Abstract Background A systematic literature review of magnetic resonance imaging (MRI)–targeted prostate biopsy demonstrates poor adherence to the Standards for the Reporting of Diagnostic Accuracy ...(STARD) recommendations for the full and transparent reporting of diagnostic studies. Objective To define and recommend Standards of Reporting for MRI-targeted Biopsy Studies (START). Design, setting, and participants Each member of a panel of 23 experts in urology, radiology, histopathology, and methodology used the RAND/UCLA appropriateness methodology to score a 258-statement premeeting questionnaire. The collated responses were presented at a face-to-face meeting, and each statement was rescored after group discussion. Outcome measurements and statistical analysis Measures of agreement and consensus were calculated for each statement. The most important statements, based on group median score, the degree of group consensus, and the content of the group discussion, were used to create a checklist of reporting criteria (the START checklist). Results and limitations The strongest recommendations were to report histologic results of standard and targeted cores separately using Gleason score and maximum cancer core length. A table comparing detection rates of clinically significant and clinically insignificant disease by targeted and standard approaches should also be used. It was recommended to report the recruitment criteria for MRI-targeted biopsy, prior biopsy status of the population, a brief description of the MRI sequences, MRI reporting method, radiologist experience, and image registration technique. There was uncertainty about which histologic criteria constitute clinically significant cancer when the prostate is sampled using MRI-targeted biopsy, and it was agreed that a new definition of clinical significance in this setting needed to be derived in future studies. Conclusions Use of the START checklist would improve the quality of reporting in MRI-targeted biopsy studies and facilitate a comparison between standard and MRI-targeted approaches.
In this study involving nearly 77,000 men, investigators analyzed the effect of screening with prostate-specific–antigen testing and digital rectal examination on the rate of death from prostate ...cancer, as compared with usual care. After a follow-up of 7 years, the death rates from prostate cancer did not differ significantly between the two study groups. Data from the 10-year follow-up (which were 67% complete) also showed no significant difference in prostate-cancer mortality.
The benefit of screening for prostate cancer with serum prostate-specific–antigen (PSA) testing, digital rectal examination, or any other screening test is unknown. There has been no comprehensive assessment of the trade-offs between benefits and risks. Despite these uncertainties, PSA screening has been adopted by many patients and physicians in the United States and other countries. The use of PSA testing as a screening tool has increased dramatically in the United States since 1988.
1
Numerous observational studies have reported conflicting findings regarding the benefit of screening.
2
As a result, the screening recommendations of various organizations differ. The American Urological Association and . . .
More than 1.5 million Americans suffer a traumatic brain injury (TBI) each year. Seventy-five percent of these patients have a mild TBI, with Glasgow Coma Scale (GCS) Score 13-15. At the authors' ...institution, the usual practice has been to admit those patients with an associated intracranial hemorrhage (ICH) to an ICU and to obtain repeat head CT scans 12-24 hours after admission. The purpose of this study was to determine if there exists a subpopulation of mild TBI patients with an abnormal head CT scan that requires neither repeat brain imaging nor admission to an ICU. This group of patients was further classified based on initial clinical factors and imaging characteristics.
A retrospective review of all patients admitted to a Level I trauma center from January 2007 through December 2008 was performed using the hospital Trauma Registry Database, medical records, and imaging data. The inclusion criteria were as follows: 1) an admission GCS score ≥ 13; 2) an isolated head injury with no other injury requiring ICU admission; 3) an initial head CT scan positive for ICH; and 4) an initial management plan that was nonoperative. Collected data included age, etiology, initial GCS score, time of injury, duration of ICU stay, duration of hospital stay, and anticoagulation status. Primary outcomes measured were the occurrence of neurological or medical decline and the need for neurosurgical intervention. Imaging data were analyzed and classified based on the predominant blood distribution found on admission imaging. Data were further categorized based on the Marshall CT classification, Rotterdam score, and volume of intraparenchymal hemorrhage (IPH). Progression was defined as an increase in the Marshall classification, an increase in the Rotterdam score, or a 30% increase in IPH volume.
