| Literature DB >> 21255429 |
Fausto Catena1, Salomone Di Saverio, Michael D Kelly, Walter L Biffl, Luca Ansaloni, Vincenzo Mandalà, George C Velmahos, Massimo Sartelli, Gregorio Tugnoli, Massimo Lupo, Stefano Mandalà, Antonio D Pinna, Paul H Sugarbaker, Harry Van Goor, Ernest E Moore, Johannes Jeekel.
Abstract
BACKGROUND: There is no consensus on diagnosis and management of ASBO. Initial conservative management is usually safe, however proper timing for discontinuing non operative treatment is still controversial. Open surgery or laparoscopy are used without standardized indications.Entities:
Year: 2011 PMID: 21255429 PMCID: PMC3037327 DOI: 10.1186/1749-7922-6-5
Source DB: PubMed Journal: World J Emerg Surg ISSN: 1749-7922 Impact factor: 5.469
STARD checklist for the reporting of studies of diagnostic accuracy
| Section and Topic | Item # | |
|---|---|---|
| TITLE/ABSTRACT/KEYWORDS | 1 | Identify the article as a study of diagnostic accuracy (recommended MeSH heading 'sensitivity and specificity') |
| INTRODUCTION | 2 | State the research questions or study aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups |
| METHODS | ||
| 3 | Describe the study population: The inclusion and exclusion criteria, setting and locations where the data were collected | |
| 4 | Describe participant recruitment: Was recruitment based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests or the reference standard? | |
| 5 | Describe participant sampling: Was the study population a consecutive series of participants defined by the selection criteria in items 3 and 4? If not, specify how participants were further selected | |
| 6 | Describe data collection: Was data collection planned before the index test and reference standard were performed (prospective study) or after (retrospective study)? | |
| 7 | Describe the reference standard and its rationale | |
| 8 | Describe technical specifications of material and methods involved including how and when measurements were taken, and/or cite references for index tests and reference standard | |
| 9 | Describe definition of and rationale for the units, cutoffs and/or categories of the results of the index tests and the reference standard | |
| 10 | Describe the number, training and expertise of the persons executing and reading the index tests and the reference standard | |
| 11 | Describe whether or not the readers of the index tests and reference standard were blind (masked) to the results of the other test and describe any other clinical information available to the readers | |
| 12 | Describe methods for calculating or comparing measures of diagnostic accuracy, and the statistical methods used to quantify uncertainty (e.g. 95% confidence intervals) | |
| RESULTS | 13 | Describe methods for calculating test reproducibility, if done |
| 14 | Report when study was done, including beginning and ending dates of recruitment | |
| 15 | Report clinical and demographic characteristics of the study population (e.g. age, sex, spectrum of presenting symptoms, comorbidity, current treatments, recruitment centers | |
| 16 | Report the number of participants satisfying the criteria for inclusion that did or did not undergo the index tests and/or the reference standard; describe why participants failed to receive either test (a flow diagram is strongly recommended) | |
| 17 | Report time interval from the index tests to the reference standard, and any treatment administered between | |
| 18 | Report distribution of severity of disease (define criteria) in those with the target condition; other diagnoses in participants without the target condition | |
| 19 | Report a cross tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard | |
| 20 | Report any adverse events from performing the index tests or the reference standard | |
| 21 | Report estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals) | |
| 22 | Report how indeterminate results, missing responses and outliers of the index tests were handled. | |
| 23 | Report estimates of variability of diagnostic accuracy between subgroups of participants, readers or centers, if done. | |
| DISCUSSION | 24 | Report estimates of test reproducibility, if done |
| 25 | Discuss the clinical applicability of the study findings | |
MeSH: Medical subject heading
STARD: STAndards for the Reporting of Diagnostic accuracy studies
This checklist is found at:http://www.consort-statement.org/index.aspx?o=2965 and http://www.consort-statement.org/index.aspx?o=2967
Categories of evidence (refer to levels of evidence and grades of recommendations on the homepage of the Centre for Evidence-Based Medicine) http://www.cebm.net/index.aspx?o=1025 Oxford Centre for Evidence-based Medicine Levels of Evidence (March 2009) (for definitions of terms used see glossary at http://www.cebm.net/?o=1116)
| Level | Therapy/Prevention, Aetiology/Harm | Prognosis | Diagnosis | Differential diagnosis/symptom prevalence study | Economic and decision analyses |
|---|---|---|---|---|---|
| 1a | SR (with homogeneity*) of RCTs | SR (with homogeneity*) of inception cohort studies; CDR† validated in different populations | SR (with homogeneity*) of Level 1 diagnostic studies; CDR† with 1b studies from different clinical centres | SR (with homogeneity*) of prospective cohort studies | SR (with homogeneity*) of Level 1 economic studies |
| 1b | Individual RCT (with narrow Confidence Interval‡) | Individual inception cohort study with > 80% follow-up; CDR† validated in a single population | Validating** cohort study with good††† reference standards; or CDR† tested within one clinical centre | Prospective cohort study with good follow-up**** | Analysis based on clinically sensible costs or alternatives; systematic review(s) of the evidence; and including multi-way sensitivity analyses |
| 1c | All or none§ | All or none case-series | Absolute SpPins and SnNouts†† | All or none case-series | Absolute better-value or worse-value analyses †††† |
| 2a | SR (with homogeneity*) of cohort studies | SR (with homogeneity*) of either retrospective cohort studies or untreated control groups in RCTs | SR (with homogeneity*) of Level >2 diagnostic studies | SR (with homogeneity*) of 2b and better studies | SR (with homogeneity*) of Level >2 economic studies |
