Care needs of caregivers of the elderly with early-stage dementia.

Objective: This study aimed to identify the care needs of family caregivers of elderly patients with early-stage dementia and examine support measures. Materials and Methods: We conducted a self-administered questionnaire survey with 115 primary caregivers of outpatients who visited A City Community General Support Center or B University Hospital Department of Neurology for memory loss consultation. The questionnaire content included demographic characteristics, the care needs scale for caregivers of the elderly with early-stage dementia (Care Needs Scale), and the Japanese short version of the Zarit Burden Interview. The Medical Ethics Committee of Fukuoka University approved this study (approval number: M047). Of the 115 participants, 104 were included in the analysis after excluding 11 respondents with missing data. We divided the participants into a young group (under 65 years of age) and an old group (65 years of age or older) and compared the variables and each scale score using the Mann-Whitney U test. We also compared the correlations between the total score and subscale scores of the Care Needs Scale and each variable, in addition, we performed multiple regression analyses using the total score of the Care Needs Scale as the dependent variable. Results: The young caregivers wanted to know how to take care, prevent deterioration, and deal with symptoms of early-stage dementia. They were trying to balance caregiving with work and housekeeping and reduce the stress and burden of long-term care. Older caregivers were confused about caregiving and wanted someone to talk about their situations. Conclusion: Both groups shared that the family's lack of understanding about caregiving and personal and role strains were associated with the care needs of caregivers of the elderly with early-stage dementia.

Ability of older male caregivers to seek help when caring for a wife or mother with dementia living at home.

Objective: We aimed to clarify factors associated with the ability to seek help among older male caregivers who care for women with dementia in their families. Patients and Methods: This information will inform strategies to support their continued provision of long-term care. Participants were 364 male caregivers recruited from three places: The study period was 2017-2018. We obtained ethical approval for this study from the relevant ethics committee. Results: The ability to seek help for care problems among male caregivers was normally distributed. We found that more than 90% of older male caregivers did not actively seek help to resolve care problems, suggesting that older male caregivers had problems with long-term care. In the high score group, health status and the number of emotional support persons in the household were significantly and somewhat strongly positively correlated. The low score group showed a significant and rather weak positive correlation between economic status and health status, and the number of emotional supporters inside and outside the household. Positive correlations for the high score group were self-esteem and depressive symptoms, and self-esteem and resources. Positive correlations for the low score group were self-esteem and depressive symptoms, self-esteem and resources, and resources and depressive symptoms. Conclusion: Male caregivers are more likely to seek help if they are employed or play a role in their community. Nurses also need to support male caregivers with positive words and praise to help them use available support and resources and continue to provide long-term care. It is important for healthcare professionals to observe whether a caregiver presents with depressive symptoms or has long-term care problems because older male caregivers do not seek help. Collaboration between caregivers and medical, long-term care, and welfare professionals is necessary. Direct and timely intervention is needed.

North American musculoskeletal ultrasound scanning protocol of the shoulder, elbow, wrist, and hand: update of a Delphi Consensus Study.

INTRODUCTION/OBJECTIVES: There has been an increase in the proficiency and utilization of ultrasound among North American rheumatologists over the past decade. This study aims to create an updated upper extremity scanning protocol to inform ultrasound curriculum development for the American College of Rheumatology affiliated fellowship programs and guide clinical practice patterns in North America. METHOD: Three Delphi survey rounds were used to reach consensus on tiered-mastery designations for scan views of the shoulder, elbow, wrist, and hand joints. The survey was disseminated by Qualtrics™ to 101 potential participants with ultrasound experience. High agreement was defined as having ≥ 85% consensus and final tier designation as > 50% agreement for a preferred tier. Changes in responses were evaluated by McNemar's chi-square test. RESULTS: Consensus was achieved for 70% of scan views of the upper extremity joints. Two views-ulnar transverse view of the wrist and the radial/ulnar orthogonal views over metacarpophalangeal joints 2 and 5 of the hand-were upgraded from tier 2 to tier 1. The suprascapular transverse and the axillary longitudinal views of the shoulder were downgraded from tier 2 to tier 3. A new anterior transverse view of the elbow was added to the protocol with tier 1 designation. CONCLUSIONS: This study reflects the current opinions of North American rheumatologists for scanning upper extremity joints and provides support for the updated protocol and guidance for educators in rheumatology ultrasound. Key Points • Ultrasound scan views of the metacarpophalangeal, wrist, elbow, and glenohumeral joint recesses and views of the biceps and rotator cuff tendons at the shoulder were perceived as essential views of the upper extremity scanning protocol for rheumatologists to master and perform routinely. • A targeted scanning approach of the upper extremity joints may be considered when focal symptoms are present. • The North American Musculoskeletal Ultrasound Scanning Protocol shares some similarities with existing musculoskeletal ultrasound protocols of other specialties and worldwide rheumatology societies but varies in the extent of examination and emphasis on certain specialty-specific focuses.

