Download Accuracy and completeness of reporting of studies

Even in the top journals the quality of diagnostic test accuracy studies in
infectious diseases is medium
Almeida LFM
Saraiva JC
Abreu MI
Lima RFP
[email protected] [email protected] [email protected] [email protected]
Carvalho AEM
Gomes DL
Gonçalves JS
João AR
[email protected] [email protected] [email protected] [email protected]
Barros MSP
Monteiro SSO
[email protected] [email protected]
Adviser: Santos CMN, [email protected]. Class: 9
Abstract
Introduction: Several studies report that the quality of diagnostic test accuracy
studies is poor. In 2003, Standards for Reporting Diagnostic Accuracy (STARD) statement
was published, giving a guideline to the structure of these studies.
Aim: Evaluate the quality of diagnostic accuracy studies in infectious diseases in
high impact factor journals, between 1995 and 2006.
Methods: English-language papers on diagnostic accuracy studies in infectious
diseases were found with an eligible query in MEDLINE. Articles were randomly selected
and two independent reviewers agreed to include them on the study, in order to have 10
articles per year (95-06). Again two independent reviewers evaluate the quality of the
studies using STARD checklist and summing the number of reported items. The evolution of
the quality was evaluated by a Spearman correlation coefficient.
Results: 111 articles were included. Mean STARD score was 15.5 (St. deviation,
3.65). The Spearman correlation coefficient is 0.2 (p = 0.036). 50% or more of the studies
didn’t report 8 very important items.
Discussion: The quality of reporting in infectious diseases diagnostic accuracy
studies is medium, even in high impact factor journals. It is recommended to the authors,
editors and reviewers to use the STARD checklist as well as a flow diagram. The
reproducibility of the test should also be analysed.
Key words: infection, diagnostic tests, sensitivity and specificity
Introduction
Over the past decade, awareness of the importance of the quality of reporting of
research articles has increased. Several meta-analysis studies have emphasized the poor
quality of research reports.[1] Key aspects of design and results, such as a patient flow and
adverse events, are often lacking in primary research articles.[1-7] As if to get around this
1
issue, guidelines have been established in order to improve the reporting of diagnostic
accuracy studies. The presentation of a flow diagram also improved the quality of reporting
of randomised controlled trials.[8] In January 2003, guidelines for the reporting of studies on
diagnostic accuracy (STARD statement) were published simultaneously in eight medical
journals (Radiology, American Journal of Clinical Pathology, Annals of Internal Medicine,
British Medical Journal, Clinical Biochemistry, Clinical Chemistry, Clinical Chemistry of
Laboratory Medicine, and Lancet).[9,10,11] The STARD statement contains a checklist of 25
items and encourages the use of a flow diagram to represent the design of the study and the
flow of patients through the study.[9,10] These items were identified by an extensive search
in the literature by the STARD steering committee and subsequently reviewed during a
two-day consensus meeting with researchers, editors, and members of professional
organizations.[9,10]
Since the publication, on January 2003, of the STARD checklist many quality
studies on reporting diagnostic accuracy tests were made, as well as meta-analyses. Still,
there weren’t at the present date any papers in medical literature about this on the subject of
infectious diseases, so the main goal of this paper was doing an evaluation of the quality of
reporting studies of diagnostic tests accuracy in infectious diseases literature published in
high impact factor journals between 1995 and 2006 and see if there was any improvement
after STARD publication (2003).
Methods
Data Sources
In order to proceed with an evaluation of this sort in infectious diseases a systematic
bibliographic review was carried on.
Eligible papers for this study were acquired trough Medline, using a base query on
Pub MED. This query states expressions that usually figure in diagnostic tests accuracy
evaluations, based in a query proposed by Devillé et al
[12],
and other words related to
infectious diseases’ theme (infectious diseases, infection, contamination, contagious).
Then the query was limited to 13 journals with impact factor greater than five, 8
from a table regarding the “Top 50 Journals That Frequently Publish Articles on Diagnostic
2
Accuracy”[11] (see annex)- Circulation, Lancet, BMJ, New England Journal of Medicine,
Archives of Internal Medicine, Annals of Internal Medicine, Gut, JAMA – and 5 from the
table of highest impact factor journals in infectious diseases retrieved “ISI Web of
Knowledge” (2005) - Emerging Infectious Diseases, Clinical Infectious Diseases, AIDS,
The Lancet Infectious Diseases, Antiviral Therapy. The search was also limited to
publications from 1995 to 2006.
A random sample of studies was done in each year in order to include 10 articles per
year in this study, so that the evolution of the quality of the diagnostic accuracy studies, the
impact of STARD statement after its publication and the possible similarities between
STARD items and pre-STARD studies could be analysed.
Selection of Studies
The data found was distributed among the ten reviewers. Each abstract was read by
two reviewers. The two of them agreed that the paper should be introduced in the study and
explained why. Disagreements were discussed and resolved, by this reviewers and a third
one, in a consensus meeting.
