Effects of family-centred care interventions on preterm infants and parents in neonatal intensive care units: A systematic review and meta-analysis of randomised controlled trials

Objective

The objective of this study was to review English and Chinese randomised controlled trials (RCTs) to determine the effects of family-centred care (FCC) interventions on preterm infants’ and parental outcomes in the neonatal intensive care units and to conduct a meta-analysis.

Radial variation of anatomical features,physicomechanical properties and chemical constituents and their potential influence on the wood quality of 45-year-old Eucalyptus propinqua

The potential commercial use of Brazilian-grown Eucalyptus propinqua for furniture and other applications has been largely ignored in favour of native woods. In part, this results from unfamiliarity with the properties of this species, especially in mature trees. To address this gap in our knowledge, we have characterised the wood anatomy, physical and mechanical properties, and chemical constituents in the radial direction of five E. propinqua trees sampled at breast height. The anatomical features follow the typical radial pattern, which includes differences in juvenile wood when compared with mature wood. Basic density peaked in samples formed 17–30 years from the pith before decreasing at ages 38–45 years (a decline reflecting the low extractive content of the sapwood). We did not observe a pattern of radial variation in mechanical properties. Extractive content increased up to 25–30 years of age and then decreased significantly at 38–45 years with values similar to those of the wood from the sample close to the pith, while the holocellulose content presented inverse behaviour. The lignin content did not change radially. We concluded that many features of E. propinqua wood vary radially, as with many other species of the Eucalyptus genus. This variation, however, was not evident in important mechanical properties and was muted in others. The quality of the wood makes it suitable for many applications, especially after some 17 years of age when ‘mature’ wood, indicated by a declining (and non-significant) rate of increase in fibre and vessel length, is first produced.     

Overweightness,obesity and arterial stiffness in healthy subjects: a systematic review and meta-analysis of literature studies

Objective: The relationship between overweightness, obesity and arterial stiffness remains unclear. We performed a meta-analysis evaluating the impact of obesity/overweightness on arterial stiffness in healthy subjects.

Methods: Literature searches were conducted using databases (eg, MEDLINE, EMBASE) and citations cross-referenced. Studies evaluating the relationship between obesity/overweightness and cfPWV, baPWV, and AIx were systematically searched. A total of 10 studies (1,124 obese/overweight subjects, 1,884 controls) were included.

Results: Compared to controls, obese/overweight subjects showed a significantly higher cfPWV (SMD 0.50 m/s; 95%CI 0.15, 0.86; P = 0.005), baPWV (SMD 0.41 m/s; 95% CI 0.08, 0.74; P = 0.014), and AIx (SMD 1.02;95%CI 0.16, 1.87; P < 0.0001). When analyzing ‘high quality’ studies, the difference in arterial stiffness among obese/overweight subjects and controls remain (SMD 0.73 m/s; 95%CI 0.16, 1.30; P = 0.013).

Conclusion: Arterial stiffness, a recognized marker of cardio vascular risk, is increased in obese/overweight subjects without overt cardiovascular diseases.     

The role of granulocyte macrophage colony stimulating factor in hospitalized children with Mycoplasma pneumoniae pneumonia

Background

Inappropriate inflammatory response in children with M. pneumoniae infection might be associated with disease severity. The role of Granulocyte macrophage colony stimulating factor (GM-CSF) in hospitalized children with Mycoplasma pneumoniae pneumonia (MPP) has not been fully discussed.

Association between sedentary behavior and normal-range lactate dehydrogenase activity

Objectives: Recent research demonstrates that lactate dehydrogenase (LDH) activity within the normal range may serve as a mediator in the (positive) relationship between physical activity and cardiovascular disease risk. Emerging work supports deleterious associations between sedentary behavior and health, independent of physical activity. Thus, this study evaluated if sedentary behavior was associated with normal-range LDH activity, independent of physical activity.

Methods: Data from the 2003–2006 NHANES were used (N = 2,087 adults; 40–79 yrs). LDH activity levels were estimated from a blood sample using LX20 and LDH reagent; participants were included if they had LDH activity levels within the normal range (105–333 IU/L). Physical activity and sedentary behavior were assessed via accelerometry.

