Biomedical subjects

Constantine A Gatsonis

Publications and source records attributed to Constantine A Gatsonis.

At least 19 recordsLinked to original sources

PubMed2006

Diagnostic architectural and dynamic features at breast MR imaging: multicenter study.

PURPOSE: To prospectively determine the prevalence and predictive value of three-dimensional (3D) and dynamic breast magnetic resonance (MR) imaging and contrast material kinetic features alone and as part of predictive diagnostic models. MATERIALS AND METHODS: The study protocol was approved by the institutional review board or ethics committees of all participating institutions, and informed consent was obtained from all participants. Although study data collection was performed before HIPAA went into effect, standards that would be compliant with HIPAA were adhered to. Data from the International Breast MR Consortium trial 6883 were used in the analysis. Women underwent 3D (minimum spatial resolution, 0.7 x 1.4 x 3 mm; minimal temporal resolution, 4 minutes) and dynamic two-dimensional (temporal resolution, 15 seconds) MR imaging examinations. Readers rated enhancement shape, enhancement distribution, border architecture, enhancement intensity, presence of rim enhancement or internal septations, and the shape of the contrast material kinetic curve. Regression was performed for each feature individually and after adjustment for associated mammographic findings. Multivariate models were also constructed from multiple architectural and dynamic features. Areas under the receiver operating characteristic curve (Az values) were estimated for all models. RESULTS: There were 995 lesions in 854 women (mean age, 53 years +/- 12 [standard deviation]; range, 18-80 years) for whom pathology data were available. The absence of enhancement was associated with an 88% negative predictive value for cancer. Qualitative characterization of the dynamic enhancement pattern was associated with an Az value of 0.66 across all lesion architectures. Focal mass margins (Az = 0.76) and signal intensity (Az = 0.70) were highly predictive imaging features. Multivariate models were constructed with an Az value of 0.880. CONCLUSION: Architectural and dynamic features are important in breast MR imaging interpretation. Multivariate models involving feature assessment have a diagnostic accuracy superior to that of qualitative characterization of the dynamic enhancement pattern.

Adolescent↗

PubMed2005

MRI detection of distinct incidental cancer in women with primary breast cancer studied in IBMC 6883.

BACKGROUND: Prior single institution studies suggest MRI may improve the assessment of the extent of cancer within the breast, and thus reduce the risk of leaving macroscopic disease in the breast following breast conservation therapy. We report on the rate of MRI and mammography detection of foci of distinct incidental cancer in a prospective, multi center trial involving 426 women with confirmed breast cancer at 15 institutions in the US, Canada, and Germany. METHODS: Women underwent mammography and MRI prior to biopsy of the suspicious index lesion. Additional incidental lesions (IL) greater than 2 cm from the index lesion that were detected by mammography and MRI were noted and characterized. Biopsy recommendations were associated with ILs given an assessment of suspicious or highly suspicous (BiRads 4 and 5). These assessments were considered a positive test. RESULTS: MRI had a significantly higher yield of confirmed cancer ILs than mammography (0.18 (95%CI: 0.142-0.214) for MRI versus 0.072 (95%CI: 0.050-0.100) for mammography). The cancer ILs detected by MRI alone appeared to be similar to those detected by mammography with respect to size and histology. The percentage of biopsies of ILs that resulted in a cancer diagnosis was similar between the modalities (MRI 0.72(95%CI: 0.6-0.81); Mammography 0.85 (95%CI: 0.62-0.96)). CONCLUSIONS: These results suggest that consideration needs to be given regarding the integration of breast MRI into the pretreatment evaluation of women seeking breast conservation therapy.

Biopsy↗

PubMed2005

American College of Radiology Imaging Network digital mammographic imaging screening trial: objectives and methodology.

