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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_2767_Библиотеки_им_академика_М_И_Перельмана
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Hypothetical cohort
1000 people in
[index test] result Actual diagnosis Implications
TP:
FP:
TN
FN: false negative – test is negative (indicates [target condition] not present) but patient has [target condition]
https://t.me/medicina_free
[setting] tested
for [target
condition] using
[index test]
[index test]
indicates [target
condition]:
<TP+FP>
[index test] indicates
[target condition]:
not present:
<TN+FN>
[TP](<100*TP/{TP+FP}>%)
[target condition] (TP)
[FP](<100*FP/{TP+FP}>%)
[target condition] not
present (FP)
[TP](<100*TN/{TN+FN}>%)
[target condition] not present (TN)
[FN](<100*FN/{TN+FN}>%)
[target condition] (FN)
Describe
consequences
Describe
consequences
Describe
consequences
Describe
consequences
true positive – test is positive (indicates (target condition]) and patient has [target condition]
false positive – test is positive (indicates [target condition]) but patient does not have [target condition]
: true negative – test is negative (indicates (target condition] not present) and patient does not have [target condition]
Figure13.3.a Template for a test consequence graphic. Text in square brackets, [], is replaced with text or numbers in the boxes in the final figure. Text
in angle brackets, <>, indicates expressions to be calculated. Source: Whiting 2018.
Hypothetical cohort
Receive appropriate
Rapid test result Actual diagnosis Implications
TP:
FP:
TN:
FN: false negative – test is negative (indicates [target condition] not present) but patient has [target condition]
https://t.me/medicina_free
antibiotics
Receive inappropriate
antibiotics
No antibiotic treatment
(appropriate)
Delayed recovery, risk of
infecting others and
possible severe
complications
1000 children
with sore throat
tested with rapid
true positive – test is positive (indicates (target condition]) and patient has [target condition]
false positive – test is positive (indicates [target condition]) but patient does not have [target condition]
true negative – test is negative (indicates (target condition] not present) and patient does not have [target condition]
test
257 (89%) Bacterial
Rapid test
indicates bacterial
infection: 289
Rapid test indicates
no bacterial
infection: 711
infection (TP)
32 (11%)
No bacterial infection (FP)
668 (94%) No bacterial
infection (TN)
43 (6%)
Bacterial infection (FN)
Figure13.3.b Application of the test consequence graphic. How accurate are rapid swab tests for bacterial infection in children with sore throat?
13.3 Contents andstructure ofa plain language summary
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13.3.8 What are thelimitations ofthe evidence?
This section should describe the main limitations of the evidence. This should include a
summary of the methodological quality of the studies included in the review and the
potential impact of bias and uncertainty on estimates of accuracy. This section should
also describe the reference standard used in the review and comment on the validity of
the reference standard. For example:
‘In the included studies, the diagnosis of target condition was made by assessing all
patients with
reliable method for deciding whether patients really had
Rapid swab tests forstrep sore throat example
In the included studies, the diagnosis of bacterial infection was confirmed by the most
accurate test available: seeing if bacteria could be grown in the laboratory from samples
taken from children’s throats (the reference standard).
reference standard (the reference standard). This is likely to have been a
target condition.’
If there was a potential for bias in the included studies, we suggest using a generic
statement and then explaining how bias may have had an impact on estimates of test
accuracy. We do not recommend going into detail about the type of bias that may have
affected the included studies, such as verification bias or review bias. For example:
‘However, there were some problems with how the studies were conducted. This may
result in the index test appearing more accurate than it really is.’
Rapid swab tests forstrep sore throat example
Although there were problems with the conduct of some studies, their results did not differ
from the more reliable studies.
If there is heterogeneity in study results, this can be highlighted here. For example:
Limitations ofthe evidence– heterogeneity
‘The test accuracy results presented are a summary based on studies in the review.
However, as estimates from individual studies varied we cannot be sure that index test
will always produce these results.’
OR
‘The test accuracy results presented are a summary based on studies in the review.
However, as estimates from individual studies varied considerably, it is likely that use of
index test in setting may give results that differ substantially from these estimates.’
Rapid swab tests forstrep sore throat example
The numbers described above are a summary based on all studies. Because estimates of
accuracy varied across individual studies, we cannot be sure that the summary accuracy
estimates in this review could be replicated in practice.
391
13 Writing aplain language summary
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Imprecision (wide confidence intervals around summary estimates) and/or small
sample size can also be captured in this section. For example:
Limitations ofthe evidence– imprecision
‘The test accuracy results presented in this review come from only # studies. It is likely
that estimates of test accuracy will change as more studies become available.’
