Validation trial for efficacy of ultrasonographic measurement method to predict ascitic volume using virtual ultrasonography

Purpose

The aim of this study was to clarify whether ultrasound quantitative methods were positively correlated with volume of ascites evaluated by whole abdominopelvic CT.

Methods

Sixty-eight patients with cirrhotic ascites were retrospectively analyzed. First, to confirm that virtual ultrasonography (VUS) is an alternative method to conventional ultrasound, 22 patients underwent both conventional ultrasonography and VUS. Second, the efficacy of US quantitative methods (3-point method, 4-point method, 5-point method, and Matsumoto’s method) was confirmed by VUS in 68 patients. We assessed whether the ascites volume predicted by VUS corresponded with that calculated by 3D-CT. Of the 68 patients, 23 patients were analyzed before and after administration of tolvaptan.

Results

The predictive volumes calculated by VUS were remarkably relative to those yielded by conventional US. Correlations between exact volume and those measured by VUS were significantly high (3-point method: r?=?0.882, p?<?0.001; 4-point method: r?=?0.797, p?<?0.001; 5-point method: r?=?0.836, p?<?0.001; Matsumoto’s method: r?=?0.453, p?<?0.001). Correlations between decreasing volume on 3D-CT and that measured by VUS were also significantly high in patients with administration of tolvaptan.

Conclusion

Ascites volume measured by ultrasound was effective, especially the 3-point and 5-point methods. It was useful to assess the efficacy of diuretics in cirrhotic patients.

     

Effects of Tiotropium Combined with Theophylline on Stable COPD Patients of Group B,D and its Impact on Small Airway Function: A Randomized Controlled Trial

Introduction

Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have investigated the long-term outcomes and efficacy of both in patients with COPD. We evaluated the effects of tiotropium and low-dose theophylline on stable COPD patients of groups B and D.

Methods

Eligible participants (n?=?170) were randomized and received either tiotropium 18 µg once daily with theophylline 100 mg twice daily (Group I) or tiotropium 18 µg once daily (Group II) for 6 months. COPD assessment test (CAT), modified Medical Research Council (mMRC) dyspnea scores and pulmonary function tests were measured before randomization and during the treatment.

Results

After 6 months of treatment, the CAT scores in both groups decreased significantly (11.41?±?3.56 and 11.08?±?3.05, p?<?0.0001). The changes of CAT (p?=?0.028) and mMRC scores (p?=?0.049) between the two groups differed after 1 month of treatment. In Group I, forced expiratory flow after 25% of the FVC% predicted (MEF₂₅% pred) was significantly improved after 3 months (4.84?±?8.73%, p?<?0.0001) and 6 months (6.21?±?8.65%, p?<?0.0001). There was a significant difference in small airway function tests (MEF₅₀% pred, MEF₂₅% pred, and MMEF% pred) between the two groups after 6 month of treatment (p?=?0.003, p?<?0.0001, and p?=?0.021, respectively).

Conclusions

Tiotropium combined with low-dose theophylline significantly improved the symptoms and general health of patients with stable COPD of groups B and D after 6 months of follow-up. Additionally, this therapy also improved the indicators of small airway function.

Trial Registration

Chinese Clinical Trial Registry (Registry ID: ChiCTR1800019027).

     

Cardiovascular magnetic resonance left ventricular strain in end-stage renal disease patients after kidney transplantation

Background

Cardiovascular disease is a significant cause of morbidity and mortality in patients with end-stage renal disease (ESRD) and kidney transplant (KT) patients. Compared with left ventricular (LV) ejection fraction (LVEF), LV strain has emerged as an important marker of LV function as it is less load dependent. We sought to evaluate changes in LV strain using cardiovascular magnetic resonance imaging (CMR) in ESRD patients who received KT, to determine whether KT may improve LV function.

Methods

We conducted a prospective multi-centre longitudinal study of 79 ESRD patients (40 on dialysis, 39 underwent KT). CMR was performed at baseline and at 12?months after KT.

Results

Among 79 participants (mean age 55 years; 30% women), KT patients had significant improvement in global circumferential strain (GCS) (p?=?0.007) and global radial strain (GRS) (p?=?0.003), but a decline in global longitudinal strain (GLS) over 12?months (p?=?0.026), while no significant change in any LV strain was observed in the ongoing dialysis group. For KT patients, the improvement in LV strain paralleled improvement in LVEF (57.4?±?6.4% at baseline, 60.6%?±?6.9% at 12?months; p?=?0.001). For entire cohort, over 12?months, change in LVEF was significantly correlated with change in GCS (Spearman’s r?=???0.42, p?<?0.001), GRS (Spearman’s r?=?0.64, p?<?0.001), and GLS (Spearman’s r?=???0.34, p?=?0.002). Improvements in GCS and GRS over 12?months were significantly correlated with reductions in LV end-diastolic volume index and LV end-systolic volume index (all p?<?0.05), but not with change in blood pressure (all p?>?0.10).

