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PubMed2006

Feasibility and cost efficiency of a diagnostic guideline for chronic polyneuropathy: a prospective implementation study.

BACKGROUND: Extensive investigations are often performed to reveal the cause of chronic polyneuropathy. It is not known whether a restrictive diagnostic guideline improves cost efficiency without loss of diagnostic reliability. METHODS: In a prospective multicentre study, a comparison was made between the workup in patients with chronic polyneuropathy before and after guideline implementation. RESULTS: Three hundred and ten patients were included: 173 before and 137 after guideline implementation. In all patients, the diagnosis would remain the same if the workup was limited to the investigations in the guideline. After guideline implementation, the time to reach a diagnosis decreased by two weeks. There was a reduction of 33% in the number and costs of routine laboratory investigations/patient, and a reduction of 27% in the total number of laboratory tests/patient, despite low guideline adherence. CONCLUSION: The implementation of a diagnostic guideline for chronic polyneuropathy can reduce diagnostic delay and the number and costs of investigations for each patient without loss of diagnostic reliability. Continuous evaluation strategies after guideline implementation may improve guideline adherence and cost efficiency.

Chronic Disease↗
PubMed1998

Diagnostic value of sural nerve biopsy in chronic inflammatory demyelinating polyneuropathy.

OBJECTIVE: To investigate the additional diagnostic value of sural nerve biopsy of 64 patients in whom chronic inflammatory demyelinating polyneuropathy (CIDP) was considered, as sural nerve biopsy is recommended in the research criteria of an ad hoc subcommittee to diagnose CIDP. METHODS: Firstly, the additional diagnostic value of sural nerve biopsy was analysed with multivariate logistic regression. Six clinical features (remitting course, symmetric sensorimotor neuropathy in arms and legs, areflexia, raised CSF protein concentration, nerve conduction studies consistent with demyelination, and absence of comorbidity or relevant laboratory abnormalities) were entered into a logistic model. Afterwards, all significant features identified from this model, as well as the results of sural nerve biopsy were forced into a second logistic model. Secondly, the diagnostic performance of a neurologist experienced in diagnosis of peripheral nerve disorders was studied by receiver operating characteristics (ROC) curve analysis. RESULTS: The results of the first logistic analysis showed that CSF protein concentration >1 g/l (odds ratio (OR)=38.5) and neurophysiological studies consistent with demyelination (OR=51.7) were strong predictors of CIDP. When forcing the significant features and the sural nerve biopsy data into the model, an independent predictive value of sural nerve biopsy could not be found. The neurologist was able to discriminate patients with and without CIDP (area under the curve (AUC)=0.95). His diagnostic performance did not improve significantly by offering him the results of sural nerve biopsy. CONCLUSION: Any additional diagnostic value of sural nerve biopsy in the diagnosis of CIDP could not be shown.

Adolescent↗
PubMed1993

Diagnostic rigid and flexible oesophagoscopy in carcinoma of the oesophagus: a comparison.

BACKGROUND: Flexible oesophagoscopy is regarded as superior to rigid oesophagoscopy on the basis of perforation rates as an end point. This advantage may be more apparent than real because no comparison has been made in a diagnostic setting in patients with carcinoma of the oesophagus with both perforation rate and diagnostic efficacy as indices. METHODS: A retrospective analysis was carried out on data on 336 diagnostic oesophagoscopies in patients with carcinoma of the oesophagus, comparing rigid with flexible oesophagoscopy. RESULTS: Both rigid and flexible oesophagoscopies were performed without perforation when they were used for diagnosis only. Rigid biopsy achieved a diagnostic success rate of 99.3%, compared with 80.5% for flexible oesophagoscopy. CONCLUSIONS: Diagnostic oesophagoscopy can be achieved without perforation with either instrument, but the chance of diagnosing carcinoma was significantly greater with the rigid instrument.

Biopsy↗
PubMed2004

131I therapeutic efficacy is not influenced by stunning after diagnostic whole-body scanning.

