Equivocal Report Research Articles

Indian Data on HER2 Fluorescence In Situ Hybridization in Invasive Breast Cancer with Immunohistochemically Equivocal Results As Per 2018 ASCO/CAP Guidelines.

Biren ParikhIntroduction Hormonal status and HER2 expression are valuable biomarkers and dictate the management of the patients diagnosed with invasive breast cancer (IBC). It is crucial to identify the patients who truly respond to anti-HER2 targeted therapy. Updated 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines has recommended certain modifications in HER2 interpretation by fluorescence in situ hybridization (FISH) with concomitant immunohistochemistry (IHC). Objectives We aimed to evaluate HER2 FISH interpretation in IBC with equivocal IHC results as per 2018 ASCO/CAP recommendations and compare FISH results with hormonal receptor status. Materials and Methods FISH results of 502 cases of IBC with equivocal IHC report between January 2016 to January 2022 were reviewed retrospectively. FISH results were categorized according to ASCO/CAP guidelines 2018 into five respective groups. Results FISH testing in IHC equivocal cases showed 219 (43.6%) cases were classic amplified (positive) belonged to group 1, 217(43.2%) cases were classic nonamplified (negative) fell into group 5, 39 (7.8%) and 02 (0.4%) patients were in group 2 (negative) and group 3 (positive), and 25 (5.0%) cases were in group 4 (negative). About 52.1 and 49.3% of cases with estrogen receptor and progesterone receptor positivity were reported as HER2 positive. Among 502 cases, 25 equivocal cases according to the 2013 guidelines were redefined as HER2 negative and 02 (0.4%) cases reported positive were classified negative as per updated 2018 guidelines. Conclusion Revised 2018 guidelines is helpful in accurate identification of HER2 status and in avoiding targeted therapy in unwarranted cases. Updated 2018 guidelines has removed equivocal HER2-FISH category that has eliminated management dilemma in these cases. Only long-term clinical follow-up will establish the validity of the updated guidelines.

Spectrophotometry of cerebrospinal fluid for xanthochromia is a sensitive and specific test for subarachnoid bleeding but adds little to computed tomography

Subarachnoid hemorrhage (SAH) is a serious neurological event associated with high morbidity and mortality. Computed tomography of the cerebrum (CTC) is the diagnostic method of choice, but in case of negative CTC but strong suspicion of SAH, lumbar puncture with spectrophotometric analysis of cerebrospinal fluid (CSF) for xanthochromia is performed. We wanted to examine the diagnostic properties of CSF spectrophotometry for xanthochromia testing. We performed a retrospective study of the diagnostic properties of CSF analysis for xanthochromia using spectrophotometry in the diagnosis of SAH. A total of 489 CSF samples were analyzed for xanthochromia, according to international guidelines, from 2009 until 2014 and for 411 of these the patient files were retrieved and examined for final clinical diagnosis and result of CTC. One patient with SAH did not have a positive spectrophotometry report and another patient with SAH had an equivocal report. In four patients did initial CTC not correctly identify SAH. For patients with a negative CTC within six hours of symptom onset spectrophotometry for xanthochromia in the CSF had a diagnostic sensitivity of 100% and a diagnostic specificity of 98.5%. The positive predictive value was 16.7% and the negative predictive value 100%. We conclude that spectrophotometry of CSF for xanthochromia is a sensitive and specific test for diagnosing SAH. However, it seems that an initial CTC identifies almost all patients with SAH. This suggests that in our and similar diagnostic settings, lumbar puncture and testing for xanthochromia might only be relevant in very few cases, if not obsolete.

An audit of ventilation and perfusion SPECT reporting for the diagnosis of pulmonary embolism in a tertiary cardiothoracic centre.

The aim of the study was to identify reporting patterns of ventilation and perfusion single-photon emission computed tomography (V/Q SPECT) scans done in our department over 3 months in 2016. Factors impacting on reporting and patient groups that would most benefit from the addition of low-dose computed tomography (CT) to V/Q SPECT were analysed. Among 178 patients, 173 (97.2%) had a definitive (positive/negative) report and 2.8% had an equivocal report. As the majority of the equivocal reports were seen in patients aged ≥70 years, we believe that addition of low-dose CT with V/Q SPECT to this patient group will reduce the non-diagnostic rate.