Conclusions

Compared with continuation of dialysis, KT was associated with significant improvements in LV strain metrics of GCS and GRS after 12?months, which did not correlate with blood pressure change. This supports the notion that KT has favorable effects on LV function beyond volume and blood pessure control. Larger studies with longer follow-up are needed to confirm these findings.

     

Health-related outcomes of critically ill patients with and without sepsis

Purpose

To determine differences in health-related quality of life (HRQoL), survival and healthcare resource use of critically ill adults with and without sepsis.

Methods

We conducted a primary propensity score matched analysis of patients with and without sepsis enrolled in a large multicentre clinical trial. Outcomes included HRQoL at 6 months, survival to 2 years, length of ICU and hospital admission and cost of ICU and hospital treatment to 2 years.

Results

We obtained linked data for 3442 (97.3%) of 3537 eligible patients and matched 806/905 (89.0%) patients with sepsis with 806/2537 (31.7%) without. After matching, there were no significant differences in the proportion of survivors with and without sepsis reporting problems with mobility (37.8% vs. 38.7%, p?=?0.86), self-care (24.7% vs. 26.0%, p?=?0.44), usual activities (44.5% vs. 46.8%, p?=?0.28), pain/discomfort (42.4% vs. 41.6%, p?=?0.54) and anxiety/depression (36.9% vs. 37.7%, p?=?0.68). There was no significant difference in survival at 2 years: 482/792 (60.9%) vs. 485/799 (60.7%) (HR 1.01, 95% CI 0.86–1.18, p?=?0.94). The initial ICU and hospital admission were longer for patients with sepsis: 10.1?±?11.9 vs. 8.0?±?9.8 days (p?<?0.0001) and 22.8?±?21.2 vs. 19.1?±?19.0 days, (p?=?0.0003) respectively. The cost of ICU admissions was higher for patients with sepsis: A$43,345?±?46,263 (€35,109?±?35,043) versus 34,844?±?38,281 (€28,223?±?31,007), mean difference $8501 (€6885), 95% CI $4342–12,660 (€3517?±?10,254), p?<?0.001 as was the total cost of hospital treatment to 2 years: A$74,120?±?60,750 (€60,037?±?49,207) versus A$65,806?±?59,856 (€53,302?±?48,483), p?=?0.005.

Conclusions

Critically ill patients with sepsis have higher healthcare resource use and costs but similar survival and HRQoL compared to matched patients without sepsis.

     

Chronic Temporomandibular Disorders: disability,pain intensity and fear of movement

Background

The objective was to compare and correlate disability, pain intensity, the impact of headache on daily life and the fear of movement between subgroups of patients with chronic temporomandibular disorder (TMD).

Methods

A cross-sectional study was conducted in patients diagnosed with chronic painful TMD. Patients were divided into: 1) joint pain (JP); 2) muscle pain (MP); and 3) mixed pain. The following measures were included: Craniomandibular pain and disability (Craniofacial pain and disability inventory), neck disability (Neck Dsiability Index), pain intensity (Visual Analogue Scale), impact of headache (Headache Impact Test 6) and kinesiophobia (Tampa Scale of Kinesiophobia-11).

Results

A total of 154 patients were recruited. The mixed pain group showed significant differences compared with the JP group or MP group in neck disability (p?<?0.001, d?=?1.99; and p?<?0.001, d?=?1.17), craniomandibular pain and disability (p?<?0.001, d?=?1.34; and p?<?0.001, d?=?0.9, respectively), and impact of headache (p?<?0.001, d?=?1.91; and p?<?0.001, d?=?0.91, respectively). In addition, significant differences were observed between JP group and MP group for impact of headache (p?<?0.001, d?=?1.08). Neck disability was a significant covariate (37 % of variance) of craniomandibular pain and disability for the MP group (β?=?0.62; p?<?0.001). In the mixed chronic pain group, neck disability (β?=?0.40; p?<?0.001) and kinesiophobia (β?=?0.30; p?=?0.03) were significant covariate (33 % of variance) of craniomandibular pain and disability.

Conclusion

Mixed chronic pain patients show greater craniomandibular and neck disability than patients diagnosed with chronic JP or MP. Neck disability predicted the variance of craniofacial pain and disability for patients with MP. Neck disability and kinesiophobia predicted the variance of craniofacial pain and disability for those with chronic mixed pain.