Where multiple index tests are evaluated, there may be different limitations in the
evidence for the different tests evaluated. This should be captured in this section.
Forexample:
Alternative example- limitations ofthe evidence– multiple index tests
‘The test accuracy results presented in this review come from a small number of studies:
four studies for the Care Start Malaria test and two studies for the Falcivax test. It is likely
that estimates of test accuracy will change as more studies become available, particularly for the Falcivax test.’
Source: Based on Agarwal 2020.
13.3.9 How upto date is this evidence?
State the month and year review authors searched for the included studies, for instance
by saying:
‘The evidence is up to date to month and year of search.’
Rapid swab tests forstrep sore throat example
The evidence is up to date to July 2015.
13.4 Chapter information
Authors: Penny Whiting (Population Health Sciences, Bristol Medical School, University
of Bristol, UK) and Clare Davenport (Institute of Applied Health Research, University of
Birmingham, UK).
Sources of support: The authors declare no sources of support for writing this
chapter.
392
13.5 References
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Declarations of interest: Penny Whiting and Clare Davenport led the development of
the guidance on how to write a plain language summary for diagnostic test accuracy
reviews. Clare Davenport is a member of Cochrane’s Diagnostic Test Accuracy Editorial
Team. The authors declare no other potential conflicts of interest relevant to the topic
of this chapter.
Acknowledgements: This chapter prepared by Penny Whiting and Clare Davenport is
based on the findings of research funded by the Cochrane Collaboration (in part by a
Cochrane’s Methods Innovation Fund Grant) and drawing on the plain language summary guidance for Cochrane Intervention Reviews. The authors thank Mariska Leeflang,
Reem Mustafa, Nancy Santesso, Gowri Gopalakrishna, Geraldine Cooney, Emily Jesper
and Joanne Thomas for their
contributions to this project.
The authors would like to thank Denise Mitchell, Jenny Negus, Brian Duncan, Karen R.
Steingart and Jacqueline Dinnes for helpful peer review comments.
13.5 References
Agarwal R, Choi L, Johnson S, Takwoingi Y. Rapid diagnostic tests for Plasmodium vivax
malaria in endemic countries. Cochrane Database of Systematic Reviews 2020;
11:CD013218.
Beishon LC, Batterham AP, Quinn TJ, Nelson CP, Panerai RB, Robinson T, Haunton VJ.
Addenbrooke’s Cognitive Examination III (ACEdementia and mild cognitive impairment. Cochrane Database of Systematic Reviews
2019; 12: CD013282.
Bossuyt PM, Irwig L, Craig J, Glasziou P. Comparative accuracy: assessing new tests against
existing diagnostic pathways. BMJ 2006; 332: 1089–1092.
Chan KK, Joo DA, McRae AD, Takwoingi Y, Premji ZA, Lang E, Wakai A. Chest
ultrasonography versus supine chest radiography for diagnosis of pneumothorax in
trauma patients in the emergency department. Cochrane Database of Systematic
Reviews 2020; 7: CD013031.
Cohen JF, Bertille N, Cohen R, Chalumeau M. Rapid antigen detection test for group A
streptococcus in children with pharyngitis. Cochrane Database of Systematic Reviews
2016; 7: CD010502.
Dinnes J, Deeks JJ, Saleh D, Chuchu N, Bayliss SE, Patel L, Davenport C, Takwoingi Y,
Godfrey K, Matin RN, Patalay R, Williams HC. Reflectance confocal microscopy for
diagnosing cutaneous melanoma in adults. Cochrane Database of Systematic Reviews
2018; 12: CD013190.
Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, Emperador D, Takwoingi
Y, Cunningham J, Beese S, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, TaylorPhillips S, Hooft L, Leeflang MM, Spijker R, Van den Bruel A. Rapid, point- of- care antigen
and molecular- based tests for diagnosis of SARS- CoV- 2infection. Cochrane Database of
Systematic Reviews 2020; 8: CD013705.
Fee PA, Macey R, Walsh T, Clarkson JE, Ricketts D. Tests to detect and inform the diagno-
sis of root caries. Cochrane Database of Systematic Reviews 2020; 12: CD013806.
Gigerenzer G. What are natural frequencies? BMJ 2011; 343: d6386.
