a systematic review of the validity of endoscopic ultrasound for rectal carcinoma staging class 1:...
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A systematic review of the validity of endoscopic
ultrasound for rectal carcinoma staging
Class 1: Adília Rafael, Agostinho Cordeiro, Alberto Lourenço, Alexandre Sarmento, Ana Beatriz Noronha, Ana Carolina Afonso, Ana Catarina Gomes, Ana Catarina Pedrosa, Ana Cristina Duque, Ana Isabel Ponte
Supervisors: Altamiro da Costa Pereira, MD, PhD; Mário Dinis Ribeiro, MD, PhD
Introduction to Medicine; Porto Faculty of Medicine 2006
Index
1) Introduction
2) Objective
3) Material and Methods
3.1) Study design
3.2) Inclusion Criteria
3.3) Exclusion criteria
3.4) Bibliographic research
3.5) Methodological quality
3.6) Data extraction
5) Results
5.1) T Staging
5.2) N Staging
6) Conclusion
7) Website
8) Planning
9) Acknowledgements
► Rectal cancer is the cancer with the
highest rate of mortality within the
Portuguese population. [Pinheiro et al,
2003]
► More than 2000 scientific papers
published in the literature have
demonstrated EUS’s high accuracy for the
diagnosis and staging of rectal cancer.
[Fusaroli and Caletti, 2005]
► Rectal cancer is staged using Tumor-
Node-Metastasis (TNM) staging system.
[Savides and Master, 2002]
Introduction
Introduction
Stage Involves Management of cancer
T1 Mucosa/submucosa Transanal local resection
T2 Into the muscularis propria
Radical resection and/or postoperative
radiation
T3 Into the perirectal fat Preoperative chemo
radiation before radical resection
T4 Into adjacent organs
N1 Metastasis in 1 to 3 regional lymph nodes
N2 Metastasis in 4 or more regional lymph
nodes
Savides T, Master S. EUS in rectal cancer. Gastrointestinal Endoscopy, Vol 56, No 4, 2002.
► According to the EUS stage, the management of the cancer is different.
[Savides and Master, 2002]
To evaluate the validity and consistency of EUS for rectal carcinoma staging in relation to surgical specimens in identifying the patients as T3/T4 and N+.
Objective
Inclusion Criteria
Material and Methods
►The selected articles describe studies designed to evaluate the accuracy of endoscopic ultrasound (EUS) in rectal carcinoma staging.
►The accuracy of EUS is evaluated in a sample of patients with rectal carcinoma.
►The results of the application of EUS are compared to the surgical specimen (gold standard).
Study design► Systematic review
Material and Methods
Exclusion Criteria► The article describes a systematic review.
► The article uses a different reference standard.
► The article evaluates the accuracy of EUS in staging of other cancers rather than rectal carcinoma.
► The article does not allow the construction of a 2x2 table (for EUS and surgical specimen).
► The article is written in languages other than English, French, Spanish or Portuguese.
► The full paper is not available on the Internet, in the facilities of the Faculty of Medicine, IPO or in the local libraries.
Bibliographic Research:
A bibliographic research was carried out in Medline using the following query:
(((((((((("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(("Endoscopic Ultrasound" [All Fields] OR "Endosonography"[All Fields])
AND ("Rectal neoplasms"[All Fields] OR "Colorectal neoplasms"[All Fields]))
Material and Methods
► This query was based on a search strategy in PubMed (MEDLINE) for publications about
the evaluation of diagnostic accuracy, suggested by a research article:
Devillé, W. L. et. al., Conducting systematic reviews of diagnostic studies:
didactic guidelines
Start
Define query
167 articles obtained
Read titles and abstracts (2 reviewers)
Apply inclusion/exclusion criteria
Article excluded by both reviewers?
Article included by both reviewers?
Consult a third reviewer
Obtain full paper
34 full papers obtained
Read full paper (2 reviewers)
Apply inclusion/exclusion criteria
Article excluded by both reviewers?
Article included by both reviewers?
20 full papers selected
Extract data (2 reviewers)
Insert data into SPSS
Analyse data
End
Exclude article
No
Yes
NoYes
Yes No
Yes
Consult a third reviewer
No
Material and Methods
Methodological Quality:
Each article was submitted to evaluation by two reviewers, who
independently graded them as far as quality was concerned.
► Disagreements were solved by consensus or arbitration (by the
supervisor).
► Methodological quality was evaluated according to the Standard for
Reporting of Diagnostic Accuracy (STARD) checklist: Bossuyt, P. M.
et. al., Towards Complete and Accurate Reporting of Studies of
Diagnostic Accuracy: The STARD Initiative, Annals of Internal
Medicine Vol 138 – No1, 7 January 2003
Section and topic Describe
#
TITLE/ABSTRACT/KEYWORDS
1
The article as a study on diagnostic accuracy (recommend MeSH heading 'sensitivity and specificity')
INTRODUCTION2 The research question(s), such as estimating diagnostic accuracy or comparing accuracy between tests or across
participant groups
METHODS
Participants 3 The study population: the inclusion and exclusion criteria, setting(s) and location(s) where the data were collected
4 Participant recruitment: was this based on presenting symptoms, results from previous tests, or the fact that the participants had received the index test(s) or the reference standard?
