Feasibility study of the Montreal Cognitive Assessment (MoCA) in patients with brain metastases

Goal of work  Detection of cognitive impairment in patients with brain metastases is important for both patient management and clinical trials. The most commonly used cognitive screen, the Mini Mental State Examination (MMSE), though convenient, is not sensitive in these patients. More sensitive tools are less convenient and, therefore, uncommonly used. Therefore, a practical and sensitive tool is needed. The Montreal Cognitive Assessment (MoCA) is a good candidate, shown to be sensitive in detecting mild cognitive impairment in the pre-dementia setting. This study is the first to explore the MoCA in cancer patients and is aimed at determining the feasibility of administering the MoCA in brain tumor patients. The secondary objective is to explore the relationship between MoCA and MMSE scores. Patients and methods  Forty patients with brain metastases being treated with whole brain radiotherapy were prospectively accrued from January to May 2007. All patients were administered both the MoCA and MMSE. Main results  The MoCA was completed in 10 min in 88% of patients. 92% of all the patients found the MoCA to be only mildly or not at all inconvenient. Eighty percent of the patients were deemed cognitively impaired by the MoCA compared with 30% by the MMSE (p < 0.0001). Of the 28 patients with a normal MMSE, 71% had cognitive impairment according to the MoCA. Overall, 50% of the patients had an abnormal MoCA, yet normal MMSE. Conclusion  The MoCA was well tolerated and provided additional information over the MMSE, justifying further validation studies of the MoCA in brain tumor patients.     

连续性评估记录和评价（CARE）量表用于脑卒中患者评定的效度研究

目的:连续性评估记录和评价(Continuity Assessment Record and Evaluation,CARE)量表是美国对患者急性期、亚急性期、慢性期进行标准化的连续性评价的综合量表,本文研究目的在于开发中文版的CARE量表,并在脑卒中患者中应用,进行该量表的效度研究。方法:确定中文版CARE量表的条目,选择30例脑卒中患者进行CARE及Barthel指数(Barthel index,BI)量表、改良Barthel指数(Modified Barthel index,MBI)量表、扩展Barthel指数(Extended Barthel Index, EBI)量表评估,将CARE与BI、MBI、EBI量表进行关联,进行Spearman相关分析以检验中文版CARE的效度。结果:中文版CARE量表与BI、MBI、EBI总分相关系数(r=0.848、0.864、0.917)呈高度相关,P<0.01。结论:中文版CARE量表具有良好的效度,是评估中国脑卒中人群功能质量标准的有用工具,可在临床推广应用。     

Comparison of three instruments to assess changes of motor impairment in acute hemispheric stroke: the Stroke Impairment Assessment Set (SIAS), the National Institute of Health Stroke Scale (NIHSS) and the Canadian Neurological Scale (CNS)

Abstract

Purpose: The purpose was to compare the performance of three representative instruments to measure changes of motor recovery with acute hemispheric stroke. Method: In 41 consecutive patients with acute hemispheric infarction, motor recovery was assessed within 3 days of onset and then every 2 weeks until the 12th week with the Stroke Impairment Assessment Set (SIAS), the National Institutes of Health stroke scale (NIHSS) and the Canadian Neurological Scale (CNS). We analyzed the relationships among the corresponding subscales of the three instruments with the Spearman’s rank correlation method, and compared their responsiveness by plotting the temporal profiles of scores of each instrument and by testing the significance of changes over time with the Friedman test. Results: High correlations were observed among the three instruments at each examination point. However, the SIAS scores were more widely dispersed at the same NIHSS and CNS scores. Friedman test revealed that the scores changed significantly during the observation period with the SIAS and the CNS but not with the NIHSS. The changes were detected later with the CNS than with the SIAS. Conclusions: Although the assessment results with the three instruments were highly inter-correlated, the SIAS performed better with respect to responsiveness to changes.

• Implication for Rehabilitation

• When providing rehabilitation services to patients with stroke, it is important to document objectively the level of their impairment from the acute stage and during the entire course of rehabilitation with standardized instrument, and to predict their functional outcomes as early and accurately as possible.