North American musculoskeletal ultrasound scanning protocol of the hip, knee, ankle, and foot: update of a Delphi consensus study.

BACKGROUND/OBJECTIVE: A North American rheumatology consensus on tiered-mastery designation for anatomic views was developed in 2011 for course and fellowship teaching. This study updates the lower extremity joint scanning protocols aiming to inform musculoskeletal ultrasound curriculum development for the American College of Rheumatology affiliated Fellowship Programs. METHODS: Three Delphi rounds were conducted to reach consensus for tiered-level mastery designation for hip, knee, ankle, and foot scanning views. The survey was disseminated (Qualtrics™) to 101 potential participants with ultrasound teaching experience. High agreement was defined as ≥ 85% consensus and final tier designation as having >50% agreement for the preferred tier. Response changes were evaluated by McNemar's chi-square test. RESULTS: Consensus regarding tier designations was reached for 80% of the views. Three knee views (anterior transverse suprapatellar, medial, and lateral longitudinal) and 2 ankle views (anterior and posterior transverse) achieved upgrades to tier 1 from 2. The transverse sacroiliac hip joint was downgraded from tier 2 to 3. The lateral longitudinal hip view was added with a tier 1 designation. CONCLUSION: Updated scanning protocols support modifications reflecting current scanning methods delivered by North American rheumatologists performing point of care ultrasound that may inform educators involved in rheumatology ultrasound. Key Points • The anterior transverse suprapatellar, medial, and lateral longitudinal knee views; the anterior and posterior transverse ankle views; and the lateral longitudinal view hip view were perceived as important to master and perform routinely. • The transverse sacroiliac joint view was suggested to be performed based on practice focus.

The Effect of IL-6 Inhibitors on Mortality Among Hospitalized COVID-19 Patients: A Multicenter Study.

BACKGROUND: The effectiveness of interleukin-6 inhibitors (IL-6i) in ameliorating coronavirus disease 2019 (COVID-19) remains uncertain. METHODS: We analyzed data for patients aged ≥18 years admitted with a positive severe acute respiratory syndrome coronavirus 2 polymerase chain reaction test at 4 safety-net hospital systems with diverse populations and high rates of medical comorbidities in 3 US regions. We used inverse probability of treatment weighting via machine learning for confounding adjustment by demographics, comorbidities, and disease severity markers. We estimated the average treatment effect, the odds of IL-6i effect on in-hospital mortality from COVID-19, using a logistic marginal structural model. RESULTS: Of 516 patients, 104 (20.1%) received IL-6i. Estimate of the average treatment effect adjusted for confounders suggested a 37% reduction in odds of in-hospital mortality in those who received IL-6i compared with those who did not, although the confidence interval included the null value of 1 (odds ratio = 0.63; 95% confidence interval, .29-1.38). A sensitivity analysis suggested that potential unmeasured confounding would require a minimum odds ratio of 2.55 to nullify our estimated IL-6i effect size. CONCLUSIONS: Despite low precision, our findings suggested a relatively large effect size of IL-6i in reducing the odds of COVID-19-related in-hospital mortality.

The mediating effect of resilience between family functioning and mental well-being in hemodialysis patients in Japan: a cross-sectional design.