Three hundred twenty-one of 1101 reviewed cases met inclusion criteria for the study. Only 4 patients (1%) suffered a neurological decline and 4 (1%) required nonemergent neurosurgical intervention. There was a medical decline in 18 of the patients (6%) as a result of a combination of events such as respiratory distress, myocardial infarction, and sepsis. Both patient age and the transfusion of blood products were significant predictors of medical decline. Overall patient mortality was 1%. Based on imaging data, the rate of injury progression was 6%. The only type of ICH found to have a significant rate of progression (53%) was a subfrontal/temporal intraparenchymal contusion. Other variables found to be significant predictors of progression on head CT scans were the use of anticoagulation, an age over 65 years, and a volume of ICH > 10 ml.
Most patients with mild TBI have a good outcome without the necessity of neurosurgical intervention. Mild TBI patients with a convexity SAH, small convexity contusion, small IPH (≤ 10 ml), and/or small subdural hematoma do not require admission to an ICU or repeat imaging in the absence of a neurological decline.
CONTEXT Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia are at high risk for subsequent stroke when treated medically. OBJECTIVE ...To test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia. DESIGN Parallel-group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002 to 2010. SETTING Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. The majority were academic medical centers. PARTICIPANTS Patients with arteriographically confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemia identified by ipsilateral increased oxygen extraction fraction measured by PET. Of 195 patients who were randomized, 97 were randomized to receive surgery and 98 to no surgery. Follow-up for the primary end point until occurrence, 2 years, or termination of trial was 99% complete. No participant withdrew because of adverse events. INTERVENTIONS Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. Antithrombotic therapy and risk factor intervention were recommended for all participants. MAIN OUTCOME MEASURE For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death from surgery through 30 days after surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. For the nonsurgical group and participants assigned to surgery who did not receive surgery, the combination of (1) all stroke and death from randomization to randomization plus 30 days and (2) ipsilateral ischemic stroke within 2 years of randomization. RESULTS The trial was terminated early for futility. Two-year rates for the primary end point were 21.0% (95% CI, 12.8% to 29.2%; 20 events) for the surgical group and 22.7% (95% CI, 13.9% to 31.6%; 20 events) for the nonsurgical group (P = .78, Z test), a difference of 1.7% (95% CI, −10.4% to 13.8%). Thirty-day rates for ipsilateral ischemic stroke were 14.4% (14/97) in the surgical group and 2.0% (2/98) in the nonsurgical group, a difference of 12.4% (95% CI, 4.9% to 19.9%). CONCLUSION Among participants with recently symptomatic AICAO and hemodynamic cerebral ischemia, EC-IC bypass surgery plus medical therapy compared with medical therapy alone did not reduce the risk of recurrent ipsilateral ischemic stroke at 2 years. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00029146
Purpose Many patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the ...efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC. Methods In this open-label, multicenter (n = 13), parallel-arm, phase II study ( ClinicalTrials.gov identifier: NCT01687244), 43 patients with HG BCG-refractory or relapsed NMIBC received intravesical rAd-IFNα/Syn3 (randomly assigned 1:1 to 1 × 10
viral particles (vp)/mL or 3 × 10
vp/mL). Patients who responded at months 3, 6, and 9 were retreated at months 4, 7, and 10. The primary end point was 12-month HG recurrence-free survival (RFS). All patients who received at least one dose were included in efficacy and safety analyses. Results Forty patients received rAd-IFNα/Syn3 (1 × 10
vp/mL, n = 21; 3 × 10
vp/mL, n = 19) between November 5, 2012, and April 8, 2015. Fourteen patients (35.0%; 90% CI, 22.6% to 49.2%) remained free of HG recurrence 12 months after initial treatment. Comparable 12-month HG RFS was noted for both doses. Of these 14 patients, two experienced recurrence at 21 and 28 months, respectively, after treatment initiation, and one died as a result of an upper tract tumor at 17 months without a recurrence. rAd-IFNα/Syn3 was well tolerated; no grade four or five adverse events (AEs) occurred, and no patient discontinued treatment because of an adverse event. The most frequently reported drug-related AEs were micturition urgency (n = 16; 40%), dysuria (n = 16; 40%), fatigue (n = 13; 32.5%), pollakiuria (n = 11; 28%), and hematuria and nocturia (n = 10 each; 25%). Conclusion rAd-IFNα/Syn3 was well tolerated. It demonstrated promising efficacy for patients with HG NMIBC after BCG therapy who were unable or unwilling to undergo radical cystectomy.
