Effectiveness of standard treatments in non-small-cell lung cancer with METexon14 skipping mutation: a real-world study.

Aim: To assess real-world clinical outcomes with standard therapies for advanced non-small-cell lung cancer (aNSCLC) with METexon14 skipping mutation (METex14). Methods: In an oncologists-led retrospective review of medical records, data were abstracted and analyzed for patients initiating first-line (1L) systemic therapy after 1 January 2017. Results: In total 287 aNSCLC patients with METex14, the real-world best overall response rate was 73.4% for capmatinib (n = 146), 68.8% for immunotherapy (IO) monotherapy (n = 48), 52.0% for chemotherapy (CT, n = 30), and 54.8% for IO + CT (n = 63). As compared with capmatinib, patients receiving IO (hazard ratio [HR]: 1.57; 95% CI: 0.77-3.20; p = 0.220), CT (HR: 2.41; 95% CI: 1.19-4.85; p = 0.014) and IO + CT (HR: 2.33; 95% CI: 1.35-4.04; p = 0.003) had higher rates of progression. Further, patients receiving CT (HR: 4.43; 95% CI: 1.54-12.75; p = 0.006) and IO + CT (HR: 3.53, 95% CI: 1.41-8.85; p = 0.007) had higher rates of mortality than patients receiving capmatinib. Conclusion: The study showed better clinical outcomes with capmatinib than other standard therapies in 1L setting for aNSCLC harboring METex14.

Real-world study that investigated the outcomes of different therapies used to treat non-small-cell lung cancer patients with mesenchymal-epithelial transition exon 14 skipping mutationWhat is this article about? A real-world study that investigated clinical outcomes in patients with diagnosis of advanced non-small-cell lung cancer (aNSCLC) with mesenchymal-epithelial transition exon 14 (METex14) skipping­a rare form of genetic mutation­who received treatment with one of the commonly used therapies for this disease: immunotherapy, chemotherapy, immunotherapy + chemotherapy combination and capmatinib, which is a highly selective inhibitor of MET tyrosine kinase protein involved in the growth of cancer cells.What were the results? The study showed that, in general, patients treated with capmatinib as the frontline therapy more frequently achieved a clinical response in the form of complete tumor resolution or tumor shrinkage, had a lower risk of disease worsening and lived longer than patients who were treated with immunotherapy, chemotherapy or immunotherapy + chemotherapy combination.What do the results of the study mean? This study suggests that capmatinib is effective in treating patients with aNSCLC with METex14 skipping who have not been treated with another anticancer therapy previously. It provides evidence to support the use of capmatinib in the frontline setting and may inform clinical decision-making in routine practice.

A Multicenter Retrospective Cohort Study to Characterize Patients Hospitalized With Multisystem Inflammatory Syndrome in Adults and Coronavirus Disease 2019 in the United States, 2020-2021.

BACKGROUND: The diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated multisystem inflammatory syndrome in adults (MIS-A) requires distinguishing it from acute coronavirus disease 2019 (COVID-19) and may affect clinical management. METHODS: In this retrospective cohort study, we applied the US Centers for Disease Control and Prevention case definition to identify adults hospitalized with MIS-A at 6 academic medical centers from 1 March 2020 to 31 December 2021. Patients MIS-A were matched by age group, sex, site, and admission date at a 1:2 ratio to patients hospitalized with acute symptomatic COVID-19. Conditional logistic regression was used to compare demographic characteristics, presenting symptoms, laboratory and imaging results, treatments administered, and outcomes between cohorts. RESULTS: Through medical record review of 10 223 patients hospitalized with SARS-CoV-2-associated illness, we identified 53 MIS-A cases. Compared with 106 matched patients with COVID-19, those with MIS-A were more likely to be non-Hispanic black and less likely to be non-Hispanic white. They more likely had laboratory-confirmed COVID-19 ≥14 days before hospitalization, more likely had positive in-hospital SARS-CoV-2 serologic testing, and more often presented with gastrointestinal symptoms and chest pain. They were less likely to have underlying medical conditions and to present with cough and dyspnea. On admission, patients with MIS-A had higher neutrophil-to-lymphocyte ratio and higher levels of C-reactive protein, ferritin, procalcitonin, and D-dimer than patients with COVID-19. They also had longer hospitalization and more likely required intensive care admission, invasive mechanical ventilation, and vasopressors. The mortality rate was 6% in both cohorts. CONCLUSIONS: Compared with patients with acute symptomatic COVID-19, adults with MIS-A more often manifest certain symptoms and laboratory findings early during hospitalization. These features may facilitate diagnosis and management.