BACKGROUND: End-stage kidney disease is highly prevalent worldwide. Currently, one of the most effective treatment modalities is dialysis therapy, which leads to serious side effects. Furthermore, psychiatric illnesses are prevalent among dialysis patients. Recently, researchers asserted that psychological resilience and family support could be helpful to maintain or improve patients' mental well-being. Therefore, the purpose of this study was to examine the mediating effects of resilience on the relationship between family functioning and mental well-being in these patients. METHODS: To investigate the aim of this study, a cross-sectional design was employed. A total of 110 hemodialysis patients, who were receiving outpatient treatment from dialysis units at the University of Fukuoka and St. Maria Health Care Center in Japan, participated. Only the patients who met the criteria and who were willing to participate in this 30-min study were given The General Health Questionnaire-12, Conner-Davidson Resilience Scale, and Family Assessment Device. Structural Equation Modeling (SEM) was performed to test the hypothesis that resilience would mediate the relationship between each subscale of family functioning, namely, cohesion, adaptability, communication, and mental well-being. Then Sobel's test was employed to examine the indirect effect. RESULTS: The results of the SEM showed that the model had an acceptable fit (RMSEA = .077; CFI = .93; and IFI = .94). According to the results, resilience fully mediated the relationship between family functioning, specifically family adaptability and communication, and mental health well-being of the dialysis patients. However, family cohesion was not associated with resilience. CONCLUSIONS: The present study revealed that higher family adaptability and communication resulted in greater resilience, thus associated with better mental health. Given that poor mental health among dialysis patients is significantly associated with a decreased likelihood to adhere to treatment plans, it may lead to a significant risk to therapeutic compliance. As such, patients may experience detrimental consequences, such as death. This study showed that in order to maintain healthy mental well-being, developing resilience is a vital factor for hemodialysis patients.

Musculoskeletal Ultrasound Scanning Protocol Consensus Statements on Scanning Conventions and Documentation in the US.

OBJECTIVE: European rheumatology and radiology-determined standards have largely driven the execution of ultrasound in rheumatology (RhUS). How this translates to American rheumatologic practice has not been examined. A rheumatology-driven consensus on documentation, scanning conventions, and tiered-mastery designation for anatomic region views was developed in 2011 and served as the framework for training and clinical research validation. The present study was undertaken to update this consensus to reflect current utilization of musculoskeletal RhUS evaluation in the US. METHODS: A 3-round Delphi method study was conducted using a 96-item questionnaire sent via Qualtrics survey software to 101 respondents experienced in RhUS education and scholarship. The target participant number was 38. High agreement was defined as ≥85% agreement on each item. McNemar's chi-square test was used to analyze changes in agreement in the responses. Comments were reviewed for content analysis. RESULTS: A total of 46 respondents completed all 3 rounds. Of documentation and scanning convention statements, 80% and 100%, respectively, reached high agreement. Comments reflected the need for rheumatology-defined and disease-specific complete scan and limited scan definitions, separate from radiology-defined definitions. CONCLUSION: Many scanning conventions from 2011 remain relevant in current practice. There is a need to determine rheumatology-defined descriptions for common procedural terminology codes for complete and limited scans that accurately reflect the current state of RhUS.

Musculoskeletal Ultrasound Instruction in Adult Rheumatology Fellowship Programs.

OBJECTIVE: Musculoskeletal ultrasound (MSUS) in rheumatology in the US has advanced by way of promotion of certifications and standards of use and inclusion of core fellowship curriculum. In order to inform endeavors for curricular integration, the objectives of the present study were to assess current program needs for curricular incorporation and the teaching methods that are being employed. METHODS: A needs-assessment survey (S1) was sent to 113 rheumatology fellowship program directors. For programs that taught MSUS, a curriculum survey (S2) was sent to lead faculty. Programs were stratified according to program size and use of a formal written curriculum. RESULTS: S1 (108 of 113 respondents; response rate 96%) revealed that 94% of programs taught MSUS, with 41% having a curriculum. Curricular implementation was unaffected by program size. Formal curricular adoption of MSUS was favored by 103 directors (95.3%), with 65.7% preferring such adoption to be optional. S2 (74 of 101 respondents; response rate 73%) showed that 41% of programs utilized a formal curriculum. Multiple teaching strategies were used, with content that was generally similar. Use of external courses, including the Ultrasound School of North American Rheumatologists course, was prevalent. Fewer barriers were noted compared to past surveys, but inadequate time, funding, and number of trained faculty still remained. Lack of divisional interest (P = 0.046) and interest of fellows (P = 0.012) were noted among programs without a formal curriculum. CONCLUSION: MSUS is taught by a significantly larger number of rheumatology fellowship programs today. Multiple teaching strategies are used with common content, and barriers still remain for some programs. Most program directors favor inclusion of a standardized MSUS curriculum, with many favoring inclusion to be optional.