Background
The prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial was undertaken to determine whether there is a reduction in prostate cancer mortality ...from screening using serum prostate-specific antigen (PSA) testing and digital rectal examination (DRE). Mortality after 7-10 years of follow-up has been reported previously. We report extended follow-up to 13 years after the trial.
Methods
A total of 76 685 men, aged 55-74 years, were enrolled at 10 screening centers between November 1993 and July 2001 and randomly assigned to the intervention (organized screening of annual PSA testing for 6 years and annual DRE for 4 years; 38 340 men) and control (usual care, which sometimes included opportunistic screening; 38 345 men) arms. Screening was completed in October 2006. All incident prostate cancers and deaths from prostate cancer through 13 years of follow-up or through December 31, 2009, were ascertained. Relative risks (RRs) were estimated as the ratio of observed rates in the intervention and control arms, and 95% confidence intervals (CIs) were calculated assuming a Poisson distribution for the number of events. Poisson regression modeling was used to examine the interactions with respect to prostate cancer mortality between trial arm and age, comorbidity status, and pretrial PSA testing. All statistical tests were two-sided.
Results
Approximately 92% of the study participants were followed to 10 years and 57% to 13 years. At 13 years, 4250 participants had been diagnosed with prostate cancer in the intervention arm compared with 3815 in the control arm. Cumulative incidence rates for prostate cancer in the intervention and control arms were 108.4 and 97.1 per 10 000 person-years, respectively, resulting in a relative increase of 12% in the intervention arm (RR = 1.12, 95% CI = 1.07 to 1.17). After 13 years of follow-up, the cumulative mortality rates from prostate cancer in the intervention and control arms were 3.7 and 3.4 deaths per 10 000 person-years, respectively, resulting in a non-statistically significant difference between the two arms (RR = 1.09, 95% CI = 0.87 to 1.36). No statistically significant interactions with respect to prostate cancer mortality were observed between trial arm and age (P
interaction = .81), pretrial PSA testing (P
interaction = .52), and comorbidity (P
interaction = .68).
Conclusions
After 13 years of follow-up, there was no evidence of a mortality benefit for organized annual screening in the PLCO trial compared with opportunistic screening, which forms part of usual care, and there was no apparent interaction with age, baseline comorbidity, or pretrial PSA testing.
CONTEXT.— The relative importance of hemodynamic factors in the pathogenesis and
treatment of stroke in patients with carotid artery occlusion remains controversial. OBJECTIVE.— To test the ...hypothesis that stage II cerebral hemodynamic failure (increased
oxygen extraction measured by positron emission tomography PET) distal to
symptomatic carotid artery occlusion is an independent risk factor for subsequent
stroke in medically treated patients. DESIGN AND SETTING.— Prospective, blinded, longitudinal cohort study of patients referred
from a group of regional hospitals between 1992 and 1996. PATIENTS.— From 419 subjects referred, 81 with previous stroke or transient ischemic
attack in the territory of an occluded carotid artery were enrolled. All were
followed up to completion of the study, with average follow-up of 31.5 months. MAIN OUTCOME MEASURES.— Telephone contact every 6 months recorded the subsequent occurrence
of all stroke, ipsilateral ischemic stroke, and death. RESULTS.— Stroke occurred in 12 of 39 patients with stage II hemodynamic failure
and in 3 of 42 patients without (P=.005); stroke
was ipsilateral in 11 of 39 patients with stage II hemodynamic failure and
in 2 of 42 patients without (P=.004). Six deaths
occurred in each group (P=.94). The age-adjusted
relative risk conferred by stage II hemodynamic failure was 6.0 (95% confidence
interval CI, 1.7-21.6) for all stroke and 7.3 (95% CI, 1.6-33.4) for ipsilateral
stroke. CONCLUSIONS.— Stage II hemodynamic failure defines a subgroup of patients with symptomatic
carotid occlusion who are at high risk for subsequent stroke when treated
medically. A randomized trial evaluating surgical revascularization in this
high-risk subgroup is warranted.
