Adaptive leadership curriculum for Indian paramedic trainees

Background

Paramedic trainees in developing countries face complex and chaotic clinical environments that demand effective leadership, communication, and teamwork. Providers must rely on non-technical skills (NTS) to manage bystanders and attendees, collaborate with other emergency professionals, and safely and appropriately treat patients. The authors designed a NTS curriculum for paramedic trainees focused on adaptive leadership, teamwork, and communication skills critical to the Indian prehospital environment.

Methods

Forty paramedic trainees in the first academic year of the 2-year Advanced Post-Graduate Degree in Emergency Care (EMT-paramedic equivalent) program at the GVK-Emergency Management and Research Institute campus in Hyderabad, India, participated in the 6-day leadership course. Trainees completed self-assessments and delivered two brief video-recorded presentations before and after completion of the curriculum.

Results

Independent blinded observers scored the pre- and post-intervention presentations delivered by 10 randomly selected paramedic trainees. The third-party judges reported significant improvement in both confidence (25 %, p?<?0.01) and body language of paramedic trainees (13 %, p?<?0.04). Self-reported competency surveys indicated significant increases in leadership (2.6 vs. 4.6, p?<?0.001, d?=?1.8), public speaking (2.9 vs. 4.6, p?<?0.001, d?=?1.4), self-reflection (2.7 vs. 4.6, p?<?0.001, d?=?1.6), and self-confidence (3.0 vs. 4.8, p?<?0.001, d?=?1.5).

Conclusions

Participants in a 1-week leadership curriculum for prehospital providers demonstrated significant improvement in self-reported NTS commonly required of paramedics in the field. The authors recommend integrating focused NTS development curriculum into Indian paramedic education and further evaluation of the long term impacts of this adaptive leadership training.

     

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.

     

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.

     

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.

     

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.

     

Assessment of right ventricular longitudinal strain by 2D speckle tracking imaging compared with RV function and hemodynamics in pulmonary hypertension

The right ventricular longitudinal strain (RVLS) of pulmonary hypertension (PH) patients and its relationship with RV function parameters measured by echocardiography and hemodynamic parameters measured by right heart catheterization was investigated. According to the WHO functional class (FC), 66 PH patients were divided into FC I/II (group 1) and III/IV (group 2). RV function parameters were measured by echocardiographic examinations. Hemodynamic parameters were obtained by right heart catheterization. Patients in group 2 had higher systolic pulmonary artery pressure (sPAP; P?<?0.05) than patients in group (1) significant between-group differences were observed in global RVLS (RVLS_global), free wall RVLS (RVLS_FW; P?<?0.01), and RV conventional function parameters (all P?<?0.05). Moreover, mPAP and PVR increased remarkably and CI decreased significantly in group (2) RVLS_global had a positive correlation with 6-min walking distance (6MWD; r?=?0.492, P?<?0.001) and N-terminal pro-brain natriuretic peptide (NT-proBNP; r?=?0.632, P?<?0.001), while RVLS_FW had a positive correlation with 6MWD (r?=?0.483, P?<?0.001) and NT-proBNP (r?=?0.627, P?<?0.001). Hemodynamics analysis revealed that RVLS_global had a positive correlation with mPAP (r?=?0.594, P?<?0.001), PVR (r?=?0.573, P?<?0.001) and CI (r?=?0.366, P?=?0.003), while RVLS_FW had a positive correlation with mPAP (r?=?0.597, P?<?0.001), PVR (r?=?0.577, P?<?0.001) and CI (r?=?0.369, P?=?0.002). According to receiver operating characteristic curves, the optimal cut-off values of RVLS_global (–15.0%) and RVLS_FW (–15.3%) for prognosis detection with good sensitivity and specificity. Evidence has shown that RVLS measurement can provide the much-needed and reliable information on RV function and hemodynamics. Therefore, this qualifies as a patient-friendly approach for the clinical management of PH patients.     

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.

     

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.

     

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.

     

Concurrent validity of the Gyko inertial sensor system for the assessment of vertical jump height in female sub-elite youth soccer players

Background

The aim of the present study was to verify concurrent validity of the Gyko inertial sensor system for the assessment of vertical jump height.

Methods

Nineteen female sub-elite youth soccer players (mean age: 14.7?±?0.6 years) performed three trials of countermovement (CMJ) and squat jumps (SJ), respectively. Maximal vertical jump height was simultaneously quantified with the Gyko system, a Kistler force-plate (i.e., gold standard), and another criterion device that is frequently used in the field, the Optojump system.