Surge in Incidence and Coronavirus Disease 2019 Hospital Risk of Death, United States, September 2020 to March 2021.

Background: Studies of the early months of the coronavirus disease 2019 (COVID-19) pandemic indicate that patient outcomes may be adversely affected by surges. However, the impact on in-hospital mortality during the largest surge to date, September 2020-March 2021, has not been studied. This study aimed to determine whether in-hospital mortality was impacted by the community surge of COVID-19. Methods: This is a retrospective cohort study of 416 962 adult COVID-19 patients admitted immediately before or during the surge at 229 US academic and 432 community hospitals in the Vizient Clinical Database. The odds ratios (ORs) of death among hospitalized patients during each phase of the surge was compared with the corresponding odds before the surge and adjusted for demographic, comorbidity, hospital characteristic, length of stay, and complication variables. Results: The unadjusted proportion of deaths among discharged patients was 9% in both the presurge and rising surge stages but rose to 12% during both the peak and declining surge intervals. With the presurge phase defined as the referent, the risk-adjusted ORs (aORs) for the surge periods were rising, 1.14 (1.10-1.19), peak 1.37 (1.32-1.43), and declining, 1.30 (1.25-1.35). The surge rise in-hospital mortality was present in 7 of 9 geographic divisions and greater for community hospitals than for academic centers. Conclusions: These data support public policies aimed at containing pandemic surges and supporting healthcare delivery during surges.

A multi-task Gaussian process self-attention neural network for real-time prediction of the need for mechanical ventilators in COVID-19 patients.

OBJECTIVE: The Coronavirus Disease 2019 (COVID-19) pandemic has overwhelmed the capacity of healthcare resources and posed a challenge for worldwide hospitals. The ability to distinguish potentially deteriorating patients from the rest helps facilitate reasonable allocation of medical resources, such as ventilators, hospital beds, and human resources. The real-time accurate prediction of a patient's risk scores could also help physicians to provide earlier respiratory support for the patient and reduce the risk of mortality. METHODS: We propose a robust real-time prediction model for the in-hospital COVID-19 patients' probability of requiring mechanical ventilation (MV). The end-to-end neural network model incorporates the Multi-task Gaussian Process to handle the irregular sampling rate in observational data together with a self-attention neural network for the prediction task. RESULTS: We evaluate our model on a large database with 9,532 nationwide in-hospital patients with COVID-19. The model demonstrates significant robustness and consistency improvements compared to conventional machine learning models. The proposed prediction model also shows performance improvements in terms of area under the receiver operating characteristic curve (AUROC) and area under the precision-recall curve (AUPRC) compared to various deep learning models, especially at early times after a patient's hospital admission. CONCLUSION: The availability of large and real-time clinical data calls for new methods to make the best use of them for real-time patient risk prediction. It is not ideal for simplifying the data for traditional methods or for making unrealistic assumptions that deviate from observation's true dynamics. We demonstrate a pilot effort to harmonize cross-sectional and longitudinal information for mechanical ventilation needing prediction.

Predictive factors for success of awake proning in hypoxemic respiratory failure secondary to COVID-19: A retrospective cohort study.