Summary
Purpose: The short‐term efficacy and safety of epilepsy surgery relative to medical therapy has been established, but it remains underutilized. There is a lack of data regarding the ...long‐term seizure‐control rates and quality of life outcomes after epilepsy surgery. This study represents the longest follow‐up study to date, with a mean follow‐up duration of 26 years.
Methods: We studied the seizure and health‐related quality of life outcomes of patients who underwent epilepsy surgery by Dr. Sidney Goldring from 1967 to 1990. Retrospective clinical chart reviews gathered perioperative data and surveys obtained follow‐up data. Seizure outcome was evaluated using the Engel classification system.
Key Findings: Of 361 patients, 117 (32.4%) completed follow‐up interviews. Fifty‐six patients (48%) were Engel class I. Mean overall Quality of Life in Epilepsy (QOLIE‐31) questionnaire score for the cohort was 68.2 ± 16. Eighty percent of patients reported their overall quality of life now as being better than before surgery. Seizure freedom was associated with better quality of life. We did not observe a statistically significant association between postoperative complications and long‐term outcome. Patients who underwent temporal lobe resection achieved better seizure outcomes than those who underwent other types of procedures. Astatic seizures and bilateral surgery were associated with a worse Engel class outcome.
Significance: Our study demonstrates that the beneficial effects of epilepsy surgery are sustained over decades, and that these beneficial effects are correlated with an improved quality of life. The confirmation of its durability makes us optimistic that the outcomes from modern epilepsy surgery will be even better and that our present enthusiasm for this treatment modality is not misplaced.
Object
More than 1.5 million Americans suffer a traumatic brain injury (TBI) each year. Seventy-five percent of these patients have a mild TBI, with Glasgow Coma Scale (GCS) Score 13–15. At the ...authors' institution, the usual practice has been to admit those patients with an associated intracranial hemorrhage (ICH) to an ICU and to obtain repeat head CT scans 12–24 hours after admission. The purpose of this study was to determine if there exists a subpopulation of mild TBI patients with an abnormal head CT scan that requires neither repeat brain imaging nor admission to an ICU. This group of patients was further classified based on initial clinical factors and imaging characteristics.
Methods
A retrospective review of all patients admitted to a Level I trauma center from January 2007 through December 2008 was performed using the hospital Trauma Registry Database, medical records, and imaging data. The inclusion criteria were as follows: 1) an admission GCS score ≥ 13; 2) an isolated head injury with no other injury requiring ICU admission; 3) an initial head CT scan positive for ICH; and 4) an initial management plan that was nonoperative.
Collected data included age, etiology, initial GCS score, time of injury, duration of ICU stay, duration of hospital stay, and anticoagulation status. Primary outcomes measured were the occurrence of neurological or medical decline and the need for neurosurgical intervention. Imaging data were analyzed and classified based on the predominant blood distribution found on admission imaging. Data were further categorized based on the Marshall CT classification, Rotterdam score, and volume of intraparenchymal hemorrhage (IPH). Progression was defined as an increase in the Marshall classification, an increase in the Rotterdam score, or a 30% increase in IPH volume.
Results
Three hundred twenty-one of 1101 reviewed cases met inclusion criteria for the study. Only 4 patients (1%) suffered a neurological decline and 4 (1%) required nonemergent neurosurgical intervention. There was a medical decline in 18 of the patients (6%) as a result of a combination of events such as respiratory distress, myocardial infarction, and sepsis. Both patient age and the transfusion of blood products were significant predictors of medical decline. Overall patient mortality was 1%.
Based on imaging data, the rate of injury progression was 6%. The only type of ICH found to have a significant rate of progression (53%) was a subfrontal/temporal intraparenchymal contusion. Other variables found to be significant predictors of progression on head CT scans were the use of anticoagulation, an age over 65 years, and a volume of ICH > 10 ml.
Conclusions
Most patients with mild TBI have a good outcome without the necessity of neurosurgical intervention. Mild TBI patients with a convexity SAH, small convexity contusion, small IPH (≤ 10 ml), and/or small subdural hematoma do not require admission to an ICU or repeat imaging in the absence of a neurological decline.
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