Holy Name Medical Center

BACKGROUND: Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain. METHODS: We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy). RESULTS: Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95% CI, -4.4 to -0.2; P=0.03). CONCLUSIONS: Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.).

BACKGROUND: Cognitive impairment in MS impacts negatively on many patients at all disease stages and in all subtypes. Full clinical cognitive assessment is expensive, requiring expert staff and special equipment. Test versions and normative data are not available for all languages and cultures. OBJECTIVE: To recommend a brief cognitive assessment for multiple sclerosis (MS) that is optimized for small centers, with one or few staff members, who may not have neuropsychological training and constructed to maximize international use. METHODS: An expert committee of twelve members representing the main cultural groups that have so far contributed considerable data about MS cognitive dysfunction was convened. Following exhaustive literature review, peer-reviewed articles were selected to cover a broad spectrum of cultures and scales that targeted cognitive domains vulnerable to MS. Each was rated by two committee members and candidates scales were rated on psychometric qualities (reliability, validity, and sensitivity), international application, ease of administration, feasibility in the specified context, and acceptability to patients. RESULTS: The committee recommended the Symbol Digit Modalities Test, if only 5 minutes was available, with the addition of the California Verbal Learning Test - Second Edition and the Brief Visuospatial Memory Test - Revised learning trials if a further 10 minutes could be allocated for testing. CONCLUSIONS: A brief cognitive assessment for MS has been recommended. A validation protocol has been prepared for language groups and validation studies have commenced.

The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheterdirected thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome.

Since there is a need for cost-effective screening techniques to identify neuropsychological impairment in multiple sclerosis (MS) patients, and because existing methods require cognitive testing with subsequent interpretation by a neuropsychologist, a brief self-report procedure was developed to screen for neuropsychological impairment in MS. In the first phase of the study, a pool of 80 items was generated based on a literature review and consultation with healthcare professionals. The set was reduced to 15 via Rasch analysis. Using these items, a brief (five minute) MS Neuropsychological Screening Questionnaire (MSNQ), including patient- and informant-report forms, was composed. In phase II, 50 MS patients and their caregivers completed the MSNQ. A comprehensive neuropsychological test battery was also administered. Analyses covered the reliability of the MSNQ and correlations between both patient- and informant-report scores and objective neuropsychological testing. Cronbach's alpha coefficients were 0.93 and 0.94 for the patient- and informant-report forms, respectively, and both forms of the test were strongly correlated with a more general cognitive complaints questionnaire. The patient MSNQ form correlated significantly with measures of depression but not with objective tests of cognitive function. In contrast, the informant form was correlated with patient cognitive performance but not depression. A cut-off score of 27 on the informant form of the MSNQ optimally separated patients based on a neuropsychological summary score encompassing measures of processing speed and memory. There were two false-negatives and one false-positive, giving the test a sensitivity of 0.83 and a specificity of 0.97. It is concluded, therefore, that this self-administered neuropsychological screening test is reliable and predicts neuropsychological impairment in MS patients with a reasonable degree of accuracy.

OBJECTIVES: To assess the relationship between donepezil treatment and time to nursing home placement (NHP) for patients with Alzheimer's disease (AD). DESIGN: Observational follow-up of patient NHP and vital status. SETTING: Community. PARTICIPANTS: Patients previously enrolled in one of three randomized, double-blind, placebo-controlled clinical trials of donepezil and two subsequent open-label studies (total N = 1,115); 671 patients provided complete data for analysis. MEASUREMENTS: Data were obtained through follow-up interviews with caregivers and chart reviews of patients with AD. Comparison groups were defined by whether patients received an effective dose of donepezil (>/=5 mg/d; >/=80% compliance) for specific numbers of weeks during the double-blind or open-label trial phase, in both phases, or in neither. Cox proportional hazards models were used to estimate risk ratios for NHP and survival curves from which median times to NHP were estimated for first dementia-related placement of longer than 2 weeks and permanent placement. The models were adjusted for age, sex, baseline Mini-Mental State Examination score, whether the caregiver was a spouse, caregiver continuity, and use of other cholinesterase inhibitors after the clinical trials. RESULTS: Use of donepezil of 5 mg/d or more was associated with significant delays in NHP. A cumulative dose-response relationship was observed between longer-term sustained donepezil use and delay of NHP. When donepezil was taken at an effective dose for at least 9 to 12 months, conservative estimates of the time gained before NHP were 21.4 months for first dementia-related NHP and 17.5 months for permanent NHP. CONCLUSION: Use of donepezil by AD patients resulted in significant delays in NHP. Long-term use of donepezil may help AD patients live longer in community settings, with consequent personal, social, and economic benefits.