     

Preoperative pain treatment in acute abdomen in Osogbo,Nigeria: a randomized double-blind placebo-controlled study

Background

Withholding analgesics in acute abdomen for fear of masking clinical features and impairing diagnosis and decision-making is still being practiced despite recent evidence to the contrary. This study assesses the effect of preoperative analgesia on clinical findings, clinical diagnosis, and decision-making in patients with non-trauma acute abdomen.

Method

This is a randomized, double-blind, placebo-controlled study using Tramal, a brand of tramadol, at the ED of LAUTECH Teaching Hospital Osogbo, Nigeria. Ninety-five patients between 18–60 years received Tramal (n?=?46) or placebo (n?=?49). The pain score, clinical findings, provisional diagnosis, and treatment plan were noted before and 15–20 min after administration of the analgesic or placebo. The final diagnosis arrived at after adequate investigation or operation was considered the gold standard. The pain scores, diagnosis, treatment plan, and decision between the two groups were compared. Statistical analysis was by SPSS 16. Results were considered statistically significant at p?<?0.05.

Results

Demography and case distribution were similar in both groups. The improvement in pain was greater in the Tramal group (p?=?0.001). The abdominal palpation findings were also better in the Tramal group (p?=?0.02). There were more changes in the diagnosis after use of Tramal (p?=?0.01). There were more changes in the decision in the Tramal group (p?=?0.03). Most of the changes in diagnosis and decision in the Tramal group were for the better.

Conclusion

The preoperative use of Tramal in acute abdomen improved the experience of pain and did not adversely affect the accuracy of the diagnosis or decision-making.

     

Clinical spectrum and short-term outcome of adult patients with purpura fulminans: a French multicenter retrospective cohort study

Purpose

Data on purpura fulminans (PF) in adult patients are scarce and mainly limited to meningococcal infections. Our aim has been to report the clinical features and outcomes of adult patients admitted in the intensive care unit (ICU) for an infectious PF, as well as the predictive factors for limb amputation and mortality.

Methods

A 17-year national multicenter retrospective cohort study in 55 ICUs in France from 2000 to 2016, including adult patients admitted for an infectious PF defined by a sudden and extensive purpura, together with the need for vasopressor support. Primary outcome variables included hospital mortality and amputation during the follow-up period (time between ICU admission and amputation, death or end of follow-up).

Results

Among the 306 included patients, 126 (41.2%; 95% CI 35.6–46.9) died and 180 (58.8%; 95% CI 53.3–64.3) survived during the follow-up period [13 (3–24) days], including 51/180 patients (28.3%, 95% CI 21.9–35.5) who eventually required limb amputations, with a median number of 3 (1–4) limbs amputated. The two predominantly identified microorganisms were Neisseria meningitidis (63.7%) and Streptococcus pneumoniae (21.9%). By multivariable Cox model, SAPS II [hazard-ratio (HR)?=?1.03 (1.02–1.04); p?<?0.001], lower leucocytes [HR 0.83 (0.69–0.99); p?=?0.034] and platelet counts [HR 0.77 (0.60–0.91); p?=?0.007], and arterial blood lactate levels [HR 2.71 (1.68–4.38); p?<?0.001] were independently associated with hospital death, while a neck stiffness [HR?0.51 (0.28–0.92); p?=?0.026] was a protective factor. Infection with Streptococcus pneumoniae [sub-hazard ratio 1.89 (1.06–3.38); p?=?0.032], together with arterial lactate levels and ICU admission temperature, was independently associated with amputation by a competing risks analysis.

Conclusion

Purpura fulminans carries a high mortality and morbidity. Pneumococcal PF leads to a higher risk of amputation.

Trials registration

NCT03216577.

     

Dynamic changes in injured myocardium,very early after acute myocardial infarction,quantified using T1 mapping cardiovascular magnetic resonance

Background

It has recently been suggested that myocardial oedema follows a bimodal pattern early post ST-segment elevation myocardial infarction (STEMI). Yet, water content, quantified using tissue desiccation, did not return to normal values unlike oedema quantified by cardiovascular magnetic resonance (CMR) imaging. We studied the temporal changes in the extent and intensity of injured myocardium using T1-mapping technique within the first week after STEMI.

Methods

A first group (n?=?31) underwent 3 acute 3?T CMR scans (time-point (TP) <?3?h, 24?h and 6?days), including cine, native shortened modified look-locker inversion recovery T1 mapping, T2* mapping and late gadolinium enhancement (LGE). A second group (n?=?17) had a single scan at 24?h with an additional T2-weighted sequence to assess the difference in the extent of area-at-risk (AAR) compared to T1-mapping.

