Effects of yoga breathing exercises on pulmonary function in patients with Duchenne muscular dystrophy: an exploratory analysis,

OBJECTIVE:

Duchenne muscular dystrophy (DMD) is the most common form of muscular dystrophy in children, and children with DMD die prematurely because of respiratory failure. We sought to determine the efficacy and safety of yoga breathing exercises, as well as the effects of those exercises on respiratory function, in such children.

METHODS:

This was a prospective open-label study of patients with a confirmed diagnosis of DMD, recruited from among those followed at the neurology outpatient clinic of a university hospital in the city of São Paulo, Brazil. Participants were taught how to perform hatha yoga breathing exercises and were instructed to perform the exercises three times a day for 10 months.

RESULTS:

Of the 76 patients who entered the study, 35 dropped out and 15 were unable to perform the breathing exercises, 26 having therefore completed the study (mean age, 9.5 ± 2.3 years; body mass index, 18.2 ± 3.8 kg/m²⁾. The yoga breathing exercises resulted in a significant increase in FVC (% of predicted: 82.3 ± 18.6% at baseline vs. 90.3 ± 22.5% at 10 months later; p = 0.02) and FEV₁ (% of predicted: 83.8 ± 16.6% at baseline vs. 90.1 ± 17.4% at 10 months later; p = 0.04).

CONCLUSIONS:

Yoga breathing exercises can improve pulmonary function in patients with DMD.     

Pocket-Sized Ultrasound as an Aid to Physical Diagnosis for Internal Medicine Residents: A Randomized Trial

BACKGROUND

Proficiency and self-confidence in the physical examination is poor among internal medicine residents and interest in ultrasound technology has expanded.

OBJECTIVE

We aimed to determine whether a pocket-sized ultrasound improves the diagnostic accuracy and confidence of residents after a 3-h training session and 1 month of independent practice.

DESIGN

This was a randomized parallel group controlled trial.

PARTICIPANTS

Forty internal medicine residents in a single program at an academic medical center participated in the study.

INTERVENTION

Three hours of training on use of pocket-sized ultrasound was followed by 1 month of independent practice.

MAIN MEASURES

The primary outcome was a comparison of the diagnostic accuracy of a physical exam alone versus a physical examination augmented with a pocket-sized ultrasound. Other outcomes included confidence in exam findings and a survey of attitudes towards the physical exam and the role of ultrasound.

KEY RESULTS

Residents in the intervention group using a pocket-sized ultrasound correctly identified an average of 7.6 of the 17 abnormal findings (accuracy rate of 44.9 %). Those in the control group correctly identified an average of 6.4 abnormal findings (accuracy rate of 37.6 %, p = 0.11). Residents in the intervention group identified on average 15.9 findings as abnormal when no abnormality existed (false positive rate of 16.8 %). Those in the control group incorrectly identified an average of 15.5 positive findings (false positive rate of 16.3 %). There was no difference between groups regarding self-assessed confidence in physical examination. Residents in the intervention group identified 6.1 of 13 abnormal cardiac findings versus the control group’s 4.5 of 13, an accuracy rate of 47.0 % versus 34.6 % (p = 0.023).

CONCLUSIONS

The diagnostic ability of internal medicine residents did not significantly improve with use of a pocket-sized ultrasound device after a 3-h training session and 1 month of independent practice.Trial Registration: clinicaltrials.gov: number {"type":"clinical-trial","attrs":{"text":"NCT01948076","term_id":"NCT01948076"}}NCT01948076; URL http://clinicaltrials.gov/ct2/show/study/{"type":"clinical-trial","attrs":{"text":"NCT01948076","term_id":"NCT01948076"}}NCT01948076?term=ultrasound+physical+exam&rank=2

Electronic supplementary material

The online version of this article (doi:10.1007/s11606-014-3086-4) contains supplementary material, which is available to authorized users.KEY WORDS: medical education, assessment/evaluation, medical education clinical skills training, clinical skills assessment, educational technology     

Sleep-disordered breathing in patients with cystic fibrosis

Objective:

To test the hypothesis that disease severity in patients with cystic fibrosis (CF) is correlated with an increased risk of sleep apnea.