III) and mini- ACE for the detection of
393
13 Writing aplain language summary
https://t.me/medicina_free
Islam N, Ebrahimzadeh S, Salameh JP, Kazi S, Fabiano N, Treanor L, Absi M, Hallgrimson Z,
Leeflang MM, Hooft L, van der Pol CB, Prager R, Hare SS, Dennie C, Spijker R, Deeks JJ,
Dinnes J, Jenniskens K, Korevaar DA, Cohen JF, Van den Bruel A, Takwoingi Y, van de
Wijgert J, Damen JA, Wang J, McInnes MD. Thoracic imaging tests for the diagnosis of
COVID-
19. Cochrane Database of Systematic Reviews 2021; 3: CD013639.
Leeflang MM, Deeks JJ, Gatsonis C, Bossuyt PM, Cochrane Diagnostic Test Accuracy
Working Group. Systematic reviews of diagnostic test accuracy. Annals of Internal
Medicine 2008; 149: 889–897.
Macey R, Walsh T, Riley P, Glenny AM, Worthington HV, Fee PA, Clarkson JE, Ricketts D.
Fluorescence devices for the detection of dental caries. Cochrane Database of Systematic
Reviews 2020; 12: CD013811.
Pitcher N, Mitchell D, Hughes C. Guidance for writing a Cochrane plain language summary
Version 1, June 2021. community.cochrane.org/sites/default/files/uploads/inline- files/
PLS%20guidance%20final%20draft%20%28v%2020%29.pdf.
Whiting P, Leeflang M, de Salis I, Mustafa RA, Santesso N, Gopalakrishna G, Cooney G,
Jesper E, Thomas J, Davenport C. Guidance was developed on how to write a plain
language summary for diagnostic test accuracy reviews. Journal of Clinical Epidemiology
2018a; 103: 112–119.
Whiting P, Davenport C. Understanding test accuracy research: a test consequence graphic.
Diagnostic and Prognostic Research 2018b; 2: 2.
Whiting PF, Davenport C, Jameson C, Burke M, Sterne JA, Hyde C, Ben- Shlomo Y. How well
do health professionals interpret diagnostic information? A systematic review. BMJ Open
2015; 5: e008155.
Zhelev Z, Garside R, Hyde C. A qualitative study into the difficulties experienced by
healthcare decision makers when reading a Cochrane diagnostic test accuracy review.
Systematic Reviews 2013; 2: 32.13.6
13.6 Appendix: Additional example plain language summary
How accurate is the Informant Questionnaire on Cognitive Decline in the Elderly
(IQCODE) test for dementia in hospital?
Key messages
●
The studies included in this review suggest the IQCODE can identify adults over 60
years in hospital who have dementia and require specialist assessment.
●
The results suggest the IQCODE is likely to be less useful in specialist memory clinics
and psychiatry wards than general hospital settings. The short version and different
language versions of the IQCODE are as accurate as the standard English language
long version.
Why is improving dementia diagnosis important?
Dementia is common and leads to memory problems. It also affects how you think,
speak, feel and behave. It is important to diagnose dementia early so that treatment
394
13.6 Appendix: Additional example plain language summary
https://t.me/medicina_free
and support for patients and carers can have maximum effect and disease progression
can be delayed. Not recognizing dementia when it is present (a false negative test
result) results in lost opportunities for early help, including drug therapies or support
for patients and carers. An incorrect diagnosis of dementia (a false positive test result)
may result in anxiety, stress, wasted resources and unnecessary investigation and
treatment.
What is theIQCODE test?
The IQCODE is a questionnaire that has been developed to help diagnose dementia.
There are two versions of the IQCODE: a ‘long’ version (26 questions) and a ‘short’ version (16 questions). Each question asks if a person’s ability to perform certain everyday
tasks has changed. Both versions are completed based on information supplied by
somebody close to the person being assessed for dementia. Questions are rated on a
scale of 1 ‘has become much better’ to 5 ‘has become much worse’. A diagnosis of
dementia is more likely with higher scores.
What did wewant tofind out?
We wanted to find out how accurate the IQCODE questionnaire is for diagnosing dementia in hospital settings.
What did wedo?
We searched for studies that had investigated the accuracy of the IQCODE test in hospital settings and we combined the results across these studies.
What did wefind?
The review included 13 relevant studies with a total of 2745 participants. Studies
included in the review were carried out in Europe, Australia, China, Singapore and
other signs of dementia, other studies included general patients admitted to
hospital. Average age ranged from 65 to 82 years. The percentage of people with a
final diagnosis of dementia was between 11% and 87% across studies (an average
of51%).