Results

The mean T1 relaxation time value within the AAR of the first group was reduced after 24?h (P?<?0.001 for TP1 vs.TP2) and subsequently increased at 6?days (P?=?0.041 for TP2 vs.TP3). However, the extent of AAR quantified using T1-mapping did not follow the same course, and no change was detected between TP1&TP2 (P?=?1.0) but was between TP2 &TP3 (P?=?0.019). In the second group, the extent of AAR was significantly larger on T1-mapping compared to T2-weighted (42?±?15% vs. 39?±?15%, P?=?0.025). No change in LGE was detected while microvascular obstruction and intra-myocardial haemorrhage peaked at different time points within the first week of reperfusion.

Conclusion

The intensity of oedema post-STEMI followed a bimodal pattern; while the extent of AAR did not track the same course. This discrepancy has implications for use of CMR in this context and may explain the previously reported disagreement between oedema quantified by imaging and tissue desiccation.

     

Implementation and feasibility of the stroke nursing guideline in the care of patients with stroke: a mixed methods study

Background

Nurses often have difficulties with using interdisciplinary stroke guidelines for patients with stroke as they do not focus sufficiently on nursing. Therefore, the Stroke Nursing Guideline (SNG) was developed and implemented. The aim of this study was to determine the implementation and feasibility of the SNG in terms of changes in documentation and use of the guideline in the care of stroke patients on Neurological and Rehabilitation wards, barriers and facilitators, and nurses’ and auxiliary nurses’ view of the implementation.

Methods

A sequential explorative mixed method design was used including pre-test post-test measures and post intervention focus groups interviews. For the quantitative part retrospective electronic record data of nursing care was collected from 78 patients and prospective measures with Barriers and Facilitators Assessment Instrument (BFAI) and Quality Indicator Tool (QIT) from 33 nursing staff including nurses and auxiliary nurses. In the qualitative part focus groups interviews were conducted with nursing staff on usefulness of the SNG and experiences with implementation.

Results

Improved nursing documentation was found for 23 items (N?=?37), which was significant for nine items focusing mobility (p?=?0.002, p?=?0.024, p?=?0.012), pain (p?=?0.012), patient teaching (p?=?0.001, p?=?0.000) and discharge planning (p?=?0.000, p?=?0.002, p?=?0.004). Improved guideline use was found for 20 QIT-items (N?=?30), with significant improvement on six items focusing on mobility (p?=?0.023), depression (p?=?0.033, p?=?0.025, p?=?0.046, p?=?0.046), discharge planning (p?=?0.012). Facilitating characteristics for change were significantly less for two of four BFAI-subscales, namely Innovation (p?=?0.019) and Context (p?=?0.001), whereas no change was found for Professional and Patient subscales. The findings of the focus group interviews showed the SNG to be useful, improving and providing consistency in care. The implementation process was found to be successful as essential components of nursing rehabilitation were defined and integrated into daily care.

Conclusion

Nursing staff found the SNG feasible and implementation successful. The SNG improved nursing care, with increased consistency and more rigorous functional exercises than before. The SNG provides nurses and auxiliary nurses with an important means for evidence based care for patients with stroke. Several challenges of implementing this complex nursing intervention surfaced which mandates ongoing attention.

     

Randomized controlled trial of supportive-expressive group therapy and body-mind-spirit intervention for Chinese non-metastatic breast cancer patients

Purpose

This study aimed to evaluate the efficacy of supportive-expressive group (SEG) therapy and body-mind-spirit (BMS) intervention on emotional suppression and psychological distress in Chinese breast cancer patients.

Methods

This three-arm randomized controlled trial assigned 157 non-metastatic breast cancer patients to BMS, SEG, or social support control group. SEG focused on emotional expression and group support, whereas BMS emphasized relaxation and self-care. All groups received 2-h weekly sessions for 8 weeks. The participants completed measurements on emotional suppression, perceived stress, anxiety, and depression at baseline and three follow-up assessments in 1 year.

Results

Using latent growth modeling, overall group difference was found for emotional suppression (χ ²(2)?=?8.88, p?=?0.012), marginally for perceived stress (χ ²(2)?=?5.70, p?=?0.058), but not for anxiety and depression (χ ²(2)?=?0.19–0.94, p?>?0.05). Post-hoc analyses revealed a significant and moderate reduction (Cohen d?=?0.55, p?=?0.007) in emotional suppression in SEG compared to control group, whereas BMS resulted in a marginally significant and moderate fall (d?=?0.46, p?=?0.024) in perceived stress. Neither SEG nor BMS significantly improved anxiety and depression (d?<?0.20, p?>?0.05).

