Detection of recurrent and metastatic thyroid cancer remains a considerable challenge in patients presenting with rising thyroglobulin levels but with negative I-131 whole body scintigraphy. Such is ...the case in this patient with follicular thyroid cancer in whom subsequent FDG PET scanning showed a solitary hypermetabolic cervical lesion. With definitive management and multidisciplinary approach in mind, radioguided surgical excision came into play through the use of Tc-99m sestamibi, leading to successful removal of the lesion. Histopathology, however, revealed a parathyroid adenoma. This highlights the importance of considering differential diagnoses in apparent cases of recurrence to avoid potential pitfalls.
Prolonged and persistent myocardial stunning has recently been demonstrated using technetium-99m sestamibi gated single-photon emission tomography (SPET) myocardial perfusion imaging post exercise or ...pharmacological stress test. In this study, we investigated the early postischemic transient myocardial stunning on early and delayed poststress thallium-201 gated SPET myocardial perfusion imaging using segmental wall motion (WM) and wall thickening (WT) analysis. A total of 1,680 segments from 84 patients' studies (53 men and 31 women, mean age 60 years) were evaluated on both early and delayed thallium-201 gated SPET treadmill exercise (59) or dobutamine stress (25) myocardial perfusion imaging. Semiquantitative analysis of perfusion, WM and WT in all segments was performed by two observers. Segments were classified according to changes in WM and WT between early and delayed images into normal, fixed abnormality, or improved abnormality (transient stunning), and were further classified according to changes in perfusion into normal, fixed defects, or ischemic. There were significant correlations between perfusion and WM, perfusion and WT, and WM and WT segmental scores on both early and delayed images. Transient stunning was seen significantly ( P < 0.001) more often in ischemic segments than were normal or fixed perfusion defects using WM (58%) and WT (50%) assessments. There was also a significant correlation between the severity of ischemia and transient stunning with either WM ( P < 0.05) or WT ( P < 0.005) evaluation. Segmental myocardial contractility assessment from gated SPET (201)Tl myocardial perfusion imaging using WM and WT was comparable, and results correlated well with the myocardial perfusion assessment. Early transient myocardial stunning was frequently observed in ischemic segments and was related to the severity of myocardial ischemia.
Medication guides (MGs) provide patients with important information about certain prescription drugs to help them take these drugs safely. We surveyed US residents about their perceptions of MG ...readability and understandability. We randomly sampled 5204 US residents (age 18+) from Ipsos's KnowledgePanel to complete a two-part survey. Only respondents who reported receiving an MG with their prescription drugs (n = 3852) completed part 2, which included two key items: How easy to (1)read/(2)understand are the MGs that you have received from a pharmacy along with your prescription medicines? (1 = Very easy, 5 = Very difficult; reverse-coded). Health literacy (HL) and demographic data were also collected. After weighting our data, we found that 85% of respondents who reported receiving an MG perceived this information as 'very easy' (27.3%), 'somewhat easy' (28.3%) or 'about average' (29.3%) to read. Eighty-seven percent of respondents who reported receiving an MG perceived it as 'very easy' (27.6%), 'somewhat easy' (30.2%) or 'about average' (29.5%) to understand. ANOVAs revealed higher average perceived MG reading and comprehension ease scores among respondents presumed to have adequate versus inadequate HL (ps ≤ 0.0006). Younger or less-educated respondents and non-Hispanic Blacks perceived MGs as easier to read and understand, on average, than their counterparts (ps ≤ 0.0001). Many of these relationships remained intact in models predicting perceived MG reading and comprehension ease (ps ≤ 0.001). Adjusted R2 values across models were small, however (≤0.06). Our findings suggest most US residents (18+) who received MGs perceived them to be 'about average' to 'very easy' to read and understand.
We aimed to assess the additional value of SPECT/CT over planar lymphoscintigraphy (PI) in sentinel node (SN) detection in malignancies with different lymphatic drainage such as breast cancer, ...melanoma, and pelvic tumors.
