Introduction
Observational studies are valuable for investigating correlations between patient-reported treatment outcomes. In this study, we report a secondary analysis of a published pharmacy-based ...observational (patient-centered “real-world” outcomes) study on experiences reported by patients who treated their headache with an over-the-counter analgesic.
Methods
A pharmacy-based exploratory survey was conducted in German community pharmacies. Patients buying a fixed-dose analgesic combination product (400 mg ibuprofen + 100 mg caffeine; IbuCaff) to treat their headache were offered a questionnaire that contained—among others—questions about time to onset of pain relief (OPR), assessment of time to onset of pain relief (AOPR), assessment of efficacy and tolerability, and pain intensity 2 h after intake. A correlation analysis of the data was performed. Moreover, perceived treatment effects compared to other acute headache medications used in the past were collected.
Results
The correlation between OPR and AOPR was high (Spearman rank correlation r = 0.594,
p
< 0.0001). Headache patients assessed the onset of analgesic action within 15 min as “very fast” and within 30 min as “fast”. The other readouts were correlated as well assessment of efficacy and % pain intensity difference (%PID) at 2 h: r = 0.487; OPR/AOPR and %PID at 2 h: r = 0.295/0.318; OPR/AOPR and assessment of tolerability: r = 0.206/0.397; OPR/AOPR and assessment of efficacy: r = 0.406/0.594; assessment of efficacy and assessment of tolerability: r = 0.608;
p
< 0.0001 for all correlations. Compared to previous treatments, most patients (>89%) assessed the speed of analgesic action, efficacy, and tolerability of IbuCaff as equal to or better than for the previous treatment.
Discussion
Headache patients assessed the onset of analgesia within 15 min as “very fast” and within 30 min as “fast”. Efficacy assessments for acute headache medication appear to be highly correlated.
PURPOSEThis study aimed to evaluate a multicomponent, child-appropriate preschool intervention program led by preschool teachers to enhance physical activity (PA) and motor skill performance (MS) in ...4- and 5-yr-old children.
METHODSEvaluation involved 709 children (mean age, 4.7 ± 0.6 yr; 49.5% girls) from 41 preschools (intervention group, n = 21; control group, n = 20) in the rural and urban surroundings of two German cities. Children in the intervention group received a daily PA intervention lasting 30 min and PA homework over one academic year, which was designed by professionals but led by preschool teachers. The intervention included educational components for parents and teachers. Primary outcomes were MS (composite MS score) and objectively measured moderate-to-vigorous PA (MVPA) by accelerometry. Measurements were performed at baseline, midintervention, and postintervention as well as 2–4 months after the end of intervention. Intervention effects were analyzed by repeated measurement analysis adjusted for group, sex, age, baseline outcomes, urban/rural location of the preschool, and cluster (preschool).
RESULTSCompared with controls, children in the intervention group showed positive effects in MS at postintervention (estimate effect, 0.625 z-score points; 95% confidence interval (CI), 0.276–0.975; P = 0.001) and at follow-up (estimate effect, 0.590 z-score points; 95% CI, 0.109–1.011; P = 0.007) and an increase in MVPA from baseline to postintervention by 0.5% of total wearing time (95% CI, 0.002%–1.01%; P = 0.049) at borderline significance. There was no benefit on MVPA for the intervention group between baseline and follow-up.
CONCLUSIONSA child-appropriate, multidimensional PA intervention could sustainably improve MS but not PA. Findings suggest that a change in health-related behaviors is difficult. Future research should implement participatory intervention components in preschool setting and better integrate the families of the children.
A method for group sequential trials that is based on the inverse normal method for combining the results of the separate stages is proposed. Without exaggerating the Type I error rate, this method ...enables data‐driven sample size reassessments during the course of the study. It uses the stopping boundaries of the classical group sequential tests. Furthermore, exact test procedures may be derived for a wide range of applications. The procedure is compared with the classical designs in terms of power and expected sample size.