Results

Compared to the force-plate, the Gyko system determined significant systematic bias for mean CMJ (?0.66 cm, p?<?0.01, d?=?1.41) and mean SJ (?0.91 cm, p?<?0.01, d?=?1.69) height. Random bias was?±?3.2 cm for CMJ and?±?4.0 cm for SJ height and intraclass correlation coefficients (ICCs) were “excellent” (ICC?=?0.87 for CMJ and 0.81 for SJ). Compared to the Optojump device, the Gyko system detected a significant systematic bias for mean CMJ (0.55 cm, p?<?0.05, d?=?0.94) but not for mean SJ (0.39 cm) height. Random bias was?±?3.3 cm for CMJ and?±?4.2 cm for SJ height and ICC values were “excellent” (ICC?=?0.86 for CMJ and 0.82 for SJ).

Conclusion

Consequently, apparatus specific regression equations were provided to estimate true vertical jump height for the Kistler force-plate and the Optojump device from Gyko-derived data. Our findings indicate that the Gyko system cannot be used interchangeably with a Kistler force-plate and the Optojump device in trained individuals. It is suggested that practitioners apply the correction equations to estimate vertical jump height for the force-plate and the Optojump system from Gyko-derived data.

     

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.

     

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.

     

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).

     

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.

     

The effect of heart rate on coronary plaque measurements in 320-row coronary CT angiography

Repeatability of quantitative assessment of atherosclerotic plaques is important for the accurate detection of high-risk plaques in coronary CT angiography (CTA). We assessed the effect of heart rate (HR) on plaque CT number using a coronary artery model and a cardiac phantom capable of simulating cardiac motion. The coronary artery model with luminal stenosis on a cardiac phantom was imaged with a simulated HR of 0, 50, 60, and 70 beats per minute using a 320-row CT scanner. We reconstructed CT images for cardiac diastolic phases (for 75% R–R interval) using filtered back projection (FBP), hybrid iterative reconstruction (AIDR3D), and model-based iterative reconstruction (FIRST). Two observers measured plaque attenuation in the lesion with 75% stenosis. The coefficient of determination (R²) was obtained to evaluate interobserver agreement. At HR 70, FIRST improved the correlation between two observers compared with FBP and AIDR3D (FIRST: R²?=?0.68, p?<?0.05; FBP: R²?=?0.29, p?=?0.31; AIDR3D: R²?=?0.22, p?=?0.18). These R² at HR 70 were lower compared with at HR 50 (FIRST: R²?=?0.92, p?<?0.05; FBP: R²?=?0.83, p?<?0.05; AIDR3D: R²?=?0.87, p?<?0.05) and HR 0 (FIRST: R²?=?0.97, p?<?0.05; FBP: R²?=?0.89, p?<?0.05; AIDR3D: R²?=?0.95, p?<?0.05). Higher HR affected plaque measurement repeatability in coronary CTA. FIRST may improve plaque measurement repeatability at the higher HR compared with FBP and AIDR3D.     

Transthoracic echocardiography and mortality in sepsis: analysis of the MIMIC-III database

Purpose

While the use of transthoracic echocardiography (TTE) in the ICU is rapidly expanding, the contribution of TTE to altering patient outcomes among ICU patients with sepsis has not been examined. This study was designed to examine the association of TTE with 28-day mortality specifically in that population.

Methods and results

The MIMIC-III database was employed to identify patients with sepsis who had and had not received TTE. The statistical approaches utilized included multivariate regression, propensity score analysis, doubly robust estimation, the gradient boosted model, and an inverse probability-weighting model to ensure the robustness of our findings. Significant benefit in terms of 28-day mortality was observed among the TTE patients compared to the control (no TTE) group (odds ratio?=?0.78, 95% CI 0.68–0.90, p?<?0.001). The amount of fluid administered (2.5 vs. 2.1 L on day 1, p?<?0.001), use of dobutamine (2% vs. 1%, p?=?0.007), and the maximum dose of norepinephrine (1.4 vs. 1 mg/min, p?=?0.001) were significantly higher for the TTE patients. Importantly, the TTE patients were weaned off vasopressors more quickly than those in the no TTE group (vasopressor-free days on day 28 of 21 vs. 19, p?=?0.004).

Conclusion

In a general population of critically ill patients with sepsis, use of TTE is associated with an improvement in 28-day mortality.

     

Early onset of efficacy with erenumab in patients with episodic and chronic migraine

Background

Subcutaneous erenumab reduced monthly migraine days and increased the likelihood of achieving a?≥?50% reduction at all monthly assessment points tested in 2 pivotal trials in episodic migraine (EM) and chronic migraine (CM). Early efficacy of migraine preventive medications is an important treatment characteristic to patients. Delays in achievement of efficacy can result in failed adherence. The objective of these post-hoc analyses were to evaluate efficacy in the first 4 weeks after initial subcutaneous administration of erenumab 70 mg, erenumab 140 mg, or placebo.