• This study therefore compared three representative instruments with established psychometric properties, the SIAS, the NIHSS and the CNS, with respect to their ability to document motor impairment and their responsiveness to recovery in patients with acute hemispheric stroke.

     

Reliability and Validity of the Functional Gait Assessment (German Version) in Subacute Stroke Patients

Thieme H, Ritschel C, Zange C. Reliability and validity of the Functional Gait Assessment (German version) in subacute stroke patients.

Objective

To investigate validity and reliability of the Functional Gait Assessment (FGA) (German version) as a measure for balance abilities during walking in subacute stroke patients.

Design

Cohort study.

Setting

Inpatient rehabilitation center.

Participants

Ambulatory subjects (N=28) at a maximum of 6 months after stroke participated in this study. One direct observer and 2 video observers rated the FGA.

Interventions

Not applicable.

Main Outcome Measures

Performance of the FGA was video recorded and directly rated. For testing concurrent validity of the FGA, subjects also completed testing in the Berg Balance Scale, fast walking speed, the Functional Ambulatory Category, the Rivermead Mobility Index, and the Barthel Index. Intrarater reliability, interrater reliability, and concurrent validity of the FGA were analyzed.

Results

Intrarater (intraclass correlation coefficient=.97) and interrater reliability (intraclass correlation coefficient=.94) were almost perfect for total scores. Reliability of single items varied between substantial and almost perfect values. Analysis revealed significant correlations between the FGA and other measures of gait and balance functions between Spearman rho values of .71 and .93. The FGA differs significantly between levels of gait ability (Functional Ambulatory Category) (P≤.01).

Conclusions

Almost perfect intrarater and interrater reliability for total FGA scores and good concurrent validity were shown in this study. Therefore, the FGA (German version) can be used as a reliable and valid tool to assess functional gait performance of patients in subacute stages after stroke.     

功能综合评定量表用于脑卒中的信度、效度及敏感度再次评价

目的：究功能综合评定（FCA）量表在脑卒中患者综合功能评定中的信度、效度和敏感度。方法：82例脑卒中患者按脑梗死和脑出血分层，各层患者随机化分成康复组和对照组，康复组给予规范的康复治疗，对照组不给予规范的康复治疗，分别于人选时，发病后第1个月月末、第3个月月末和第6个月月末采用FCA量表及改良Barthel指数进行评定，并对FCA量表进行内部一致性信度、分半信度、内容效度、标准效度和敏感度检测。统计采用相关分析与重复测量数据的方差分析。结果：康复组和对照组，FCA量表Cronbach α系数为0．901～0．973；分半信度系数（R）为0．949～0．981，FCA量表内部一致性信度较好；FCA量表18个项目与总分之间呈现中度至高度相关，P〈0．01，具有较好的内容效度；FCA量表的BADL项目与改良Barthel指数的相关性研究，结果相关性均良好，r=0．41～0．98，P〈0．01。比较康复组与对照组治疗前、后FCA总分、FCA运动分量表分、FCA认知分量表分，康复组均表现出较大效应尺度，FCA量表敏感度较高。结论：FCA量表内部一致性、内容效度及与改良Barthel指数的标准效度均较好，是评定脑卒中综合功能可信度、有效度、敏感度均较好的评测量表。     

Feasibility of yoga as a complementary therapy for patients with type 2 diabetes: The Healthy Active and in Control (HA1C) study