Results: Sedentary behavior was inversely associated with normal-range LDH activity when physical activity was excluded from the model (OR = 0.89; 95% CI: 0.83–0.97, P = 0.009 for LDH activity quartile 4 vs. 1). However, sedentary behavior was no longer associated with normal-range LDH activity after controlling for physical activity and other covariates (OR = 1.00, P = 0.49 for LDH activity quartile 2 vs. 1; OR = 1.00, P = 0.72 for LDH quartile 3 vs. 1; and OR = 0.99, P = 0.36 for LDH quartile 4 vs. 1).

Conclusion: Unlike physical activity, sedentary behavior is not independently associated with normal-range LDH activity.     

Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia

Objectives: Few studies of oral glucose-lowering drugs exist in newly diagnosed type 2 diabetes (T2D) patients with marked hyperglycemia, and insulin is often proposed as initial treatment. We evaluated the oral initial combination of metformin and linagliptin, a dipeptidyl peptidase-4 inhibitor, in this population.

Methods: We performed a pre-specified subgroup analysis of a randomized study in which newly diagnosed T2D patients with glycated hemoglobin A1c (HbA1c) 8.5%–12.0% received linagliptin/metformin or linagliptin monotherapy. Subgroups of baseline HbA1c, age, body-mass index (BMI), renal function, race, and ethnicity were evaluated, with efficacy measured by HbA1c change from baseline after 24 weeks.

Results: HbA1c reductions from baseline (mean 9.7%) at week 24 in the overall population were an adjusted mean ?2.81% ± 0.12% with linagliptin/metformin (n = 132) and ?2.02% ± 0.13% with linagliptin (n = 113); treatment difference ?0.79% (95% CI ?1.13 to ?0.46, P < 0.0001). In patients with baseline HbA1c ≥9.5%, HbA1c reduction was ?3.37% with linagliptin/metformin (n = 76) and ?2.53% with linagliptin (n = 61); difference ?0.84% (95% CI ?1.32 to ?0.35). In those with baseline HbA1c <9.5%, HbA1c reduction was ?2.08% with linagliptin/metformin (n = 56) and ?1.39% with linagliptin (n = 52); difference ?0.69% (95% CI ?1.23 to ?0.15). Changes in HbA1c and treatment differences between the linagliptin/metformin and linagliptin groups were of similar magnitudes to the overall population across patient subgroups based on age, BMI, renal function, and race. Drug-related adverse events occurred in 8.8% and 5.7% of linagliptin/metformin and linagliptin patients, respectively; no severe hypoglycemia occurred.

Conclusion: Linagliptin/metformin combination in newly diagnosed T2D patients with marked hyperglycemia was well tolerated and elicited substantial improvements in glycemic control regardless of baseline HbA1c, age, BMI, renal function, or race. Thus, newly diagnosed, markedly hyperglycemic patients may be effectively treated by combinations of oral agents.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT01512979     

Impact of age and obstacle negotiation on timing measures of gait initiation

Introduction

The separate and combined impacts of age and walkway obstruction on reaction time, anticipatory postural adjustment phases of gait initiation and cognitive dual task performance are not well understood. This study aimed to a) examine the impact of age and task complexity on reaction and anticipatory postural adjustment phases separately b) examine the impact of age and walkway obstruction on cognitive task performance while walking.

Tai Chi with music improves quality of life among community-dwelling older persons with mild to moderate depressive symptoms: A cluster randomized controlled trial

Depression leads to a poorer quality of life (QOL) which is a determinant of healthy ageing. Cost-effective solutions for enhancing QOL in the older population are much needed in China, with its rapidly ageing population. We conducted a randomized controlled trial involving 112 community-dwelling older participants with mild to moderate depression, to evaluate the effect of Tai Chi with music on QOL (57 in intervention group, 55 in control group). WHO Quality of Life-BREF was used to measure QOL at baseline and at every month for three months. Following the adjustments for sociodemographic data, the effect of intervention on QOL was assured (F = 25.145, P < 0.001, η_p²= 0.435, F = 18.696, P < 0.001, η_p²= 0.364, F = 17.473, P< 0.001, η_p²= 0.348, and F = 29.576, P < 0.001, η_p²= 0.475 for physical, psychological, social, and environment domains respectively). This intervention represents an economically viable solution to better QOL and healthy ageing in a highly populous developing nation.     