Methods

There is no generally accepted methodology to measure onset of action for migraine preventive medications. We used a comprehensive approach with data from both studies to evaluate change from baseline in weekly migraine days (WMD), achievement of ≥?50% reduction in WMD, and proportion of patients experiencing migraine measured on a daily basis. The 7-day moving averages were overlaid with observed data.

Results

In both studies (EM: N?=?955; CM: N?=?667), there was evidence of onset of efficacy of erenumab vs. placebo during the first week of treatment, which in some cases reached nominal significance. For EM the changes in WMD were (least squares mean [LSM] [95% CI]): placebo, ??0.1 (??0.3, 0.0); erenumab 70 mg, ??0.3 (??0.5, ??0.2) p?=?0.130; erenumab 140 mg, ??0.6 (??0.7, ??0.4) p?<?0.001. For CM the changes were: placebo, ??0.5 (??0.8, ??0.3); erenumab 70 mg, ??0.9 (??1.2, ??0.7) p?=?0.047; erenumab 140 mg, ??0.8 (??1.1, ??0.5) p?=?0.18. Achievement of ≥?50% reduction in WMD was observed as early as Week 1 (adjusted OR [95% CI] erenumab vs placebo) in EM: erenumab 70 mg, 1.3 (1.0, 1.9) p?=?0.097; erenumab 140 mg, 2.0 (1.4, 2.7) p?<?0.001. A similar outcome was observed for CM: erenumab 70 mg, 1.8 (1.1, 2.8) p?=?0.011; erenumab 140 mg, 1.9 (1.2, 2.9) p?=?0.009. Seven-day moving averages of observed data showed each treatment arm differed from placebo by Week 1 (OR [95% CI]): in EM Day 3 for erenumab 140 mg, 0.7 (0.5, 1.0) p?=?0.031 and at Day 7 for 70 mg, 0.6 (0.4, 0.8) p?=?0.002; in CM: Day 6 for erenumab 70 mg, 0.6 (0.4, 0.9) p?=?0.022 and at Day 7 for 140 mg, 0.7 (0.4, 1.0); p?=?0.038.

Conclusion

Erenumab showed early onset of efficacy with separation from placebo within the first week of treatment in both chronic and episodic migraine patients.

     

Clinical Efficacy and Safety of Current Interventions for Choroidal Neovascularization Associated with Rare Diseases: A Systematic Literature Review

Introduction

The aim of this systematic literature review was to evaluate the efficacy and safety of interventions for the treatment of choroidal neovascularization (CNV) secondary to etiologies other than age-related macular degeneration and pathologic myopia.

Methods

Relevant randomized controlled trials (RCTs) and prospective observational studies were identified by searching MEDLINE, MEDLINE In-Process, EMBASE, and CENTRAL.

Results

The search identified 5 RCTs; no relevant observational studies were identified. The studies differed in terms of underlying cause of CNV, patient numbers (n?=?9–178), follow-up time (2–36 months) and quality assessment. In the largest RCT (n?=?178 across a range of rare CNV etiologies), intravitreal ranibizumab showed superior efficacy versus sham from baseline to month 2 [mean best-corrected visual acuity (BCVA): +?9.5 vs. ??0.4 letters; p?<?0.001]; the gain was maintained up to month 12. In the treatment of CNV secondary to presumed ocular histoplasmosis syndrome (POHS), both intravitreal ranibizumab and photodynamic therapy (PDT) showed significant improvement from baseline BCVA over the 12-month period (n?=?9); however, all patients in the PDT group required rescue ranibizumab therapy. Unlicensed intravitreal bevacizumab was associated with a statistically significant improvement in BCVA compared to PDT at 12 months (p?<?0.001) in patients with CNV secondary to multifocal choroiditis (n?=?27). The use of steroids before PDT showed better BCVA outcomes than PDT alone (p?<?0.05) in patients with idiopathic CNV (n?=?20). Argon green laser therapy showed limited efficacy in patients with CNV secondary to OHS (n?=?134).

Conclusion

There is evidence from a relatively large, good-quality study to support the use of intravitreal ranibizumab for the treatment of CNV secondary to rare diseases. However, the limited number of RCTs for this indication and differences in study characteristics between RCTs mean that there is uncertainty regarding comparative clinical effectiveness of interventions. RCTs with an active comparator are required to fully establish the comparative effectiveness of treatments for CNV secondary to rare diseases.