Calcium and Magnesium Levels Are down Regulated in Nigerian Children with Autism Spectrum Disorder and Cerebral Palsy

Autism Spectrum Disorders (ASDs) and Cerebral Palsy (CP) are amongst the leading neurodevelopmental disorders in children worldwide causing diminished quality of life. Unlike CP caused by brain damage affecting muscle tone, movement and motor skills, equivocal report of different genes with varying loci as genetic malformation and genetic modulation by environmental factors have been the focus of attention in the aetiology of ASD. This study investigated levels of toxic metal (Pb) and macro elements (Ca and Mg) in blood of children with ASD and CP in Nigeria. 8 and 18 Children (aged 2 - 12 years) clinically screened for features of ASD and CP respectively by pediatric neurologist using DMS-IV classification along with 15 age-matched neurologically healthy ones as controls were recruited. Plasma levels of Ca, Mg and Pb were determined in the children using Induction Coupled Plasma Mass Spectroscopy (ICP-MS). Results were analyzed using students t-test. The gender difference was not significant in the children (P = 0.216) while developmental milestones’ abnormalities (stable neck, sitting, crawling and walking) was significantly prevalent among CP children relative to ASD and normal children (P= 0.003, 0.003, 0.003 and 0.000 respectively); however, abnormality in talking was common in ASD and CP relative to normal children (P = 0.000). There was significant difference in educational background of ASD and CP parents relative to those of normal children (P = 0.025). Mean plasma calcium and magnesium levels was significantly reduced in children with ASD (7.90 ± 0.17 mg/dl, 2.44 ± 0.07 mg/dl) and CP (7.26 ± 0.31 mg/dl, 2.42 ± 0.08 mg/dl) in comparison to the controls (8.97 ± 0.20 mg/dl and 3.26 ± 0.16 mg/dl); (P < 0.001; P < 0.000 and P < 0.002; P < 0.000) respectively. However, mean lead levels in children with CP (10.38 ± 1.45 μg/dl) were significantly greater than in ASD (7.92 ± 1.30 μg/dl) and normal children (6.83 ± 0.72 μg/dl) (P < 0.433; P < 0.047). Hypocalcaemia and hypomagnesaemia with concurrent plumbism (more pronounced in CP) was observed in children with ASD and CP in this study).

A pilot study to assess the utility of five established variables to standardize exercise treadmill test reporting

BackgroundThe prognostic utility of 5 established variables (functional capacity, Duke treadmill score, chronotropic response to exercise, heart rate recovery, and premature ventricular contractions) together after routine exercise treadmill testing (ETT) has not been determined. MethodsWe assessed the combined prognostic ability of 5 established variables for the primary outcome (myocardial infarction [MI], coronary revascularization [CR] or all-cause mortality) and the secondary outcome of unnecessary downstream testing (defined as receipt of further noninvasive imaging without CR, MI, or death) compared with standard methods. Using a retrospective study design, 1857 consecutive patients were enrolled in the year 2014 and followed until December 31, 2015. Optimal discrimination and global fit statistics were assessed from logistic regression models. Classification and regression tree (CART) methodology was used for the final model. ResultsThe mean [SD] age was 56.0 [12.5]years; median comorbidities (2, IQR 2) with 26% having an equivocal report. Compared to other models, a model with age, sex, and the 5 established variables showed an improvement in discrimination for the primary [c-statistic 0.85 versus (0.69–0.79)] and secondary [c-statistic 0.73 versus (0.65–0.71)] outcomes with substantial improvement in global fit. The final, optimal, 10-fold cross-validated CART model had a c-statistic of 0.78. ConclusionsThe utility of the 5-established variables, based on the current study, resides in its ability to decrease unnecessary downstream testing and improve cardiovascular event prognostication. This is accomplished by removing the subjective interpretation of currently used ETT variables that can lead to an equivocal report.

Evaluation and Management of the Nursing Home Resident With Respiratory Symptoms and an Equivocal Chest X-Ray Report