ObjectivesThis study:Healthy Active and in Control (HA1C), examined the feasibility and acceptability of yoga as a complementary therapy for adults with Type-2 Diabetes (T2DM).DesignA 2-arm randomized clinical trial comparing Iyengar yoga with a supervised walking program.SettingHospital based gym-type facility and conference rooms.InterventionsParticipants were randomized to a 12-week program of either; (1) a twice weekly Iyengar yoga, or (2) a twice-weekly program of standard exercise (SE).Main Outcome MeasuresPrimary outcomes assessed feasibility and acceptability, including enrollment rates, attendance, study completion, and participant satisfaction. Secondary outcomes included HbA1c, physical activity, and measures of diabetes-related emotional distress, self-care and quality of life (QOL). Assessments were conducted at baseline, end of treatment, 6-months and 9-months post-enrollment.ResultsOf 175 adults screened for eligibility, 48 (30 women, 18 men) were eligible and enrolled. The most common reasons for ineligibility were orthopedic restrictions, HbA1c levels <6.5 and BMI > 42. Session attendance was high (82% of sessions attended), as was follow-up completion rates (92%). Program satisfaction rated on a 5-point scale, was high among both Yoga (M = 4.63, SD = 0.57) and SE (M = 4.77, SD = 0.52) participants. Overall 44 adverse events (26 Yoga, 18 SE) were reported. Of these, six were deemed “possibly related” (e.g., neck strain, back pain), and 1 “probably related” (ankle pain after treadmill) to the study. Yoga produced significant reductions in HbA1c. Median HbA1c at 6 months was 1.25 units lower for Yoga compared to SE (95% CI: -2.54 -0.04).Greater improvements in diabetes self-care, quality of life, and emotional distress were seen among Yoga participants than among SE participants. Increases in mindfulness were seen in Yoga but not in SE.ConclusionsThe yoga intervention was highly feasible and acceptable, and produced improvements in blood glucose and psychosocial measures of diabetes management.     

慢性疾病病耻感量表-8在脑卒中患者中应用的信效度研究

目的：调查慢性疾病病耻感量表-8（SSCI-8）在脑卒中患者中的信效度。方法：采用便利抽样的方法抽取204名社区脑卒中患者进行调查,进行信效度检验。结果：项目分析显示中文版SSCI-8能够鉴别高分组和低分组（P<0.01）,各条目得分与SSCI-8总分的相关系数为0.611~0.843;与抑郁、日常生活能力、SF-12心理维度及生理维度的相关系数为0.537、-0.440、-0.450、-0.441（P<0.01）。探索性因子分析提取2个公因子,累计方差贡献率为75.39%,各条目在其相应维度上有较高的因子负荷,验证性因子分析结果显示,各拟合指数均在可接受范围内,SSCI-8的Cronbach’s α系数为0.892,重测信度为0.809。结论：中文版SSCI-8在脑卒中具有较好的信效度,可在脑卒中及神经系统疾病病耻感的相关研究中使用。     

Comparison of the Orpington Prognostic Scale (OPS) and the National Institutes of Health Stroke Scale (NIHSS) for the prediction of the functional status of patients with stroke

Purpose. The aim of our study is to compare the Orpington Prognostic Scale (OPS) and the National Institutes of Health Stroke Scale (NIHSS) and to evaluate whether they help us estimate the future functional status of patients with stroke.

Method. Twenty-five patients with stroke were administered the OPS and NIHSS on the 7th day of stroke in order to define the severity of the disease, and the Barthel Index was performed in order to evaluate the functional status and the activities of daily living (ADL) at the 1st, 3rd, and 6th months.

Results. Both scales were statistically correlated (P = 0.0001). When the predictability of these scales in terms of the ADL and functional status was evaluated, the regression coefficient at the 1st month was ?14.746, R² = 0.58, P < 0.0001 and ?4.885, R² = 0.50, P < 0.0001 for OPS and NIHSS, respectively, the same coefficient at the 3rd month was ?12.482, R² = 0.41, P = 0.001 for OPS and ?3.280, R² = 0.23, P = 0.016 for NIHSS, and at the 6th month it was ?11.662, R² = 0.38, P = 0.001 for OPS and ?2.997, R² = 0.20, P = 0.02 for NIHSS.

Conclusion. In patients with stroke, OPS and NIHSS had significant contribution to the estimation of the functional status and OPS was more effective than NIHSS.     

Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial

Purpose

Cognitive impairment after critical illness is common and debilitating. We developed a cognitive therapy program for critically ill patients and assessed the feasibility and safety of administering combined cognitive and physical therapy early during a critical illness.

Methods

We randomized 87 medical and surgical ICU patients with respiratory failure and/or shock in a 1:1:2 manner to three groups: usual care, early once-daily physical therapy, or early once-daily physical therapy plus a novel, progressive, twice-daily cognitive therapy protocol. Cognitive therapy included orientation, memory, attention, and problem-solving exercises, and other activities. We assessed feasibility outcomes of the early cognitive plus physical therapy intervention. At 3 months, we also assessed cognitive, functional, and health-related quality of life outcomes. Data are presented as median (interquartile range) or frequency (%).