Methods:

A total of 34 CF patients underwent clinical and functional evaluation, as well as portable polysomnography, spirometry, and determination of IL-1β levels.

Results:

Mean apnea-hypopnea index (AHI), SpO₂ on room air, and Epworth Sleepiness Scale score were 4.8 ± 2.6, 95.9 ± 1.9%, and 7.6 ± 3.8 points, respectively. Of the 34 patients, 19 were well-nourished, 6 were at nutritional risk, and 9 were malnourished. In the multivariate model to predict the AHI, the following variables remained significant: nutritional status (β = −0.386; p = 0.014); SpO₂ (β = −0.453; p = 0.005), and the Epworth Sleepiness Scale score (β = 0.429; p = 0.006). The model explained 51% of the variation in the AHI.

Conclusions:

The major determinants of sleep apnea were nutritional status, SpO₂, and daytime sleepiness. This knowledge not only provides an opportunity to define the clinical risk of having sleep apnea but also creates an avenue for the treatment and prevention of the disease.     

Phase II,randomized, open,controlled study of AS03‐adjuvanted H5N1 pre‐pandemic influenza vaccine in children aged 3 to 9 years: follow‐up of safety and immunogenicity persistence at 24 months post‐vaccination

Background

An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years.

Methods

In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3–9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03_A or AS03_B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. ({"type":"clinical-trial","attrs":{"text":"NCT00502593","term_id":"NCT00502593"}}NCT00502593).

Results

The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4⁺ T cells with a T_H1 profile were observed.

Conclusions

Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination.     

A multicentre,prospective, randomized,controlled trial comparing EVARREST? fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection

Background

This multicentre, randomized clinical trial assessed the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch (FP) in treating parenchymal bleeding following anatomic and non-anatomic liver resections.

Methods

One hundred and two patients were stratified according to the type of hepatic resection (anatomic/non-anatomic), and randomized (1:1) after identification of an appropriate bleeding site, to FP vs Standard of Care (SoC, manual compression ± topical haemostat). The primary endpoint was haemostasis at 4 min from bleeding site identification with no re-bleeding requiring re-treatment.

Results

The FP was superior in achieving haemostasis at 4 min (96%, 48/50) to SoC (46%, 24/52; p < 0.001). Stratification for resection type showed treatment differences for primary endpoint for anatomic (24/25 FP vs 13/23 SoC; p = 0.001) and non-anatomic liver resections (24/25FP vs 11/29 SoC; p < 0.001). Adverse events related to the study procedure were reported in 40/50 patients (80%) in the FP group and 43/52 patients (83%) in the SoC group. One (2%) adverse event (infected intra-abdominal fluid collection) was possibly related to study treatment.

Conclusion

This clinical trial confirms that the FP is safe and highly effective in controlling parenchymal bleeding following hepatectomy regardless of the type of resection.ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01993888","term_id":"NCT01993888"}}NCT01993888.     

A Randomized Controlled Trial of a CPR and Intubation Video Decision Support Tool for Hospitalized Patients

BACKGROUND

Decisions about cardiopulmonary resuscitation (CPR) and intubation are a core part of advance care planning, particularly for seriously ill hospitalized patients. However, these discussions are often avoided.

OBJECTIVES

We aimed to examine the impact of a video decision tool for CPR and intubation on patients’ choices, knowledge, medical orders, and discussions with providers.

DESIGN

This was a prospective randomized trial conducted between 9 March 2011 and 1 June 2013 on the internal medicine services at two hospitals in Boston.

PARTICIPANTS

One hundred and fifty seriously ill hospitalized patients over the age of 60 with an advanced illness and a prognosis of 1 year or less were included. Mean age was 76 and 51 % were women.

INTERVENTION

Three-minute video describing CPR and intubation plus verbal communication of participants’ preferences to their physicians (intervention) (N = 75) or control arm (usual care) (N = 75).

MAIN MEASURES

The primary outcome was participants’ preferences for CPR and intubation (immediately after viewing the video in the intervention arm). Secondary outcomes included: orders to withhold CPR/intubation, documented discussions with providers during hospitalization, and participants’ knowledge of CPR/ intubation (five-item test, range 0–5, higher scores indicate greater knowledge).