ObjectivesPneumonia is a leading cause of morbidity and mortality in nursing home (NH) residents. Chest x-ray evidence is considered a key diagnostic criterion for pneumonia by the Infectious Disease Society of America (IDSA) diagnostic guidelines, the modified McGeer diagnostic criteria, and the Loeb criteria for initiating antibiotics; however, x-ray interpretation is often equivocal. We conducted chart audits of patients in NHs who had chest x-rays for new respiratory symptoms to determine the degree of ambiguity in the radiology reports and their relationship to antibiotic prescription decisions. DesignCross-sectional study. SettingThirty-one NHs in North Carolina. ParticipantsTwo hundred twenty-six NH residents who had a chest x-ray. MethodsMedical charts were abstracted to record (1) the patient's clinical presentation when a chest x-ray was ordered, (2) the verbatim report of the chest x-ray, and (3) the patient's course during the subsequent 7 days. To standardize the radiologist reports, a seven-category coding system was developed, which was further aggregated into three groups based on the radiologist's description of the likelihood of pneumonia. ResultsOf the 226 chest x-rays, 118 (52%) identified a very low likelihood of pneumonia, 67 (30%) indicated that pneumonia was present or highly likely, and the remaining 41 (18%) used a variety of terms to describe uncertainty regarding the presence of pneumonia. NH medical providers tended to treat ambiguous chest x-ray reports similarly to positive x-ray reports, prescribing antibiotic therapy to 71% of patients with ambiguous reports and 78% of positive reports. Also notable is that 40 (34%) of the 118 patients with a very low likelihood of pneumonia based on chest x-ray results were prescribed antibiotics, the majority of whom failed to meet criteria for a clinical diagnosis of pneumonia or chronic obstructive pulmonary disease exacerbation. ConclusionThe moderate rate of ambiguous x-ray interpretations in NH residents is likely a combination of the poor quality of portable x-rays, a high prevalence of chronic lung conditions, and conservative (ie, cautious) decision making by radiologists whose interpretation is based on little clinical information and a suboptimal quality film. As a result, data suggest that chest x-rays obtained in NHs may unnecessarily encourage antibiotic prescribing because a majority of readings are ambiguous or show a low likelihood of pneumonia, yet more than half of the patients are still treated. From an antibiotic stewardship standpoint, the apparent solution is to more closely rely on clinical signs and symptoms for diagnosis of pneumonia and to place less emphasis on the role of the chest x-ray given the high number of unclear readings.

Evaluation and Management of the Nursing Home Resident With Respiratory Symptoms and an Equivocal Chest X-Ray Report

Evaluation and Management of the Nursing Home Resident With Respiratory Symptoms and an Equivocal Chest X-Ray Report

Screening tests for Chlamydia trachomatis or Neisseria gonorrhoeae using the cobas 4800 PCR system do not require a second test to confirm: an audit of patients issued with equivocal results at a sexual health clinic in the Northwest of England, UK

ObjectivesTo assess the clinical utility of supplementary PCRs following a positive cobas 4800 CT/NG PCR screening test result.MethodsLaboratory reports, for Chlamydia trachomatis or Neisseria gonorrhoeae, issued to genitourinary medicine patients...

P53 PCR screening tests for Chlamydia trachomatis or Neisseria gonorrhoeae do not require a second test to confirm: an audit of patients issued with equivocal results

BackgroundUK testing algorithms for chlamydia or gonorrhoea should have a positive predicative value (PPV) >90%. Repeat of testing of screen positive samples might be required to achieve this. Patients issued...

Ancillary testing in liquid based cytology to distinguish cervical glandular neoplasia from tuboendometrial metaplasia in a young woman

A 33-year old woman had a cervical sample taken at colposcopy clinic. Seven years prior to this, at the age of 26, she had had a cytological diagnosis of cervical glandular neoplasia (cytology descriptor indicated cells suspicious of endocervical neoplasia) and severe dyskaryosis. Confirmation and treatment were by LLETZ and knife cone, and, in keeping with England and Wales National Health Service guidelines, this woman was under follow-up by the colposcopy clinic. Intervening cytological follow-up included a number of negative cytological samples interspaced with one equivocal report. A recent repeat cytology which was rather cellular contained several hyperchromatic crowded cell groups (HCCG's). Careful examination revealed benign endometrial clusters, LUS, TEM and endocervical cells in strips showing pseudostratification and loss of polarity. Following an agar block, there was positive staining for p16 and Ki-67 in the abnormal groups whilst the benign TEM cells stained positive for bcl-2.

19. Correlation between loss of mismatch repair enzyme expression and microsatellite instability in colorectal carcinomas in a general hospital setting