Conclusions

The present results did not demonstrate overall effectiveness for either BMS or SEG therapy in the present sample of Chinese non-metastatic breast cancer patients. The participants appear to derive only modest benefits in terms of their psychological well-being from either intervention.

     

Subtypes of pediatric acute respiratory distress syndrome have different predictors of mortality

Purpose

Acute respiratory distress syndrome (ARDS) is heterogeneous in etiology, which may affect outcomes. Stratification into biologically-defined subtypes may reduce heterogeneity. However, it is unknown whether pediatric ARDS has clinically relevant subtypes. We aimed to determine whether clinical characteristics and predictors of mortality differed between direct and indirect ARDS, and separately between infectious and non-infectious ARDS.

Methods

This was a single center, prospective cohort study of 544 children with ARDS (Berlin) between July 2011 and June 2017, stratified into direct versus indirect ARDS, and separately into infectious versus non-infectious ARDS. Multiple logistic regression was used to test for predictors of mortality in the entire cohort, and separately within subtypes. Effect modification by subtype was assessed using interaction tests.

Results

Direct ARDS had lower severity of illness (p?<?0.001) but worse oxygenation (p?<?0.001), relative to indirect. Predictors of mortality were similar for direct and indirect ARDS. When comparing infectious and non-infectious ARDS, infectious ARDS had lower severity of illness (p?<?0.001), worse oxygenation (p?=?0.014), and lower mortality (p?=?0.013). In multivariable analysis, immunocompromised status demonstrated effect modification between infectious and non-infectious ARDS (p?=?0.005 for interaction), with no association with mortality in non-infectious ARDS.

Conclusions

In children, direct and indirect ARDS have distinct clinical characteristics, but similar outcomes and similar predictors of mortality. In contrast, infectious and non-infectious ARDS demonstrate heterogeneity of clinical characteristics, mortality, and predictors of mortality, with traditional predictors of ARDS mortality only applicable to infectious ARDS.

     

Normative values for musculoskeletal- and neuromotor fitness in apparently healthy Norwegian adults and the association with obesity: a cross-sectional study

Background

Up-to-date research on musculoskeletal- and neuromotor fitness (MSMF) is lacking. The aims of the present paper were to a) establish normative values of MSMF by gender and age, and b) to assess how much of the variance in MSMF can be explained by obesity in adults.

Methods

A random selection of 726 Norwegians (20–65 years) participated in a national cross-sectional study. Muscular endurance, muscular strength, explosive power, flexibility and balance were assessed in addition to waist circumference (WC).

Results

Females displayed significantly higher scores compared to males on muscular endurance of the back extensors and on the flexibility tests (p?<?0.001). Males displayed significantly higher scores than females (p?<?0.001) on handgrip strength, modified push-ups, and explosive power. An inverse association was found between age and all MSMF scores for females (Beta:?0.06–(?0.92), p?≤?0.044) and males (Beta:?0.15–(0.91), p?≤?0.006), where younger participants displayed higher test scores on all MSMF tests, compared to older participants. Furthermore, participants showing higher scores on WC displayed lower scores on the following MSMF tests for both females and males: muscular endurance of the back extensors, balance, flexibility of the shoulder, and explosive power (p?<?0.001). Additionally, male participants with higher WC scores showed lower scores on muscular endurance of the upper body and flexibility of the hamstrings compared to males with lower WC scores (p?<?0.001).

Conclusions

The data provide normative values of MSMF for adults based on age and gender, and support an inverse relationship of MSMF to age and WC.

     

vWF/ADAMTS13 is associated with on-aspirin residual platelet reactivity and clinical outcome in patients with stable coronary artery disease

Background

The mechanisms behind residual platelet reactivity (RPR) despite aspirin treatment are not established. It has been shown that coronary artery disease (CAD) patients with high on-aspirin RPR have elevated levels of von Willebrand factor (vWF). ADAMTS13 is a metalloprotease cleaving ultra large vWF multimers into less active fragments.Our aim was to investigate whether ADAMTS13 and vWF/ADAMTS13 ratio were associated with high RPR, and further with clinical endpoints after 2 years.

Methods

Stable aspirin-treated CAD patients (n?=?999) from the ASCET trial. RPR was assessed by PFA-100. ADAMTS13 antigen and activity were analysed using chromogenic assays. Endpoints were a composite of acute myocardial infarction, stroke and death.

