Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_2767_Библиотеки_им_академика_М_И_Перельмана
.pdf
13.3 Contents andstructure ofa plain language summary
https://t.me/medicina_free
on how to approach writing a Cochrane plain language summary, including general
advice on writing in plain language (Pitcher 2021).
Key points include:
●
use everyday language;
●
avoid long words, research jargon, and words or phrases with dual or nuanced
meanings;
●
explain ‘common’ medical words and technical medical terms;
●
avoid acronyms and abbreviations;
●
write for an international audience;
●
keep paragraphs and sentences short (average of 20words);
●
use the active voice;
●
use pronouns;
●
use good verbs;
●
write numbers as numerals rather than words;
●
be concise; and
●
use subheadings and bullet points.
Research involving a range of user groups (Whiting 2018a) suggested that the following
terms and technical language should be avoided in plain language summaries of test
accuracy reviews:
●
sensitivity and specificity;
●
positive and negative likelihood ratio;
●
positive and negative predictive value; and
●
risk of bias, verification bias, review bias, spectrum bias.
The term bias is not well understood by lay audiences and sources of bias specific to
test accuracy reviews are unlikely to be familiar to lay audiences or health professionals. Bias can be explained in terms of its impact on test accuracy estimates and suggested language is provided in Section 13.3.8. Terms such as positive test result,
negative test result and reference standard require explanation in plain language summaries. Positive and negative test results are sometimes associated by lay audiences
with good and bad outcomes, respectively. Therefore, these terms require explanation
in terms of their potential implications for patient outcomes.
Textual and graphical approaches to presenting test accuracy are presented in
Section 13.3.7. You could consider using graphics to present test accuracy in the
findings section of the main review.
13.3 Contents andstructure ofa plain language summary
We suggest including the following subheadings in the plain language summary and
highlight key considerations for the content required under each subheading. We use
the example of a review evaluating the accuracy of rapid swab tests for the diagnosis
ofstrep sore throat in children (Cohen 2016), where the potential positive consequence
379
13 Writing aplain language summary
https://t.me/medicina_free
of rapid swab tests would be to reduce unnecessary antibiotic use. This example is
supplemented with alternative examples where needed to allow for different review
and data formats, and the appendix contains a complete example.
13.3.1 Title
The main review question should be written in plain language. If the review title includes
technical terms or jargon, consider re- writing it for the plain language summary. As a
minimum, the review title should contain information about the following three key
elements:
●
The test or tests being studied (index tests). It is important to ensure that the type
oftest being studied is clear (e.g. a questionnaire, a blood test, a swab, a urine test
orsome form of medical imaging). Avoid using acronyms or characteristics of the
index test, for example describing the index test as a ‘rapid’ test without including
information about test type.
●
The condition that the test (or tests) is designed to detect (the target condition).
●
The people who will receive the test (for example adults, children, people with certain
symptoms such as sore throat or low back pain). It may also be important to include
any restrictions on the healthcare setting where the test will be applied; for example,
if the test will only be used in hospital settings and not the community.
Examples of plain language summary title formats include:
‘How accurate is index test for target condition in healthcare setting/population?’
Rapid swab tests forstrep sore throat example
How accurate are rapid swab tests for strep sore throat in children?
13.3.2 Key messages
Use at least two and no more than three bullet points to summarize the main findings
and implications of the review.
Start with a brief summary statement regarding whether the results of the review
suggest that the index test has the potential to be useful to detect the target condition
inthe target population. This could be accompanied by a statement aboutthe potential
consequences of improved accuracy, no difference in accuracy or reduced accuracy, as
indicated by the review findings. If the evidence reviewed is not sufficient to draw a
conclusion, this should be stated here. For example, ‘It is unclear whether [index test]
can be used to detect [target condition] in [target population]’.
Important variation in test accuracy estimates, for example in different patient
groups, due to different test thresholds, or with different versions of the test, can also
be highlighted in this section. Where potential benefits from a reduction in test errors
need to be balanced against other test attributes, such as cost, time to result,
accessibility and acceptability, this can also be mentioned here. For example:
380
13.3 Contents andstructure ofa plain language summary
https://t.me/medicina_free
‘The studies included in this review suggest that index test can/cannot identify popula-
with target condition in setting. This may lead to consequences.
tion
Estimates were similar for different versions of the
Results suggest that
index test is likely to be less useful in setting 1 than in setting 2.’
index test.