Molecular epidemiology of Clostridioides difficile and risk factors for the detection of toxin gene-positive strains

In this study, we investigated all Clostridioides difficile strains isolated from stool samples in Nagasaki University Hospital between January 2012 and December 2014. Toxin genes (tcdA, tcdB and cdtA/cdtB) were analyzed for multiplex PCR in a total of 213 strains. In the toxin gene-positive strain, PCR ribotyping was conducted using capillary gel electrophoresis-based PCR and the Webribo database. Patients’ backgrounds were analyzed by departments, disorders, antimicrobials, and clinical dates. The positive rates of tcdA, tcdB, and cdtA/cdtB genes were 62.9%, 63.4%, and 2.8%, respectively. The most frequent PCR ribotype was 047 (14.1%), followed by 014/0 (11.1%) and 002/0 (8.2%). In univariate analysis, the risk factors for the detection of toxin gene-positive strains in patients were older age (p = 0.0036), over ≥ 65 years old (p = 0.0175), the patients hospitalized at Department of Digestive Surgery (P = 0.0059), higher CRP level (P = 0.0395), and lower albumin level (p = 0.0014). In the multivariate analysis, the risk factor for detection of toxin gene-positive strains was the patients hospitalized at Department of Digestive Surgery (OR; 4.62, 95% CI; 1.18–18.0, p = 0.0274). In this study, the percentage of toxin gene-positive and cdtA/cdtB gene-positive strains was almost the same as that reported in previous studies, but the ribotype was different. In addition, we revealed that the risk factor associated with the detection of toxin gene-positive strains was the patients hospitalized at Department of digestive surgery.     

Problems of regeneration of the mature Eucalyptus regnans F. Muell, (The Big Ash) forest,in the absence of fire at Wallaby Creek,Victoria, Australia

This paper is based on observations on the regeneration of a mature E. regnans forest begun in 1949 and extending over the next 50 years. Any regeneration of E. regnans in the unburnt, mature forest is confronted by a phalanx of obstacles. The formation of large gaps which synchronously involve the overstorey, shrub understorey and fern stratum are an essential prerequisite for establishment, although success may not be assured unless the seedbed has been favourably prepared by mechanical disturbance or fire. In this study, regeneration, which was initiated experimentally by a heavy sowing of seed, scarification of soil, addition of nitrogenous fertilizer, creation of moderately good light conditions and the removal of competition by seedlings of understorey species in the first season, failed completely after 10–11 years even though understorey species which germinated from the soil seed bank continued to thrive.

Processes of seed germination and seedling development are explored in terms of seed harvesting by ants, insect attack, heating and desiccation of the soil surface, mammal browsing, light intensity and dimorphic leaf orientation, mycorrhizal associations, root competition, allelopathic factors, leaf spot fungi and chewing and gall-forming insects. In the tall forest lateral light is considered critical for continued vigour of advanced seedlings with pendulous foliage. Thus, gaps which permit satisfactory development of young seedlings are inadequate for saplings, especially if they are in competition with vigorous regeneration of understorey species. Under light-limiting conditions, survival is severely jeopardized by any factor affecting leaf area or leaf function. It is concluded that while E. regnans appears to be physiologically tolerant of moderate shade it lacks the wider ecological tolerance to it.

Without fire, the regeneration of E. regnans will almost certainly fail in the mature forest unless accompanied by exceptional circumstances. Group tree falls are needed to create regeneration but only on sites incompletely covered by dense ground fern. Synchronous gaps may be needed to disperse herbivore activity in the critical early years. Crown fire eliminates most of the difficulties encountered by E. regnans regeneration by causing mass seedfall, creating a suitable seed bed and by temporarily changing the microclimate, soil moisture regime, soil nutrient status, microbial populations and ant foraging activity. Regeneration may occur in groups following surface fires if large canopy gaps have been produced. In the unlikely event of a very long period without fire, succession to a form of rainforest is likely to occur, although the species may not be eliminated entirely from the area due to the possibility of chance establishment.     

