,
4.
,
(association)
. ,
(exposure) (outcome) [4].
() ,
[1].
.
.
.
( 5) [19]:
17
1. (chance) (random
variation).
2. (bias).
3. (confounding).
4. (reverse causality).
5. (causality).
..
.
4. 1.
.
. ,
.
XY
YX
. !
5:
18
(.. 5%)
.
,
.
.
.
4.2
, .
,
.
[16,20]:
(Selection bias) (information or
measurement bias).
.
,
,
(case-control).
. ,
. -
.
,
[21]. ,
. ,
.
19
[8].
. , , ,
. (recall bias)
[1].
. ,
o
. (..
) ,
. ,
(randomized controlled trials),
, .. ,
(.. )
,
.
4.3 (Confounding)
, ,
[4]. : )
) .
.
, .
. ( 6)
() ().
.
.
20
.
. ,
[4].
4.4 (reverse causality)
,
, ,
, . ,
,
,
.
, .
4.5
,
.
.
,
Bradford Hill ( 7) [20].
6:
21
1960 70 [9].
5.
. :
, (outcome)
, , (..
)
.
5.1 (Health Outcomes)
,
( )
(exposure)
( )
( )
( )
( )
( )
( ;)
( , )
( ;)
( )
7: Hill
22
. ,
: )
(.. ,
) )
. -
.
( )
,
.. ( ).
,
: ) (Death), ) (Disability), )
(Disease Status), )
(Dissatisfaction with process of care) )
(Discomfort about the effects of disease). ,
five Ds [22].
5.2 (Measures of Effect)
(
)
. , :
(relative measures) (absolute measures).
(relative risk)
(odds ratio).
,
[2].
.
90%,
30%.
(relative risk reduction) 66% (90%-30% / 90%
=66%). (absolute risk reduction) 60% (90% -
30% = 60%). , 9%,
23
3%, 66%
6%.
,
.
,
.
( )
(absolute risk)
(attributable risk) ,
(number needed to treat)
() [2].
,
.
, NNT
,
.
90% 30% ,
60%
100/60=1,66 . 9% 3% ,
6% 16,66 .
NNT
.
24
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[2] Sackett B, Straus S, Richardson WS, Rosenberg W, Haynes RB. Evidence Based
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[11] Pocock SJ. Clinical Trials. A practical Approach. John Wiley & Sons: Chichester 1983.
[12] Kunz R, Oxman AD (1998). The unpredictability paradox: review of empirical
comparisons of randomised and non-randomised clinical trials.
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[14] McKee M, Britton A, Black N, McPherson K, Sanderson C, Bain C (1999). Methods in
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[15] (2001). . 17:232-
236.
25
[16] (2001). .
17:440-445.
[17] Thompson SG. Why sources of heterogeneity in meta-analysis should be investigated.
Br Med J 1994, 309, 1351-1355.
[18] Lau J, Ioannidis JPA, Schmid CH. Summing up evidence: one answer is not always
enough. Lancet 1998, 351, 123-127.
[19] Lewis G, Thomas H, Cannon M, Jones P. Epidemiological Methods. In Textbook of
Community Psychiatry, edited by Thornicroft G and Szmukler G. Oxford University Press:
Oxford 2001.
[20] Rothman KJ, Greenland S. Modern Epidemiology 2nd edition. Lippincott Williams and
Wilkins: Philadelphia 1998.
[21] Brown GW, Harris T. Social Origins of Depression. Tavistock: London 1978.
[22] Muir Gray J. Evidence based health care. How to make health policy and management
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.
, - .1 , ( , , -), -, .2 ,, (evidence-based medicine),3 , , , . -, - , , .
; , ; ; -, , - . British Medical Journal , , , Internet (www.bmj.com).
( ). 4 -, 1993, , , , - , , . , - 19501997 - , , - -. , , , 1960 .
.5 , , . -, , . (randomizedcontrolled trial, RCT) - .6
7 (. 1). , -
EDITORIAL
17(5), 2000 441
, , -, -, (.., , ), , , . , - , - - , -. , , .8 -, -. , , -:
, - ;
19501997;
, ;
, , , , .
, , , -. , - Murlow,9 , , :
. (gen-eralisability), (consistency) (inconsistency) . , - - , 4 .6 , -, . , 4 (trend) , , (. 2). , , -, .5
. (power) (precision) - (effect).
1 . .
2 . . -.*
1 155/1906 187/1900 0,81 (0,651,01) 2 56/2051 84/2030 0,65 (0,460,92) 3 174/3302 248/3293 0,68 (0,560,83) 4 56/3304 96/3301 0,58 (0,410,80) 441/10563 615/10524 0,70 (0,620,79)
* Pignone et al. Br Med J 2000, 321:15. :
( / ) ( / ) ( 9 5 % )
(as-sociation), .10 . , ( ) .11 2, - -,6 , , 1906 - , 155 ( 81,3 1000). , 187 1900 ( 98,4 1000). 3800 , 17,1 1000 . , , - 43%!12
, 6.500 , 80%. , ( ), - , , (chance). , - ( ' ) , , 20.000 , .
- , -, (precision) . , 95% . - , , - , . , - - (point es-timate) - (odds ratio) -. 95% - , ,
, (true value) (-, 2, 0,46 0,92 0,620,79).
- (. 1). , ' - . . (biases), (selection bias).
, -.13 - (association) . , , (random error) (confounding), . ' , - . - -. , , - .
, - . (reference population), , - , ,
442 ARCHIVES OF HELLENIC MEDICINE 17(5), 2000
. , , - . -, , - ( ) (eligible population).
(. 3). , - - -. - ., . - , , (publication/citationbias).14 , .15 , . , - -. - !
, ; . , , .
, -.16 () , .. MedLine, Em-base, Cinahl, Psychinfo, Current Contents, () , - - ( 100%). - ' ,() - , , , , , () , () - , () , on-line Cochrane(Cochrane Collaboration), () , .. (gray literature).
, . , . -, - .( : , - ). , , :4 () 19801996 19791996 , () 19501997,
17(5), 2000 443
3 . .
1. (source population) 2.
(eligible population)
19751997 , () -, () , , 19701995, () 19601995. ( , !). , . .., , , - .
, . - (inclusion-exclusion), , . , , . , -, - - , , , :5 () , 65 , . , - . () , , (blind). () ,
, , , .., - , , , , .., , - (falls) . , . , - 244 . , 29 15 .
(data extraction) .7 -, , , , , - , -, , , , , , .. , - , -, , . (heterogeneity) .17 ( ), ( ) ( ). -, , .18
, -. -, : () - , .
444 ARCHIVES OF HELLENIC MEDICINE 17(5), 2000
17(5), 2000 445
, , , - , , . () - , . () - , , , x2 . ' , (weight-ed average) .
. -, , . . . . , , - - . ,, . , , .18 , ,19 , , , , -, - , - .
.
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