Assessment of adherence to visual correction and occlusion therapy in the Infant Aphakia Treatment Study

AbstractOcclusion therapy throughout early childhood is believed to be efficacious in treating deprivation amblyopia but has not been rigorously assessed in clinical trials. Further, tools to assess adherence to such therapy over an extended period of time are lacking. Using data from the Infant Aphakia Treatment Study, a randomized clinical trial of treatment for unilateral congenital cataract, we examined the use of quarterly 48-h recall interviews and annual 7-day prospective diaries to assess reported hours of patching in 114 children throughout the first 5 years of life. Consistency of data reported was assessed using correlation coefficients and intraclass correlation coefficients. Both interview and diary data showed excellent consistency with Cronbach’s Alpha’s ranging from 0.69 to 0.88 for hours of patching and 0.60 to 0.73 for hours of sleep. However, caregivers reported somewhat more adherence in prospective diaries than retrospective interviews. Completion rates, on the other hand, were substantially higher for telephone interviews than prospective diaries. For example, four years after surgery response rates to telephone interviews exceeded 75% versus completion rates of only 54% for diaries. In situations where occlusion dose monitors cannot be used for assessing adherence to occlusion therapy, such as in infants or over an extended period of time, quantitative assessments of occlusion therapy can be obtained by parental report, either as a series of prospective diaries or a series of recall interviews

Prophylactic balloon angioplasty fails to prolong the patency of expanded polytetrafluoroethylene arteriovenous grafts: Results of a prospective randomized study

AbstractPurpose: Maintenance of hemodialysis access grafts represents an enormous social and clinical problem. Current grafts and graft salvage techniques are inadequate. Consequently, there has been increasing interest in the use of minimally invasive catheter techniques to prophylactically treat stenoses in functioning arteriovenous grafts. Prophylactic balloon angioplasty has been widely suggested as prolonging assisted primary patency. We have performed a prospective randomized trial to compare patients who underwent percutaneous transluminal angioplasty (PTA) for graft stenoses >50% with a control group that received no intervention. Our hypothesis was that to be efficacious a minimal benefit of 20% prolongation in patency would be necessary.Methods: Color flow duplex scanning was used to detect >50% stenoses in functioning expanded polytetrafluoroethylene grafts. Patients were then subjected to confirmatory angiographic evaluation. Those who had angiographic stenoses >50% were randomized to balloon angioplasty or observation. Patients were followed-up with duplex scanning every 2 months. Statistical analysis was performed using the Kaplan-Meier technique. Although demographically the patient groups were well matched, there were more prior interventions and concurrent central stenoses in the treatment group. Outcomes were graft thrombosis, graft dysfunction that precluded dialysis, and six or more PTA procedures within 18 months.Results: In the treatment and observation groups, the 6-month patency rates were 69% ± 7% and 70% ± 7%, respectively. The 12-month patency rates for the treatment and observation groups were 51% ± 6% and 47% ± 4%, respectively. There was no significant difference between these two groups ( p = 0.97), with an 80% confidence limit for detection of a difference greater than 20%.Conclusions: This study demonstrates that a generic approach of PTA to treat all polytetrafluoroethylene grafts with stenoses >50% does not prolong patency and cannot be supported

Intracranial Stenosis: Impact of Randomized Trials on Treatment Preferences of US Neurologists and Neurointerventionists

Medical and endovascular treatment options for stroke prevention in patients with symptomatic intracranial stenosis have evolved over the past several decades, but the impact of 2 major multi-center randomized stroke prevention trials on physician practices has not been studied. We sought to determine changes in US physician treatment choices for patients with intracranial atherosclerotic stenosis (ICAS) following 2 NIH-funded clinical trials that studied medical therapies (antithrombotic agents and risk factor control) and percutaneous transluminal angioplasty and stenting (PTAS)

GATA-4 and GATA-6 expression in human ovarian surface epithelial carcinoma

GATA-4 and GATA-6 are zinc finger transcription factors named for their recognition motif and involved in ovarian development and function. GATA factors are strongly expressed and primarily localized within the nuclei of ovarian surface epithelial cells. GATA factors have been previously shown to be expressed in sex-cord stromal ovarian tumors and may contribute to the tumor phenotype. Differential expression of GATA-4 within serous and mucinous ovarian carcinomas has been reported. Using immunohistochemistry, we studied GATA-4 and GATA-6 expression in 50 ovarian surface epithelial carcinomas and examined the relationship to clinicopathologic parameters and outcome. We found that the majority of the carcinomas retained GATA-4 expression, whereas approximately two-thirds of the carcinomas had mislocalization or loss of GATA-6 expression. No statistically significant correlations were found between histologic type, histologic grade, or patient outcome and GATA-4. Cytoplasmic GATA-6 expression tended to correlate with overall survival (P=0.0756). These findings suggest that although GATA factors play a role in ovarian surface epithelial carcinoma oncogenesis, they do not seem to affect clinicopathologic parameters

Relationship Between Blood Pressure and Stroke Recurrence in Patients With Intracranial Arterial Stenosis