RESULTS

Intervention participants (vs. controls) were more likely not to want CPR (64 % vs. 32 %, p <0.0001) and intubation (72 % vs. 43 %, p < 0.0001). Intervention participants (vs. controls) were also more likely to have orders to withhold CPR (57 % vs. 19 %, p < 0.0001) and intubation (64 % vs.19 %, p < 0.0001) by hospital discharge, documented discussions about their preferences (81 % vs. 43 %, p < 0.0001), and higher mean knowledge scores (4.11 vs. 2.45; p < 0.0001).

CONCLUSIONS

Seriously ill patients who viewed a video about CPR and intubation were more likely not to want these treatments, be better informed about their options, have orders to forgo CPR/ intubation, and discuss preferences with providers.Trial registration: Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01325519","term_id":"NCT01325519"}}NCT01325519Registry Name: A prospective randomized trial using video images in advance care planning in seriously ill hospitalized patients.     

Impact of the prolonged slow expiratory maneuver on respiratory mechanics in wheezing infants

OBJECTIVE:

To evaluate changes in respiratory mechanics and tidal volume (V_T) in wheezing infants in spontaneous ventilation after performing the technique known as the prolonged, slow expiratory (PSE) maneuver.

METHODS:

We included infants with a history of recurrent wheezing and who had had no exacerbations in the previous 15 days. For the assessment of the pulmonary function, the infants were sedated and placed in the supine position, and a face mask was used and connected to a pneumotachograph. The variables of tidal breathing (V_T and RR) as well as those of respiratory mechanics-respiratory system compliance (Crs), respiratory system resistance (Rrs), and the respiratory system time constant (prs)-were measured before and after three consecutive PSE maneuvers.

RESULTS:

We evaluated 18 infants. The mean age was 32 ± 11 weeks. After PSE, there was a significant increase in V_T (79.3 ± 15.6 mL vs. 85.7 ± 17.2 mL; p = 0.009) and a significant decrease in RR (40.6 ± 6.9 breaths/min vs. 38.8 ± 0,9 breaths/min; p = 0.042). However, no significant differences were found in the variables of respiratory mechanics (Crs: 11.0 ± 3.1 mL/cmH₂O vs. 11.3 ± 2.7 mL/cmH₂O; Rrs: 29.9 ± 6.2 cmH₂O • mL⁻¹ • s⁻¹ vs. 30.8 ± 7.1 cmH₂O • mL⁻¹ • s⁻¹; and prs: 0.32 ± 0.11 s vs. 0.34 ±0.12 s; p > 0.05 for all).

CONCLUSIONS:

This respiratory therapy technique is able to induce significant changes in V_T and RR in infants with recurrent wheezing, even in the absence of exacerbations. The fact that the variables related to respiratory mechanics remained unchanged indicates that the technique is safe to apply in this group of patients. Studies involving symptomatic infants are needed in order to quantify the functional effects of the technique.     

Low molecular weight heparin once versus twice for thromboprophylaxis following esophagectomy: a randomised,double-blind and placebo-controlled trial

Background

Venous thromboembolism (VTE) remained common complication following surgical resection of esophageal cancer. In this prospective randomized double-blind placebo-controlled trial ({"type":"clinical-trial","attrs":{"text":"NCT01267305","term_id":"NCT01267305"}}NCT01267305), we aim to compare the safety and efficacy between low molecular weight heparin (LMWH) once-daily (QD) and twice-daily (BID) for the prophylaxis of VTE following esophagectomy.

Methods

During August 2012 to July 2013, patients underwent esophagectomy were randomly assigned to nadroparin calcium QD (4,100 AxaIU qd + placebo qd, group QD), or nadroparin calcium BID (4,100 AxaIU q12h, group BID) in the prophylaxis of VTE. All patients received thrombelastography (TEG) before and 0/24/48/72 hours after operation. Daily vascular ultrasound of lower extremities was followed during the first 7 postoperative days to confirm the suspected deep venous thrombosis (DVT). Cumulatively postoperative chest drainage at 72 hours after the surgery was collected to identify the difference in volume and red blood cell (RBC) counts between the two groups. Any bleeding events and thromboembolic events were also documented.