Results

Early cognitive therapy was a delivered to 41/43 (95 %) of cognitive plus physical therapy patients on 100 % (92–100 %) of study days beginning 1.0 (1.0–1.0) day following enrollment. Physical therapy was received by 17/22 (77 %) of usual care patients, by 21/22 (95 %) of physical therapy only patients, and 42/43 (98 %) of cognitive plus physical therapy patients on 17 % (10–26 %), 67 % (46–87 %), and 75 % (59–88 %) of study days, respectively. Cognitive, functional, and health-related quality of life outcomes did not differ between groups at 3-month follow-up.

Conclusions

This pilot study demonstrates that early rehabilitation can be extended beyond physical therapy to include cognitive therapy. Future work to determine optimal patient selection, intensity of treatment, and benefits of cognitive therapy in the critically ill is needed.     

Validity and generalizability of the Withdrawal Assessment Tool-1 (WAT-1) for monitoring iatrogenic withdrawal syndrome in pediatric patients

Critically ill pediatric patients frequently receive prolonged analgesia and sedation to provide pain relief and facilitate intensive care therapies. Iatrogenic withdrawal syndrome occurs when these drugs are stopped abruptly or weaned too rapidly. We investigated the validity and generalizability of the Withdrawal Assessment Tool-1 (WAT-1) in children during weaning of analgesics and sedatives. Of 308 children initially supported on mechanical ventilation for acute respiratory failure, 126 (41%) from 21 centers (median age 1.6 years; interquartile range 0.6-7.7 years) were exposed to 5 or more days of opioids. Subjects were assessed for withdrawal symptoms with the WAT-1, an 11-item (12-point) scale, from the first day of weaning from analgesia/sedation until 72 h after the last opioid dose. A total of 836 daily WAT-1 assessments were completed, with a median (interquartile range) WAT-1 score of 2 (0-4) over 6 (3-9) days per subject. There were no significant differences in WAT-1 scores as a function of age. Factor analyses confirmed that motor-related symptoms and behavioral state accounted for the most variance in WAT-1 scores. Supporting construct validity, cumulative opioid exposures were greater [40.2 (19.7-83.4) vs 17.6 (14.6-39.7) mg/kg, P = .004], length of opioid treatment before weaning was longer [7 (6-11) vs 5 (5-8) days, P = .004], and length of weaning from opioids was longer [10 (6-14) vs 6 (3-9) days, P = .008] in subjects with WAT-1 scores of ?3 compared to subjects with WAT-1 scores of <3. The WAT-1 shows good psychometric performance and generalizability when used to assess clinically important withdrawal symptoms in pediatric intensive care and general ward settings.     

When Patients' Assessments of Treatment for Subjective Symptoms are At Odds with Authoritative Assessments in the Biomedical Literature: The Case of Patients Treated with Acupuncture for Low Back Pain in a Traditional Chinese Medicine Clinic in China (and Story of a Bewildered Chicken)

Assessments of treatments for ‘subjective symptoms’ are problematic and potentially contentious. These are symptoms without ascertainable pathophysiology, also referred to as ‘medically unexplained.’ Treatments of them may be assessed from different perspectives, and an assessment as seen from one perspective may be discrepant with an assessment as seen from another perspective. The observational study described in the paper represents one perspective. Patients in the study were treated with acupuncture for the subjective symptom of low back pain in a Traditional Chinese Medicine Clinic in China; acupuncture is a form of TCM, which is indigenous to China. Shortly after treatment began and six months afterward, patients reported ‘clinically important improvements’ on a variety of standard, cross-culturally validated outcome measures, including pain intensity, physical functioning, and emotional functioning; this assessment is consistent with numerous assessments of acupuncture in China and other Southeastern Asian countries. On the other hand, clinical trials represent another perspective from which to assess acupuncture. Although assessments based on trials are not uniform, several assessments based on them, including those published in journals such as Lancet and New England Journal of Medicine, conclude that acupuncture is not effective. These trials, however, were mainly situated in the U.S., western European countries, and other WEIRD (W estern, E ducated, I ndustrialized, R ich, D emocratic) countries. This is notable, because the population of China, the indigenous context of acupuncture, is greater than populations of WEIRD countries combined. Patients' expectations of a treatment such as acupuncture and their prior familiarity with it vary among contexts, and patients' experiences of treatment outcomes may vary accordingly. In short, although clinical trials constitute a test of truth in biomedicine and inform authoritative assessments in WEIRD countries, they do not necessarily represent the truth from the perspective of those experiencing outcomes of especially indigenous treatments for subjective symptoms in non-WEIRD contexts.     