Aims To audit the correlation between immunostaining for DNA mismatch repair enzymes performed in routine diagnostic practice and the results of microsatellite instability analysis in colorectal carcinomas. Methods Immunostains for MLH1, MSH2, MSH6 and PMS2 were performed as part of the regular histopathological investigation of carcinomas of the large intestine. The microsatellite instability status was determined for all cases reported as showing loss of immunoexpression or equivocal immunoexpression. Results The study population consisted of 153 patients, of which 28 (18%) were classified as showing loss of immunoexpression, and 29 (19%) were classified as equivocal. All of the cases classified as showing loss of expression were microsatellite unstable. Of the 29 cases with equivocal expression, only one case was unstable on microsatellite analysis. Conclusions Loss of immunoexpression for mismatch repair enzymes can be reported reliably in a general hospital setting, and had a positive predictive value in this series of 100%. In our experience, an equivocal report on immunostaining was generally found in stable carcinomas. Microsatellite instability (MSI) is found in about 15% of colorectal carcinomas. In most cases, it is a sporadic phenomenon due to loss of expression of the enzyme MLH1 as a result of hypermethylation of the promoter region. Occasionally, it is due to a germline mutation in a gene encoding one of the DNA mismatch repair enzymes; such patients have Lynch syndrome, or hereditary non-polyposis colorectal cancer. Whether sporadic or hereditary, cancers with loss of DNA mismatch repair function exhibit a high level of instability in microsatellite regions of DNA and are described as unstable or showing high levels of MSI (MSI-H). To audit the correlation between immunostaining for DNA mismatch repair enzymes performed in routine diagnostic practice and the results of microsatellite instability analysis in colorectal carcinomas. Immunostains for MLH1, MSH2, MSH6 and PMS2 were performed as part of the regular histopathological investigation of carcinomas of the large intestine. The microsatellite instability status was determined for all cases reported as showing loss of immunoexpression or equivocal immunoexpression. The study population consisted of 153 patients, of which 28 (18%) were classified as showing loss of immunoexpression, and 29 (19%) were classified as equivocal. All of the cases classified as showing loss of expression were microsatellite unstable. Of the 29 cases with equivocal expression, only one case was unstable on microsatellite analysis. Loss of immunoexpression for mismatch repair enzymes can be reported reliably in a general hospital setting, and had a positive predictive value in this series of 100%. In our experience, an equivocal report on immunostaining was generally found in stable carcinomas.

Clinical audit and standard setting for symptomatic breast imaging in south thames region

Audit is recognized as an important part of the UK National Health Service Breast Screening programme. This paper describes a simple method of auditing breast imaging in symptomatic women which was applied in the South Thames (East) Region of England. No appropriate standards were available before this audit started. Standards were set at the end of the first cycle by the Regional Radiology Audit Committee and these were used in the second cycle of this audit. A comparison between hospitals which organize both breast screening and symptomatic imaging and those with units providing symptomatic breast imaging only shows no significant difference in the accuracy diagnosis and the false negative and false positive rates between the two. However non-screening units, are significantly more likely to issue an equivocal radiology report (P = 0.000001). Measures to reduce the incidence of equivocal reporting, by prospectively issuing an audit grade with the report and double reporting of equivocal images are recommended.

Fine needle aspiration cytology of the breast: improving the predictive value of equivocal cytologic reports by monoclonal antibody B72.3

<h2>Abstract</h2> The monoclonal antibody B72.3 was tested on 77 consecutive patients with masses where cytology was reported as equivocal; all patients had been examined by palpation, sonography and mammography and underwent surgical biopsy. The positive predictive value of an equivocal cytologic report in this series was 49.3% (38 carcinomas, 39 benign lesions). B72.3 immunocytochemical assay was highly accurate (sensitivity = 94.7%, specificity=82.0%) and had a higher positive predictive value (83.7%) than conventional cytology. The B72.3 assay may be valuable in cases with equivocal cytology, as it may improve the final diagnostic judgement.

Diagnostic Value of DNA Analysis in Effusions by Flow Cytometry and Image Analysis: A Prospective Study on 102 Patients as Compared with Cytologic Examination

One hundred twenty-six effusion samples from 102 patients were examined by cytology and flow cytometry (FCM). Overall, there was an 84% correlation between cytologic and FCM results. Of the 36 malignant cases determined by cytologic examination, FCM revealed an aneuploid peak in 20 (56%). Image analysis (IA) performed on the malignant cytologic cases with a diploid flow pattern detected two additional aneuploid peaks. In addition, FCM indicated three aneuploid cases in which cytologic characteristics were initially interpreted as benign (false negative). Aneuploidy was therefore detected in 64% of the malignant effusion specimens by FCM and IA. Twenty-three of the total of 24 aneuploid cases detected by FCM were associated with malignancy (predictive value = 96%). The one nonmalignant case was that of hemorrhagic pancreatitis with infected pseudocyst. FCM is an excellent tool when moderate to large numbers of tumor cells are present, whereas use of IA is advantageous for specimens containing smaller numbers of malignant cells because these can be directly analyzed. When an aneuploid peak is present, a diagnosis of malignancy must be suspected, and, if the initial cytologic screen is negative, a critical review of the cytology slides is justified. In those cases with an equivocal atypical cytology report and an abnormal cytometric histogram, additional investigation is warranted. In some malignancies the tumor cells will be diploid (in this study 36%) and neither FCM nor IA will add to tumor detection, leaving cytologic examination as the definitive technique.

Equivocation in EEG Reporting: The Clinician's Response

Evidence is presented that about 29% of the time that an electroencephalographer feels he needs to equivocate about the findings in an EEG, the clinician interprets, or at least recalls, the EEG without this equivocation. When there is a lack of recall of an equivocal report, the clinician's error is usually in the direction of considering that the record has been interpreted by the electroencephalographer as being abnormal.