Results

The number of patients with high RPR was 258 (25.8%). Their serum thromboxane B₂ (TxB₂) levels were low, indicating inhibition of COX-1. They had significantly lower levels of ADAMTS13 antigen compared to patients with low RPR (517 vs 544 ng/mL, p?=?0.001) and significantly lower ADAMTS13 activity (0.99 vs 1.04 IU/mL, p?=?0.020). The differences were more pronounced when relating RPR to ratios of vWF/ADAMTS13 antigen and vWF/ADAMTS13 activity (p?<?0.001, both). We found an inverse correlation between vWF and ADAMTS13 antigen (r?=??0.14, p?<?0.001) and ADAMTS13 activity (r?=??0.11, p?<?0.001). No correlations between TxB₂ and ADAMTS13 antigen or activity, were observed, implying that ADAMTS13 is not involved in TxB2 production. Patients who experienced endpoints (n?=?73) had higher vWF level (113 vs 105%, p?=?0.032) and vWF/ADAMTS13 antigen ratio (0.23 vs 0.20, p?=?0.012) compared to patients without. When dichotomizing vWF/ADAMTS13 antigen at median level we observed that patients above median had higher risk for suffering endpoints, with an adjusted OR of 1.86 (95% CI 1.45, 2.82).

Conclusion

These results indicate that ADAMTS13 is of importance for RPR, and that it in combination with vWF also is associated with clinical endpoints in stable CAD patients on aspirin.

Trial registration

Clinicaltrials.gov NCT00222261. Registered 13.09.2005. Retrospectively registered.

     

Sickle cell disease,sickle trait and the risk for venous thromboembolism: a systematic review and meta-analysis

Background

Globally, sickle cell disease (SCD) is one of the most common haemoglobinopathy. Considered a public health problem, it leads to vessel occlusion, blood stasis and chronic activation of the coagulation system responsible for vaso-occlussive crises and venous thromboembolism (VTE) which may be fatal. Although contemporary observational studies suggest a relationship between SCD or sickle trait (SCT) and VTE, there is lack of a summary or meta-analysis data on this possible correlation. Hence, we propose to summarize the available evidence on the association between SCD, SCT and VTE including deep vein thrombosis (DVT) and pulmonary embolism (PE).

Methods

We searched PubMed and Scopus to identify all cross-sectional, cohort and case-control studies reporting on the association between SCD or SCT and VTE, DVT or PE in adults or children from inception to April 25, 2017. For measuring association between SCD or SCT and VTE, DVT, or PE, a meta-analysis using the random-effects method was performed to pool weighted odds ratios (OR) of risk estimates.

Results

From 313 records initially identified from bibliographic databases, 10 studies were eligible and therefore included the meta-analysis. SCD patients had significantly higher risk for VTE (pooled OR 4.4, 95%CI 2.6–7.5, p?<?0.001), DVT (OR 1.1, 95% CI 1.1–1.2, p?<?0.001) and PE (pooled OR 3.7, 95% CI 3.6–3.8, p?<?0.001) as compared to non SCD-adults. A higher risk of VTE (OR 33.2, 95% CI 9.7–113.4, p?<?0.001) and DVT (OR 30.7, 95% CI 1.6–578.2, p =?0.02) was found in pregnant or postpartum women with SCD as compared to their counterparts without SCD. Compared to adults with SCT, the risk of VTE was higher in adults with SCD (pooled OR 3.1, 95% CI 1.8–5.3, p?<?0.001), and specifically in SCD pregnant or postpartum women (OR 20.3, 95% CI 4.1–102, p?=?0.0003). The risk of PE was also higher in adults with SCD (OR 3.1, 95% CCI 1.7–5.9, p?=?0.0004) as compared to those with SCT. The risk of VTE was higher in individuals with SCT compared to controls (pooled OR 1.7, 95% CI 1.3–2.2, p?<?0.0001), but not in pregnant or postpartum women (OR 0.9, 95% CI 0.3–2.9, p?=?0.863). Compared to controls, SCT was associated with a higher risk of PE (pooled OR 2.1, 95% CI 1.2–3.8, p?=?0.012) but not of DVT (pooled OR 1.2, 95% CI 0.9–1.7, p?=?0.157).

Conclusion

Individuals with SCD, especially pregnant or postpartum women, might have a higher risk of VTE compared to the general population. SCT might also increases the risk of VTE. However, currently available data are not sufficient to allow a definite conclusion. Further larger studies are needed to provide a definitive conclusion on the association between SCD, SCT and VTE.

     

Man vs machine in emergency medicine – a study on the effects of manual and automatic vital sign documentation on data quality and perceived workload,using observational paired sample data and questionnaires

Background

Emergency medicine is characterized by a high patient flow where timely decisions are essential. Clinical decision support systems have the potential to assist in such decisions but will be dependent on the data quality in electronic health records which often is inadequate. This study explores the effect of automated documentation of vital signs on data quality and workload.