| 2b | Individual cohort study (including low quality RCT; e.g., <80% follow-up) | Retrospective cohort study or follow-up of untreated control patients in an RCT; Derivation of CDR† or validated on split-sample§§§ only | Exploratory** cohort study with good††† reference standards; CDR† after derivation, or validated only on split-sample§§§ or databases | Retrospective cohort study, or poor follow-up | Analysis based on clinically sensible costs or alternatives; limited review(s) of the evidence, or single studies; and including multi-way sensitivity analyses |
| 2c | "Outcomes" Research; Ecological studies | "Outcomes" Research | Ecological studies | Audit or outcomes research | |
| 3a | SR (with homogeneity*) of case-control studies | SR (with homogeneity*) of 3b and better studies | SR (with homogeneity*) of 3b and better studies | SR (with homogeneity*) of 3b and better studies | |
| 3b | Individual Case-Control Study | Non-consecutive study; or without consistently applied reference standards | Non-consecutive cohort study, or very limited population | Analysis based on limited alternatives or costs, poor quality estimates of data, but including sensitivity analyses incorporating clinically sensible variations. | |
| 4 | Case-series (and poor quality cohort and case-control studies§§) | Case-series (and poor quality prognostic cohort studies***) | Case-control study, poor or non-independent reference standard | Case-series or superseded reference standards | Analysis with no sensitivity analysis |
| 5 | Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" | Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" | Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" | Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles" | Expert opinion without explicit critical appraisal, or based on economic theory or "first principles" |
Produced by Bob Phillips, Chris Ball, Dave Sackett, Doug Badenoch, Sharon Straus, Brian Haynes, Martin Dawes since November 1998. Updated by Jeremy Howick March 2009.
Notes
Users can add a minus-sign "-" to denote the level of that fails to provide a conclusive answer because:
a single result with a wide Confidence Interval
a Systematic Review with troublesome heterogeneity.
Such evidence is inconclusive, and therefore can only generate Grade D recommendations.
* By homogeneity we mean a systematic review that is free of worrisome variations (heterogeneity) in the directions and degrees of results between individual studies. Not all systematic reviews with statistically significant heterogeneity need be worrisome, and not all worrisome heterogeneity need be statistically significant. As noted above, studies displaying worrisome heterogeneity should be tagged with a "-" at the end of their designated level.
† Clinical Decision Rule. (These are algorithms or scoring systems that lead to a prognostic estimation or a diagnostic category.)
‡ See note above for advice on how to understand, rate and use trials or other studies with wide confidence intervals.
§ Met when all patients died before the Rx became available, but some now survive on it; or when some patients died before the Rx became available, but none now die on it.
§§ By poor quality cohort study we mean one that failed to clearly define comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both exposed and non-exposed individuals and/or failed to identify or appropriately control known confounders and/or failed to carry out a sufficiently long and complete follow-up of patients. By poor quality case-control study we mean one that failed to clearly define comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both cases and controls and/or failed to identify or appropriately control known confounders.
§§§ Split-sample validation is achieved by collecting all the information in a single tranche, then artificially dividing this into "derivation" and "validation" samples.
†† An "Absolute SpPin" is a diagnostic finding whose Specificity is so high that a Positive result rules-in the diagnosis. An "Absolute SnNout" is a diagnostic finding whose Sensitivity is so high that a Negative result rules-out the diagnosis.
‡‡ Good, better, bad and worse refer to the comparisons between treatments in terms of their clinical risks and benefits.
††† Good reference standards are independent of the test, and applied blindly or objectively to applied to all patients. Poor reference standards are haphazardly applied, but still independent of the test. Use of a non-independent reference standard (where the 'test' is included in the 'reference', or where the 'testing' affects the 'reference') implies a level 4 study.
†††† Better-value treatments are clearly as good but cheaper, or better at the same or reduced cost. Worse-value treatments are as good and more expensive, or worse and the equally or more expensive.
** Validating studies test the quality of a specific diagnostic test, based on prior evidence. An exploratory study collects information and trawls the data (e.g. using a regression analysis) to find which factors are 'significant'.
*** By poor quality prognostic cohort study we mean one in which sampling was biased in favour of patients who already had the target outcome, or the measurement of outcomes was accomplished in <80% of study patients, or outcomes were determined in an unblinded, non-objective way, or there was no correction for confounding factors.
**** Good follow-up in a differential diagnosis study is >80%, with adequate time for alternative diagnoses to emerge (for example 1-6 months acute, 1 - 5 years chronic)
Grading system for ranking recommendations in clinical guidelines
| Grade of recommendation | |
|---|---|
| A | Good evidence to support a recommendation for use |
| B | Moderate evidence to support a recommendation for use |
| C | Poor evidence to support a recommendation, or the effect may not exceed the adverse effects and/or inconvenience (toxicity, interaction between drugs and cost) |
| D | Moderate evidence to support a recommendation against use |
| E | Good evidence to support a recommendation against use |