5 Participant sampling: was this a consecutive series of patients defined by selection criteria in (3) and (4)? If not specify how patients were further selected.
6 Data collection: were the participants identified and data collected before the index test(s) and reference standards were performed (prospective study) or after (retrospective study)?
Reference standard
7The reference standard and its rationale
Test methods 8 Technical specification of material and methods involved including how and when measurements were taken, and/or cite references for index test(s) and reference standard
9 Definition and rationale for the units, cutoffs and/or categories of the results of the index test(s) and the reference standard
10
The number, training and expertise of the persons (a) executing and (b) reading the index test(s) and the reference standard
11
Whether or not the reader(s) of the index test(s) and reference standard were blind (masked) to the results of the other test(s) and describe any information available to them
STARD checklist
Material and Methods
Statistical methods 12 Methods for calculating measures of diagnostic accuracy or making comparisons, and the statistical methods used to quantify uncertainty (e.g. 95% confidence intervals)
13 Methods for calculating test reproducibility, if done
RESULTS
Participants 14 When study was done, including beginning and ending dates of recruitment
15 Clinical and demographic characteristics (e.g. age, sex, spectrum of presenting symptom(s), comorbidity, current treatment(s), recruitment center)
16 How many participants satisfying the criteria for inclusion did or did not undergo the index test and/or the reference standard; describe why participants failed to receive either test (a flow diagram is strongly recommended)
Reference standard 17 Time interval and any treatment administered between index and reference standard
18 Distribution of severity of disease (define criteria) in those with the target condition; describe other diagnoses in participants without the target condition
Test results 19 A cross tabulation of the results of the index test(s) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard
20 Indeterminate results, missing responses and outliers of index test(s) stratified by reference standard result and how they were handled
21 Adverse events of index test(s) and reference standard
Estimation 22 Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals)
23 Estimates of variability of diagnostic accuracy between subgroups of participants, readers or centers, if done
24 Measures of test reproducibility, if done
DISCUSSION 25 The clinical applicability of the study findings
Material and Methods
Bossuyt, P. M. et. al., Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative, Annals
of Internal Medicine Vol 138 – nº1, 7 January 2003
Material and Methods
Data extracted
► Information about the study : location, initial number of
participants, final number of participants, including mean
age and number of feminine and masculine participants.
► Results: number of true positives, false positives, true
negatives and false positives in TNM staging.
► Information about the equipment used: type of
instrument, brand, number of operators.
► Quality assessment: presence or absence of the items in
STARD checklist.
ArticleAkasu T, 1997Sailer M, 1997Maldjian C, 1998Nishimori H, 1998Blomquist L, 1999Lee P, 1999Hunerbein M, 1999Kazuya A, 2000Akasu T, 2000Gualdi F, 2000Hunerbein M, 2000Akahoshi K, 2001Kalantzis C, 2002Starck M, 2002Scott R, 2002Tseng Y, 2002Garcia-Aguilar J, 2002Fuchsjager M, 2002Bali C, 2004Hurlstone P, 2005
164154147049346339154263015980604586545283152
20181613162015161671491718181617181816
Final number of
participants
Quality (STARD checklist items)
Brand of instrumentused
OlympusCombisonOlympusOlympusOlympusB&KB&KMissing valueMissing valueMissing valueMissing valueMissing valueOlympusB&KOlympusOlympusMissing valueMissing valueB&KOlympus
Results
T staging:
Specificity (articles ordered by date of publication)
Results
Results
Sensitivity
Results
Specificity and Sensitivity (articles ordered by final number of participants in the study)
Number of participants>60
Results
Specificity and Sensitivity (articles ordered by brand of instrument used in the study)
Number of participants>60 and using Olympus
ResultsN-staging:
Specificity (articles ordered by date of publication)
Results
Sensitivity
Results
Specificity and Sensitivity (articles ordered by final number of participants in the study)
Number of participants>60
Results
Specificity and Sensitivity (articles ordered by brand of instrument used in the study)
Conclusion
As far as T staging (T1+T2 vs T3+T4), EUS validity results are
heterogenous across studies.
► However, when more than 60 patients and Olympus instruments are used both high sensitivity = 0.95 and high specificity = 0.87 are found.
T Staging
► The results were very heterogeneous
► Although no pooled results can be used, a high specificity was found in studies with more than 60 participants included.
N Staging
Conclusion
Some limitations in our study may be the cause of
some heterogeneity
► Only the articles written in English, French, Spanish
and Portuguese were read;
► The research was performed in a single database -
Medline;
► The articles obtained were collected from IPO,
Faculty of Medicine and the Internet, neglecting all
other possible sources.
Conclusion
It seems that beyond training, further
improvement in N staging should be studied:
redefinition of N involvement in EUS
EUS improvement (new instruments)
EUS is more accurate in defining T stage (wall involvement)
than N stage.
Website
Planning
Planning
Professor Altamiro da Costa Pereira
Professor Mário Dinis Ribeiro
Acknowledgements