BACKGROUND: Solitary fibrous tumors (SFT) are rare neoplasms that most commonly involve the pleura, mediastinum, and lung. They are believed to be submesothelial in origin. Histologically, they are characterized by fibroblast-like cells and connective tissue in varying proportions. The "patternless pattern" and the hemangiopericytoma-like pattern are the most common arrangements. The majority of SFTs have been immunoreactive for CD34. Very little has been reported regarding the cytologic findings in these tumors. METHODS: The authors reviewed the radiographic findings and studied fine-needle aspiration biopsies performed on seven patients with SFT of the pleura, and examined subsequent histologic material. The cell blocks or smears of all cases were stained with a monoclonal antibody to CD34. RESULTS: The cytologic preparations showed varying degrees of cellularity. Smears were comprised of spindled cells in a bloody background with small amounts of collagen. The three malignant tumors had a greater number of cells, both dispersed and in clusters, with nuclear pleomorphism and prominent nucleoli. The cell blocks characteristically showed varying degrees of cellularity with thickened blood vessels and a hemangiopericytoma-like pattern. The cells from the four benign tumors tended to be smaller in size and grouped in more cohesive clusters than the malignant ones. CD34 stained the spindle tumor cells in the cell blocks or smears from five cases; one malignant and one benign case failed to stain. The corresponding histologic samples from these cases demonstrated the same CD34 staining pattern in all cases except one. CONCLUSIONS: The differential diagnosis of SFT includes neurogenic tumors, mesotheliomas, sarcomatoid carcinoma, synovial sarcoma, hemangiopericytoma, and fibrosarcoma. CD34, when present, may prove equally helpful as a positive marker in cytology and in histologic preparations in the differential diagnosis of SFT.

In an earlier study, we developed the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) to assist in the screening for neuropsychological (NP) impairments. Self-report MSNQ scores correlated significantly with measures of depression, whereas informant-report MSNQ scores correlated with cognitive performance, but not depression. This study was criticized for use of a small sample and lack of data regarding normal performance and test-retest reliability. The present study was designed to replicate the earlier work with a larger sample of patients and normal controls obtained from multiple sites. We also evaluated the test-retest reliability and predictive validity of the MSNQ. The sample included 85 multiple sclerosis (MS) patients and 40 normal controls, matched on demographic variables. All participants completed the MSNQ and underwent NP testing. Thirty-four patients were re-examined at one week. Pearson and ANOVA techniques were utilized for univariate comparisons. Bayesian statistics were calculated to assess predictive validity. Patient self- and informant-report MSNQ scores differed from normal and test retest reliability indices were high. Both self- and informant-reports were correlated with cognitive dysfunction and depression scales. Self-report MSNQ scores correlated more strongly with depression than cognitive performance, whereas the opposite pattern was observed with informant-report scores. Bayesian statistics showed that informant-report MSNQ scores predict cognitive impairment and patient self-report scores identify patients with cognitive impairment or depression. It is concluded that the MSNQ is useful, although patient self-reports may be exaggerated in depressed patients or reduced in patients with severe cognitive impairment.