This study was approved by the Institutional Review Board (IRB) of the American College of Radiology Imaging Network (ACRIN) and each participating site and by the IRB and the Cancer Therapy Evaluation Program at the National Cancer Institute. The study was monitored by an independent Data Safety and Monitoring Board, which received interim analyses of data to ensure that the study would be terminated early if indicated by trends in the outcomes. The ACRIN, which is funded by the National Cancer Institute, conducted the Digital Mammographic Imaging Screening Trial (DMIST) primarily to compare the diagnostic accuracy of digital and screen-film mammography in asymptomatic women presenting for screening for breast cancer. Over the 25.5 months of enrollment, a total of 49 528 women were included at the 33 participating sites, which used five different types of digital mammography equipment. All participants underwent both screen-film and digital mammography. The digital and screen-film mammograms of each subject were independently interpreted by two radiologists. If findings of either examination were interpreted as abnormal, subsequent work-up occurred according to the recommendations of the interpreting radiologist. Breast cancer status was determined at biopsy or follow-up mammography 11-15 months after study entry. In addition to the measurement of diagnostic accuracy by using the interpretations of mammograms at the study sites, DMIST included evaluations of the relative cost-effectiveness and quality-of-life effects of digital versus screen-film mammography. Six separate reader studies using the de-identified archived DMIST mammograms will also assess the diagnostic accuracy of each of the individual digital mammography machines versus screen-film mammography machines, the effect of breast density on diagnostic accuracy of digital and screen-film mammography, and the effect of different rates of breast cancer on the diagnostic accuracy in a reader study.

Breast Neoplasms↗

PubMed2004

Magnetic resonance imaging of the breast prior to biopsy.

CONTEXT: Breast magnetic resonance imaging (MRI) has been shown to have high sensitivity for cancer detection and is increasingly used following mammography to evaluate suspicious breast lesions. OBJECTIVE: To determine the accuracy of breast MRI in conjunction with mammography for the detection of breast cancer in patients with suspicious mammographic or clinical findings. DESIGN, SETTING, AND PATIENTS: Prospective multicenter investigation of the International Breast MR Consortium conducted at 14 university hospitals in North America and Europe from June 2, 1998, through October 31, 2001, of 821 patients referred for breast biopsy for American College of Radiology category 4 or 5 mammographic assessment or suspicious clinical or ultrasound finding. INTERVENTIONS: MRI examinations performed prior to breast biopsy; MRI results were interpreted at each site, which were blinded to pathological results. MAIN OUTCOME MEASURES: Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of breast MRI. RESULTS: Among the 821 patients, there were 404 malignant index lesions, of which 63 were ductal carcinoma in situ (DCIS) and 341 were invasive carcinoma. Of the 417 nonmalignant index lesions, 366 were benign, 47 showed atypical histology, and 4 were lobular carcinoma in situ. The AUC pooled over all institutions was 0.88 (95% confidence interval [CI], 0.86-0.91). MRI correctly detected cancer in 356 of 404 cancer cases (DCIS or invasive cancer), resulting in a sensitivity of 88.1% (95% CI, 84.6%-91.1%), and correctly identified as negative for cancer 281 of 417 cases without cancer, resulting in a specificity of 67.7% (95% CI, 62.7%-71.9%). MRI performance was not significantly affected by mammographic breast density, tumor histology, or menopausal status. The positive predictive values for 356 of 492 patients was 72.4% (95% CI, 68.2%-76.3%) and of mammography for 367 of 695 patients was 52.8% (95% CI, 49.0%-56.6%) (P<.005). Dynamic MRI did not improve the AUC compared with 3-dimensional MRI alone, but the specificity of a washout pattern for 123 of 136 patients without cancer was 90.4% (95% CI, 84%-95%). CONCLUSIONS: Breast MRI has high sensitivity but only moderate specificity independent of breast density, tumor type, and menopausal status. Although the positive predictive value of MRI is greater than mammography, MRI does not obviate the need for subsequent tissue sampling in this setting.

Adult↗

PubMed2004

Stereotactic and sonographic large-core biopsy of nonpalpable breast lesions: results of the Radiologic Diagnostic Oncology Group V study.