Results

A total of 117 patients were enrolled in this study, and 111 eligible patients were randomly assigned (group QD: 55 patients; group BID: 56 patients). Patients’ clinical features were close between the two groups. TEG analysis [R time, K time, alpha angel and maximum amplitude (MA)] before and instantly after operation showed nearly identical results. However, compared with group QD, all TEG measurements of 24/48/72 hours postoperatively showed significantly prolonged R time and K time, and decreased alpha angel in group BID. In ultrasound follow-ups, a total of four cases of DVT (four cases in group QD and no case in group BID) were found in this cohort (7.27% versus 0%, P=0.046), and one case of pulmonary embolism (PE) (in group QD) was observed. The incidence of VTE was lower in group BID (9.09% versus 0%, P=0.032). At 72 hours after surgery, the cumulative volume of chest drainage were close between these two groups (1,001.39±424.58 versus 1,133.61±513.93 mL, P=0.406). RBC counts in chest drainage were also identical between two groups [(2.56±1.98)×10⁵ versus (2.71±4.67)×10⁵, P=0.61]. No patient died due to VTE or bleeding events.

Conclusions

For the prophylaxis of VTE, BID LMWH provided more potent efficacy and equal safety when compared to QD LMWH in patients undergoing selective esophagectomy. Further study based on larger population is required to confirm these findings.     

Use of Renin-Angiotensin Inhibitors in People with Renal Artery Stenosis

Background and objectives

People with atherosclerotic renal artery stenosis may benefit from renin-angiotensin inhibitors, angiotensin-converting enzyme inhibitors, and angiotensin-receptor blockers, but little is known about the factors associated with their use.

Design, setting, participants, & measurements

The Cardiovascular Outcomes in Renal Atherosclerotic Lesions study (ClinicalTrials.gov identified: {"type":"clinical-trial","attrs":{"text":"NCT00081731","term_id":"NCT00081731"}}NCT00081731) is a prospective, international, multicenter clinical trial that randomly assigned participants with atherosclerotic renal artery stenosis who received optimal medical therapy to stenting versus no stenting from May 2005 through January 2010. At baseline, medication information was available from 853 of 931 randomly assigned participants. Kidney function was measured by serum creatinine–based eGFR at a core laboratory.

Results

Before randomization, renin-angiotensin inhibitors were used in 419 (49%) of the 853 participants. Renin-angiotensin inhibitor use was lower in those with CKD (eGFR<60 ml/min per 1.73 m²) (58% versus 68%; P=0.004) and higher in individuals with diabetes (41% versus 27%; P<0.001). Presence of bilateral renal artery stenosis or congestive heart failure was not associated with renin-angiotensin inhibitor use. Although therapy with renin-angiotensin inhibitors varied by study site, differences in rates of use were not related to the characteristics of the site participants. Participants receiving a renin-angiotensin inhibitor had lower systolic BP (mean±SD, 148±23 versus 152±23 mmHg; P=0.003) and more often had BP at goal (30% versus 22%; P=0.01).

Conclusions

Kidney function and diabetes were associated with renin-angiotensin inhibitor use. However, these or other clinical characteristics did not explain variability among study sites. Patients with renal artery stenosis who received renin-angiotensin inhibitor treatment had lower BP and were more likely to be at treatment goal.     

Acute Effects of Continuous Positive Air way Pressure on Pulse Pressure in Chronic Heart Failure

Background

Patients with heart failure (HF) have left ventricular dysfunction and reduced mean arterial pressure (MAP). Increased adrenergic drive causes vasoconstriction and vessel resistance maintaining MAP, while increasing peripheral vascular resistance and conduit vessel stiffness. Increased pulse pressure (PP) reflects a complex interaction of the heart with the arterial and venous systems. Increased PP is an important risk marker in patients with chronic HF (CHF). Non-invasive ventilation (NIV) has been used for acute decompensated HF, to improve congestion and ventilation through both respiratory and hemodynamic effects. However, none of these studies have reported the effect of NIV on PP.