Methods

An observational study of 200 vital sign measurements was performed to evaluate the effects of manual vs automatic documentation on data quality. Data collection using questionnaires was performed to compare the workload on wards using manual or automatic documentation.

Results

In the automated documentation time to documentation was reduced by 6.1?min (0.6?min vs 7.7?min, p?<? 0.05) and completeness increased (98% vs 95%, p?<? 0.05). Regarding workflow temporal demands were lower in the automatic documentation workflow compared to the manual group (50 vs 23, p?<? 0.05). The same was true for frustration level (64 vs 33, p?<? 0.05). The experienced reduction in temporal demands was in line with the anticipated, whereas the experienced reduction in frustration was lower than the anticipated (27 vs 54, p?<?0.05).

Discussion

The study shows that automatic documentation will improve the currency and the completeness of vital sign data in the Electronic Health Record while reducing workload regarding temporal demands and experienced frustration. The study also shows that these findings are in line with staff anticipations but indicates that the anticipations on the reduction of frustration may be exaggerated among the staff. The open-ended answers indicate that frustration focus will change from double documentation of vital signs to technical aspects of the automatic documentation system.

     

Safety and tolerability of Kinesio<Superscript>®</Superscript> Taping in patients with arm lymphedema: medical device clinical study

Purpose

The aim of this study is to assess the safety and tolerability of Kinesio^® Taping (KT) in patients with arm lymphedema.

Method

Medical device clinical study in women with arm lymphedema. Kinesio^® Tex Gold bandage was applied by the KT technique. Assessments and interviews were carried out both at the beginning and 4 days after intervention. Skin disorders, reported tolerance and modification of limb volume and function after intervention were assessed. Changes in limb volume and functionality before and after intervention were compared by the Student’s t test and the Wilcoxon Signed-Rank test, considering significant p value <0.05.

Results

Twenty-four women were studied. After intervention, no patient had cutaneous lesions, vesicle or limb hyperthermia, and 4.2 % presented skin peeling and redness. Most patients reported no change in social life and that they felt safer in the daily activity and were very pleased with the treatment. The patients presented improvement of upper limb functionality after intervention (p?<?0.001). No difference of limb volume was found after intervention (p?=?0.639).

Conclusions

Kinesio^® Tex Gold bandage by the KT technique proved to be safe and tolerable in patients with lymphedema, with improved functionality and no change of the affected limb volume.

     

A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker

Introduction

To compare the transconjunctival sutureless 23 gauge (G) pars plana vitrectomy (PPV) with 20 G PPV regarding inflammation, safety, visual outcome and patient comfort.

Methods

We included 103 patients with symptomatic macular hole or macular pucker, scheduled for vitrectomy in this prospective, randomized, controlled, mono-center clinical trial. Patients were randomized 1:1 to either 20G PPV (n?=?51) or 23G PPV (n?=?52). All eyes underwent standard 20G or 23G PPV with membrane peeling. Primary outcome measure was change in aqueous humor flare 3 weeks after surgery compared with baseline. Secondary outcome measures were flare values 2 days and 26 weeks after surgery, subjective discomforts measured with a visual analog scale, best-corrected visual acuity, duration of surgery, intraocular pressure (IOP) and adverse events.

Results

There was no significant difference in change of flare 3 weeks after PPV [? 1.7, 95% CI (? 6.3 to 2.9), p?=?0.466]. Both groups showed a significant increase in flare 2 days after surgery (20G: p?<?0.001, 23G: p?=?0.002), but only the 20G group after 3 weeks (p?=?0.011). The gain in visual acuity after 3 weeks was higher after 23G PPV (4.2 95% CI (0.4–8.0, p?=?0.029), but without a difference after 6 months. The duration of surgery was shorter in the 23G group (p?<?0.001). Patient comfort 3 weeks after surgery was greater after 23G PPV (foreign body sensation p?=?0.002; itching: p?=?0.021). However, the rate of complications did not differ between the groups.

Conclusion

The primary aim, showing the superiority of the 23G group regarding the change of flare value from baseline to 3 weeks after surgery, was not met, but the level of inflammation decreased faster after 23G PPV. Clear advantages of the 23G PPV were a lower risk of postoperative IOP elevation, a shorter surgery time, faster visual recovery and greater patient comfort in the early postoperative phase.

Clinical Trial Registration Number

ClinicalTrials.gov NCT01969929.

     

Sarcopenia and inflammation are independent predictors of survival in male patients newly diagnosed with small cell lung cancer

Purpose

Sarcopenia is suggested to be associated with cancer-related inflammation. We assessed the clinical outcome of small cell lung cancer (SCLC) patients according to sarcopenia and the neutrophil-to-lymphocyte ratio (NLR).