The papers should be included if they report an evaluation of the diagnostic tests
accuracy in infectious diseases. They should be written in English.
Data extraction
The participant studies were assigned among ten reviewers. Every single paper was
read by two different people as if to improve the reliability of the evaluation. A consensus
evaluation was obtained by discussing and resolving disagreements between the two
reviewers and a third one.
Evaluation of the studies’ quality
For evaluation of the studies quality the STARD checklist was used. The 25 items
of this checklist are divided in 5 groups (Title/ Abstract/ keywords, Introduction, Methods,
Results, Discussion) and some of them have subgroups that regard the important aspects
that should be present in this kind of studies like the criteria of the study population choice
3
as well as the date and place of recruitment, the type of study, characteristics of the study
population, statistical methods, how the test is evaluated, the clinical applicability, etc. A
total STARD score for each paper was calculated by summing the number of reported items
(0-25 points available; one point for each item). Higher scores indicated better quality of
reporting.
Statistical Analysis
The reproducibility of this study was analysed, between the abstracts reviewers, by
a proportion of agreement (PA) and a kappa statistics and, between the full texts reviewers,
by an intraclass correlation coefficient (ICC) and a Bland and Altman limit.
In order to assess the quality of all the participant studies, the reviewers used the 25
items of the STARD statement. After calculating the STARD score for each study, an
average score per year was done. The normal distribution of the STARD items was checked
with a histogram and a Kolmogorov- Smirnov test.
Spearman correlation coefficient between STARD score and year was done, so that
the evolution of the quality of diagnostic test accuracy studies could be analysed.
Statistical analysis was performed by using SPSS for Windows 14.0.
Results
Studies’ inclusion
With the mentioned base query at Pub MED 2128 papers were retrieved. The
number of papers found per year is regarded in table 1.
After the application of inclusion criteria in abstract review, 111 studies were
selected (10 studies in each year, except 1996 – 6 studies and 1998 – 3 studies). The
agreement between the reviewers was good (PA = 0.89; kappa statistic, 0.77).
Studies’ analysis
The mean of STARD score is 15.5 and the mean of this score per year is in table 1.
Here the inter-reviewer agreement was also satisfactory (ICC, 0,92; Bland and Altman
4
limit, [-2.6, 2.9]). The distribution of STARD items is normal according KolmogorovSmirnov test (p = 0.0383).
Table 1 - STARD score
Papers
Year of publication
found
N
Mean
Std. Deviation
1995
95
10
14.0
1.49
1996
92
8
13.8
2.49
1997
114
10
13.6
2.99
1998
104
3
15.7
3.51
1999
121
10
17.6
3.53
2000
96
10
17.4
4.81
2001
125
10
14.9
4.25
2002
132
10
14.0
3.06
2003
112
10
15.1
4.61
2004
161
10
18.0
2.00
2005
143
10
16.8
2.74
2006
138
10
14.7
4.17
Total
1433
111
15.5
3.65
Throughout the years the STARD score increased very slightly (Spearman
correlation coefficient, 0.2; p = 0.036). However, the mean of STARD score in the post
STARD triennial (04/06; mean, 16.5) is inferior to the triennial 98/00 (17.3), although it is
greater than the triennials 01/03 (14.7) and 95/97 (13.8).
Frequency of STARD items evaluation
The graph in figure 1 shows the frequency of STARD items in the analysed studies.
50% of the studies or more didn’t report: the number, training and expertise of the persons
executing and reading the index tests and the reference standard (item 10); whether or not
the readers of the index tests and reference standard were blind to the results of the other
5
test and describe other clinical information available to the readers (item 11); methods for
calculating test reproducibility (item 13); when study was done, including beginning and
ending dates of recruitment (item 14); time interval from the index tests to the reference
standard, and any treatment administered between (item 17); any adverse events from
performing the index tests or the reference standard (item 20); how indeterminate results,
missing responses, and outliers were handled (item 22); estimates of test reproducibility
(item 24).
The items 10,11,13,14 and 20 are the least present in all triennials analysed.
Even though the item 16 (The number of participants satisfying the criteria for
inclusion that did or did not undergo the index tests/or the reference standard; describe why
participants failed to receive either test (a flow diagram is strongly recommended)) is
present in 60,4% of the studies analysed, only 8 studies have a flow diagram.
Discussion
The results of this study indicate that the quality of diagnostic test accuracy studies
between 1995 and 2006 is medium, even in journals with a high impact factor (mean, 15.5;
std. deviation, 3.65).
6
Although the spearman correlation coefficient is positive (0.2, p=0.036), the quality
of the studies throughout the years didn’t improve very much and consequences of STARD
publication haven’t been seen yet. In fact, the quality of the studies in post-STARD
triennial is inferior than in the triennial 1998/2000, in which STARD statement publication
didn’t have influence.