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BFBNIB, FZAB, GIS, IJS, INZLJ, KILJ, NLZOH, NMLJ, NUK, OILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK, ZRSKP
Fever is a very common adaptive immune response in acute respiratory tract disorders during infancy. Antipyretic / analgesic drugs such as paracetamol (acetaminophen) are widely used to improve the ...comfort of the child but may cause medically unneeded antipyresis and rare but potentially serious side effects. We assess whether treatment with Pelargonium sidoides extract EPs 7630 reduces the administration of paracetamol in children with acute tonsillopharyngitis (ATP) or acute bronchitis (AB).
Meta-analysis of randomised, placebo-controlled clinical trials.
We searched clinical trial registries (ISRCTN, ClinicalTrials.gov ) and medical literature (MEDLINE, EMBASE), for randomised, placebo-controlled trials investigating the administration of EPs 7630 to children with ATP or AB and reporting the co-administration of paracetamol. Based on the individual participant data of the eligible trials, study populations were characterized according to sex and age, and meta-analyses were performed for cumulative paracetamol use and ability to attend school at treatment end.
Six trials including a total of 523 children aged 6-10 years (EPs 7630: 265; placebo: 258) and suffering from non-β-hemolytic streptococcal ATP (3 trials) or from AB (3 trials) were identified and eligible. Children received EPs 7630 or placebo for 6 (ATP) or 7 days (AB). Compared to placebo, EPs 7630 reduced the cumulative dose of paracetamol in 5 out of the 6 trials, by an average of 244 mg (Hedges' g; - 0.28; 95% confidence interval: - 0.53; - 0.02; p < 0.03). At treatment end, 30.2% (EPs 7630) and 74.4% (placebo) of the children were still unable to attend school (risk ratio: 0.43; 95% confidence interval: 0.29; 0.65; p < 0.001).
In children aged 6-10 years with AB or ATP, EPs 7630 alleviated the symptom burden and accelerated recovery. Although EPs 7630 has no known antipyretic effect, concomitant use of paracetamol was reduced.
Cognitive behavioral therapy for psychosis (CBT) is an effective treatment in adult patients with schizophrenia. However, no randomized controlled and blinded trial in adolescents with early-onset ...psychosis (EOP) has been conducted. Therefore, the present pilot study explores the acceptance, tolerability, feasibility, and safety of a modified CBT in adolescents with EOP. Twenty-five adolescents with EOP were randomized to either 9 months (20 sessions) of CBT + treatment as usual (TAU) or TAU alone. The primary endpoint was the PANSS-positive subscale (P1-7). Secondary endpoints included psychopathology, global functioning, and quality of life (QoL). Acceptance, tolerability, feasibility, and safety were assessed. Blinded assessments took place by the end of the treatment (9 months) and at 24-month follow-up. Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least
d
= 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least
d
= 0.35 after 24 months. CBT in EOP was highly acceptable (73.5% agreed to randomization), well-tolerated (83.1% attendance rate, no drop-outs), and safe (one serious adverse event (SAE) in CBT + TAU in comparison with six SAEs in TAU). These findings suggest that CBT adapted to the needs of adolescents with EOP is a promising approach regarding negative symptoms, functioning, and QoL. CBT is a safe and tolerable treatment. However, due to the small sample size and the pilot character of the study, these conclusions are limited, and should be tested in a larger, adequately powered randomized controlled trial.