BACKGROUND: There are no published MRI studies comparing interferon beta 1b (IFNbeta-1b) and glatiramer acetate (GA) for treatment of relapsing multiple sclerosis (MS). OBJECTIVE: To compare the efficacy of IFNbeta-1b and GA for suppression of MS disease activity as evidenced on frequent brain MRI. METHODS: A total of 75 patients with relapsing-remitting MS or clinically isolated syndromes were randomized to standard doses of IFNbeta-1b or GA and followed by monthly brain MRI for up to 2 years with a protocol optimized to detect enhancement. The primary outcome was the number of combined active lesions (CAL) per patient per scan during the first year, which included all enhancing lesions and nonenhancing new T2/fluid-attenuated inversion recovery (FLAIR) lesions. Secondary outcomes were the number of new lesions and clinical exacerbations over 2 years. RESULTS: Baseline characteristics were similar between the groups. The primary outcome showed similar median (75th percentile) CAL per patient per scan for months 1-12, 0.63 (2.76) for IFNbeta-1b, and 0.58 (2.45) for GA (p = 0.58). There were no differences in new lesion or clinical relapses for 2 years. Only 4.4% of CAL on monthly MRI scans were nonenhancing new T2/FLAIR lesions. CONCLUSION: Patients with relapsing multiple sclerosis randomized to interferon beta 1b or glatiramer acetate showed similar MRI and clinical activity.

BACKGROUND: In the United States, adults with Autism Spectrum Disorder (ASD) experience high rates of unemployment and underemployment in relation to adults with other disabilities and the general population. Yet there is little research examining their employment experiences and the predictors of employment status. OBJECTIVE: The purpose of this study was to examine the employment characteristics and histories of both employed and unemployed adults with ASD, and the factors that contributed to their employment status. METHODS: This cross-sectional study used an online survey and the Short Effort Reward Imbalance (ERI) Scale to gather data. Multivariate logistic regression analyses were used to examine predictors of employment status and self-reported health. RESULTS: Of the 254 adults with ASD who participated in this study, 61.42% were employed and 38.58% were unemployed. Over half of the participants reported job imbalance on the Short ERI Scale and the vast majority did not receive any job assistance. Participants who disclosed their ASD diagnosis to their employer were more than three times as likely to be employed than those who did not disclose. Education level was also a significant predictor of employment status. CONCLUSIONS: This study suggests disability disclosure and education level are factors that contribute to employment status.

Considerable evidence indicates that cognitive dysfunction and impairments in everyday life activities are common in multiple sclerosis (MS). However, the relationship between these cognitive and functional deficits has not been thoroughly investigated. The purpose of this study was to examine the role of cognitive dysfunction in the functional status of individuals with MS. Participants were 74 adults with MS and 35 healthy comparison participants (HCs) who underwent neuropsychological testing and completed the Executive Functions Performance Test (EFPT; Baum, Morrison, Hahn, & Edwards, 2003), an objective measure of everyday life activities. Between-groups comparisons and correlational analyses were conducted to examine the relationship between cognition and functional capacity. Significant differences in EFPT performance were revealed between individuals with MS with and without cognitive impairment and HCs. In individuals with MS, performance on cognitive constructs was related to performance on the EFPT. Furthermore, a linear regression model comprised of indices of cognitive functioning explained a significant portion of the variance in everyday life activities. Findings suggest that individuals with and without cognitive impairment differ in functional status and that aspects of cognition are predictive of functional status in MS.

We report a laboratory-confirmed case of severe acute respiratory syndrome (SARS) in a pregnant woman. Although the patient had respiratory failure, a healthy infant was subsequently delivered, and the mother is now well. There was no evidence of viral shedding at delivery. Antibodies to SARS virus were detected in cord blood and breast milk.