Objective

The objective of this study was to determine the acute effects of NIV with CPAP on PP in outpatients with CHF.

Methods

Following a double-blind, randomized, cross-over, and placebo-controlled protocol, twenty three patients with CHF (17 males; 60 ± 11 years; BMI 29 ± 5 kg/cm², NYHA class II, III) underwent CPAP via nasal mask for 30 min in a recumbent position. Mask pressure was 6 cmH₂O, whereas placebo was fixed at 0-1 cmH₂O. PP and other non invasive hemodynamics variables were assessed before, during and after placebo and CPAP mode.

Results

CPAP decreased resting heart rate (Pre: 72 ± 9; vs. Post 5 min: 67 ± 10 bpm; p < 0.01) and MAP (CPAP: 87 ± 11; vs. control 96 ± 11 mmHg; p < 0.05 post 5 min). CPAP decreased PP (CPAP: 47 ± 20 pre to 38 ± 19 mmHg post; vs. control: 42 ± 12 mmHg, pre to 41 ± 18 post p < 0.05 post 5 min).

Conclusion

NIV with CPAP decreased pulse pressure in patients with stable CHF. Future clinical trials should investigate whether this effect is associated with improved clinical outcome.     

Oxygen desaturation in healthy subjects undergoing the incremental shuttle walk test

OBJECTIVE:

To determine the probability of oxygen desaturation in healthy individuals undergoing the incremental shuttle walk test (ISWT).

METHODS:

We enrolled 83 healthy subjects: 55 males (including 1 smoker) and 28 females. We determined pre-ISWT FEV₁, FEV₆, HR and SpO₂, as well as post-ISWT HR and SpO₂.

RESULTS:

Mean values overall were as follows: age, 35.05 ± 12.53 years; body mass index, 24.30 ± 3.47 kg/m²; resting HR, 75.12 ± 12.48 bpm; resting SpO₂, 97.96 ± 1.02%; FEV₁, 3.75 ± 0.81 L; FEV₆, 4.45 ± 0.87 L; FEV₁/FEV₆ ratio, 0.83 ± 0.08 (no restriction or obstruction); incremental shuttle walk distance, 958.30 ± 146.32 m; post-ISWT HR, 162.41 ± 18.24 bpm; and post-ISWT SpO₂, 96.27 ± 2.21%. In 11 subjects, post-ISWT SpO₂ was higher than was pre-ISWT SpO₂. In 17 subjects, there was a 4% decrease in SpO₂ after the ISWT. There were no statistically significant differences between the groups with and without post-ISWT oxygen desaturation in terms of age, gender, FEV₁, FEV₆, FEV₁/FEV₆, pre-ISWT SpO₂, incremental shuttle walk distance, HR, or percentage of maximal HR. In the individuals with post-ISWT oxygen desaturation, the body mass index was higher (p = 0.01) and post-ISWT SpO₂ was lower (p = 0.0001).

CONCLUSIONS:

Healthy individuals can present oxygen desaturation after the ISWT. Using the ISWT to predict subtle respiratory abnormalities can be misleading. In healthy subjects, oxygen desaturation is common after the ISWT, as it is during any intense physical activity.     

Heart Rate Recovery in the First Minute at the Six-Minute Walk Test in Patients with Heart Failure

Background

Heart rate recovery at one minute of rest (HRR₁) is a predictor of mortality in heart failure (HF), but its prognosis has not been assessed at six-minute walk test (6MWT) in these patients.

Objective

This study aimed to determine the HRR₁ at 6MWT in patients with HF and its correlation with six-minute walk distance (6MWD).

Methods

Cross-sectional, controlled protocol with 161 individuals, 126 patients with stable systolic HF, allocated into 2 groups (G1 and G2) receiving or not β-blocker and 35 volunteers in control group (G3) had HRR₁ recorded at the 6MWT.