PURPOSE: To determine if stunning can be seen with a 185-MBq (5-mCi) dose of iodine 131 (131I) at diagnostic whole-body scanning and, if stunning is seen, determine if there is any 131I therapeutic efficacy. MATERIALS AND METHODS: A retrospective review of findings involving 166 patients who underwent thyroidectomy for differentiated thyroid carcinoma was performed. Diagnostic 131I scans were compared with postablation scans for evidence of stunning. Stunning was defined when the diagnostic scan showed activity that was subsequently decreased on the postablation scan. The sample population was divided into two groups: group NS, patients with no stunning, and group S, patients with stunning. Patients were considered successfully treated if no functioning thyroid tissue and/or metastases were seen on follow-up diagnostic scans. Fisher exact and Student t tests were used to evaluate the statistical significance of therapy success rates, clinical characteristics, and scanning parameters between the two groups. RESULTS: Group NS included 135 (81.3%) of 166 patients, with 36 (26.7%) of 135 lost to follow-up. Group S included 31 (18.7%) of 166 patients, with eight (26%) of 31 patients lost to follow-up. There was no significant difference (P =.61) in treatment success rates between group NS (87 of 99, 88%) and group S (21 of 23, 91%). The treatment success rates for thyroid remnants were 87% (48 of 55) for group NS and 91% (10 of 11) for group S (P =.63). Treatment success rates for metastases (mostly lymph nodes) were 89% (39 of 44) for group NS and 83% (10 of 12) for group S (P =.55). CONCLUSION: Thyroid stunning can occur with 185 MBq of 131I in diagnostic imaging. However, data did not show any effect of stunning on the efficacy of 131I therapy for differentiated thyroid carcinoma.

Adenocarcinoma, Follicular↗
PubMed2005

Quality of reporting of diagnostic accuracy studies.

PURPOSE: To evaluate quality of reporting in diagnostic accuracy articles published in 2000 in journals with impact factor of at least 4 by using items of Standards for Reporting of Diagnostic Accuracy (STARD) statement published later in 2003. MATERIALS AND METHODS: English-language articles on primary diagnostic accuracy studies in 2000 were identified with validated search strategy in MEDLINE. Articles published in journals with impact factor of 4 or higher that regularly publish articles on diagnostic accuracy were selected. Two independent reviewers evaluated quality of reporting by using STARD statement, which consists of 25 items and encourages use of a flow diagram. Total STARD score for each article was calculated by summing number of reported items. Subgroup analyses were performed for study design (case-control or cohort study) by using Student t tests for continuous outcomes and chi(2) tests for dichotomous outcomes. RESULTS: Included were 124 articles published in 2000 in 12 journals: 33 case-control and 91 cohort studies. Only 41% of articles (51 of 124) reported on more than 50% of STARD items, while no articles reported on more than 80%. A flow chart was presented in two articles. Assessment of reporting on individual items of STARD statement revealed wide variation, with some items described in 11% of articles and others in 92%. Mean STARD score (0-25 points available) was 11.9 (range, 3.5-19.5). Mean difference in STARD score between cohort studies and case-control studies was 1.53 (95% confidence interval: 0.24, 2.82). CONCLUSION: Quality of reporting in diagnostic accuracy articles published in 2000 is less than optimal, even in journals with high impact factor. Authors, editors, and reviewers should pay more attention to reporting by checking STARD statement items and including a flow diagram to represent study design and patient flow.

Case-Control Studies↗
PubMed2006

Developmental dysplasia of the hip: quality of reporting of diagnostic accuracy for US.

PURPOSE: To systematically review the quality of diagnostic accuracy reporting in studies on the use of ultrasonography (US) for the diagnosis of developmental dysplasia of the hip (DDH). MATERIALS AND METHODS: A systematic review of the MEDLINE, EMBASE, DARE, and Cochrane Library databases was performed by using a validated search strategy. Two independent reviewers evaluated articles by using the Standards for Reporting of Diagnostic Accuracy (STARD) and Quality Assessment of Studies of Diagnostic Accuracy included in Systematic Reviews (QUADAS) statements. Items were reported individually for STARD and QUADAS because these instruments do not incorporate a summary score. A simple kappa statistic with 95% confidence intervals was used to measure the level of agreement between the two reviewers. RESULTS: Ten studies were included. In three studies, reliability was investigated, and in seven studies elements of both validity and reliability were investigated. In no study did the authors adequately report more than 40% of the STARD items. The quality of methods that were used in the studies was poor. Only one (14%) of seven studies provided information on more than 50% of the QUADAS items. All studies included a good description of image acquisition, but data analysis was imperfect and lacked estimates of diagnostic accuracy and precision. Authors tended to overinterpret their results. CONCLUSION: Overall, there was imperfect reporting of diagnostic accuracy in studies on the use of US for diagnosis of DDH.

Hip Dislocation, Congenital↗
PubMed1996

A receiver operating characteristic partial area index for highly sensitive diagnostic tests.