Rapid swab tests forstrep sore throat example
●
The studies in this review suggest that rapid swab tests can detect most bacterial
infections (Strep A) in children with sore throats, leading to early and appropriate
treatment with antibiotics.
●
The number of children receiving unnecessary antibiotics following a rapid test is still
likely to be lower than the number of children who would receive unnecessary
antibiotics if the test is not used.
●
Both types of rapid tests studied in the review had similar accuracy.
13.3.3 ‘Why is improving [...] diagnosis important?’
This section should include information about the target condition and a description of
the potential consequences of false positive test errors and false negative test errors. It is
helpful to introduce the concept of test errors in this section ahead of presenting results.
●
What are the consequences of a false positive result (index test positive but target
condition absent, i.e. incorrectly labelling individuals who actually do not have the
condition as having the condition)?
●
What are the consequences of a false negative result (index test negative but target condition present, i.e. missing the condition in individuals who actually have the condition)?
For example:
‘[Describe target condition in terms of prevalence, morbidity, cost in the population of
interest].
Not recognizing target condition when it is present (a false negative test result) may
result in consequences of false negative.
An incorrect diagnosis of target condition (a false positive result) may result in conse-
quences of false positive
.’
Rapid swab tests forstrep sore throat example
Why is improving the diagnosis of bacterial throat infection important?
Sore throat is very common in children. It can be caused by viruses or bacteria. Antibiotic
treatment is only useful for sore throat caused by bacteria, most commonly group A
streptococcus (’strep throat’).
Not recognizing bacterial infection when it is present (a false negative test result) may
result in delayed recovery and an increased risk of infecting others. It may also result in
rare but serious complications such as abscesses in the throat, bacterial infection of the
sinuses and ears, and rheumatic fever.
An incorrect diagnosis of bacterial infection (a false positive test result) may mean that
children are given antibiotics when there is no benefit to be gained.
381
13 Writing aplain language summary
https://t.me/medicina_free
13.3.4 ‘What is the[...] test?’
This section should include a brief description of the index test and its proposed role in
the diagnostic pathway (see Chapter5).
●
What was the index test(s) addressed in the review? Give enough information for
readers to judge whether the test(s) being studied is relevant to them, for example
where in the clinical pathway the test is likely to be applied (the community, hospital),
who would conduct the test.
●
Describe how use of the index test might benefit individuals suspected of having the
target condition. For example, the index test may be more accurate, may provide
quicker results, or may be more accessible (less costly, require less expertise) than
tests currently in use.
●
Describe potential negative effects of using the index test. For example, the index test
may cause anxiety, pain, harms such as exposure to ionizing radiation, or be less
accessible than tests currently in use.
●
What is the role of the index test (e.g. triage, add- on, or replacement test; seeChapter5,
Section 5.3.1) (Bossuyt 2006)? Review authors should avoid using these technical
terms and instead describe how the index test would be placed in the current testing
pathway in relation to other tests.
●
If there is more than one index test included in a review, the plain language summary
should also explain how the tests differ. For example, one test may be quicker to give
results or easier to perform, tests may be produced by a different manufacturer or
require different processing techniques, one test may be a blood test and another a
swab test.
●
Describe the test result that indicates if the target condition is present (what is
considered a positive test result) or absent (what is considered a negative test
result).
Rapid swab tests forstrep sore throat example
What are rapid swab tests for strep sore throat?
Rapid swab tests require a simple throat swab taken by a nurse or doctor from the
patient. This gives an immediate result allowing clinicians to decide whether to prescribe antibiotics. This is an advantage compared to conventional laboratory tests,
which take 48 hours to give a result.
Two types of rapid swab tests were studied. These use different biochemical methods
to identify the bacterial infection.
13.3.5 What did wewant tofind out?
State the aim of the review as concisely and simply as possible. If the review compares
multiple index tests, then this should also be described.
382
13.3 Contents andstructure ofa plain language summary
https://t.me/medicina_free
‘We wanted to find out how accurate index test(s) is in setting/population.’
Rapid swab tests forstrep sore throat example
We wanted to find out how accurate rapid tests are for detecting bacterial infections in
children with sore throat.