BACKGROUND: Awake prone positioning has been recommended as an adjunctive measure in spontaneously breathing patients with hypoxemic respiratory failure during the COVID-19 pandemic. It remains uncertain as to how long this should be implemented, what variables to follow and who would be the ideal candidates for this adjunctive therapy. METHODS: A retrospective chart review of patients admitted from April to August 2020 within our institution with multifocal pneumonia and hypoxemic respiratory failure secondary to COVID-19 who underwent awake-proning for at least 3 hours was conducted. RESULTS: Improvement in respiratory parameters including ROX (SpO2/Fio2/ Respiratory Rate) indices and inflammatory markers within 4 days of institution of awake proning predicted a higher chance for success of this strategy in preventing need for mechanical ventilation. Moreover, benefits of awake proning were limited to patients with mild to moderate ARDS. CONCLUSIONS: Awake prone positioning can be safely performed with improvement in oxygenation. However, its institution may be beneficial only in patients with mild to moderate ARDS and requires careful evaluation of respiratory parameters and serum inflammatory markers to avoid a delay in endotracheal intubation and consequent increase in mortality rates.

Diagnostic yield of electromagnetic navigational bronchoscopy: A safety net community-based hospital experience in the United States.

INTRODUCTION: Electromagnetic navigational bronchoscopy (ENB) is an excellent tool to diagnose peripheral pulmonary nodules, especially in the setting of emphysema and pulmonary fibrosis. However, most of these procedures are done by interventional pulmonologists and academic tertiary centers under general anesthesia. Studies evaluating the diagnostic utility of this tool in safety-net community hospitals by pulmonologists not formally trained in this technology are lacking. The objective was to evaluate the diagnostic yield of ENB done in such a setting and its associated complications. METHODS: Retrospective chart review of consecutive ENB procedures over 5 years from 2014, since its inception in our institution-a safety-net community based hospital was performed. Multiple variables were analyzed to assess their impact on diagnostic yields. RESULTS: After exclusion criteria were applied, 72 patients with 76 procedures were eventually included within our study, with an overall 1-year diagnostic yield of 80.2%. Sensitivity for malignancy was 73% and negative predictive value of 65%. Primary lung cancer was the most common diagnosis obtained, followed by tuberculosis (TB). The overall complication rates were low, with only 1 patient (1.3%) requiring hospitalization due to pneumothorax needing tube thoracostomy. No deaths or respiratory failures were noted within the cohort. The only significant variable affecting diagnostic yield was forced expiratory volume in 1 s. The presence of emphysema did not affect diagnostic yield. CONCLUSIONS: ENB is safe and feasible with a high diagnostic success rate even when performed by pulmonologists not formally trained in interventional pulmonology in low resource settings under moderate sedation.

Safety and incidence of complications associated with bronchoscopy in an obese population.

INTRODUCTION: The safety of bronchoscopy in obese patients and those with obstructive sleep apnea (OSA) is unclear. Our objective was to evaluate the incidence of complications during bronchoscopy under moderate sedation in obese patients and to assess the impact of OSA, body mass index (BMI), and duration of the procedure. METHODS: We performed a retrospective study in adult patients undergoing bronchoscopy from January 2010 to August 2019. All patients with BMI > 30 kg/m2 were included. Logistic regression analyses were used to identify the factors associated with all-complications and respiratory complications. RESULTS: A total of 345 obese patients were identified. The average BMI in our cohort was 35.3 ± 5.1 kg/m2 . During the pre-procedure risk assessment, 165 (47.8%) patients were labelled as "suspected OSA." The most common doses of sedation given during the bronchoscopies were fentanyl 50 mcg (34.5%) and midazolam 3 mg (33.6%). The incidence of major complications was 0.6% and minor complications were 41.2%. Minor respiratory (22.9%) and cardiac (26.4%) complications were common. No deaths occurred due to bronchoscopy. Factors that were associated with increased respiratory complications were female gender, suspected OSA, and bronchoscopy duration 20-30 minutes and bronchoscopy duration greater than 1 hour. CONCLUSION: Bronchoscopy under moderate sedation performed in obese patients is safe; however, increased risk may exist with females, increased procedure time, and suspected OSA.

Clinical Characteristics and Etiologies of Miliary Nodules in the US: A Single-Center Study.

