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Background: Bowel symptoms are considered indicators of the presence of colorectal cancer and other bowel diseases. Self administered questionnaires that elicit information about lower bowel symptoms have not been assessed for reliability, although this has been done for upper bowel symptoms. Our aim was to develop a self administered questionnaire for eliciting the presence, nature and severity of lower bowel symptoms potentially related to colorectal cancer, and assess its reliability.Methods: Immediately before consulting a gastroenterologist or colorectal surgeon, 263 patients likely to have a colonoscopy completed the questionnaire. Reliability was assessed in two ways: by assessing agreement between patient responses and (a) responses given by the doctor at the consultation; and (b) responses given by patients two weeks later.Results: There was more than 75% agreement for 78% of the questions for the patient-doctor comparison and for 92% of the questions for the patient-patient comparison. Agreement for the length of time a symptom was present, its severity, duration, frequency of occurrence and whether or not medical consultation had been sought, all had agreement of greater than 70%. Over all questions, the chance corrected agreement for the patient-doctor comparison had a median kappa of 65% (which represents substantial agreement), interquartile range 57-72%. The patient-patient comparison also showed substantial agreement with a median kappa of 75%, interquartile range 68-81%.Conclusion: This self administered questionnaire about lower bowel symptoms is a useful way of eliciting details of bowel symptoms. It is a reliable instrument that is acceptable to patients and easily completed. Its use could guide the clinical consultation, allowing a more efficient, comprehensive and useful interaction, ensuring that all symptoms are assessed. It will also be a useful tool in research studies on bowel symptoms and their predictive value for colorectal cancer and other diseases. Studies assessing whether bowel symptoms predict the presence of colorectal cancer should provide estimates of the reliability of the symptom elicitation. [ABSTRACT FROM AUTHOR]

Background: Magnetic resonance imaging (MRI) may guide breast cancer surgery by measuring residual tumor size post-neoadjuvant chemotherapy (NAC). Accurate measurement may avoid overly radical surgery or reduce the need for repeat surgery. This individual patient data (IPD) meta-analysis examines MRI's agreement with pathology in measuring the longest tumor diameter and compares MRI with alternative tests., Methods: A systematic review of MEDLINE, EMBASE, PREMEDLINE, Database of Abstracts of Reviews of Effects, Heath Technology Assessment, and Cochrane databases identified eligible studies. Primary study authors supplied IPD in a template format constructed a priori. Mean differences (MDs) between tests and pathology (i.e. systematic bias) were calculated and pooled by the inverse variance method; limits of agreement (LOA) were estimated. Test measurements of 0.0 cm in the presence of pathologic residual tumor, and measurements >0.0 cm despite pathologic complete response (pCR) were described for MRI and alternative tests., Results: Eight studies contributed IPD (N = 300). The pooled MD for MRI was 0.0 cm (LOA: +/-3.8 cm). Ultrasound underestimated pathologic size (MD: -0.3 cm) relative to MRI (MD: 0.1 cm), with comparable LOA. MDs were similar for MRI (0.1 cm) and mammography (0.0 cm), with wider LOA for mammography. Clinical examination underestimated size (MD: -0.8 cm) relative to MRI (MD: 0.0 cm), with wider LOA. Tumors "missed" by MRI typically measured 2.0 cm or less at pathology; tumors >2.0 cm were more commonly "missed" by clinical examination (9.3 %). MRI measurements >5.0 cm occurred in 5.3 % of patients with pCR, but were more frequent for mammography (46.2 %)., Conclusions: There was no systematic bias in MRI tumor measurement, but LOA are large enough to be clinically important. MRI's performance was generally superior to ultrasound, mammography, and clinical examination, and it may be considered the most appropriate test in this setting. Test combinations should be explored in future studies.

Background: Measures of clinical utility (net benefit and event free life years) have been recommended in the assessment of a new predictor in a risk prediction model. However, it is not clear how they relate to the measures of predictive ability and reclassification, such as the c-statistic and Net Reclassification Improvement (NRI), or how these measures are affected by differences in mean risk between populations when a fixed cutpoint to define high risk is assumed., Methods: We examined the relationship between measures of clinical utility (net benefit, event free life years) and predictive ability (c-statistic, binary c-statistic, continuous NRI(0), NRI with two cutpoints, binary NRI) using simulated data and the Framingham dataset., Results: In the analysis of simulated data, the addition of a new predictor tended to result in more people being treated when the mean risk was less than the cutpoint, and fewer people being treated for mean risks beyond the cutpoint. The reclassification and clinical utility measures showed similar relationships with mean risk when the mean risk was less than the cutpoint and the baseline model was not strong. However, when the mean risk was greater than the cutpoint, or the baseline model was strong, the reclassification and clinical utility measures diverged in their relationship with mean risk.Although the risk of CVD was lower for women compared to men in the Framingham dataset, the measures of predictive ability, reclassification and clinical utility were both larger for women. The difference in these results was, in part, due to the larger hazard ratio associated with the additional risk predictor (systolic blood pressure) for women., Conclusion: Measures such as the c-statistic and the measures of reclassification do not capture the consequences of implementing different prediction models. We do not recommend their use in evaluating which new predictors may be clinically useful in a particular population. We recommend that a measure such as net benefit or EFLY is calculated and, where appropriate, the measure is weighted to account for differences in the distribution of risks between the study population and the population in which the new predictors will be implemented.