The role of caregiver burden in the familial functioning, social support, and quality of family life of family caregivers of elders with dementia.

Objective: The present study aimed to examine the role that caregiver burden plays in the familial functioning, social support, and quality of family life (QOFL) of caregivers of elderly family members with dementia. Methods: A survey was conducted with 200 primary caregivers of elderly dementia patients who resided in prefecture "S". The questionnaire consisted of items that required demographic information, the Japanese versions of the Zarit Burden Inventory (ZBI) and the Family Adaptability and Cohesion Evaluation Scales (FACES II), and scales that measure quality of family life and social support. On the basis of the median ZBI score (i.e., 30.8), participants were divided into two groups: group A (i.e., ZBI score < 30) and group B (i.e., ZBI score > 30). Stepwise multiple regression analysis was conducted with QOFL as the dependent variable. Version 24 of the Statistical Package for the Social Sciences for Windows was used to conduct all the statistical analyses; the statistical significance level was specified as 0.05. Results: Group A and B obtained average ZBI scores of 18.5 and 43.8, respectively. The study targeted 81 patients from group A (average age = 61.0 years) and 77 patients from group B (average age = 61.7 years). Time that was spent on caregiving tasks was significantly higher for group B, when compared to group A. In addition, significant differences in cohesion and adaptability, which are two dimensions that are measured by the FACES II, and QOFL emerged between the two groups. The results of the multiple regression analysis showed that cohesion (ß = 0.38), practical support (ß = 0.32), adaptability (ß = 0.30), and living arrangement (ß = -0.12) significantly predicted QOFL. Conclusion: Family cohesion and adaptability are indicators of healthy familial functioning. In order to improve the QOFL of caregivers of elderly dementia patients, it is necessary to strengthen emotional ties, maintain emotional attachment, and flexibly respond to the burden of nursing care and changes in power structures and role relationships.

Emotional and instrumental support influencing male caregivers for people with dementia living at home.

Object: To clarify the emotional and instrumental support influencing male caregivers for people with dementia living at home. Patients/Materials and Methods: The subjects were 298 male caregivers. Nursing care burden was assessed using the Zarit Caregiver Burden Scale. Ability to cope with care problems was assessed using the Nursing Care Problems Coping Scale for Male Caregivers for People with Dementia Living at Home (NCSM). Emotional support was assessed using the Emotional Support Network Scale. Instrumental support was assessed using the question "Do you have someone to help when you have a problem with nursing care?". Results: There was a significant correlation (P < 0.04) between the point (index) of NCSM and Zarit Caregiver Burden Scale. A positive significant correlation was found in three coping styles. A negative significant correlation was found in one coping style, and no significant correlation in one coping style. The 'Solve the problem' coping style was linked to support from both within and beyond the family. Both 'Emotional avoidance' and 'Cognitive transformation' coping styles were linked to support from within the family, and "Request assistance" style only to external support. There were no correlations between the source of support and the "Careful supervision and waiting" coping style. Conclusion: Emotional and instrumental support for male caregivers was more than three times more likely to be obtained from within the family than outside it. With families becoming smaller, it is becoming more important for communities and society in general to provide emotional and instrumental support for male caregivers. Male caregivers need support from someone with whom they feel comfortable. It is particularly necessary to consider how to support male caregivers who use the "Emotional avoidance" coping style.