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DOBA, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, IZUM, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, ODKLJ, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, SIK, UILJ, UKNU, UL, UM, UPUK, VKSCE, VSZLJ, ZAGLJ
This study evaluated 2-dimensional (2D) transthoracic echocardiography (TTE) using Valve Academic Research Consortium–2 (VARC-2) criteria and 3-dimensional (3D) TTE for assessment of aortic ...regurgitation (AR) after transcatheter aortic valve implantation (TAVI) in comparison with cardiac magnetic resonance (CMR) imaging. In 71 patients, 2D TTE, 3D TTE, and CMR imaging were performed to assess AR severity after TAVI. Using 2D TTE, AR severity was graded according to VARC-2 criteria and regurgitant volume (RVol) was determined. Three-dimensional color Doppler TTE allowed direct planimetry of the vena contracta area of the paravalvular regurgitation jet and calculation of the RVol as product with the velocity-time integral. RVol by CMR imaging was measured by phase-contrast velocity mapping in the ascending aorta. After TAVI, mean RVol determined by CMR imaging was 9.2 ± 9.6 ml/beat and mean regurgitant fraction was 13.3 ± 10.3%. AR was assessed as none or mild in 58 patients (82%) by CMR imaging. Correlation of 3D TTE and CMR imaging on RVol was better than correlation of 2D TTE and CMR imaging (r = 0.895 vs 0.558, p <0.001). There was good agreement between RVol by CMR imaging and by 3D TTE (mean bias = 2.4 ml/beat). Kappa on grading of AR severity was 0.357 between VARC-2 and CMR imaging versus 0.446 between 3D TTE and CMR imaging. Intraobserver variability for analysis of RVol of AR after TAVI was 73.5 ± 52.2% by 2D TTE, 16.7 ± 21.9% by 3D TTE, and 2.2 ± 2.0% by CMR imaging. In conclusion, 2D TTE considering VARC-2 criteria has limitations in the grading of AR severity after TAVI when CMR imaging is used for comparison. Three-dimensional TTE allows quantification of AR with greater accuracy than 2D TTE. Observer variability on RVol after TAVI is considerable using 2D TTE, significantly less using 3D TTE, and very low using CMR imaging.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objectives This study sought to evaluate the impact of new conduction defects after transcatheter aortic valve implantation (TAVI) on the evolution of left ventricular (LV) function during 1-year ...follow-up. Background New left bundle branch block (LBBB) or need for permanent pacing due to atrioventricular (AV) block are frequent after TAVI. Methods A total of 90 consecutive patients treated with TAVI and who had 12-month echocardiographic follow-up were included in the study. In 39 patients, a new conduction defect (new LBBB or need for permanent pacemaker activity.) persisted 1 month after TAVI. In 51 patients, no persistent new conduction defect was observed. Two-dimensional echocardiography using parasternal short-axis, apical 4-chamber, and apical 2-chamber views was performed before TAVI and at 1-year follow-up to determine LV volumes and ejection fraction based on Simpson's rule. Speckle-tracking echocardiography was applied using standard LV short-axis images to assess the effect of new conduction defects on time-to-peak radial strain of different LV segments as a parameter of LV dyssynchrony. Results New conduction defects resulted in marked heterogeneity in time-to-peak strain between the 6 analyzed short-axis segments. During 1-year follow-up after TAVI, there was a significant increase in left ventricular ejection fraction (LVEF) in patients without new LBBB (53 ± 11% pre TAVI to 59 ± 10% at follow-up; p < 0.001), whereas there was no change in LVEF in patients with a new conduction defect (52 ± 11% pre TAVI to 51 ± 12% at follow-up, p = 0.740). Change in LV end-systolic volume was also significantly different between patient groups (−1.0 ± 14.2 vs. −11.2 ± 15.7 ml, p = 0.042). New conduction defect and LVEF at baseline were independent predictors of reduced LVEF at 12-month follow-up after TAVI. Conclusions LVEF improves after TAVI for treatment of severe aortic stenosis in patients without new conduction defects. In patients with a new conduction defect after TAVI, there is no improvement in LVEF at follow-up.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Analysis of procedural effects in patients undergoing percutaneous mitral valve repair (PMVR) using the edge-to-edge technique is complex, and common methods to define mitral regurgitation severity ...based on 2-dimensional (2D) echocardiography are not validated for postprocedural double-orifice mitral valve. This study used 3D transesophageal echocardiography (TEE) to determine the functional and morphological effects of PMVR.
In 39 high-risk surgical patients with moderate to severe functional mitral valve regurgitation, 3D TEE with and without color Doppler as well as 2D transthoracic and TEE was performed before and after PMVR (MitraClip device). Mitral valve regurgitant volume by color Doppler 3D TEE was determined as the product of vena contracta areas defined by direct planimetry and velocity time integral using continuous-wave Doppler. Regurgitant volume was reduced from 84.1±38.3 mL preintervention to 35.6±25.6 mL postintervention. Patients in whom vena contracta area could be reduced >50% had a smaller preprocedural mitral annulus area compared with patients with ≤50% reduction (11.9±3.9 versus 16.1±8.5 cm(2), respectively; P=0.036) and tended to have a smaller mitral annulus circumference (13.0±2.0 versus 14.8±4.1 cm, respectively; P=0.112). At 6 months follow-up, left atrial and left ventricular end-diastolic volumes were significantly more reduced in patients in whom regurgitant vena contracta area was reduced by >50% compared with those with less reduction (-11.4±5.2 versus -4.8±7.7%; P=0.005, and -11.0±7.2 versus -4.5±9.3%; P=0.028). The maximum diastolic mitral valve area decreased from 6.0±2.0 to 2.9±0.9 cm(2) (P<0.0001).