The results of these studies indicate that in theory, if the IQCODE were to be used in
hospital settings in a group of 1000 people, of whom 500 (50%) have dementia:
●
An estimated 625would have an IQCODE result indicating dementia and of these 170
(27%) would not have dementia.
●
Of the 375 people with a result indicating that dementia is not present, 45 (12%)
would actually have dementia.
395
Hypothetical cohort
IQCODE indicates
IQCODE result Actual diagnosis Implications
TP:
FP:
TN
FN: false negative – test is negative (indicates [target condition] not present) but patient has [target condition]
https://t.me/medicina_free
dementia: 625
455 (73%)
Dementia (TP)
Specialist assessment,
appropriate
intervention
170 (27%)
1000 people in
hospital settings
tested for
dementia using
the IQCODE
IQCODE indicates
dementia not
present: 375
true positive – test is positive (indicates (target condition]) and patient has [target condition]
false positive – test is positive (indicates [target condition]) but patient does not have [target condition]
: true negative – test is negative (indicates (target condition] not present) and patient does not have [target condition]
No dementia (FP)
330 (88%)
No dementia (TN)
45 (12%)
Dementia (FN)
wasted resources
Anxiety, stress,
No intervention,
consider other
diagnoses
Miss early
intervention &
support
13.6 Appendix: Additional example plain language summary
https://t.me/medicina_free
The IQCODE produces more false positive and false negative results (more people in the
red ovals in the diagram) in specialist memory clinics and psychiatry wards than in general hospital clinics and wards. There is no difference in results between long and short
versions of the IQCODE or for languages other than English (similar numbers in each
box in the diagram).
What are thelimitations ofthe evidence?
In the included studies, the diagnosis of dementia was made by assessing all patients
with an in- depth clinical interview (the reference standard). This is likely to have been a
reliable method for deciding whether patients really had dementia. However, there
were some problems with how the studies were conducted. This may result in the
IQCODE appearing more accurate than it really is, increasing the number of correct
IQCODE test results (green rectangles) in the diagram.
How upto date is this review?
The evidence is up to date to January 2013.
Source: Adapted from Harrison JK, Fearon P, Noel- Storr AH, McShane R, Stott DJ, Quinn TJ.
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) for the diagnosis of
dementia within a secondary care setting. Cochrane Database of Systematic Reviews 2015;
3:CD010772.
397
Index
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Page locators in bold indicate tables. Page locators in italics indicate figures. This index uses
letter-by-letter alphabetization.
2x2 tables
data collection 134–135, 141–144, 142, 143,
145–146, 149–150, 161
measures of test accuracy
68,69
meta-analysis
presenting findings 330
study design
abstracts
conference abstracts 132
data collection 132, 144
literature searches 98–100, 108, 112, 119–120
acceptability criteria 55–56
add-on tests 79
adverse events
advisory groups 12
Akaike’s information criterion (AIC) 223
algorithmic search features 103, 119
allocation sequence
applicability see risk of bias and applicability
assessment
area under the curve (AUC) 66, 113, 309
atypical data sets 296–305, 297–298, 302, 303,
305
AUC see area under the curve
author contact 108, 134–135
Authors’ conclusions 350, 369–374
author team
criteria for authorship 12
importance of the team 11
219, 236, 297, 316
49
151
54, 56–57, 57,
179
incorporating relevant perspectives and
stakeholder involvement
planning a systematic review of test
accuracy
bias see individual bias types; risk of bias and
applicability assessment
bibliographic databases 101–104, 119, 121
binary data 54
BIOSIS Previews
bivariate model 215–219, 218, 218
analysis with small numbers of
studies
Bayesian estimation in rjags
287–291, 290–291, 316–317, 318
comparing index tests
237–238, 237
comparison of summary points
estimation of a summary point 251–266
fitting model using R 256–260, 284–287,
299–301
fitting model using SAS 251–253, 274–280,
276, 298–299
fitting model using Stata 253–256, 280–284,
283,299
generating an SROC plot 265, 276
imperfect reference standards 316–321,
318,320
investigating heterogeneity 222–230, 225, 226
monitoring convergence
317,318
11–13
103
238–239
12–13
261–263, 263,
231–232, 233, 233,
272–291
263–264, 270,
Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy, First Edition. Edited by
Jonathan J. Deeks, Patrick M. Bossuyt, Mariska M. Leeflang and Yemisi Takwoingi.
© 2023 The Cochrane Collaboration. Published 2023 by John Wiley & Sons Ltd.
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