Methods

A total of 117 male SCLC patients treated with first-line chemo- or chemoradiotherapy were assessed based on a retrospective chart review. The mass of the pectoralis muscle was measured by computed tomography and normalized to height. Patients with the lowest quartile of muscle mass were considered to have sarcopenia. Patients were classified into four groups according to their sarcopenia and NLR statuses: sarcopenia/high NLR, sarcopenia/low NLR, non-sarcopenia/high NLR, and non-sarcopenia/low NLR.

Results

Sarcopenic patients had lower progression-free survival (PFS) than did non-sarcopenic patients (median 6.0 vs. 7.5 months, p?=?0.009), but the difference in overall survival (OS) was not statistically significant (median 10.5 vs. 13.5 months, p?=?0.052). However, the OS of sarcopenic patients with high NLR was significantly lower than that in all other groups (median 3.2 vs. 16.0 vs. 12.5 vs. 13.7 months, respectively, p?<?0.001), as was PFS (median 3.2 vs. 7.7 vs. 7.6 vs. 7.1 months, respectively, p?<?0.001). On multivariate analysis, sarcopenia with high NLR was an independent prognostic factor for shorter PFS and OS. Early discontinuation of treatment (20.0 vs. 10.3 %) and treatment-related mortality (50.0 vs. 8.4 %) occurred more frequently in these patients than in the other groups (p?<?0.001).

Conclusions

In SCLC, sarcopenic male patients with high NLR have a poor prognosis and do not tolerate standard treatment. Intensive supportive care is needed in these patients.

     

Acceleration of the learning curve for mastering basic critical care echocardiography using computerized simulation

Purpose

To assess the impact of computerized transthoracic echocardiography (TTE) simulation on the learning curve to achieve competency in basic critical care echocardiography (CCE).

Methods

In this prospective bicenter study, noncardiologist residents novice in ultrasound followed either a previously validated training program with adjunctive computerized simulation on a mannequin (two 3 h-sessions; Vimedix simulator, CAE Healthcare) (interventional group; n?=?12) or solely the same training program (control group; n?=?12). All trainees from the same institution were assigned to the same study group to avoid confusion bias. Each trainee was evaluated after 1 (M1), 3 (M3) and 6 (M6) months of training using our previously validated scoring system. Competency was defined by a score?≥?90% of the maximal value.

Results

The 24 trainees performed 965 TTE in patients with cardiopulmonary compromise during their 6-month rotation. Skills assessments relied on 156 TTE performed in 106 patients (mean age 53?±?14 years; mean Simplified Acute Physiologic Score 2: 55?±?19; 79% ventilated). When compared to the control group, trainees of the interventional group obtained a significantly higher mean skills assessment score at M1 (41.5?±?4.9 vs. 32.3?±?3.7: P?=?0.0004) and M3 (45.8?±?2.8 vs. 42.3?±?3.7: P?=?0.0223), but not at M6 (49.7?±?1.2 vs. 50.0?±?2.7: P?=?0.6410), due to higher practical and technical skills scores. Trainees of the control group required significantly more supervised TTE to obtain competency than their counterparts (36?±?7 vs. 30?±?9: p?=?0.0145).

Conclusions

Adjunctive computerized simulation accelerates the learning curve of basic CCE in improving practical and technical skills and reduces the number of TTE examinations required to reach competency.

     

The Impact of Adding a Training Device to Familiar Counselling on Inhalation Technique and Pulmonary Function of Asthmatics

Introduction

We have investigated the effect of adding a pressurized metered dose inhaler (pMDI) training device to verbal counselling on pulmonary function and inhalation technique.

Methods

A total of 304 adult asthmatic subjects (>?18 years old) were enrolled in a 3-month study of assessment and education. They were divided into an investigation group (Trainhaler plus Flo-Tone and verbal counselling, n?=?261, mean age 49.2 years) and a control group (verbal counselling only, n?=?43, mean age 48.7 years). Pulmonary function and inhalation technique were evaluated, mistakes noted, and the correct technique advised at three consecutive monthly visits. Visits also included verbal pMDI counselling (both groups) and training device coaching (investigation group).

Results

By visit 2, the mean number of technique errors decreased significantly (p?<?0.05) in both groups (investigation group p?<?0.001). The investigation group demonstrated a marked decrease in the frequency of the critical error of maintaining a slow inhalation rate until the lungs are full—a technique difficult to learn via verbal counselling alone. The improvement in pulmonary function was significant from the second clinic visit in the investigation group (p?<?0.05) and from the third visit in both groups (p?<?0.001).

Conclusions

Use of a training device combined with verbal counselling improved inhalation technique. An earlier, significant improvement was also noted in pulmonary function.