PURPOSE: Area under a receiver operating characteristic (ROC) curve (Az) is widely used as an index of diagnostic performance. However, Az is not a meaningful summary of clinical diagnostic performance when high sensitivity must be maintained clinically. The authors developed a new ROC partial area index, which measures clinical diagnostic performance more meaningfully in such situations, to summarize an ROC curve in only a high-sensitivity region. MATERIALS AND METHODS: The mathematical formation of the partial area index was derived from the conventional binormal model. Statistical tests of apparent differences in this index were formulated analogous to that of Az. One common statistical test involving the partial area index was validated by computer simulations under realistic conditions. RESULTS: An example in mammography illustrates a situation in which the partial area index is more meaningful than Az in measuring clinical diagnostic performance. CONCLUSION: The partial area index can be used as a more meaningful alternative to the conventional Az index for highly sensitive diagnostic tests.

ROC Curve↗
PubMed1999

Evacuation proctography: a prospective study of diagnostic and therapeutic effects.

PURPOSE: To determine the diagnostic and therapeutic effects of evacuation proctography. MATERIALS AND METHODS: Forty-seven referring clinicians completed preevacuation proctography questionnaires for 50 patients, detailing diagnoses, confidence in these, intended management, and what they hoped to learn. After evacuation proctography, the radiology report was returned with a second questionnaire asking the diagnosis in the light of evacuation proctographic findings, their confidence, and what they had learned. Clinicians quantified management contribution and indicated how useful they found evacuation proctography in general. Results from pre- and post-evacuation proctography questionnaires were compared to determine the diagnostic and therapeutic effects. RESULTS: Diagnostic confidence rose significantly after evacuation proctography (mean, 7.0 before evacuation proctography vs 8.4 after evacuation proctography; P < .001). Lead diagnosis changed in nine (18%) patients. Intended surgical management became nonsurgical after evacuation proctography in seven (14%) patients, and intended nonsurgical therapy became surgical in two (4%). Surgery remained likely in 15 patients, but its nature changed in five (10%). Five (10%) clinicians stated that evacuation proctographic findings resolved diagnostic conflict, and nine (18%) found that evacuation proctographic findings revealed unsuspected diagnoses. Clinicians found evacuation proctography of major benefit in 20 (40%) cases studied and of moderate benefit in 20 (40%). In general, 20 (43%) clinicians found evacuation proctography very useful and 24 (51%) found it moderately useful. CONCLUSION: Evacuation proctography has a substantial diagnostic and therapeutic effect and is of considerable benefit to referring clinicians.

Defecography↗
PubMed2000

Peripheral arterial disease: meta-analysis of the diagnostic performance of MR angiography.

PURPOSE: To summarize the overall diagnostic performance of magnetic resonance (MR) angiography in the evaluation of peripheral arteriosclerotic occlusive disease and to identify the most important sources of variation in diagnostic accuracy between studies. MATERIALS AND METHODS: A search strategy in MEDLINE and citation tracking were used to identify relevant English-language articles published since 1991. Each article was critically appraised for examination, patient, and study design characteristics. The accuracy data from different studies were analyzed by constructing summary receiver operating characteristic curves; multiple linear regression was used to examine the variation between study results. RESULTS: Twenty-three studies were included. There was much heterogeneity in the study results, which could not be explained as differences in the threshold for a positive result. About half of the variation was due to the type of MR angiographic examination and the extent of image evaluation. The relative diagnostic odds ratio (DOR) for three-dimensional (3D) gadolinium-enhanced MR angiography compared with two-dimensional (2D) time-of-flight MR angiography was 7.46 (95% CI: 2.48, 22.20). The relative DOR for review of transverse source images or multiplanar reformations in addition to maximum intensity projections (MIPs) compared with the use of only MIPs for image evaluation was 4.53 (95% CI: 1.46, 13.87). CONCLUSION: The diagnostic accuracy of 3D gadolinium-enhanced MR angiography is superior to that of 2D time-of-flight MR angiography. Also, the review of transverse source images or use of additional postprocessing techniques, such as multiplanar reformation, results in significantly better diagnostic performance.

Arterial Occlusive Diseases↗
PubMed2001

Fourth updated ESACP consensus report on diagnostic DNA image cytometry.