Three dimensional TEE demonstrates significant reduction of regurgitant volume after PMVR. The unique visualization of the mitral valve by 3D TEE allows improved understanding of the morphological and functional changes induced by PMVR.
The efficacy of Pelargonium sidoides preparation EPs 7630 in the common cold (CC) was assessed by performing meta-analyses of randomized, double-blind, placebo-controlled trials. Mean differences ...(MD) and risk ratios (RR) with their 95% confidence intervals (CI) were computed. Five trials with a total of 833 patients were included. All trials had a treatment period of ten days with visits at days 3, 5, and 10 after baseline and used a ten-symptom Cold Intensity Score (CIS) as the primary outcome. Significant differences favoring EPs 7630 were observed for total CIS reduction (day 5: MD = -2·30; 95%CI = -4·12,-0·49; day 10: MD = -1·16; 95%CI = -2·22,-0·10), proportion of patients with substantial improvement (day 5: RR = 1·73; day 10: RR = 1·06) and complete remission (day 5: RR = 2·52; day 10: RR = 2·13). Subjects treated with EPs 7630 missed fewer days at work, used less paracetamol and had an improved sleep quality. No serious adverse reactions to EPs 7630 were reported. The results support the efficacy of EPs 7630 in adults with CC.
Respiratory system; Infectious disease; Pharmacology; Evidence-based medicine; Clinical research; Common cold, Efficacy, EPs 7630, Meta-analysis, Pelargonium sidoides, Safety
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Quantitative analysis of segmental myocardial deformation of different myocardial layers has become possible using strain-encoded cardiac magnetic resonance imaging (SENC) and speckle-tracking ...echocardiography (STE). We evaluated and compared the quantitative analysis of myocardial deformation using SENC and STE.
In 44 patients (age 61 ± 13 years, 34 men), SENC by cardiac magnetic resonance imaging using a 1.5-Tesla whole-body scanner and two-dimensional STE were performed prospectively. Quantitative layer-specific analysis of segmental left ventricular function was performed to determine the peak circumferential and peak longitudinal systolic strain values using SENC and STE of an endocardial and epicardial myocardial layer. In addition, segmental function was defined as normokinetic, hypokinetic, or akinetic by visual analysis of the magnetic resonance imaging cine sequences.
The endocardial and epicardial strain defined by SENC or STE differed significantly between the visually defined segmental function states. The correlation of the peak circumferential endocardial strain by SENC versus STE (intraclass correlation coefficient ICC 0.493, 95% CI 0.358-0.597) tended to be better than the correlation of the circumferential epicardial strain using both methods (ICC 0.321, 95% CI 0.238-0.399). The correlation of the peak longitudinal endocardial strain by SENC and STE was similar (ICC 0.472, 95% CI 0.398-0.541), in contrast to the longitudinal epicardial strain analysis by both techniques (ICC 0.554, 95% CI 0.417-0.655). Circumferential strain analysis by STE allowed better distinction of the hypokinetic or akinetic segments from the normokinetic segments than did the circumferential strain analysis by SENC of the endocardial layer (area under the receiver operating characteristic curve AUC ROC 0.946 vs 0.884; P < .001) or epicardial layer (AUC ROC 0.884 vs 0.782; P < .001). Longitudinal strain analysis using STE and SENC of the endocardial layer (AUC ROC 0.851 vs 0.839; P = .5838) and epicardial layer (AUC ROC 0.849 vs 0.833; P = .4321) had similar diagnostic value for identifying the presence of hypokinetic and akinetic segments.
Quantitative analysis of segmental deformation by SENC and STE allowed accurate distinction of myocardial segments with different functional states. Circumferential endocardial strain analysis by STE allowed the best distinction of segments with impaired function from the normokinetic segments.
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