Unexplained mortality differences between septic shock trials: a systematic analysis of population characteristics and control-group mortality rates

Purpose

Although the definition of septic shock has been standardized, some variation in mortality rates among clinical trials is expected. Insights into the sources of heterogeneity may influence the design and interpretation of septic shock studies. We set out to identify inclusion criteria and baseline characteristics associated with between-trial differences in control group mortality rates.

Methods

We conducted a systematic review of RCTs published between 2006 and 2018 that included patients with septic shock. The percentage of variance in control-group mortality attributable to study heterogeneity rather than chance was measured by I². The association between control-group mortality and population characteristics was estimated using linear mixed models and a recursive partitioning algorithm.

Results

Sixty-five septic shock RCTs were included. Overall control-group mortality was 38.6%, with significant heterogeneity (I² = 93%, P < 0.0001) and a 95% prediction interval of 13.5–71.7%. The mean mortality rate did not differ between trials with different definitions of hypotension, infection or vasopressor or mechanical ventilation inclusion criteria. Population characteristics univariately associated with mortality rates were mean Sequential Organ Failure Assessment score (standardized regression coefficient (β) = 0.57, P = 0.007), mean serum creatinine (β = 0.48, P = 0.007), the proportion of patients on mechanical ventilation (β = 0.61, P < 0.001), and the proportion with vasopressors (β = 0.57, P = 0.002). Combinations of population characteristics selected with a linear model and recursive partitioning explained 41 and 42%, respectively, of the heterogeneity in mortality rates.

Conclusions

Among 65 septic shock trials, there was a clinically relevant amount of heterogeneity in control group mortality rates which was explained only partly by differences in inclusion criteria and reported baseline characteristics.

     

Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial

Purpose

Shortening the duration of antibiotic therapy (ABT) is a key measure in antimicrobial stewardship. The optimal duration of ABT for treatment of postoperative intra-abdominal infections (PIAI) in critically ill patients is unknown.

Methods

A multicentre prospective randomised trial conducted in 21 French intensive care units (ICU) between May 2011 and February 2015 compared the efficacy and safety of 8-day versus 15-day antibiotic therapy in critically ill patients with PIAI. Among 410 eligible patients (adequate source control and ABT on day 0), 249 patients were randomly assigned on day 8 to either stop ABT immediately (n = 126) or to continue ABT until day 15 (n = 123). The primary endpoint was the number of antibiotic-free days between randomisation (day 8) and day 28. Secondary outcomes were death, ICU and hospital length of stay, emergence of multidrug-resistant (MDR) bacteria and reoperation rate, with 45-day follow-up.

Results

Patients treated for 8 days had a higher median number of antibiotic-free days than those treated for 15 days (15 [6–20] vs 12 [6–13] days, respectively; P < 0.0001) (Wilcoxon rank difference 4.99 days [95% CI 2.99–6.00; P < 0.0001). Equivalence was established in terms of 45-day mortality (rate difference 0.038, 95% CI ? 0.013 to 0.061). Treatments did not differ in terms of ICU and hospital length of stay, emergence of MDR bacteria or reoperation rate, while subsequent drainages between day 8 and day 45 were observed following short-course ABT (P = 0.041).

Conclusion

Short-course antibiotic therapy in critically ill ICU patients with PIAI reduces antibiotic exposure. Continuation of treatment until day 15 is not associated with any clinical benefit.

Clinicaltrials.gov identifier

NCT01311765.