A task force of experts in the field of diagnostic DNA image cytometry, invited by the ESACP, and further scientists or physicians revealing experience in that diagnostic procedure (names are given in Addendum A), agreed upon the following 4th updated Consensus Report on Standardised Diagnostic DNA Image Cytometry during the 7th International Congress of that society in Caen, 2001. This report is based on the three preceding ones [6,14,17]. It deals with the following items:- Critical review and update of the definitions given in the 1997 Consensus Update;- Review and detailed description of basic terms, principles and algorithms for diagnostic interpretation;- Recommendations concerning diagnostic or prognostic applications in specific fields of tumour pathology. This update is not aimed to substitute the 1997 consensus, but to make necessary addenda and give more detailed descriptions of those items not unequivocally to interpret by potential users of the methodology.

Algorithms↗
PubMedDate not supplied

Prevalence of dental caries in Latvian 11- to 15-year-Old children and the enhanced diagnostic yield of temporary tooth separation, FOTI and electronic caries measurement.

The aim of this study was to test the feasibility of employing clinical visual examination at the D(1) (enamel and dentine caries) diagnostic threshold, fibre-optic transillumination (FOTI), elective temporary tooth separation (ETTS) and electronic caries measurement (ECM) in the environment of an epidemiological study or clinical trial. It also aimed to compare the diagnostic yield of these diagnostic aides and methods. The sample consisted of 182 Latvian children, mean age 13.3 years (range = 10.6-15.7). For 12-year-old subjects the mean D(3)MFS was 10.58 (SD 6.05) and the mean D(1)MFS was 19.97 (SD 10.47). The additional diagnostic yield from FOTI examination of approximal sites was 40.0% at the D(1) threshold. The additional apparent yield for ETTS was 52.8% at the D(1) threshold. ETTS detected 38.3% more carious surfaces than FOTI at the D(1) threshold. Conversely 57 surfaces thought to be carious on FOTI examination were judged sound following ETTS. Although the ECM appeared practical to use, it broke early in the trial and the results obtained prior to breakdown appeared inaccurate. In conclusion, all diagnostic methods were feasible under the conditions of an epidemiological study or clinical trial.

Adolescent↗
PubMedDate not supplied

Severe oligohydramnios with intact membranes: an indication for diagnostic amnioinfusion.

OBJECTIVE: To quantify the improvement in ultrasonographic fetal imaging following diagnostic amnioinfusion for the indication of unexplained midtrimester oligohydramnios. METHODS: Patients referred for unexplained midtrimester oligohydramnios were retrospectively reviewed. Videotapes of those undergoing diagnostic antenatal amnioinfusion were analyzed for quality of visualization of routinely imaged structures before and after the infusion procedure. RESULTS: The overall rate of adequate visualization of fetal structures improved from 50.98 to 76.79% (p < 0.0001). In fetuses having preinfusion-identified obstructive uropathy, there was improvement in identification of associated anomalies from 11.8 to 31.3%. CONCLUSIONS: Several authors have suggested that diagnostic amnioinfusion can facilitate fetal imaging and increase diagnostic precision in the setting of unexplained severe oligohydramnios. We have quantified the improvement in the rate of optimal visualization of fetal structures which likely translates, in experienced hands, into this observed improved diagnostic precision. Of particular importance is the improvement in appreciation of associated anomalies in cases of obstructive uropathy in which such findings may determine whether or not invasive fetal therapy is indicated.

Abnormalities, Multiple↗
PubMedDate not supplied

The concept of generalized anxiety disorder: between the too narrow and too wide diagnostic criteria.

The Structured Clinical Interview for DSM-III-R, modified for DSM-IV and ICD-10 Diagnostic Criteria for Research (ICD-10-DCR), was administered to 73 consecutive patients with agoraphobia/panic disorder in order to determine diagnostic agreement for comorbid generalized anxiety disorder (GAD) between DSM-IV and ICD-10-DCR and reexamine the GAD symptom structure and significance of each symptom as diagnostic criterion for GAD. The diagnostic agreement for GAD (kappa) was 0.86. The analysis of the frequency of GAD symptoms in 45 patients suggests that in order to better differentiate GAD from depression and other anxiety disorders, a diagnostic conceptualization of GAD may be improved with the requirement of the presence of at least 4 of the 7 first-rank symptoms (pertaining to tension, vigilance and scanning) and 1 of the 5 second-rank symptoms (pertaining to physiological hyperarousal).

Adult↗
PubMed2001

Diagnostic accuracy of percent free prostate-specific antigen in prostatic pathology and its usefulness in monitoring prostatic cancer patients.