Comparative study concerning the value of acoustic radiation force impulse elastography (ARFI) in comparison with transient elastography (TE) for the assessment of liver fibrosis in patients with chronic hepatitis B and C

Our aim was to compare liver stiffness (LS) measurements by means of acoustic radiation force impulse (ARFI) elastography and transient elastography (TE) in patients with chronic hepatitis B and C, according to the severity of fibrosis. We also compared the correlation strength of ARFI and TE measurements with liver fibrosis. We included 53 patients with hepatitis B and 107 with hepatitis C in which liver biopsy, ARFI and TE measurements were performed in the same session. The mean LS values measured with ARFI were similar in patients with chronic hepatitis B and C and depended on the stage of fibrosis. The correlation strength of LS measurements by ARFI and by TE with fibrosis was similar in chronic hepatitis B and C patients. In conclusion, for the same stage of fibrosis, the mean LS values by ARFI were similar in patients with chronic hepatitis B and C. ARFI had similar predictive value with TE in both chronic viral hepatitis.     

Superiority of high sensitivity cardiac troponin T vs. I for long-term prognostic value in patients with chest pain; data from the Akershus cardiac Examination (ACE) 3 study

BackgroundCardiac troponins (cTn) are essential in the diagnostic assessment of non-ST-segment-elevation acute coronary syndrome (NSTE-ACS). Elevated concentrations of cTnT and cTnI predict cardiovascular events in non-acute settings, but the individual troponin isotype association with long-term mortality in patients with suspected unstable angina pectoris (UAP) is less clear.MethodsPatients hospitalized with chest pain between June 2009 and December 2010 were included in the Akershus Cardiac Examination 3 Study and followed for median 6.6 (IQR 6.2-7.1) years. The index diagnosis was adjudicated by an independent committee as NSTE-myocardial infarction (NSTEMI), UAP or non-ACS. Blood samples were collected within 24 h of admission and analyzed with high sensitivity assays for cTnT (hs-cTnT, Roche) and cTnI (hs-cTnI, Singulex).ResultsOf 402 patients included, 74 (18%) were classified as NSTEMI, 88 (22%) UAP and 240 (60%) non-ACS. hs-cTnI concentrations were detectable in all patients (median 3 [IQR 1–11] ng/L), while hs-cTnT concentrations were above the level of blank in 205 (51%) (median 3 [IQR 3–16] ng/L). In patients with UAP, both log₂-transformed hs-cTnT and hs-cTnI were associated with all-cause mortality in analyses that adjusted for other risk factors: HR 2.40 [95% CI 1.75–3.30], p < 0.001 and HR 1.44 [1.14–1.81], p = 0.002. There were no significant sex-dependent differences in the association between hs-cTnT or hs-cTnI and outcome. Time dependent receiver-operating characteristics area under the curve was 0.85 (95% CI 0.79–0.92) for hs-cTnT and 0.74 (0.64–0.84) for hs-cTnI, p = 0.008 for difference between values.ConclusionsHigher concentrations of hs-cTnT and hs-cTnI were both associated with all-cause mortality in patients with UAP, but the association with outcome was stronger for hs-cTnT than for hs-cTnI.     