The Arctic is entering a new ecological state, with alarming consequences for humanity. Animal-borne sensors offer a window into these changes. Although substantial animal tracking data from the Arctic and subarctic exist, most are difficult to discover and access. Here, we present the new Arctic Animal Movement Archive (AAMA), a growing collection of more than 200 standardized terrestrial and marine animal tracking studies from 1991 to the present. The AAMA supports public data discovery, preserves fundamental baseline data for the future, and facilitates efficient, collaborative data analysis. With AAMA-based case studies, we document climatic influences on the migration phenology of eagles, geographic differences in the adaptive response of caribou reproductive phenology to climate change, and species-specific changes in terrestrial mammal movement rates in response to increasing temperature.

The aim of this study was to determine if learned helplessness, self-efficacy, and cognitive distortions would predict depression in a sample of 80 individuals with multiple sclerosis (MS) and 80 individuals with a spinal cord injury (SCI). As MS and SCI usually present with disparate disease courses and etiologies, a secondary objective was to determine if individuals with MS would exhibit greater levels of helplessness, cognitive distortions, and depression and lower levels of self-efficacy than those with SCI. Results indicated that helplessness and self-efficacy significantly predicted depression for both the MS and SCI groups after controlling for confounding variables. Cognitive distortions had no independent effect, indicating that cognitive distortions may have caused feelings of helplessness and low self-efficacy and, in this way, had indirect effects on depression. The MS group exhibited significantly greater levels of depression and helplessness and significantly lower levels of self-efficacy than the SCI group. It was hypothesized that it may have been the combination of an unpredictable course of disease activity and the possibility of being affected by MS in many different ways that produced greater feelings of depression, helplessness, and low self-efficacy in the MS group.

BACKGROUND: Sexual dysfunction is a prevalent symptom in multiple sclerosis (MS) that may affect patients' health-related quality of life (HrQoL). OBJECTIVE: The objective of this paper is to examine the impact of sexual dysfunction on HrQoL in a large national sample using The Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19). METHODS: Participants were recruited from a large MS registry, the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. Participants self-reported demographic information and completed the Patient Determined Disease Steps (PDDS), MSISQ-19, and the Short Form-12 (SF-12). RESULTS: The study population included 6183 persons (mean age: 50.6, SD = 9.6; 74.7% female, 42.3% currently employed). Using multivariate hierarchical regression analyses, all variables excluding gender predicted both the physical component summary (PCS-12) and the mental component summary (MCS-12) of the SF-12. Scores on the MSISQ-19 uniquely accounted for 3% of the variance in PCS-12 scores while disability level, as measured by PDDS, accounted for 31% of the variance. Conversely, MSISQ-19 scores uniquely accounted for 13% of the variance in MCS-12 scores, whereas disability level accounted for less than 1% of the variance. CONCLUSION: In patients with MS, sexual dysfunction has a much larger detrimental impact on the mental health aspects of HrQoL than severity of physical disability.

PURPOSE: Robotically-assisted total knee arthroplasty (TKA) has been shown to improve alignment and decrease outliers, an important goal in TKA procedures. The purpose of this cadaveric study was to compare the accuracy and reproducibility of a recently introduced TKA robotic system to conventional instrumentation for bone resections. METHODS: This cadaveric study compared 14 robotically-assisted TKA with 20 conventional TKAs. Four board-certified high volume arthroplasty surgeons with no prior experience in robotics (except one) performed the procedures with three different implant systems. Angle and level of bone resections obtained from optical navigation or calliper measurements were compared to the intra-operative plan to determine accuracy. Group comparison was performed using Student t test (mean) and F test (variance), with significance at p < 0.05. RESULTS: The robotic group demonstrated statistically more accurate results (p < 0.05) and fewer outliers (p < 0.05) than conventional instrumentation when aiming for neutral alignment. Final limb alignment (HKA) had an accuracy of 0.8° ± 0.6° vs 2.0° ± 1.6°, with 100% vs 75% of cases within 3° and 93% vs 60% within 2°. For the robotically-assisted knees, the accuracy of bone resection angles was below 0.6° with standard deviations below 0.4°, except for the femur flexion (1.3° ± 1.0°), and below 0.7 mm with standard deviations below 0.7 mm for bone resection levels. CONCLUSION: This in vitro study has demonstrated that this novel TKA robotic system produces more accurate and more reproducible bone resections than conventional instrumentation. It supports the clinical use of this new robotic system. LEVEL OF EVIDENCE: Cadaveric study, Level V.