Results

HRR₁ and 6MWD were significantly different in the 3 groups. Mean values of HRR₁ and 6MWD were: HRR₁ = 12 ± 14 beat/min G1; 18 ± 16 beat/min G2 and 21 ± 13 beat/min G3; 6MWD = 423 ± 102 m G1; 396 ± 101m G2 and 484 ± 96 m G3 (p < 0.05). Results showed a correlation between HRR₁ and 6MWD in G1(r = 0.3; p = 0.04) and in G3(r = 0.4; p= 0.03), but not in G2 (r= 0.12; p= 0.48).

Conclusion

HRR₁ response was attenuated in patients using βB and showed correlation with 6MWD, reflecting better exercise tolerance. HRR₁ after 6MWT seems to represent an alternative when treadmill tests could not be tolerated.     

Evaluation of von Willebrand factor in COPD patients

OBJECTIVE:

To compare the absolute serum von Willebrand factor (vWF) levels and relative serum vWF activity in patients with clinically stable COPD, smokers without airway obstruction, and healthy never-smokers.

METHODS:

The study included 57 subjects, in three groups: COPD (n = 36); smoker (n = 12); and control (n = 9). During the selection phase, all participants underwent chest X-rays, spirometry, and blood testing. Absolute serum vWF levels and relative serum vWF activity were obtained by turbidimetry and ELISA, respectively. The modified Medical Research Council scale (cut-off score = 2) was used in order to classify COPD patients as symptomatic or mildly symptomatic/asymptomatic.

RESULTS:

Absolute vWF levels were significantly lower in the control group than in the smoker and COPD groups: 989 ± 436 pg/mL vs. 2,220 ± 746 pg/mL (p < 0.001) and 1,865 ± 592 pg/mL (p < 0.01). Relative serum vWF activity was significantly higher in the COPD group than in the smoker group (136.7 ± 46.0% vs. 92.8 ± 34.0%; p < 0.05), as well as being significantly higher in the symptomatic COPD subgroup than in the mildly symptomatic/asymptomatic COPD subgroup (154 ± 48% vs. 119 ± 8%; p < 0.05). In all three groups, there was a negative correlation between FEV₁ (% of predicted) and relative serum vWF activity (r² = −0.13; p = 0.009).

CONCLUSIONS:

Our results suggest that increases in vWF levels and activity contribute to the persistence of systemic inflammation, as well as increasing cardiovascular risk, in COPD patients.     

Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans

Objective

We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling.

Research Design and Methods

In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM.

Results

The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: −0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: −0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p’s ≤ 0.05) but not at 6 months (p’s > 0.20).

Conclusions

Providing patients with genetic test results was not more effective in changing patient behavior to reduce the risk of DM compared to conventional risk counseling.Trial registration: ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01060540","term_id":"NCT01060540"}}NCT01060540 http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01060540","term_id":"NCT01060540"}}NCT01060540

Electronic supplementary material

The online version of this article (doi:10.1007/s11606-015-3315-5) contains supplementary material, which is available to authorized users.KEY WORDS: Diabetes mellitus, Genetic counseling, Risk factors     

Bronchodilator response in adults with bronchiectasis: correlation with clinical parameters and prognostic implications

Background

Bronchial dilation testing is an important tool to assess airway reversibility in adults with bronchiectasis. This study aims to investigate the association of bronchodilator response (BDR) and clinical parameters in bronchiectasis, and the utility of BDR to indicate lung function decline and risks of bronchiectasis exacerbations (BEs).

Methods

We recruited 129 patients with clinically stable bronchiectasis. Baseline measurements included assessment of sputum inflammation and matrix metalloproteinase-8 and -9, sputum bacterial culture, spirometry, bronchial dilation test (for baseline FEV₁ less than 80% predicted only) and chest high-resolution computed tomography (HRCT). Bronchiectasis patients were followed-up for 1 year to determine the incidence of BEs and lung function trajectories. Significant BDR was defined as FEV₁ improvement from pre-dose value by at least 200 mL and 12%. Clinical trial registry No.: {"type":"clinical-trial","attrs":{"text":"NCT01761214","term_id":"NCT01761214"}}NCT01761214; URL: www.clinicaltrials.gov.