In 1996, shortly after the founding of The Cochrane Collaboration, leading figures in test evaluation research established a Methods Group to focus on the relatively new and rapidly evolving methods for the systematic review of studies of diagnostic tests. Seven years later, the Collaboration decided it was time to develop a publication format and methodology for Diagnostic Test Accuracy (DTA) reviews, as well as the software needed to implement these reviews in The Cochrane Library. A meeting hosted by the German Cochrane Centre in 2004 brought together key methodologists in the area, many of whom became closely involved in the subsequent development of the methodological framework for DTA reviews. DTA reviews first appeared in The Cochrane Library in 2008 and are now an integral part of the work of the Collaboration.

Background: The aim of this project was to investigate the reliability of a new 11-item quality appraisal tool for studies of diagnostic reliability (QAREL). The tool was tested on studies reporting the reliability of any physical examination procedure. The reliability of physical examination is a challenging area to study given the complex testing procedures, the range of tests, and lack of procedural standardisation., Methods: Three reviewers used QAREL to independently rate 29 articles, comprising 30 studies, published during 2007. The articles were identified from a search of relevant databases using the following string: "Reproducibility of results (MeSH) OR reliability (t.w.) AND Physical examination (MeSH) OR physical examination (t.w.)." A total of 415 articles were retrieved and screened for inclusion. The reviewers undertook an independent trial assessment prior to data collection, followed by a general discussion about how to score each item. At no time did the reviewers discuss individual papers. Reliability was assessed for each item using multi-rater kappa (κ)., Results: Multi-rater reliability estimates ranged from κ = 0.27 to 0.92 across all items. Six items were recorded with good reliability (κ > 0.60), three with moderate reliability (κ = 0.41 - 0.60), and two with fair reliability (κ = 0.21 - 0.40). Raters found it difficult to agree about the spectrum of patients included in a study (Item 1) and the correct application and interpretation of the test (Item 10)., Conclusions: In this study, we found that QAREL was a reliable assessment tool for studies of diagnostic reliability when raters agreed upon criteria for the interpretation of each item. Nine out of 11 items had good or moderate reliability, and two items achieved fair reliability. The heterogeneity in the tests included in this study may have resulted in an underestimation of the reliability of these two items. We discuss these and other factors that could affect our results and make recommendations for the use of QAREL.

Background: People vary in how they respond to symptoms. The purpose of this study was to assess whether serious disease is more likely to be present in patients who report that they take any symptoms less seriously than other people do, and to assess the reliability of a question which can be used to identify the extent to which patients take any symptom seriously. To do this we assessed whether the likelihood of detecting colorectal cancer is higher in patients who report that they take symptoms less seriously than other people do., Methods: Cross sectional study of 7736 patients who had colonoscopy to find colorectal cancer. Before colonoscopy, patients completed a questionnaire on bowel symptoms and were also asked: "Compared to other people of your age and sex, how seriously do you think you take any symptoms?" Likelihood of detecting colorectal cancer according to responses to this question was assessed by logistic regression models, unadjusted and adjusted for symptoms and other known predictors of colorectal cancer.Question reliability was assessed in a different sample using percentage agreement and the kappa statistic for the answers given by each patient on two occasions. Agreement between patient and doctor responses was also assessed (n = 108)., Results: Patients who reported they took symptoms less seriously were 3.28 (95%CI: 2.02, 5.33) times more likely to have colorectal cancer than patients who took symptoms more seriously than others. The effect was smaller (1.85 (95%CI: 1.11, 3.09)), but remained statistically significant in models including symptoms and other predictors of colorectal cancer. The question was reliable: on repeat questioning, 70% of responses were in absolute agreement and 92% were within 1 category, kappa 57%. Patient-doctor agreement was 66%, within 1 category 92%, kappa 48%., Conclusion: Patients who take their symptoms less seriously have a considerably higher likelihood of colorectal cancer than those who identify themselves as taking any symptoms more seriously than other people. The question is easy to ask and has good reliability. Doctors also reliably identify how patients assess themselves. Assessment of how seriously patients take any symptoms can contribute to the clinical assessment of a patient.