Venetoclax is efficacious in relapsed/refractory t(11;14) multiple myeloma, thus warranting investigation in light-chain amyloidosis (AL). This retrospective cohort includes 43 patients with previously treated AL, from 14 centers in the US and Europe. Thirty-one patients harbored t(11;14), 11 did not, and one t(11;14) status was unknown. Patients received a venetoclax-containing regimen for at least one 21- or 28-day cycle; the median prior treatments was three. The hematologic response rate for all patients was 68%; 63% achieved VGPR/CR. t(11;14) patients had higher hematologic response (81% vs. 40%) and higher VGPR/CR rate (78% vs. 30%, odds ratio: 0.12, 95% CI 0.02-0.62) than non-t(11;14) patients. For the unsegregated cohort, median progression-free survival (PFS) was 31.0 months and median OS was not reached (NR). For t(11;14), median PFS was NR and for non-t(11;14) median PFS was 6.7 months (HR: 0.14, 95% CI 0.04-0.53). Multivariate analysis incorporating age, sex, prior lines of therapy, and disease stage suggested a risk reduction for progression or death in t(11;14) patients. Median OS was NR for either subgroup. The organ response rate was 38%; most responders harbored t(11;14). Grade 3 or higher adverse events occurred in 19% with 7% due to infections. These promising results require confirmation in a randomized clinical trial.

BACKGROUND: Sexual dysfunction is common in multiple sclerosis (MS) but reliable and valid measurement in this population is needed. OBJECTIVE: The objective of this research is to re-validate the Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 in a large US sample. METHODS: A total of 6300 MS patients from the NARCOMS registry completed the MSISQ-19. Unforced principal component analysis utilizing oblique rotation with Kaiser Normalization validated its construct validity. RESULTS: The scree plot supported a three-component solution, with 63% of total variance explained. The components mirrored the original validation study measuring primary, secondary, and tertiary sexual dysfunction. PCA suggested the scale could be shortened to 15 items, which were found to apply equally well to males and females (with one primary item specific for each sex). The components were moderately intercorrelated (Pearson rs ranged from 0.5 to 0.67). The secondary subscale correlated most highly with self-reported disability (r (6081) = 0.44, p < 0.001), whereas the tertiary subscale correlated most highly with psychological distress (r (5992) = -.37, p < 0.001). Cronbach's alpha for the total scale (0.92) and the subscales (primary, 0.87; secondary, 0.82; tertiary, 0.91) demonstrated good reliability. CONCLUSION: The revised 15-item MSISQ is a reliable and valid measure of sexual dysfunction in men and women with MS.

A novel ¹⁸F-labeled ligand for the norepinephrine transporter (<i>N</i>-[3-bromo-4-(3-¹⁸F-fluoro-propoxy)-benzyl]-guanidine [LMI1195]) is in clinical development for mapping cardiac nerve terminals in vivo using PET. Human safety, whole-organ biodistribution, and radiation dosimetry of LMI1195 were evaluated in a phase 1 clinical trial. <b>Methods:</b> Twelve healthy subjects at 3 clinical sites were injected intravenously with 150–250 MBq of LMI1195. Dynamic PET images were obtained over the heart for 10 min, followed by sequential whole-body images for approximately 5 h. Blood samples were obtained, and heart rate, electrocardiogram, and blood pressure were monitored before and during imaging. Residence times were determined from multiexponential regression of organ region-of-interest data normalized by administered activity (AA). Radiation dose estimates were calculated using OLINDA/EXM. Myocardial, lung, liver, and blood-pool standardized uptake values were determined at different time intervals. <b>Results:</b> No adverse events due to LMI1195 were seen. Blood radioactivity cleared quickly, whereas myocardial uptake remained stable and uniform throughout the heart over 4 h. Liver and lung activity cleared relatively rapidly, providing favorable target-to-background ratios for cardiac imaging. The urinary bladder demonstrated the largest peak uptake (18.3% AA), followed by the liver (15.5% AA). The mean effective dose was 0.026 ± 0.0012 mSv/MBq. Approximately 1.6% AA was seen in the myocardium initially, remaining above 1.5% AA (decay-corrected) through 4 h after injection. The myocardium-to-liver ratio was approximately unity initially, increasing to more than 2 at 4 h. <b>Conclusion:</b> These preliminary data suggest that LMI1195 is well tolerated and yields a radiation dose comparable to that of other commonly used PET radiopharmaceuticals. The kinetics of myocardial and adjacent organ activity suggest that cardiac imaging should be possible with acceptable patient radiation dose.