From 2010 to 2013, 1,508 patients were recruited in a multicenter study: 1,182 breast cancer, 262 melanoma, and 64 pelvic malignancies (prostate, cervix, penis, vulva). PI was followed by SPECT/CT 1-3 h after injection of (99m)Tc-colloid particles. Surgery was performed the same or next day.
Significantly more SNs were detected by SPECT/CT for breast cancer (2,165 vs. 1,892), melanoma (602 vs. 532), and pelvic cancer (195 vs. 138), all P < 0.001. The drainage basin mismatch between PI and SPECT/CT was 16.5% for breast cancer, 11.1% for melanoma, and 51.6% for pelvic cancers. Surgical adjustment was 17% for breast cancer, 37% for melanoma, and 65.6% for pelvic cancer.
SPECT/CT detected more SNs and changed the drainage territory, leading to surgical adjustments in a considerable number of patients in all malignancies studied but especially in the pelvic cancer group because of this group's deep lymphatic drainage. We recommend SPECT/CT in all breast cancer patients with no SN visualized on PI, all patients with melanoma of the head and neck or trunk, all patients with pelvic malignancies, and those breast cancer and melanoma patients with unexpected drainage on PI.
Pneumonia is the leading infection-related cause of death. The use of simple clinical criteria and contemporary epidemiology to identify patients at high risk of nosocomial pneumonia should enhance ...prevention efforts and facilitate development of new treatments in clinical trials.
What are the clinical criteria and contemporary epidemiology trends that are helpful in the identification of patients at high risk of nosocomial pneumonia?
Within the ICUs of 28 US hospitals, we conducted a prospective cohort study among adults who had been hospitalized >48 hours and were considered high risk for pneumonia (defined as treatment with invasive or noninvasive ventilatory support or high levels of supplemental oxygen). We estimated the proportion of high-risk patients who experienced the development of nosocomial pneumonia. Using multivariable logistic regression, we identified patient characteristics and treatment exposures that are associated with increased risk of pneumonia development during the ICU admission.
Between February 6, 2016, and October 7, 2016, 4,613 high-risk patients were enrolled. Among 1,464 high-risk patients (32%) who were treated for possible nosocomial pneumonia, 537 (37%) met the study pneumonia definition. Among high-risk patients, a multivariable logistic model was developed to identify key patient characteristics and treatment exposures that are associated with increased risk of nosocomial pneumonia development (c-statistic, 0.709; 95% CI, 0.686-0.731). Key factors associated with increased odds of nosocomial pneumonia included an admission diagnosis of trauma or cerebrovascular accident, receipt of enteral nutrition, documented aspiration risk, and receipt of systemic antibacterials within the preceding 90 days.
Treatment for nosocomial pneumonia is common among patients in the ICU who are receiving high levels of respiratory support, yet more than one-half of patients who are treated do not fulfill standard diagnostic criteria for pneumonia. Application of simple clinical criteria may improve the feasibility of clinical trials of pneumonia prevention and treatment by facilitating prospective identification of patients at highest risk.
PROPHETIC Bergin, Stephen P.; Coles, Adrian; Calvert, Sara B. ...
Chest,
December 2020, 2020-12-00, Volume:
158, Issue:
6
Journal Article
Peer reviewed
Open access
Pneumonia is the leading infection-related cause of death. The use of simple clinical criteria and contemporary epidemiology to identify patients at high risk of nosocomial pneumonia should enhance ...prevention efforts and facilitate development of new treatments in clinical trials.
What are the clinical criteria and contemporary epidemiology trends that are helpful in the identification of patients at high risk of nosocomial pneumonia?
Within the ICUs of 28 US hospitals, we conducted a prospective cohort study among adults who had been hospitalized >48 hours and were considered high risk for pneumonia (defined as treatment with invasive or noninvasive ventilatory support or high levels of supplemental oxygen). We estimated the proportion of high-risk patients who experienced the development of nosocomial pneumonia. Using multivariable logistic regression, we identified patient characteristics and treatment exposures that are associated with increased risk of pneumonia development during the ICU admission.