     

Combined Application of <Emphasis Type="Italic">Candida</Emphasis> sp. SSm-39 and Low Dose of Mineral Fertilizer for Improvement of Sesame Cultivation

The prime concept of agricultural sustainability is to develop effective farming strategy encompassing organic food production maintaining environmental safety. Soil amendment by organic and inorganic input is an effective approach for soil conditioning to achieve such organic production. This study reveals the efficacy of SSm-39 as soil inoculant for quality production of sesame crop. Soil amendment with varied amount of inoculant and MF was attempted. Application of full dose of inoculant with low dose of MF in sesame cultivation enhanced the soil nutrient availability and the microbial diversity, further supports the nutrient uptake efficiency and growth of the test plant. Notable enhancement (150 %) in crop growth was observed with the standardized treatment condition. In regression analysis, nutrient uptake efficiency (R² = 0.88–0.99) of test crop and microbial load (R² = 0.94) in post harvest bulk soil, showed a proportional positive correlation with the inoculant amount. This study suggests an effective farming strategy, involving soil inoculant with low inorganic inputs that lead to enhancement in crop yield (82 %), NPK uptake (223 %) and effectively maintains the soil micro-ecosystem. This is the first report of using Candida sp. in sesame cropping.     

Improvements in cardiometabolic risk markers,aerobic fitness,and functional performance following a physical therapy weight loss program

Objective: The objectives of this study were to determine the efficacy of a current physical therapy and weight loss program model on exercise performance, physical function, and cardiometabolic risk factors in obese patients. Design: Retrospective pre-post design. Subjects: A total of 192 patients who previously underwent testing of anthropometric measurements, cardiovascular biomarkers, and lower extremity function scale (LEFS) were included. Results: There was a significant reduction in body weight [5.91 ± 3.47 (95% CI, 5.4 to 6.4) kg; p < 0.001; n = 187] and waist circumference [7.1 ± 5 (95% CI, 6.3 to 7.9) cm; p < 0.001; n = 187]. Submaximal exercise capacity (VO_2ex) increased by [5.29 ± 4.74 (95% CI, 4.38 to 6.19) ml/kg/min; p < 0.001; n = 107], and lower extremity functional scale (LEFS) improved by [9 ± 11 (95% CI, 7 to 12) scale points; p < 0.001; n = 75]. Both systolic (pre SBP: 125.7 ± 15 vs. post SBP: 118.4 ± 12 mmHg; p < 0.001; n = 150) and diastolic (pre DBP: 78.5 ± 10 vs. post DBP: 74 ± 8.5 mmHg; p < 0.001; n = 150) blood pressures as well as fasting blood glucose (pre FBG: 112.8 ± 37 vs. post FBG: 99 ± 18 mg/dL; p < 0.001; n = 132) were significantly reduced. Conclusions: This study indicates the importance and significance of weight loss in improving physical function and cardiometabolic risk profiles across a cohort of outpatient physical therapy patients. Our study also suggests that weight loss can be achieved in a comprehensive exercise intensive physical therapy program for obese patients.     

Effluent loading rates for irrigated plantations—a water balance model

Disposal of municipal and industrial effluents to rivers is a major source of river pollution in Australia. Since an increasingly popular alternative for reducing discharge of nutrients to rivers and promoting wood production, is to use effluents to irrigate tree plantations, there is a strong demand for accurate information on the water and nutrient consumption of effluent-irrigated plantations. Research on growth and water-use of Pinus radiada (D. Don) plantations treated with a wide range of water and nutrient supplements over 4 years has resulted in the development of WATLOAD, an empirical water-balance model of irrigated plantations. The central biological parameter is the amount of foliage carried by the trees, which affects throughfall and stemflow, the transpiration rate of the trees and the evapotranspiration rate of the pasture grass or understorey. The model calculates the monthly amount of effluent that can be applied to a plantation in a given climate from planting to canopy closure with minimal risk of increasing nutrient contamination to waterways. It calculates the area required to treat a given volume of effluent and the amount of winter storage required.     