PURPOSE: To report a randomized study that investigated the safety (risk of major bleeds) and potential efficacy of edoxaban, an oral anticoagulant that targets the major components of arterial thrombi, to prevent loss of patency following endovascular treatment (EVT). METHODS: Between February 2012 and June 2014, 203 patients who underwent femoropopliteal EVT were randomized to receive aspirin plus edoxaban or aspirin plus clopidogrel for 3 months in the Edoxaban in Peripheral Arterial Disease (ePAD) study ( ClinicalTrials.gov identifier NCT01802775). Randomization assigned 101 patients (mean age 68.0±10.4 years; 67 men) to the edoxaban group and 102 patients (mean age 66.7±8.6 years; 78 men) to the clopidogrel group. The primary safety endpoint was bleeding as classified by the TIMI (Thrombolysis in Myocardial Infarction) criteria and ISTH (International Society of Thrombosis and Hemostasis) criteria; the efficacy endpoint was the rate of restenosis/reocclusion. RESULTS: There were no major or life-threatening bleeding events in the edoxaban group, while there were 2 major and 2 life-threatening bleeding events in the clopidogrel group by the TIMI criteria. By the ISTH classification, there was 1 major and 1 life-threatening bleeding event vs 5 major and 2 life-threatening bleeding events, respectively [relative risk (RR) 0.20, 95% confidence interval (CI) 0.02 to 1.70]. The bleeding risk was not statistically different with either treatment when assessed by TIMI or ISTH. Following 6 months of observation, there was a lower incidence of restenosis/reocclusion with edoxaban compared with clopidogrel (30.9% vs 34.7%; RR 0.89, 95% CI 0.59 to 1.34, p=0.643). CONCLUSION: These results suggest that patients who have undergone EVT have similar risks for major and life-threatening bleeding events with edoxaban and aspirin compared with clopidogrel and aspirin. The incidence of restenosis/reocclusion events, while not statistically different, was lower with edoxaban and aspirin, but an adequately sized trial will be needed to confirm these findings.

OBJECTIVES: To compare the levels of pain and anxiety associated with amniocentesis (AC), transabdominal chorionic villus sampling (TA-CVS), and transcervical chorionic villus sampling (TC-CVS). METHODS: We prospectively administered a questionnaire about pain and anxiety to 124 women undergoing AC, 40 undergoing TA-CVS, and 24 undergoing TC-CVS for singleton pregnancies. The level of pain was quantified with numerical and pictorial scales and the degree of anxiety was quantified with a numerical scale (0-100 in increments of 10). RESULTS: The mean pain score for TA-CVS, 41.4 +/- 18.1, was significantly higher than that for TC-CVS, 26.4 +/- 25.3, p = 0.008. The mean pain score for AC, 35.1 +/- 27.6, was intermediate. A higher degree of anxiety was associated with younger maternal age and nulliparity. A higher degree of anxiety was associated with a higher level of pain. CONCLUSION: In general, each procedure is associated with a tolerable amount of pain. TA-CVS appears to be the most painful procedure while TC-CVS appears to be the least painful procedure. In certain groups of patients, the procedures may be associated with higher levels of pain and/or anxiety.