BACKGROUND: Miliary nodules have been typically described as a radiological manifestation of disseminated tuberculosis. However, miliary nodules are known to occur in a wide variety of conditions. The primary objective of the study was to identify clinical characteristics and etiologies of miliary nodules within our institution. METHODS: Using International Classification of Diseases, Ninth and Tenth Revision codes, electronic medical records were used to retrospectively identify 53 patients who fulfilled criteria of miliary nodules over the last 10 years. Demographic and clinical data were extracted for all the patients in this cross-sectional study. RESULTS: The diagnosis of tuberculosis was made in 15 (28.3%) patients, sarcoidosis in 12 (22.6%), silicosis in 7 (13.2%), extrathoracic malignancy in 5 (9.4%), and histoplasmosis in 4 (7.6%) patients. Four of 9 HIV patients had histoplasmosis. There was 1 case each of hypersensitivity pneumonitis, Pneumocystis jiroveci pneumonia, Mycobacterium-avium complex, Epstein-Barr virus pneumonia, cryptococcosis, aspergillosis, and primary lung cancer. Sputum was positive for acid fast bacilli in 4 cases (28%), and bronchoscopy had a 57% successful yield in miliary tuberculosis. CONCLUSION: Our study is the largest single-center data review evaluating the etiology of miliary nodules within the United States; most of the data exist in case reports.

Factors Affecting Racial Disparities in End-of-Life Care Costs Among Lung Cancer Patients: A SEER-Medicare-based Study.

OBJECTIVES: Racial disparities exist in end-of-life lung cancer care, which could potentially lead to considerable racial differences in end-of-life care costs. This study for the first time estimates the racial differences in end-of-life care costs among lung cancer patients, and identifies and quantifies factors that contribute the most to these differences using a statistical decomposition method. METHODS: This is a retrospective analysis of patients 66 years and older, diagnosed with stage I-IV lung cancer, who died on or before December 31, 2013, using the Surveillance Epidemiology and End Result-Medicare data from 1991 to 2013. Ordinary least square regression of logarithmically transformed cost was used to estimate racial differences in end-of-life care costs among lung cancer patients. Blinder-Oaxaca decomposition was used to identify and quantify factors that contributed the most to these differences. RESULTS: Non-Hispanic blacks had 10% to 13% higher end-of-life care costs as compared with non-Hispanic whites. Geographic variations, baseline comorbidity indices and stage at diagnosis contributed the most to explaining the racial differences in costs, with geographic variation explaining most of the differences. However, the observed factors could only explain 25% to 32% of the racial differences in end-of-life care costs. CONCLUSIONS: Geographic differences in access to timely and appropriate care, and provider practice patterns, should be examined to understand the reasons behind geographic variations in racial disparity. Provider-level educational interventions to reduce small area practice variations and differential management of patients by race, as well as racially sensitive patient-level educational and navigational interventions might be critical in improving quality of care and reducing costs during end-of-life.

Acute Kidney Injury Following Failed Total Hip and Knee Arthroplasty.

BACKGROUND: Acute kidney injury (AKI) can complicate primary total joint arthroplasty (TJA) of the hip and knee, although the incidence of AKI following revision TJA including prosthetic joint infection (PJI) is poorly defined. We assessed the incidence and risk factors for AKI following revision TJA including surgical treatment of PJI with placement of an antibiotic-loaded cement (ALC) spacer. METHODS: We retrospectively reviewed 3218 consecutive failed TJAs. Patients with aseptic failure were compared to those with PJI. AKI was determined by RIFLE creatinine criteria. PJIs treated with placement of ALC were compared to PJIs without. Risk factors for AKI were determined by multivariable analysis within the whole group and within those with PJI. RESULTS: AKI developed in 3.4% of 2147 patients revised for aseptic reasons and in 45% of 281 with PJI, including 29% of 197 receiving an ALC and 82% of 84 patients treated with other procedures. By multivariable analysis, age, surgery for PJI, total number of surgeries, and estimated GFR 60-90 compared to >90 cc/min/1.73 m2 were significantly associated with AKI in the whole cohort. Among PJI patients, age, Charlson comorbidity index, and reimplantation surgery were associated with AKI by multivariable analysis. No differences were found between patients with PJI treated with or without ALC. No modifiable factors were found. CONCLUSION: AKI develops following aseptic revision TJA at a rate similar to primary TJA, but at a significantly higher rate following surgery for PJI with or without placement of ALC.

Racial-Ethnic Disparities in End-of-Life Care Quality among Lung Cancer Patients: A SEER-Medicare-Based Study.