A randomized study comparing the efficacy and safety of nadroparin 2850 IU (0.3 mL) vs. enoxaparin 4000 IU (40 mg) in the prevention of venous thromboembolism after colorectal surgery for cancer

BACKGROUND: The optimal thromboprophylactic dosage regimen of low-molecular-weight heparins in high-risk general surgery remains debatable. OBJECTIVES: We performed a randomized, double-blind study to compare the efficacy and safety of nadroparin 2850 IU (0.3 mL) and enoxaparin 4000 IU (40 mg) in the prevention of venous thromboembolism (VTE) after colorectal surgery for cancer. Patients and methods: Patients undergoing resection of colorectal adenocarcinoma were randomized to receive once daily either 2850 IU nadroparin or 4000 IU enoxaparin s.c. for 9 +/- 2 days. The primary efficacy outcome was the composite of deep vein thrombosis (DVT) detected by bilateral venography or documented symptomatic DVT or pulmonary embolism up to day 12. The main safety outcome was major bleeding. A blinded independent committee adjudicated all outcomes. RESULTS: Out of 1288 patients analyzed, efficacy was evaluable in 950 (73.8%) patients. The VTE rate was 15.9% (74/464) in nadroparin-treated patients and 12.6% (61/486) in enoxaparin-treated patients, a relative risk of 1.27 (95% confidence interval; CI: 0.93-1.74) that did not met the criterion for non-inferiority of nadroparin. The rate of proximal DVT was comparable in the two groups (3.2% vs. 2.9%, respectively), but that of symptomatic VTE was lower in nadroparin-treated patients (0.2% vs. 1.4%). There was significantly (P = 0.012) less major bleeding in nadroparin- than in enoxaparin-treated patients (7.3% vs. 11.5%, respectively). CONCLUSION: Compared with those receiving enoxaparin 4000 IU, patients treated with nadroparin 2850 IU showed a higher incidence of asymptomatic distal DVT, but a lower incidence of symptomatic VTE. Nadroparin treatment was safer in terms of bleeding risk.     

Review of use of a new rapid real-time PCR,the Cepheid GeneXpert® (Xpert) CT/NG assay,for Chlamydia trachomatis and Neisseria gonorrhoeae: results for patients while in a clinical setting

Rapid diagnostics for Chlamydia trachomatis and Neisseria gonorrhoeae are desirable so that patients can be treated while they are still in the clinic or doctor’s office. The Cepheid GeneXpert^® (Xpert) CT/NG assay was US FDA-cleared in December 2012. The assay is a rapid real-time PCR nucleic acid amplified test. The cartridge-based assay detects DNA of Chlamydia trachomatis and Neisseria gonorrhoeae. It is FDA-cleared for use in female endocervical swabs, patient-collected vaginal swabs and for female and male urine specimens from symptomatic and asymptomatic patients. It has demonstrated near-perfect sensitivity and specificity in urogenital specimens. The Xpert is a modular platform for testing samples directly from patients, which requires no hands-on manipulation from specimen loading until results are available. Results are provided in approximately 90 minutes. It has been graded by the FDA as moderately complex for Clinical Laboratory Improvement Amendments. Several publications have reported its promising use in clinical settings.     

Controlled Attenuation Parameter (CAP): A Novel VCTE™ Guided Ultrasonic Attenuation Measurement for the Evaluation of Hepatic Steatosis: Preliminary Study and Validation in a Cohort of Patients with Chronic Liver Disease from Various Causes

There is a need for noninvasive methods to detect liver steatosis, which can be a factor of liver fibrosis progression. This work aims to evaluate a novel ultrasonic controlled attenuation parameter (CAP) devised to target, specifically, liver steatosis using a sophisticated process based on vibration control transient elastography (VCTE™). CAP was first validated as an estimate of ultrasonic attenuation at 3.5 MHz using Field II simulations and tissue-mimicking phantoms. Performance of the CAP was then appraised on 115 patients, taking the histological grade of steatosis as reference. CAP was significantly correlated to steatosis (Spearman ρ = 0.81, p < 10⁻¹⁶). Area under receiver operative characteristic (ROC) curve (AUC) was equal to 0.91 and 0.95 for the detection of more than 10% and 33% of steatosis, respectively. Furthermore, results show that CAP can efficiently separate several steatosis grades. These promising results suggest that CAP is a noninvasive, immediate, objective and efficient method to detect and quantify steatosis. (E-mail: magali.sasso@echosens.com)