Different imaging tests forcollapsed lung example
“We wanted to find out whether ultrasound imaging of the chest is better than an X- ray
of the chest for diagnosing acollapsed lung in patients who have suffered a physical
injury and present to the emergency department” (Chan2020).
13.3.6 What did wedo?
Briefly describe the review methods (for example, that the review searched for studies
with specific characteristics, summarizing their results and evaluating the evidence).
We suggest a sentence based on the following.
‘We searched for studies that had investigated the accuracy of index tests for target con-
dition in population and we combined the results across these studies.’
Rapid swab tests forstrep sore throat example
We searched for studies that had investigated the accuracy of rapid swab tests for
detecting bacterial infection in children and we combined the results across these
studies.
13.3.7 What did wefind?
This section should cover the number of included studies, the characteristics of the
included studies, and the main results of the review.
13.3.7.1 Describing theincluded studies
This section should describe briefly the number of included studies and total number
ofparticipants. To clarify that the number of participants applies to the sum total of
participants across included studies, it is helpful to structure this sentence as follows.
‘The review included # relevant studies with a total of # participants.’
Rapid swab tests forstrep sore throat example
The analysis included results from 98 studies that included 58,244 children with sore
throat.
383
13 Writing aplain language summary
https://t.me/medicina_free
‘The review included # relevant studies with a total of # participants. # studies (# participants) evaluated
Example where multiple index tests are evaluated
“The review included 34 studies with a total of 9339 participants. Thirty(8014 participants) evaluated chest CT; three studies evaluated chest Xticipants) and one study evaluated lung ultrasound (100 participants)” (Islam 2021).
index test 1 and # studies (# participants) evaluated index test 2.’
one studies
rays (1243 par-
When describing included studies in reviews containing multiple tests, different versions of the same test or test accuracy in different subgroups, review authors should
state the number of studies and number of participants contributing to each of the
index test evaluations.
This section should also provide a brief summary of the characteristics of included
studies as an indication of their applicability. The mean or median proportion of study
participants with the target condition across studies should be included, provided this
comes from single-
group studies. Multi- group studies (also known as diagnostic casecontrol studies) should not be included in this summary, because the proportions with
and without the target condition in such studies are determined by the researchers.
In addition, a brief summary of information on the applicability of the review findings
should be presented. This information may include the organization of healthcare services that might have an impact on the accessibility of index tests and participant characteristics, such as symptoms, disease severity, age, sex and prior tests received. Details
about how the index test is conducted, in terms of age or version of the technology,
specific assays or expertise of the persons conducting the test, can also be mentioned.
For example:
‘Studies were conducted in countries [comment on representativeness of geographical
location]
on presentation and variation across studies]. Overall, an average of # out of every 100
(#%) participants were found to have target condition with this number ranging from #
out of every 100 (#%) to # out of every 100 (#%).’
Rapid swab tests forstrep sore throat example
Studies included in the review were carried out in 25 countries with almost half conducted in the USA. Tests produced by42 different manufacturers were assessed. Children
in included studies appeared to have more severe disease than typically seen in the community. The average age of children was 7 years. Overall, an average of 29 out of every
100 (29%) children were found to have a bacterial throat infection, with this number
ranging from 10 out of every 100 (10%) to 67 out of every 100 (67%) across studies.
. The age range of participants/symptom severity/healthcare setting [comment
13.3.7.2 Presenting information ontest accuracy
When it is considered appropriate to present numerical estimates of accuracy (single or
summary estimates), the following are key points to consider.
Natural frequencies are better understood than probabilities (Gigerenzer 2011).
A natural frequency is a joint frequency of two events, such as the number of patients
384
13.3 Contents andstructure ofa plain language summary
https://t.me/medicina_free
with the target condition and a positive test result. We suggest presenting accuracy
based on a hypothetical group of individuals receiving the index test (e.g. 1000) with
a proportion with the target condition that reflects the settings in which the index test
is to be used.
●
Presenting accuracy with reference to the index test result (predictive values) rather
than actual disease status (sensitivity and specificity) may be preferred and more
relevant to potential recipients of the test.
●
Prominence should be given to test errors (false positives and false negatives) over
true- positive and true- negative test results (Whiting 2018a).