Results

BDR was negatively correlated with baseline FEV₁ percentage predicted, but not blood or sputum eosinophil count. Significant BDR was not associated with greater proportion of never-smokers, poorer past history, greater HRCT scores, poorer diffusing capacity or increased sputum matrix metalloproteinases (all P>0.05). There was a trend towards higher bronchiectasis severity index (BSI) and greater proportion of patients with Pseudomonas aeruginosa isolation or infection. Significant BDR at baseline was linked to poorer spirometry, but not more rapid lung function decline, throughout follow-up. Patients with significant BDR demonstrated non-significantly lower risks of experiencing the first BEs than those without (P=0.09 for log-rank test).

Conclusions

Significant BDR is associated with poorer lung function compared with non-significant BDR. Whether BDR predicts future risks of BEs needs to be tested in a larger cohort.     

Evaluation of a Methodology for Estimating HbA1c Value by a New Glucose Meter

Background:

Accuracy/robustness of HbA1c estimation (eA1c) with an algorithm built into the MyStar Extra blood glucose (BG) meter has been demonstrated by in silico testing. We evaluated the performance and use of eA1c in a clinical setting.

Methods:

Subjects took the BG meter home for 4 months to obtain eA1c in this open-label, single-center study. Laboratory HbA1c values were obtained approximately every 2 weeks and the corresponding eA1c documented. Subjects completed a questionnaire at study end ({"type":"clinical-trial","attrs":{"text":"NCT01885546","term_id":"NCT01885546"}}NCT01885546).

Results:

There were 133 enrolled subjects (mean [SD] age 60.0 [15.0] years, 69 males, 104 with diabetes, HbA1c 7.0% [1.4]). A total of 1008 pairs of eA1c and laboratory HbA1c values were available. In subjects with diabetes, 97.5% of the eA1c results fell within ±20% of the laboratory HbA1c, 95.0% within ±18%, and 90.7% within ±15%. When results were limited to the reportable HbA1c range of ≥6 to ≤10%, 99.3% of eA1c values fell within ±20% of the laboratory HbA1c, 98.5% within ±18%, and 96.2% within ±15% Most subjects agreed/strongly agreed that the eA1c section in the user guide and flash cards was easy to follow (72%), they would use the system to track their eA1c (70%), they found the eA1c tool helpful (79%), and the tool may motivate them to manage their diabetes better (83%).

Conclusions:

Accuracy of the eA1c feature in this clinical setting was similar to the performance in silico. The majority of subjects found this tool helpful and agreed it may motivate to manage their diabetes better.     

Subclinical Ventricular Dysfunction Detected by Speckle Tracking Two Years after Use of Anthracycline

Background

Heart failure is a severe complication associated with doxorubicin (DOX) use. Strain, assessed by two-dimensional speckle tracking (2D-STE), has been shown to be useful in identifying subclinical ventricular dysfunction.

Objectives

a) To investigate the role of strain in the identification of subclinical ventricular dysfunction in patients who used DOX; b) to investigate determinants of strain response in these patients.

Methods

Cross-sectional study with 81 participants: 40 patients who used DOX ±2 years before the study and 41 controls. All participants had left ventricular ejection fraction (LVEF) ≥55%. Total dose of DOX was 396mg (242mg/ms²). The systolic function of the LV was evaluated by LVEF (Simpson), as well as by longitudinal (ε_LL), circumferential (ε_CC), and radial (ε_RR) strains. Multivariate linear regression (MLR) analysis was performed using ε_LL (model 1) and ε_CC (model 2) as dependent variables.

Results

Systolic and diastolic blood pressure values were higher in the control group (p < 0.05). ε_LL was lower in the DOX group (-12.4 ±2.6%) versus controls (-13.4 ± 1.7%; p = 0.044). The same occurred with ε_CC: -12.1 ± 2.7% (DOX) versus -16.7 ± 3.6% (controls; p < 0.001). The S’ wave was shorter in the DOX group (p = 0.035). On MLR, DOX was an independent predictor of reduced ε_CC (B = -4.429, p < 0.001). DOX (B = -1.289, p = 0.012) and age (B = -0.057, p = 0.029) were independent markers of reduced ε_LL.