INTRODUCTION: The aim of our study was to evaluate the clinical usefulness of percent free prostate-specific antigen (PSA) [ratio of free PSA (fPSA) to total PSA (tPSA); f/tPSA] in prostatic pathology and its usefulness in monitoring prostatic cancer patients. PATIENTS AND METHODS: Our prospective study was carried out on 470 consecutive male patients referred to our outpatient urological clinic for observation. We looked for relationships between tPSA, fPSA and percent free PSA and the patient's age, prostatic volume and histologic diagnosis as assessed by prostatic biopsies or surgical specimens (benign prostatic hypertrophy, carcinoma, hypertrophy with inflammation). In all cases, we calculated the specificity, sensitivity and diagnostic accuracy of percent free PSA in the diagnosis of prostatic diseases, using cutoff values ranging from 14 to 20%. In prostatic cancer patients, we considered the relationships between the various PSA molecular forms and staging, grading and follow-up values. We also evaluated the effects of hormonosuppressive therapy on the serum markers and noted for which tPSA value percent free PSA possessed the greatest diagnostic accuracy. RESULTS: While tPSA and fPSA values appeared to be correlated with patient age and prostatic volume, percent free PSA did not show a relationship with these parameters. The specificity, sensitivity and overall diagnostic accuracy were better assuming a 16% cutoff value for percent free PSA than with other cutoff values. Prostatic inflammation associated with benign hypertrophy can cause false positives in both tPSA and f/tPSA measurements, since 60% of these patients have an f/tPSA ratio below 16%. In diagnosing carcinoma, the diagnostic accuracy of percent free PSA is 100% when tPSA is between 2.5 and 4.0 ng/ml. Percent free PSA is not linked with staging in prostatic cancer, but it does appear to be related to the Gleason score. In patients receiving hormonosuppressive treatment, f/tPSA decreased significantly, and more so in patients with a higher Gleason score. In patients with disease in rapid progression, percent free PSA was lower than in patients in a stable condition. CONCLUSIONS: Based on our experience, 16% as the f/tPSA cutoff value for discriminating between benign and malignant pathologies is the best possible choice, as it provides the highest overall values of sensitivity, specificity and diagnostic accuracy (80, 61.5 and 84.5%, respectively) in the diagnosis of prostatic cancer. We believe that f/tPSA is not a definitive test for diagnosing prostatic cancer. Our observations on the behavior of percent free PSA in relation to prostatic carcinoma grading and staging and in the follow-up of carcinoma patients are interesting; however, further studies are needed to define the appropriate role of f/tPSA in patients with an established diagnosis of prostatic carcinoma and in the follow-up of patients with prostatic cancer.

Adult↗
PubMed2000

Diagnostic hysteroscopy for the investigation of abnormal uterine bleeding in premenopausal patients.

The aim of this observational clinical study was to evaluate the feasibility and diagnostic accuracy of outpatient diagnostic hysteroscopy in premenopausal patients suffering from abnormal uterine bleeding. Between September 1996 and September 1999, 819 patients were referred to our outpatient hysteroscopy clinic, 317 of which were premenopausal, and presenting with menstrual symptoms. All hysteroscopies were performed using a standard 30 degrees 5-mm hysteroscope, and the uterine cavity was generally distended with normal saline. Hysteroscopy was completed successfully in 305 cases (96.2%), but since the routine use of lidocaine spray in 1998 this figure increased up to 98.9%. Intrauterine pathology was diagnosed in almost 34% of patients, the most frequent being submucous myomas (14%) and endometrial polyps (14%); there was no case of endometrial cancer in this subset of patients. Moreover, there was an age-related distribution of intrauterine pathology, with the highest incidence in patients aged 41-50 years. Diagnostic hysteroscopy is a simple and safe technique, well accepted by the vast majority of patients; due to its excellent diagnostic accuracy, and its high success rate as an outpatient procedure, we wonder why inpatient D&C under general anesthesia is still regarded a diagnostic or even therapeutic option for patients with abnormal uterine bleeding.

Adolescent↗
PubMedDate not supplied

International surveys on the use of ICD-10 and related diagnostic systems.