In this study, it was also verifiable that the majority of the studies analysed didn’t
report some methods and results that are indispensable to the reader decide whether that is
or isn’t a good diagnostic test. For a doctor who wants to know if a diagnostic test is
efficient, it is extremely important that its diagnostic accuracy study is well reported,
because if it isn’t how could the doctor believe in the contents of the study?
In order to improve the quality of the reporting studies it is essential that the authors
pay attention to the STARD checklist, specially to those items which have been poorly
reported, such as the number of the persons executing the tests, if the readers are or aren’t
blind to the results, date and place of population recruitment, population characteristics,
adverse events and indeterminate results and how they were handled. All the STARD items
are important, but a large number of studies lacked those described above.
There are other two items that frequently were not reported in the studies – the items
about the reproducibility of the test (items 13 and 24). These two items are facultative in
the STARD checklist, however we think that they shouldn’t be, because if agreement
among the raters is good the test could be good as well, on the other hand if the their
agreement is poor, the usefulness of the test is limited [16].
As it was referred in the results, the number of participants satisfying the inclusion
criteria that did or didn’t undergo the index tests or the reference standard wasn’t the least
reported item, but the use of a flow diagram is rare, which is something that needs to be
improved, because a flow diagram turns this explanation more simple and pleasant for the
reader.
The STARD guidelines are not the first to focus on the reporting of studies.
CONSORT, QUORUM, and MOOSE have emphasized the importance of better reporting
of other study designs
[11-15]
, so that authors should pay attention to these guidelines, in
order to improve the report of their studies.
7
The STARD statement focuses on the quality of reporting, not the methodological
quality of the diagnostic study. For example, if the authors reported that the readers of the
index tests and reference standard were not blind to other results, the item 11 is well
reported, although it is methodological incorrect. Nevertheless, the quality of reporting a
study may be associated to the quality of this study methods. It is easier to report on a wellperformed study than on a study that was poorly design or in which a large number of
deviations occurred. Moreover, in the latter case, the authors may be less inclined to report
in detail what happened. Increase attention to the quality of reporting and strict
requirements for reporting in journals might, in the long term, thus also improve the quality
of diagnostic research [11].
Although other studies about the quality of reporting in diagnostic test accuracy
have been published, this one is the first on the subject of infectious diseases. This study
has a fewer limitations, because the query used to search in MEDLINE may have missed
some studies, even though a random sample was used. In years 1996 and 1998, only six and
three articles, respectively, were included what could be a deviation because they were
compared with years with 10 studies each. However, all the abstracts of those years found
with the query were read and only this limited number of studies could be included.
Finally it is strongly recommended that authors, editors and reviewers use the
STARD checklist to write and review a diagnostic accuracy studies and, even though it is
facultative in this checklist, the reproducibility of the test should be reported as well as the
use of a flow diagram. Hopefully this will lead to an improvement of reporting in the future
and, in a longer term, to better diagnostic tests.
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Annex
1. Query used on Pubmed:
(((((((("sensitivity and specificity"[All Fields] OR "sensitivity and
specificity/standards"[All Fields]) OR "specificity"[All Fields]) OR
"screening"[All Fields]) OR "false positive"[All Fields]) OR "false
negative"[All Fields]) OR "accuracy"[All Fields]) OR (((("predictive
value"[All Fields] OR "predictive value of tests"[All Fields]) OR
"predictive value of tests/standards"[All Fields]) OR "predictive
values"[All Fields]) OR "predictive values of tests"[All Fields])) OR
(("reference value"[All Fields] OR "reference values"[All Fields]) OR
"reference values/standards"[All Fields]) OR ((((((((((("roc"[All Fields]
OR "roc analyses"[All Fields]) OR "roc analysis"[All Fields]) OR "roc
and"[All Fields]) OR "roc area"[All Fields]) OR "roc auc"[All Fields]) OR
"roc characteristics"[All Fields]) OR "roc curve"[All Fields]) OR "roc
curve method"[All Fields]) OR "roc curves"[All Fields]) OR "roc
estimated"[All Fields]) OR "roc evaluation"[All Fields]) OR ("likelihood
ratio"[All Fields])) AND ((( “infectious diseases”[All Fields] OR
“infection”[All Fields] OR “contagious”[All Fields] OR
“contamination”[All Fields]) AND ("Circulation"[Jour] OR Lancet[Jour] OR
"BMJ"[Jour] OR "The New England journal of medicine"[Jour] OR "Archives
of internal medicine"[Jour] OR "Annals of internal medicine"[Jour] OR
"Gut"[Jour] OR "JAMA : the journal of the American Medical
Association"[Jour])) OR ("The Lancet infectious diseases"[Jour] OR
"Clinical infectious diseases : an official publication of the Infectious
Diseases Society of America"[Jour] OR "AIDS"[Jour] OR "Emerging
infectious diseases"[Jour] OR "Antiviral therapy"[Jour])) NOT
(review[Publication Type] OR letter[Publication Type])
10
2. Table used to choose some of the journals
11
3. References of the participant studies
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