●
Keep numerical information to a minimum, while ensuring that the review objectives
(as stated in Section13.3.5) are addressed.
Chapter11 illustrates how to derive natural frequencies from summary estimates of
sensitivity and specificity from the systematic review and an estimate of the proportion
with the target condition in those undergoing testing.
13.3.7.3
Presenting single estimates ofaccuracy
Where it is considered appropriate to present numerical results, based on the key points
outlined we suggest the following template.
The results of these # studies indicate that if the index test were to be used in setting in a
group of 1000 people where # (#%) have target condition then:
●
An estimated [TP + FP] would have an index test result indicating target condition is
present and of these [FP] would be incorrectly classified as having the [target
condition].
●
Of the [TN + FN] people with a result indicating that target condition is not present,
FN would be incorrectly classified as not having target condition.
Rapid swab tests forstrep sore throat example
The results of these studies indicate that if rapid swab tests were to be used in a group of
1000 children with sore throats, of whom 300 (30%) are actually caused by bacterial
infection, then:
●
An estimated 289would have a rapid test result indicating that their sore throat is
caused by a bacterial infection; of these, 32 (11%) would not have a bacterial
infection.
●
An estimated 711 children would have a rapid test result indicating that their sore
throat is not caused by a bacterial infection; of these, 43 (6%) would actually have a
bacterial infection.
●
Both types of rapid test showed similar results.
To reduce numerical complexity, do not report confidence intervals in the plain language summary. Uncertainty in estimates of accuracy should be discussed as part of
plain language summaries; see Section13.3.8.
385
13 Writing aplain language summary
https://t.me/medicina_free
13.3.7.4 Presenting multiple estimates ofaccuracy: two index tests
A key objective of Cochrane Reviews of diagnostic test accuracy is comparison of test
accuracy. Here we suggest howthe user- tested template for presenting a single estimate of test accuracy might be modified for plain language summaries of reviews that
compare two tests and for reviews that compare more than two tests.
When the accuracy of two index tests is compared, review authors can extend the
basic template to report the accuracy of each test. For example:
Example where multiple index tests are evaluated
The results of these studies indicate that, in theory, if ultrasound of the chest was used
on a group of 100 patients where 30 (30%) have a collapsed lung:
●
An estimated 28would have an ultrasound result indicating the presence of collapsed lung
and of these one (3.6%) would be incorrectly classified as having a collapsed lung (FP).
●
Of the 72 patients with a result indicating that they do not have a collapsed lung,
three (4.2%) would actually have a collapsed lung (FN).
In contrast, if an X- ray of the chest was used on this same group of 100 patients where
30 (30%) have a collapsed lung:
●
An estimated 14would have a chest X- ray result indicating the presence of a collapsed
lung and none of these would be incorrectly classified as having a collapsed lung (FP).
●
Of the 86 patients with a result indicating that they do not have a collapsed lung,
16(18.6%) would actually have a collapsed lung (FN).
Source: Based on Chan 2020.
Alternatively, absolute differences in sensitivity and specificity between the index
tests could be illustrated in terms of the incremental change in the number of false
positives and false negatives. For example:
Alternative example: Two index tests, incremental difference inaccuracy
The results of these studies indicate that if Reflectance Confocal Microscopy (RCM) was
used in 1000lesions, of which 300 (30%) actually are melanoma:
●
An estimated 396would have an RCM result indicating that melanoma was present
and, of these, 126 (32%) would not be melanoma (false positive results); in the same
group of 1000lesions, dermoscopy would indicate that 406lesions were melanoma
when they were not (false positive results). RCM would therefore avoid unnecessary
surgery in an additional 280lesions compared to dermoscopy.
●
An estimated 604lesions would have an RCM result indicating that melanoma was
not present, of which 30 (5%) would actually be melanoma (false negatives); in the
same group, dermoscopy would indicate that melanoma was not present in
324lesions, of which 30 (9%) would actually be melanoma. The two tests would
therefore miss the same number of lesions that are actually melanoma.
Source: Based on Dinnes 2018.