Several interesting surveys on the use of diagnostic systems have been conducted over the past two decades, initially focused on ICD-9 and DSM-III and then on more recent editions of these systems. They have reported on the extent and perceived value of their use as well as offered recommendations for future systems. The widest survey to date is that on ICD-10 and related systems recently conducted by the WHO Committee on Evaluating and Updating the ICD-10 Mental Health Component and the WPA Section on Classification and Diagnostic Assessment. It involved the participation of 205 psychiatrists from 66 different countries across all continents. Comparing the two most visible diagnostic systems, it found that ICD-10 was more frequently used and more valued for clinical diagnosis and training and that DSM-IV was more valued for research. Accessibility to diagnostic manuals and training appeared limited, particularly concerning the research criteria, primary care, and multiaxial versions of ICD-10. It also elicited structural and strategic recommendations for the elaboration of new diagnostic systems. It is suggested that it may be useful to widen the scope of future surveys, to additionally include policy makers, patients and families, and to conduct naturalistic studies of clinical care.

Attitude of Health Personnel↗
PubMedDate not supplied

Reliability of the El Escorial diagnostic criteria for amyotrophic lateral sclerosis.

BACKGROUND: The El Escorial diagnostic criteria are the most commonly used in clinical studies and therapeutic trials in patients with amyotrophic lateral sclerosis (ALS). The accuracy of the El Escorial criteria was tested in clinical practice, but the reliability is unknown when the diagnosis of ALS must be assessed on the basis of medical records. OBJECTIVE: To assess the reliability of the El Escorial criteria for the diagnosis of ALS in different settings. DESIGN AND METHODS: Semistructured forms were used to include the main diagnostic information on 20 patients with definite (n = 6), probable (n = 6), possible (n = 6), and suspected ALS (n = 2) and 19 patients with clinical conditions considered in the differential diagnosis. Agreement was tested by comparing the diagnosis made by the attending physician (the 'gold standard') with that of 4 raters with different backgrounds: a teaching neurologist with research and practical experience in the field of motor neuron disorders, a neurologist with specific interest in motor neuron disorders and neurophysiological background, a neurophysiologist, and a general neurologist with only occasional ALS patients. Sources of disagreement were discussed and the agreement was tested further on the medical records of 98 additional cases taken from an ongoing ALS registry. Eight additional cases (ALS: 4; other conditions: 4) were examined directly by the 4 raters. RESULTS: The interrater agreement on the medical records was poor (overall kappa 0.05-0.29). When the differential diagnosis was made between ALS (all diagnostic levels) and other conditions, interrater agreement was at best modest, with moderate variations when raters were compared in pairs (kappa 0.03-0.58) and when each rater was compared with the physician (kappa 0.27-0.51). Agreement was higher after direct examination of the patients (kappa 0.33-1) and increased significantly on the medical records after training (overall kappa 0.52-0.79). However, concordance was low (overall kappa 0.08-0.36), even after training, at the lowest diagnostic level (definite to suspected ALS vs. other conditions). CONCLUSIONS: The El Escorial criteria are a poor diagnostic indicator when patients' records are examined. Although medical education significantly improves the reliability of the criteria, concordance is still modest when the diagnosis includes suspected ALS.

Amyotrophic Lateral Sclerosis↗
PubMed2004

Diagnostic yield of capsule endoscopy in obscure gastrointestinal bleeding.

OBJECTIVES: Chronic occult blood loss from the gastrointestinal tract is a recognized major cause of iron-deficiency anemia. After conventional investigation of the upper and lower parts of the gastrointestinal tract, the source of bleeding remains unidentified in approximately 10% of these patients. We evaluated the diagnostic yield of capsule endoscopy from patients enrolled in clinical studies due to persistent or recurrent iron-deficiency anemia. METHODS: In this large cohort study, patients with obscure gastrointestinal bleeding were identified in a company-sponsored clinical study (Given Imaging, Ltd.) database which contains data from >50 clinical studies. Information on suitable patients was derived from 31 of them. Each subject swallowed an M2A Given Capsule containing a miniature video camera, batteries, a transmitter and an antenna. Recording time was approximately 8 h. The capsule was excreted naturally in the patient's bowel movement, and the data it transmitted were retrieved and interpreted the next day. RESULTS: 293 patients were studied (135 males, 46.1%, mean age 59.4 +/- 16.8 years) whose mean number of bleeding episodes was 4.3 +/- 5.5 and mean hemoglobin level was 9.8 +/- 2.4 g/dl. The average number of diagnostic procedures per patient prior to the capsule endoscopy study was 5.59. Capsule endoscopy detected definitive findings in 213/293 patients (72%) and findings missed by other diagnostic procedures in 22/293 patients (8%). Neither capsule endoscopy nor the other diagnostic procedures yielded diagnoses in 58/293 patients (20%). CONCLUSIONS: Capsule endoscopy has a high diagnostic yield in evaluating patients with obscure gastrointestinal bleeding.

Adolescent↗