INTRODUCTION: Cancer end-of-life care and associated racial-ethnic disparities have been in focus during the last few years due to concerns regarding subjective care variations and poor quality of care. Given the high mortality rate and disease burden of lung cancer, end-of-life care quality is particularly crucial for this disease. This study uses previously validated measures and examines racial-ethnic disparities in lung cancer end-of-life care quality. METHODS: This study involves retrospective analysis of patients ≥66 years, who were diagnosed with stage I-IV lung cancer, and who died on or before December 31, 2013, using the Surveillance Epidemiology and End Result-Medicare data from 1991-2013. Poor quality of care was measured using three themes: (1) potentially preventable medical encounters, (2) delayed hospice referral, and (3) aggressive chemotherapy provision during end-of-life. The patients were analyzed as two separate cohorts of NSCLC and SCLC patients. Logistic regression analyses were performed to estimate racial-ethnic disparities in the adjusted odds of receiving poor quality end-of-life care. RESULTS: The study found considerable racial-ethnic disparities in end-of-life care quality. The racial-ethnic minorities had higher odds of experiencing potentially preventable medical encounters in the last month of life as compared with non-Hispanic whites. Odds of delayed hospice referral and aggressive chemotherapy provision during end-of-life were lower in non-Hispanic blacks as compared with non-Hispanic whites. CONCLUSIONS: The study findings highlight the continued lack of access and care disparity among the minorities, which could precipitate potentially preventable utilizations, and limit access to hospice care during end-of-life. The study suggests the need to develop educational, patient navigational and other interventions that could potentially reduce aggressive utilizations and improve appropriate hospice care provision during end-of-life.

The cost of implementing two small media interventions to promote HPV vaccination.

OBJECTIVE: To estimate the cost of implementing lay health worker delivered print-based photonovella intervention and iPad-based tailored interactive multimedia intervention (TIMI) to promote Human Papillomavirus (HPV) vaccine uptake and completion among Hispanic parents of daughters 9-17years old. METHODS: We recruited 301 participants in control, 422 in photonovella, and 239 in TIMI clinics. Intervention costs were estimated using micro-costing from the societal perspective. Cost included time spent planning, training the promotoras, recruiting study participants, and delivering the interventions. Overhead for utilities and project administration was estimated at 30% of direct costs. RESULTS: The total cost per person for the photonovella and TIMI interventions were $88 and $108, respectively. Less than 10% of costs were fixed and therefore the average cost estimates were insensitive to the size of the target groups. CONCLUSION: The electronic medium for HPV vaccine education was 23% more costly than the standard low-tech print based approach. The cost difference should be considered relative to the effectiveness of these methods in achieving increases in immunization rates. The cost estimates provide information for cost-effectiveness and budget impact assessments of new HPV immunization intervention programs.

The cost of developing a computerized tailored interactive multimedia intervention vs. a print based Photonovella intervention for HPV vaccine education.

Mobile technology is opening new avenues for healthcare providers to create and implement tailored and personalized health education programs. We estimate and compare the cost of developing an i-Pad based tailored interactive multimedia intervention (TIMI) and a print based (Photonovella) intervention to increase human papillomavirus (HPV) immunization. The development costs of the interventions were calculated using a societal perspective. Direct cost included the cost of planning the study, conducting focus groups, and developing the intervention materials by the research staff. Costs also included the amount paid to the vendors who produced the TIMI and Photonovella. Micro cost data on the staff time and materials were recorded in logs for tracking personnel time, meeting time, supplies and software purchases. The costs were adjusted for inflation and reported in 2015 USD. The total cost of developing the Photonovella was $66,468 and the cost of developing the TIMI was $135,978. The amortized annual cost for the interventions calculated at a 3% discount rate and over a 7-year period was $10,669 per year for the Photonovella and $21,825 per year for the TIMI intervention. The results would inform decision makers when planning and investing in the development of interactive multimedia health interventions.

The Immediate Impact of the 2009 USPSTF Screening Guideline Change on Physician Recommendation of a Screening Mammogram: Findings from a National Ambulatory and Medical Care Survey-Based Study.