Methotrexate Dosage Reduction Upon Adalimumab Initiation: Clinical and Ultrasonographic Outcomes from the Randomized Noninferiority MUSICA Trial.

OBJECTIVE: To examine the clinical and ultrasonographic (US) outcomes of reducing methotrexate (MTX) dosage upon initiating adalimumab (ADA) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis (RA). METHODS: MUSICA (NCT01185288) was a double-blind, randomized, parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening. Patients were randomized to high dosage (20 mg/week) or low dosage (7.5 mg/week) MTX; all patients received 40 mg open-label ADA every other week for 24 weeks. The primary endpoint was Week 24 mean 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) to test for noninferiority of low-dosage MTX using a 15% margin. US images were scored using a 10-joint semiquantitative system incorporating OMERACT definitions for pathology, assessing synovial hypertrophy, vascularity, and bony erosions. RESULTS: Rapid improvement in clinical indices was observed in both groups after addition of ADA. The difference in mean DAS28-CRP (0.37, 95% CI 0.07-0.66) comparing low-dosage (4.12, 95% CI 3.88-4.34) versus high-dosage MTX (3.75, 95% CI 3.52-3.97) was statistically significant and non-inferiority was not met. Statistically significant differences were not detected for most clinical, functional, and US outcomes. Pharmacokinetic and safety profiles were similar. CONCLUSION: In MUSICA, Week 24 mean DAS28-CRP, the primary endpoint, did not meet non-inferiority for the low-dosage MTX group. Although the differences between the 2 MTX dosage groups were small, our study findings did not support routine MTX reduction in MTX inadequate responders initiating ADA.

Changes in Ultrasonographic Vascularity Upon Initiation of Adalimumab Combination Therapy in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

OBJECTIVE: To assess joint disease activity by ultrasound (US) in patients with rheumatoid arthritis (RA) initiating treatment with adalimumab (ADA) plus methotrexate (MTX). METHODS: Data for this post hoc analysis originated from the MUSICA trial (ClinicalTrials.gov identifier: NCT01185288), which evaluated the efficacy of initiating ADA (40 mg every other week) plus 7.5 or 20 mg/week MTX in 309 patients with RA with an inadequate response to MTX. Synovial vascularization over 24 weeks was assessed bilaterally at metacarpophalangeal joint 2 (MCP2), MCP3, MCP5, metatarsophalangeal joint 5, and the wrists by power Doppler US (PDUS). A semiquantitative 4-grade scale was used. Disease activity was assessed using the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) and Simplified Disease Activity Index (SDAI). The correlation between continuous variables was assessed using Pearson's correlation coefficient. RESULTS: After 24 weeks of treatment with ADA plus MTX, rapid improvements in the mean synovial vascularity score were observed; the greatest improvements were in MCP2 (-0.5), MCP3 (-0.4), and the wrist (-0.4). At week 24, patients with the lowest DAS28-CRP (<2.6) had the lowest mean 5-joint and 3-joint composite synovial vascularity scores. The 5-joint and 3-joint scores were strongly correlated (ρ > 0.9). Synovial vascularity scores correlated poorly with DAS28, swollen joint count in 66 joints (SJC66), SJC28, tender joint count in 68 joints (TJC68), TJC28, Clinical Disease Activity Index (CDAI), SDAI, physician's global assessment, patient's global assessment of pain, and disease duration (ρ < 0.2). Thirty-two (70%) of 46 patients with a DAS28-CRP of <2.6, and 11 (58%) of 19 patients with an SDAI indicating remission had at least 1 joint with a synovial vascularity score of ≥1. CONCLUSION: PDUS detects changes in synovial vascularity in RA patients treated with ADA plus MTX, and residual synovial vascularity in patients in whom clinical disease control has been achieved.

Development of a nursing care problems coping scale for male caregivers for people with dementia living at home.