RATIONALE AND OBJECTIVES: To determine the diagnostic accuracy of stereotactically and sonographically guided core biopsy (CB) for the diagnosis of nonpalpable breast lesions. MATERIALS AND METHODS: Twenty-two institutions enrolled 2,403 women who underwent imaging-guided fine needle aspiration followed by imaging-guided large-CB of nonpalpable breast abnormalities. All mammograms were reviewed for study eligibility by one of two breast imaging radiologists. The protocol for image-guided biopsy, using either ultrasound (USCB) or stereotactic (SCB) guidance, was standardized at all institutions and all biopsy specimens were over-read by one of three expert pathologists. Patients with atypical ductal hyperplasia (ADH), atypical lobular hyperplasia, or lobular neoplasia on CB underwent surgical excision. Those with negative CB but suspicious ("discordant") pre-biopsy mammography also underwent surgical excision. Patients having a negative CB that was concordant with the pre-biopsy mammography suspicion were assigned to follow-up mammography at 6, 12, and 24 months following CB. RESULTS: A gold standard diagnosis based on definitive histopathologic diagnosis, mammography follow-up, or an imputed gold standard diagnosis was established for 1,681 patients. Of 310 cases with a gold standard diagnosis of invasive breast carcinoma, 261 (84.2%) were invasive carcinoma, 31 (10%) were ductal carcinoma in situ (DCIS), four (1.3%) were ADH, one (0.3%) was a non-breast cancer, and 13 (4.2%) were benign on CB. For 138 cases with a gold standard diagnosis of DCIS, 113 (81.9%) were DCIS, 20 (14.5%) were ADH, and five (3.6%) were benign on CB. For 57 cases (13 masses, 44 calcifications) with an initial CB diagnosis of ADH, atypical lobular hyperplasia or lobular neoplasia, 20 (35.1%) had a gold standard diagnosis of DCIS (4 masses, 16 calcifications) and four (7.0%) had a gold standard diagnosis of invasive cancer (4 calcifications). Of 144 cases (22 masses, 122 calcifications) with an initial CB diagnosis of DCIS, 31 (21.5%) had a gold standard diagnosis of invasive cancer (10 masses, 21 calcifications). The sensitivity, specificity and accuracy for CB by either imaging guidance method in this trial were .91, 1.00, and .98, respectively. The sensitivity, predictive value negative, and accuracy of CB for diagnosing masses (.96, .99, and .99, respectively) were significantly greater (P < .001) than for calcifications (.84, .94, and .96, respectively). The sensitivity (.89) of SCB for diagnosing all lesions was significantly lower (P = 0.029) than that of USCB (.97) because of the preponderance of calcifications biopsied by SCB versus USCB. There was no difference between USCB and SCB in sensitivity, predictive value negative, or accuracy for the diagnosis of masses (97.3, 98.9, and 99.2, respectively for USCB; 95.6, 98.5, and 98.9 respectively for SCB). CONCLUSION: Percutaneous, imaged-guided core breast biopsy is an accurate diagnostic alternative to surgical biopsy in women with mammographically detected suspicious breast lesions.

Adult↗

PubMed2004

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: Our aim was to improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalizability of its results. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation and/or the reference standard. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve, to the advantage of clinicians, researchers, reviewers, journals and the public.

Bias↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.

BACKGROUND: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors. OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in the study and to evaluate its generalizability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, methodologists and statisticians, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

PubMed2003

The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalizability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding, and dissemination of the checklist. The document contains a clarification of the meaning, rationale, and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.

Algorithms↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in a study, and to evaluate a study's generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two day consensus meeting, with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25 item checklist, by using evidence, whenever available. A prototype of a flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation and the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the STARD checklist and flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

PubMed2003

Toward complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

RATIONALE AND OBJECTIVES: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, and analysis of such studies. The authors sought to develop guidelines for improving the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers better to assess the validity and generalizability of study results. MATERIALS AND METHODS: The Standards for Reporting of Diagnostic Accuracy group steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and to extract potential guidelines for authors and editors. An extensive list of items was prepared. Members of the steering committee then met for 2 days with other researchers, editors, methodologists, statisticians, and members of professional organizations to develop a checklist and a prototypical flowchart to guide authors and editors of studies of diagnostic accuracy. RESULTS: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which the group produced an initial list of 75 items. This list was honed to 25 key items by group consensus and on the basis of published research on bias. A prototypical flowchart was developed as a tool for conveying information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference test, or both. Potential users reviewed the conference version of the checklist and flowchart and provided additional suggestions, which were then incorporated. CONCLUSION: Use of these carefully developed, consensus-based guidelines should enable clearer and more complete reporting of studies of diagnostic accuracy, as well as better reader understanding of the validity and generalizability of study results.

Bias↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering group searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, using evidence, whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

BACKGROUND: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalizability of its results. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals and the public.

Diagnostic Errors↗

PubMed2003

Toward complete and accurate reporting of studies of diagnostic accuracy. The STARD initiative.

Our objective was to improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study, and to evaluate its generalizability. The Standards for Reporting of Diagnostic Accuracy Steering Committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, using evidence whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference standard, or both. Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve, to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy.

BACKGROUND: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors. OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

PubMed2003

The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in healthcare.

Algorithms↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

PubMed2003

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalisability of its results. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