Regular screening is considered the most effective method to reduce the mortality and morbidity associated with breast cancer. Nevertheless, contradictory evidence about screening mammograms has led to periodic changes and considerable variations among different screening guidelines. This study is the first to examine the immediate impact of the 2009 US Preventive Services Task Force (USPSTF) guideline modification on physician recommendation of mammograms. The study included visits by women aged 40 years and older without prior breast cancer from the National Ambulatory and Medical Care Survey 2008-2010. Bivariate and multiple logistic regressions were used to determine the factors associated with mammography recommendation. Approximately 29,395 visits were included and mammography was recommended during 1350 visits; 50-64-year-old women had 72% higher odds, and 65-74-year-old women had twice the odds of getting a mammogram recommendation compared with 40-49-year-old women in 2009. However, there was no difference in recommendation by age groups in 2008 and 2010. Obstetricians and gynecologists did not modify their recommendation behavior in 2009, unlike all other specialists who reduced their recommendation for 40-49-year-old women in 2009. Other characteristics associated with mammogram recommendations were certain patient comorbidities, physician specialty and primary care physician status, health maintenance organization status of the clinic, and certain visit characteristics. This study demonstrated a temporary effect of the USPSTF screening guideline change on mammogram recommendation. However, in light of conflicting recommendations by different guidelines, the physicians erred toward the more rigorous guidelines and did not permanently reduce their mammogram recommendation for women aged 40-49 years.

Cost Effectiveness of Screening Colonoscopy Depends on Adequate Bowel Preparation Rates - A Modeling Study.

BACKGROUND: Inadequate bowel preparation during screening colonoscopy necessitates repeating colonoscopy. Studies suggest inadequate bowel preparation rates of 20-60%. This increases the cost of colonoscopy for our society. AIM: The aim of this study is to determine the impact of inadequate bowel preparation rate on the cost effectiveness of colonoscopy compared to other screening strategies for colorectal cancer (CRC). METHODS: A microsimulation model of CRC screening strategies for the general population at average risk for CRC. The strategies include fecal immunochemistry test (FIT) every year, colonoscopy every ten years, sigmoidoscopy every five years, or stool DNA test every 3 years. The screening could be performed at private practice offices, outpatient hospitals, and ambulatory surgical centers. RESULTS: At the current assumed inadequate bowel preparation rate of 25%, the cost of colonoscopy as a screening strategy is above society's willingness to pay (<$50,000/QALY). Threshold analysis demonstrated that an inadequate bowel preparation rate of 13% or less is necessary before colonoscopy is considered more cost effective than FIT. At inadequate bowel preparation rates of 25%, colonoscopy is still more cost effective compared to sigmoidoscopy and stool DNA test. Sensitivity analysis of all inputs adjusted by ±10% showed incremental cost effectiveness ratio values were influenced most by the specificity, adherence, and sensitivity of FIT and colonoscopy. CONCLUSIONS: Screening colonoscopy is not a cost effective strategy when compared with fecal immunochemical test, as long as the inadequate bowel preparation rate is greater than 13%.

Thrombolysis for acute ischemic stroke in patients with cancer: a population study.

BACKGROUND AND PURPOSE: The safety of thrombolysis for acute stroke in patients with cancer is not well established. Our aim is to study the outcomes after thrombolysis in patients with stroke with cancer. METHODS: Patients with acute ischemic stroke who received thrombolysis were identified from the 2009 and 2010 Nationwide Inpatient Sample. Patients with cancer-associated strokes and noncancer strokes were compared based on demographics, comorbidities, and outcomes. RESULTS: Of the 32 576 strokes treated with thrombolysis, cancer-associated strokes had significantly higher comorbidity indices overall, but fewer vascular risk factors than noncancer strokes. There was no difference in the rates of home discharge and in-hospital mortality, after adjusting for confounders. Subgroup analysis showed that compared with liquid cancers, patients with solid tumors had worse home discharge (odds ratio, 0.178; 95% confidence interval, 0.109-0.290; P<0.001) and higher in-hospital mortality (odds ratio, 3.018; 95% confidence interval, 1.37-6.646; P=0.006) after thrombolysis. Metastatic cancers had poorest outcomes, but intracerebral hemorrhage rates were similar. CONCLUSIONS: Thrombolytic therapy for acute stroke in patients with cancer is not associated with increased risk of intracerebral hemorrhage or in-hospital mortality. However, careful consideration of the cancer subtype may help delineate the subset of patients with poor response to thrombolysis. Prospective confirmation is warranted.