Background— Many clinicians allow blood pressure to run high in patients with intracranial stenosis to protect against hypoperfusion. We sought to determine whether higher blood pressure decreases the risk of stroke in these patients. Methods and Results— Data on 567 patients in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial were analyzed. Time to ischemic stroke and stroke in the same territory of the stenotic vessel was compared in patients grouped by mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) during the study. Additional analyses were based on severity and location of stenosis. Ischemic stroke risk increased with increasing mean SBP and DBP on univariate analysis ( P <0.0001, P <0.0001) and after adjustment for risk factors ( P =0.0008, P <0.0001). Elevated mean SBP and DBP also resulted in increased risk of stroke in the territory in univariate ( P =0.0065, P <0.0001) and adjusted ( P =0.0002, P =0.0005) analyses. The increased risk of stroke with increasing SBP was driven largely by patients in the highest SBP group. Patients with moderate (<70%) stenosis had increased risk of stroke ( P <0.0001, P =0.003) and stroke in the territory ( P =0.0002, P =0.010) with increased SBP and DBP. Patients with severe (≥70%) stenosis had increased risk of stroke and stroke in the territory with elevated DBP ( P =0.004, P =0.004). Conclusions— In patients with intracranial stenosis, higher blood pressure is associated with increased (not decreased) risk of ischemic stroke and stroke in the territory of the stenotic vessel. These findings argue strongly against the common clinical practice of maintaining high blood pressure in patients with intracranial stenosis

Abstract P569: Adherence to Preventive Therapy and Early Recurrent Cerebral Ischemia in Patients With Symptomatic Intracranial Atherosclerotic Disease: Analysis of the Myriad Study

Background: Intracranial atherosclerotic disease (IAD) is a common cause of stroke with high rate of early recurrence despite maximal medical therapy. We sought to determine adherence to secondary preventive therapy and its association with early recurrent ischemia in patients with symptomatic IAD. Methods: The Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD) study included patients with recent stroke or transient ischemic attack due to moderate-to-severe IAD. Although MyRIAD did not mandate treatment, patients were recommended to follow standard secondary preventive management including antiplatelet therapy, lipid-lowering medications, antihypertensives for blood pressure (BP) goal <140/90 mmHg, smoking cessation and regular physical activity. Patients underwent 6-8 weeks assessment for medication adherence, smoking status, and physical activity compliance. Adherence to preventive therapy was correlated with new infarcts in the affected vessel territory on brain MRI. Results: Eighty-nine out of 105 patients enrolled in MyRIAD completed 6-8 weeks clinical and brain MRI assessment (mean age 64 +/- 12 years; 57% men). During follow up, 99% were on antiplatelets, 89% on lipid-lowering medications, 81% on antihypertensives, 48% had systolic BP at goal, 79% had diastolic BP at goal, 93% were not active smokers, and 47% were compliant with physical activity. Overall, new infarcts on brain MRI were found in 25% patients. Although no significant differences were found, patients with uncontrolled BP, active smokers and those not compliant with physical activity had a higher frequency of new infarcts in the affected vessel territory (Table). Conclusions: Medication adherence was high after IAD-related stroke. However, a noteworthy fraction of patients had uncontrolled BP, continue to smoke, and were not compliant with physical activity. The latter may represent important therapeutic targets to prevent early recurrent ischemia

Risk Factors Control and Early Recurrent Cerebral Infarction in Patients with Symptomatic Intracranial Atherosclerotic Disease

•Only one-fifth on patients with symptomatic intracranial atherosclerosis (IAD) had optimal stroke risk factors control during early follow-up.•Uncontrolled systolic blood pressure and physical inactivity were frequent during early follow-up in patients with symptomatic IAD.•None of the participants with optimal risk factors control had early recurrent cerebral infarction, thus suggesting that lifestyle modifications and pharmacotherapy are important in reducing risk of recurrent ischemia in patients with symptomatic IAD. The risk of early recurrent cerebral infarction (RCI) is high in patients with symptomatic intracranial atherosclerotic disease (IAD). We sought to determine the relationship between risk factor control and early RCI risk among patients with symptomatic IAD. We analyzed participants with symptomatic IAD in the multi-center prospective observational MYRIAD study. Risk factor control was assessed at 6-8-week follow-up. Optimal risk factor control was defined by target systolic blood pressure, being non-smoker, target physical activity, and antiplatelet and antilipidemic therapy compliance. Age-adjusted associations were calculated between risk factor control and RCI determined by MRI-evident new infarcts in the territory of the stenotic vessel at 6-8 weeks from the index event. Among 82 participants with clinical and brain MRI information available 6-8 weeks after the index event (mean age 63.5 ±12.5 years, 62.2% men), RCI occurred in 21 (25.6%) cases. At 6-8-week follow-up, 37.8% had target systolic blood pressure, 92.7% were non-smokers, 51.2% had target physical activity, and 98.8% and 86.6% were compliant with antiplatelet and antilipidemic therapy, respectively. Optimal risk factor control increased from 4.9% at baseline to 19.5% at 6-8-week follow-up (p=0.01). None of the participants with optimal risk factor control at follow-up had RCI (0% vs. 31.8%, p<0.01). Only one-fifth of MYRIAD participants had optimal risk factor control during early follow-up. Approximately half and two-thirds had physical inactivity and uncontrolled systolic blood pressure, respectively. These risk factors may represent important therapeutic targets to prevent early RCI in patients with symptomatic IAD