Conclusion

a) ε_LL, ε_CC and the S’ wave are reduced in patients who used DOX ±2 years prior to the study despite normal LVEF, suggesting the presence of subclinical ventricular dysfunction; b) DOX was an independent predictor of reduced ε_CC; c) prior use of DOX and age were independent markers of reduced ε_LL.     

Sex-Specific Equations to Estimate Maximum Oxygen Uptake in Cycle Ergometry

Background

Aerobic fitness, assessed by measuring VO₂max in maximum cardiopulmonary exercise testing (CPX) or by estimating VO₂max through the use of equations in exercise testing, is a predictor of mortality. However, the error resulting from this estimate in a given individual can be high, affecting clinical decisions.

Objective

To determine the error of estimate of VO₂max in cycle ergometry in a population attending clinical exercise testing laboratories, and to propose sex-specific equations to minimize that error.

Methods

This study assessed 1715 adults (18 to 91 years, 68% men) undertaking maximum CPX in a lower limbs cycle ergometer (LLCE) with ramp protocol. The percentage error (E%) between measured VO₂max and that estimated from the modified ACSM equation (Lang et al. MSSE, 1992) was calculated. Then, estimation equations were developed: 1) for all the population tested (C-GENERAL); and 2) separately by sex (C-MEN and C-WOMEN).

Results

Measured VO₂max was higher in men than in WOMEN: -29.4 ± 10.5 and 24.2 ± 9.2 mL.(kg.min)^-1 (p < 0.01). The equations for estimating VO₂max [in mL.(kg.min)^-1] were: C-GENERAL = [final workload (W)/body weight (kg)] x 10.483 + 7; C-MEN = [final workload (W)/body weight (kg)] x 10.791 + 7; and C-WOMEN = [final workload (W)/body weight (kg)] x 9.820 + 7. The E% for MEN was: -3.4 ± 13.4% (modified ACSM); 1.2 ± 13.2% (C-GENERAL); and -0.9 ± 13.4% (C-MEN) (p < 0.01). For WOMEN: -14.7 ± 17.4% (modified ACSM); -6.3 ± 16.5% (C-GENERAL); and -1.7 ± 16.2% (C-WOMEN) (p < 0.01).

Conclusion

The error of estimate of VO₂max by use of sex-specific equations was reduced, but not eliminated, in exercise tests on LLCE.     

Safety and immunogenicity of two doses of quadrivalent meningococcal conjugate vaccine or one dose of meningococcal group C conjugate vaccine,both administered concomitantly with routine immunization to 12- to 18-month-old children

OBJECTIVES:

To describe the immunogenicity and safety of a two-dose series of a quadrivalent meningococcal (serogroups A, C, Y and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) administered to toddlers.

METHODS:

Children were randomly assigned (1:1) at study entry to receive MenACYW-D at 12 and 18 months of age (group 1; n=61) or meningococcal serogroup C conjugate vaccine (MCC) at 12 months of age (group 2; n=62). All received routine childhood immunizations. A, C, Y and W antibody titres were measured in group 1 before and one month after the 18-month MenACYW-D vaccination and were measured in group 2 at one and seven months post-MCC vaccination. Antibodies elicited by diphtheria and tetanus toxoids, and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine and Haemophilus influenzae b conjugate (DTaP-IPV-Hib) vaccine coadministered at the 18-month vaccination were measured one month later. Safety data were collected.

RESULTS:

At 19 months of age, ≥96% in group 1 achieved protective titres for the four meningococcal serogroups after dose 2; 67% in group 2 exhibited protective titres against serogroup C 28 days after MCC vaccination at 12 months of age, declining to 27% seven months later. DTaP-IPV-Hib elicited high antibody concentrations/titres in groups 1 and 2, consistent with historical values. The safety profiles after each dose generated no unexpected safety signals; no serious adverse events were related to vaccination.

DISCUSSION:

A two-dose series of MenACYW-D given concomitantly with a DTaP-IPV-Hib booster dose at 18 months of age demonstrated a good immunogenicity and safety profile. A two-dose series of MenACYW-D can be used as an alternative to one dose of MCC and provides protection against additional serogroups (NCT ID: {"type":"clinical-trial","attrs":{"text":"NCT01359449","term_id":"NCT01359449"}}NCT01359449).