Prospective gene signature study using microRNA to identify the tissue of origin in patients with carcinoma of unknown primary.

PURPOSE: Accurate identification of tissue of origin (ToO) for patients with carcinoma of unknown primary (CUP) may help customize therapy to the putative primary and thereby improve the clinical outcome. We prospectively studied the performance of a microRNA-based assay to identify the ToO in CUP patients. EXPERIMENTAL DESIGN: Formalin-fixed paraffin-embedded (FFPE) metastatic tissue from 104 patients was reviewed and 87 of these contained sufficient tumor for testing. The assay quantitates 48 microRNAs and assigns one of 25 tumor diagnoses by using a biologically motivated binary decision tree and a K-nearest neighbors (KNN). The assay predictions were compared with clinicopathologic features and, where suitable, to therapeutic response. RESULTS: Seventy-four of the 87 cases were processed successfully. The assay result was consistent or compatible with the clinicopathologic features in 84% of cases processed successfully (71% of all samples attempted). In 65 patients, pathology and immunohistochemistry (IHC) suggested a diagnosis or (more often) a differential diagnosis. Out of those, the assay was consistent or compatible with the clinicopathologic presentation in 55 (85%) cases. Of the 9 patients with noncontributory IHC, the assay provided a ToO prediction that was compatible with the clinical presentation in 7 cases. CONCLUSIONS: In this prospective study, the microRNA diagnosis was compatible with the clinicopathologic picture in the majority of cases. Comparative effectiveness research trials evaluating the added benefit of molecular profiling in appropriate CUP subsets are warranted. MicroRNA profiling may be particularly helpful in patients in whom the IHC profile of the metastasis is nondiagnostic or leaves a large differential diagnosis.

Silicone Foley's catheter: A useful splint in ear surgeries.

UNLABELLED: Maintenance of ear projection and post auricular sulcus in staged ear reconstruction in microtia is a trying problem. So also is the maintenance of the patency of the external auditory meatus following recanalization and meatoplasty. Numerous splints and dressing techniques have been described for the above situations. Some of the problems encountered include the availability of the materials, cost, expertise in fabrication and compliance. AIMS: To devise a simple, reliable, inexpensive and readily available splint for the maintenance of post auricular sulcus and external auditory meatus opening. SETTINGS AND DESIGN: A silicone catheter is made out of a soft and inert material that doesn't cause tissue necrosis or any loss of skin graft. The basic design is that of a simple, self-retaining type of splint that doesn't dislodge and can be prepared within minutes on the operating table. MATERIALS AND METHODS: This splint has been used in four cases of microtia reconstruction and one case of congenital external auditory meatus stenosis between June 2006 and August 2007. A 14 or 16 Fr silicone Foley's catheter was used. The proximal end of a catheter of required length was retained and the distal part was cut off. The catheter was looped into a circle around the base of the reconstructed ear and secured in position with a suture. A similar construct was used in cases of external auditory meatus reconstruction or recanalization. The funnel-shaped distal drainage end was sutured to the circular frame near the region of the tragus. This funnel was inserted into the external auditory canal. RESULTS: The catheter was found to sit snugly in the newly created sulcus, thereby maintaining the sulcus and ear projection. It aided in maintaining the meatal opening of a satisfactory diameter in the case of external auditory canal recanalization. It was never found to slip or get dislodged in any of the cases. There was no skin graft loss or tissue necrosis due to the use of the splint. CONCLUSIONS: The silicone Foley's catheter is found to be a simple, readily available, inexpensive and reliable self-retaining splint following ear elevation in microtia and external auditory meatus recanalization. The catheter is easily constructed and applied intraoperatively. The results following its usage have been uniformly good in all cases without causing any adverse events at the operated site or discomfort to the patient ensuring good compliance.