OBJECTIVE: The number of male caregivers has increased, but male caregivers face several problems that reduce their quality of life and psychological condition. This study focused on the coping problems of men who care for people with dementia at home. It aimed to develop a coping scale for male caregivers so that they can continue caring for people with dementia at home and improve their own quality of life. The study also aimed to verify the reliability and validity of the scale. PATIENTS/MATERIAL AND METHODS: The subjects were 759 men who care for people with dementia at home. The Care Problems Coping Scale consists of 21 questions based on elements of questions extracted from a pilot study. Additionally, subjects completed three self-administered questionnaires: the Japanese version of the Zarit Caregiver Burden Scale, the Depressive Symptoms and the Self-esteem Emotional Scale, and Rosenberg Self-Esteem Scale. RESULTS: There were 274 valid responses (36.1% response rate). Regarding the answer distribution, each average value of the 21 items ranged from 1.56 to 2.68. The median answer distribution of the 21 items was 39 (SD = 6.6). Five items had a ceiling effect, and two items had a floor effect. The scale stability was about 50%, and Cronbach's α was 0.49. There were significant correlations between the Care Problems Coping Scale and total scores of the Japanese version of the Zarit Caregiver Burden Scale, the Depressive Symptoms and Self-esteem Emotional Scale, and the Rosenberg Self-Esteem Scale. CONCLUSION: The answers provided on the Care Problems Coping Scale questionnaire indicated that male caregivers experience care problems. In terms of validity, there were significant correlations between the external questionnaires and 19 of the 21 items in this scale. This scale can therefore be used to measure problems with coping for male caregivers who care for people with dementia at home.

Musculoskeletal ultrasound objective structured clinical examination: an assessment of the test.

OBJECTIVE: To determine the reliability and validity of an objective structured clinical examination (OSCE) for musculoskeletal ultrasound (MSUS). METHODS: A 9-station OSCE was administered to 35 rheumatology fellows trained in MSUS and to 3 expert faculty (controls). Participants were unaware of joint health (5 diseased/4 healthy). Faculty assessors (n = 9) graded image quality with predefined checklists and a 0-5 global rating, blinded to who performed the study. Interrater reliability, correlation between a written multiple choice question examination (MCQ) and OSCE performance, and comparison of fellow OSCE results with those of the faculty were measured to determine OSCE reliability, concurrent validity, and construct validity. RESULTS: Assessors' interrater reliability was good (intraclass correlation coefficient [ICC] 0.7). Score reliability was good in the normal wrist and ankle stations (ICC 0.7) and moderate in the abnormal wrist and ankle stations (ICC 0.4). MCQ grades significantly correlated with OSCE grades (r = 0.52, P < 0.01). The fellows in the bottom quartile of the MCQ scored 3.07 on the OSCE, significantly worse than the top quartile fellows (3.32) and the faculty (3.29; P < 0.01). Scores also significantly discriminated bottom quartile fellows from faculty in the normal wrist and ankle stations (3.38 versus 3.78; P < 0.01), but not in the abnormal stations (3.37 versus 3.49; P = 0.08). CONCLUSION: MSUS OSCE is a reliable and valid method for evaluation of MSUS skill. Normal joint assessment stations are more reliable than abnormal joint assessment stations and better discriminate poorly performing fellows from faculty. Therefore, MSUS OSCE with normal joints can be used for the assessment of MSUS skill competency.

Musculoskeletal ultrasound training and competency assessment program for rheumatology fellows.

OBJECTIVES: The purpose of this study was to establish standards for musculoskeletal ultrasound competency through knowledge and skills testing using criterion-referenced methods. METHODS: Two groups of rheumatology fellows trained in musculoskeletal ultrasound through a standardized curriculum, which required submission of ultrasound studies for review over 8 months. Both groups then completed written and practical examinations in musculoskeletal ultrasound. Instructors, advanced users, and intermediate users of musculoskeletal ultrasound served as comparison groups. A passing score (competency) was established for the written examination by the Angoff procedure and for the practical examination by the borderline method. RESULTS: Thirty-eight fellows (19 in each group) took the final examination. Five fellows failed the written examination, and 1 failed the practical examination, whereas none of the advanced users failed. Written examination scores did not differ between the two fellow groups (74% versus 70%; P > .05), were reliable, and were able to discriminate between the intermediate and advanced groups. Practical and written examination results correlated in both groups (first group, r = 0.70; P = .0008; second group, r = 0.59; P = .009). CONCLUSIONS: Criterion-referenced methods were used for the first time to determine fellow musculoskeletal ultrasound competency. The examination used to determine competency was reproducible, was reliable, and could differentiate musculoskeletal ultrasound users with different levels of experience. Most rheumatology fellows completing our program passed the written and practical examinations, suggesting achievement of basic musculoskeletal ultrasound competency.