386
13.3 Contents andstructure ofa plain language summary
https://t.me/medicina_free
13.3.7.5 Presenting multiple estimates ofaccuracy: more than two
index tests
Where more than two index tests are compared, the challenge is to balance complexity
of numerical presentation with effective and non- selective reporting of results. Review
authors may choose to report the accuracy of one test numerically, as outlined in the
single- test example above, while making a narrative statement about the comparative
accuracy of other included index tests. Review authors are advised to provide a statement about the accuracy of all included index tests to avoid the risk of selective reporting of results.
In the following plain language summary for rapid point- of- care molecular and antigen tests to diagnose COVID- 19 infection, a total of 5 different antigen tests and
13 molecular tests were included. The review authors provided more detail on the
larger volume of molecular test studies because they had less confidence in the smaller
number of more heterogeneous antigen test studies. For example:
Example where multiple index tests are evaluated
There was considerable variation in the number of false negative test results
(peoplein whom the test result indicated COVID- 19was absent when it was in fact
present) across included antigen test studies. Antigen tests very rarely suggested that
aperson without COVID- 19 actually had the disease (a small number of false positive
results).
For the molecular tests, the results of these studies suggested that if the tests were to
be used in a group of 1000 people of whom 100 actually have COVID-
19:
●
An estimated 105 people would have a test result indicating that they have
COVID- 19, and of these, 10 people (10%) would not have COVID- 19 (false positive
result).
●
An estimated 895 people would test negative for COVID- 19. Of these, 5 people (1%)
would actually have COVID- 19 (false negative result).
Source: Based on Dinnes 2020.
13.3.7.6
When presenting anumerical summary oftest accuracy is not
appropriate
Presentation of numerical estimates of test accuracy, even when accompanied by caveats about the volume of studies included, their risk of bias or applicability (Section13.3.7),
can misrepresent the trustworthiness of findings.
There may be valid reasons for not undertaking meta- analysis in a systematic review
of test accuracy; for example, where data are sparse or when there is a substantial unexplained heterogeneity. Where meta- analysis is not possible because of sparse data,
review authors may consider it appropriate to present the range of test accuracy
estimates observed across included studies as an indication of index test performance.
For example:
387
13 Writing aplain language summary
https://t.me/medicina_free
Example where numerical summaries are not presented
For detecting mild cognitive impairment, the results of these studies indicate that if
theACE-
III or mini- ACE were to be used in a group of 1000 people with suspected mild
cognitive impairment of whom 535 actually have mild cognitive impairment:
●
An estimated 440 to 675would have an ACE- III or mini- ACE result indicating the presence of mild cognitive impairment, and of these 98 to 167 (22% to 25%) would be
incorrectly classified as having mild cognitive impairment (false positive).
●
An estimated 325 to 560 people would have a result indicating the absence of mild
cognitive impairment, and of these 27 to 193 (8% to 34%) would actually have mild
cognitive impairment (false negative).
Source: Based on Beishon 2019.
Alternatively, in situations where a meta- analysis has not been conducted because to
do so would be inappropriate (for example, methodologically flawed studies or substantial heterogeneity), review authors may not consider it appropriate to present any
numerical estimates of test accuracy. For example:
Alternative example– no numerical estimate oftest accuracy presented
Two studies evaluated the use of devices within the mouth (4938 tooth surfaces) and
twostudies (59 tooth surfaces) evaluated the use of devices on extracted teeth. Due to
the small number of studies and differences between studies we could not provide an
overall combined summary of the accuracy of the different tests.
Source: Based on Fee 2020.
13.3.7.7 Graphical illustration oftest accuracy results
The use of graphics facilitates understanding of probabilistic information (Whiting
2015). An example of a test consequence graphic to complement the rapid swab tests
for strep sore throat plain language summary example is provided in Figure13.3.a and
Figure13.3.b (Whiting 2018b). A graphic could be included within the findings section of
the main review or a link to a graphic could be provided in the online version of a
Cochrane Review plain language summary (Macey 2020).
The graphic is populated using natural frequencies (see Chapter11), combined with
the information on the implications of positive (true positive and false positive) and
negative (true negative and false negative) index test results.
A limitation of the structure of the test consequence graphic presented in Figure13.3.a
and Figure 13.3.b is that it rapidly becomes complicated when estimates of test
accuracy for more than one index test are being presented.
388
Соседние файлы в папке Библиотека им академика М.И. Перельмана