Funding

Novartis Pharmaceuticals UK Ltd, Surrey, UK.

     

[<Superscript>18</Superscript>F]Fluorocholine Uptake of Parathyroid Adenoma Is Correlated with Parathyroid Hormone Level

Purpose

The aim of the study was to investigate the relationship between [¹⁸F]fluoromethyl-dimethyl-2-hydroxyethylammonium ([¹⁸F]FCh) positron emission tomography (PET) parameters, laboratory parameters, and postoperative histopathological results in patients with primary hyperparathyroidism (pHPT) due to parathyroid adenomas.

Procedures

This retrospective study was conducted in 52 patients with biochemically proven pHPT. [¹⁸F]FCh-PET parameters (maximum standardized uptake value: SUV_max) in early phase (after 2 min) and late phase (after 50 min), metabolic volume, and adenoma-to-background ratio (ABR), preoperative laboratory results (PTH and serum calcium concentration), and postoperative histopathology (location, size, volume, and weight of adenoma) were assessed. Relationship of PET parameters, laboratory parameters, and histopathological parameters was assessed using the Mann-Whitney U test and Spearman correlation coefficient. MRI characteristics of parathyroid adenomas were also analyzed.

Results

The majority of patients underwent a PET/MR scan, 42 patients (80.7 %); 10 patients (19.3 %) underwent PET/CT. We found a strong positive correlation between late-phase SUV_max and preoperative PTH level (r?=?0.768, p?<?0.001) and between late-phase ABR and preoperative PTH level (r?=?0.680, p?<?0.001). The surgical specimen volume was positively correlated with the PET/MR lesion volume (r?=?0.659, p?<?0.001). No significant association was observed between other [¹⁸F]FCh-PET parameters, laboratory parameters, and histopathological findings. Cystic adenomas were larger than non-cystic adenomas (p?=?0.048).

Conclusions

[¹⁸F]FCh uptake of parathyroid adenomas is strongly correlated with preoperative PTH serum concentration. Therefore, the preoperative PTH level might potentially be able to predict success of [¹⁸F]FCh-PET imaging in hyperparathyroidism, with higher lesion-to-background ratios being expected in patients with high PTH. PET/MR is accurate in estimating the volume of parathyroid adenomas.

     

Left ventricular synchrony,torsion, and recoil mechanics in Ebstein’s anomaly: insights from cardiovascular magnetic resonance

Background

Disease progression and heart failure development in Ebstein’s Anomaly (EA) of the tricuspid valve is characterized by both right and left ventricular (LV) deterioration. The mechanisms underlying LV dysfunction and their role in heart failure development are incompletely understood. We hypothesized that LV dyssynchrony and impaired torsion and recoil mechanics induced by paradoxical movement of the basal septum may play a role in heart failure development.

Methods

31 EA patients and 31 matched controls underwent prospective cardiovascular magnetic resonance (CMR). CMR feature tracking (CMR-FT) was performed on apical, midventricular and basal short-axis and 4D–volume analysis was performed using three long-axis views and a short axis cine stack employing dedicated software. Circumferential uniformity ratio estimates (CURE) time-to-peak-based circumferential systolic dyssynchrony index (C-SDI), 4D volume analysis derived SDI (4D–SDI), torsion (Tor) and systolic (sysTR) and diastolic torsion rate (diasTR) were calculated for the LV. QRS duration, brain natriuretic peptide, NYHA and Total R/L-Volume Index (R/L Index) were obtained.

Results

EA patients (31.5 years; controls 31.4 years) had significantly longer QRS duration (123.35 ms?±?26.36 vs. 97.33 ms ±?11.89 p <?0.01) and showed more LV dyssynchrony (4D–SDI 7.60%?±?4.58 vs. 2.54%?±?0.62, p <?0.001; CURE 0.77?±?0.05 vs. 0.86?±?0.03, p?<?0.001; C-SDI 7.70?±?3.38 vs. 3.80?±?0.91, p =?0.001). There were significant associations of LV dyssynchrony with heart failure parameters and QRS duration. Although torsion and recoil mechanics did not differ significantly (p >?0.05) there was an association of torsion and recoil mechanics with dyssynchrony parameters CURE (sysTR r =??0.426; p =?0.017, diasTR r =?0.419; p =?0.019), 4D–SDI (sysTR r =?0.383; p =?0.044) and C-SDI (diasTR r =??0.364; p?=?0.044).

Conclusions

EA is characterized by LV intra-ventricular dyssynchrony, which is associated with heart failure and disease severity parameters. Markers of dyssynchrony can easily be quantified from CMR-FT, and may have a role in the assessment of altered cardiac function, carrying potential management implications for EA patients.