Frequency of abnormal biphasic aPTT clot waveforms in patients with underlying disorders associated with disseminated intravascular coagulation.

Abnormal biphasic waveform (BPW) patterns were previously reported when the activated partial thromboplastin time (aPTT) was performed in plasma from patients with disseminated intravascular coagulation (DIC). In this study, the prevalence of the BPW was examined in a cohort of 508 hospitalized patients with elevated fibrinogen degradation products (FDP) levels (>10 microg/mL). The presence of a BPW was automatically flagged by the MDA analyzer when the slope of the precoagulation phase in the waveform exceeded a threshold value of -0.25%T/sec. In our cohort, 76 patients (15%) were diagnosed with overt DIC according to the criteria recently proposed by the International Society of Thrombosis and Haemostasis (ISTH), whereas 96 patients (18.9%) were diagnosed with DIC following the criteria of the Japanese Ministry of Health and Welfare (JMHW). The JMHW and ISTH criteria agreed in 93% of cases (kappa coefficient 0.76). The concordance between both scoring systems was high in patients with infection but low in solid cancer. The BPW appeared in 65 patients (12.8%), with the highest prevalence (23.6%) in patients with infection. The BPW was more prevalent in the subgroup of patients with DIC: 59.2% and 47.9% for DIC diagnosed by ISTH and JMWH scores, respectively. The prevalence of the BPW was particularly high in patients with DIC and infection: 86.4% and 75.0% for DIC diagnosed by ISTH and JMWH scores, respectively. For the total cohort, the presence of the BPW was significantly associated with DIC. Odds ratios were 29.9 and 19.0 for ISTH and JMWH scores, respectively (p<0.0001). The BPW showed a moderate sensitivity (59.2% for the ISTH score; 47.9% for the JMWH score), but a high specificity (95.4% for both scores). Waveform analysis of the aPTT potentially provides a practical tool in risk assessment of critical care patients, in whom development of DIC is known to worsen the prognosis.

Diagnosis of deep vein thrombosis by plasma-soluble fibrin or D-dimer.

The present study was designed to determine the cutoff values of D-dimer and soluble fibrin (SF) for the diagnosis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in Japanese patients. Plasma levels of these molecules were measured in 243 patients suspected of having DVT and 100 healthy volunteers (controls). Out of 243 patients, 20 patients were diagnosed with DVT. In the control group, plasma levels of D-dimer and SF did not show normal distribution, and the 95% confidence intervals (CI) of D-dimer and SF were 2.45 microg/mL and 6.92 microg/mL, respectively. Plasma levels of D-dimer and SF of patients with DVT were significantly higher than of those without DVT. In patients with DVT, the minimum values of D-dimer and SF were 1.71 and 1.44 microg/mL, respectively. When the cutoff value was set at the average+1 SD of those of the control (D-dimer, about 1.8 microg/mL; SF, about 1.4 microg/mL), 1 and 0 patient with DVT was overlooked, respectively. The sensitivity and specificity of D-dimer and SF for DVT were 95% and 100%, and 61.9% and 53.8%, respectively. When the cutoff value was set at 95% CI of the control (D-dimer, 2.5 microg/mL; SF, 6.9 microg/mL), 2 and 9 patients with DVT were overlooked, respectively. The sensitivity and specificity of D-dimer and SF were 90% and 50%, and 77.6% and 88.3%, respectively. When the cutoff values set at 2.5 microg/mL of D-dimer or 6.9 microg/mL of SF, 1 DVT patient was overlooked, with sensitivity and specificity of 95% and 69.5%. Our data suggest that both D-dimer and SF are useful markers for the diagnosis of DVT and that measurement of both D-dimer and SF increases the sensitivity and specificity for the diagnosis of DVT/PE.