Background: Colonoscopy is an invasive and costly procedure with a risk of serious complications. It would therefore be useful to prioritise colonoscopies by identifying people at higher risk of either cancer or premalignant adenomas. The aim of this study is to assess a model that identifies people with colorectal cancer, advanced, large and small adenomas., Methods: Patients seen by gastroenterologists and colorectal surgeons between April 2004 and December 2006 completed a validated, structured self-administered questionnaire prior to colonoscopy. Information was collected on symptoms, demographics and medical history. Multinomial logistic regression was used to simultaneously assess factors associated with findings on colonoscopy of cancer, advanced adenomas and adenomas sized 6 -9 mm, and ≤ 5 mm. The area under the curve of ROC curve was used to assess the incremental gain of adding demographic variables, medical history and symptoms (in that order) to a base model that included only age., Results: Sociodemographic variables, medical history and symptoms (from 8,204 patients) jointly provide good discrimination between colorectal cancer and no abnormality (AUC 0.83), but discriminate less well between adenomas and no abnormality (AUC advanced adenoma 0.70; other adenomas 0.67). Age is the dominant risk factor for cancer and adenomas of all sizes. Having a colonoscopy within the last 10 years confers protection for cancers and advanced adenomas., Conclusions: Our models provide guidance about which factors can assist in identifying people at higher risk of disease using easily elicited information. This would allow colonoscopy to be prioritised for those for whom it would be of most benefit.

Background: Cancer is a major cause of mortality and morbidity in patients with chronic kidney disease (CKD). In patients without kidney disease, screening is a major strategy for reducing the risk of cancer and improving the health outcomes for those who developed cancers by detecting treatable cancers at an early stage. Among those with CKD, the effectiveness, the efficacy and patients' preferences for cancer screening are unknown., Methods/design: This work describes the protocol for the DETECT study examining the effectiveness, efficiency and patient's perspectives of colorectal cancer screening using immunochemical faecal occult blood testing (iFOBT) for people with CKD. The aims of the DETECT study are 1) to determine the test performance characteristics of iFOBT screening in individuals with CKD, 2) to estimate the incremental costs and health benefits of iFOBT screening in CKD compared to no screening and 3) to elicit patients' perspective for colorectal cancer screening in the CKD population. Three different study designs will be used to explore the uncertainties surrounding colorectal cancer screening in CKD. A diagnostic test accuracy study of iFOBT screening will be conducted across all stages of CKD in patients ages 35-70. Using individually collected direct healthcare costs and outcomes from the diagnostic test accuracy study, cost-utility and cost-effective analyses will be performed to estimate the costs and health benefits of iFOBT screening in CKD. Qualitative in-depth interviews will be undertaken in a subset of participants from the diagnostic test accuracy study to investigate the perspectives, experiences, attitudes and beliefs about colorectal cancer screening among individuals with CKD., Discussion: The DETECT study will target the three major unknowns about early cancer detection in CKD. Findings from our study will provide accurate and definitive estimates of screening efficacy and efficiency for colorectal cancer, and will allow better service planning and budgeting for early cancer detection in this at-risk population.The DETECT study is also registered with the Australia New Zealand Clinical Trials Registry ACTRN12611000538943.

Background: Bowel symptoms are often considered an indication to perform colonoscopy to identify or rule out colorectal cancer or precancerous polyps. Investigation of bowel symptoms for this purpose is recommended by numerous clinical guidelines. However, the evidence for this practice is unclear. The objective of this study is to systematically review the evidence about the association between bowel symptoms and colorectal cancer or polyps., Methods: We searched the literature extensively up to December 2008, using MEDLINE and EMBASE and following references. For inclusion in the review, papers from cross sectional, case control and cohort studies had to provide a 2×2 table of symptoms by diagnosis (colorectal cancer or polyps) or sufficient data from which that table could be constructed. The search procedure, quality appraisal, and data extraction was done twice, with disagreements resolved with another reviewer. Summary ROC analysis was used to assess the diagnostic performance of symptoms to detect colorectal cancer and polyps., Results: Colorectal cancer was associated with rectal bleeding (AUC 0.66; LR+ 1.9; LR- 0.7) and weight loss (AUC 0.67, LR+ 2.5, LR- 0.9). Neither of these symptoms was associated with the presence of polyps. There was no significant association of colorectal cancer or polyps with change in bowel habit, constipation, diarrhoea or abdominal pain. Neither the clinical setting (primary or specialist care) nor study type was associated with accuracy.Most studies had methodological flaws. There was no consistency in the way symptoms were elicited or interpreted in the studies., Conclusions: Current evidence suggests that the common practice of performing colonoscopies to identify cancers in people with bowel symptoms is warranted only for rectal bleeding and the general symptom of weight loss. Bodies preparing guidelines for clinicians and consumers to improve early detection of colorectal cancer need to take into account the limited value of symptoms.