Between February 6, 2016, and October 7, 2016, 4,613 high-risk patients were enrolled. Among 1,464 high-risk patients (32%) who were treated for possible nosocomial pneumonia, 537 (37%) met the study pneumonia definition. Among high-risk patients, a multivariable logistic model was developed to identify key patient characteristics and treatment exposures that are associated with increased risk of nosocomial pneumonia development (c-statistic, 0.709; 95% CI, 0.686-0.731). Key factors associated with increased odds of nosocomial pneumonia included an admission diagnosis of trauma or cerebrovascular accident, receipt of enteral nutrition, documented aspiration risk, and receipt of systemic antibacterials within the preceding 90 days.
Treatment for nosocomial pneumonia is common among patients in the ICU who are receiving high levels of respiratory support, yet more than one-half of patients who are treated do not fulfill standard diagnostic criteria for pneumonia. Application of simple clinical criteria may improve the feasibility of clinical trials of pneumonia prevention and treatment by facilitating prospective identification of patients at highest risk.
Background. Transient postischemic stunning (TIS) has been reported in images obtained 12 to 1 hour after stress with technetium 99m tracers but has not been investigated in images obtained shortly ...after stress with thallium 201. We also quantified the global extent and severity of TIS, which has not been done previously. Methods and Results. We evaluated 82 patients with either treadmill or dobutamine stress Tl-201 myocardial perfusion imaging. Images were semiquantitatively examined with a 20-segment model. The extent and severity of myocardial ischemia and TIS were assessed by the summed difference score from the early and delayed scores of perfusion, wall motion (WM), and wall thickening (WT). The mean left ventricular ejection fraction (LVEF) was significantly lower in early images than in delayed images in patients with ischemia (P < .01), TIS by WM (P < .001), and TIS by WT (P < .001), and the LVEF difference was more significantly different as the summed difference score of perfusion, WM, or WT increased. No significant LVEF difference was seen in patients with ischemia who did not have TIS. Conclusions. In stress gated Tl-201 single photon emission computed tomography myocardial perfusion imaging, early TIS is frequently seen in patients with ischemia and is equivalently detected by WM and WT assessments. Significant exercise-induced transient left ventricular global dysfunction is associated with more severe and extensive ischemia and can be predicted by the measurement of the extent and severity of TIS from the same images. (J Nucl Cardiol 2002;9:482-90)
Background. The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrug-resistant infections. The evaluation of new antibacterial drugs for efficacy ...in this population is important, as many antibacterial drugs have demonstrated limitations when studied in this population. HABP/VABP trials are expensive and challenging to conduct due to protocol complexity and low patient enrollment, among other factors. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development by streamlining HABP/VABP clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. Methods. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with HABP/VABP protocol complexity. The Project Team developed potential solutions to streamline HABP/VABP trials using a Quality by Design approach. Results. CTTI recommendations focus on 4 key areas to improve HABP/VABP trials: informed consent processes/practices, protocol design, choice of an institutional review board (IRB), and trial outcomes. Informed consent processes should include legally authorized representatives. Protocol design decisions should focus on eligibility criteria, prestudy antibacterial therapy considerations, use of new diagnostics, and sample size. CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, including defining a clinical failure and evaluating the impact of concomitant antibacterial drugs. Conclusions. Streamlining HABP/VABP trials by addressing key protocol elements can improve trial startup and patient recruitment/retention, reduce trial complexity and costs, and ensure patient safety while advancing antibacterial drug development.
Background. Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to ...the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development (ABDD) by streamlining clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. Methods. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with current data collection processes. Experts defined "data collection" as the act of capturing and reporting certain data on the case report form as opposed to recording of data as part of routine clinical care. The ABDD Project Team developed strategies for streamlining safety data collection in HABP/VABP trials using a Quality by Design approach. Results. Current safety data collection processes in HABP/VABP trials often include extraneous information. More targeted strategies for safety data collection in HABP/VABP trials will rely on optimal protocol design and prespecification of which safety data are essential to satisfy regulatory reporting requirements. Conclusions. A consensus and a cultural change in clinical trial design and conduct, which involve recognition of the need for more efficient data collection, are urgently needed to advance ABDD and to improve HABP/VABP trials in particular.
PDF