Wood properties of Eucalyptus globulus at three sites in Western Australia: effects of fertiliser and plantation stocking

Wood properties of 10-year-old trees in Eucalyptus globulus plantations at three sites in Western Australia were examined. Silvicultural treatments applied at age two years were stocking (unthinned, 1250 stems ha^–1; thinned to 600 stems ha^–1 or 300 stems ha^–1) and nitrogen fertiliser application (0 or 250 kg ha^–1 elemental nitrogen) in factorial combination. The three sites differed markedly in their annual rainfall (620–1100 mm), open-pan evaporation and soil water-holding capacity. Wood cores were collected at breast height from a total of 263 trees (~15 trees for each site-by-treatment combination), and radial samples prepared for analysis by SilviScan to produce radial profiles of air-dry density and microfibril angle (MFA) and modulus of elasticity (MOE), and by radial near infrared (NIR) surface scanning to produce radial profiles of NIR-predicted Kraft pulp yield (KPY) and cellulose content (CC). Sampling interval was 0.025 mm for density and 5 mm for the other properties. For wood property mean values (i.e. wood property averages of each pith-to-cambium sample), sites differed significantly only in air-dry density. The Boyup Brook site, which had low annual rainfall, the lowest climate wetness index and soil water-storage capacity and the slowest diameter growth, had the highest mean wood density (648 kg m^–3), while Scott River, with the highest rainfall, had mean density that was 10% lower. The Wellstead site (low rainfall but highest soil water-storage capacity) was intermediate for density. The only other significant differences for mean wood properties were caused by fertiliser addition, which reduced NIR-predicted KPY from 54.6% (without fertiliser) to 54.1% and predicted CC from 43.7% to 43.1%. Clear radial trends were evident for all wood properties. Density, MOE, KPY and CC all increased from pith to the cambium, while MFA declined. From the innermost (pith) 10% to the outermost (cambial) 10% of the radius, density increased on average by 21%, MOE by 103%, KPY by 9% and cellulose by 11%, while MFA declined by 47%. NIR calibrations developed using the SilviScan and NIR spectral data explained 71% of variance in MOE for an independent set of radial wood samples of E. globulus from Victoria, but less than 50% of variance for density and MFA. Implications for paper pulp and veneer manufacture are briefly considered.     

Estimating dry matter content of fresh leaves from the residuals between leaf and water reflectance

At about 1720 nm wavelength, there is an absorption feature of leaf dry matter based on a C?H stretch overtone, which is difficult to detect in fresh green leaves because of the absorption spectrum of liquid water. We applied a method originally proposed in Remote Sensing of Environment by B.-C. Gao and A.F.H. Goetz (Estimating dry matter content of fresh leaves from the residuals between leaf and water reflectance, pp. 137–145, 1994) that used linear regression between the natural logarithm of leaf spectral reflectance and the specific absorption coefficient of liquid water over wavelengths from 1500 to 1800 nm to calculate an expected reflectance spectrum. The residual difference between the measured and expected leaf reflectance spectra enhanced the absorption feature of dry matter. The absorption feature was quantified using the normalized dry matter index (NDMI) based on the contrast between the residual leaf reflectance at 1649 and 1722 nm. NDMI was linearly related to leaf dry matter content (g cm^?2) for data obtained in the field (coefficient of determination r ² = 0.636) and for the leaf optical properties experiment (LOPEX; r ² = 0.684). Lignin and cellulose contents were also measured during LOPEX, but NDMI was weakly correlated to these variables, indicating NDMI was sensitive to all leaf biochemical constituents. Estimation of dry matter content combined with estimates of water content will facilitate the calculation of the fuel moisture content for prediction of wildfire.     

A randomized,double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design

Objectives: The objective of this paper was to evaluate the efficacy, duration of effect, and tolerability of SHP465 mixed amphetamine salts (MAS) extended-release versus placebo and immediate-release MAS (MAS IR) in adults with attention-deficit/hyperactivity disorder (ADHD).

Methods: Adults with ADHD Rating Scale, Version IV (ADHD-RS-IV) scores ≥24 were randomized to SHP465 MAS (50 or 75 mg), placebo, or 25 mg MAS IR in a double-blind, three-period, crossover study using a simulated adult workplace environment. On the final day of each 7-day treatment period, efficacy was assessed for 16 h postdose. Primary efficacy analyses for Permanent Product Measure of Performance (PERMP) total score averaged across all postdose assessments and each postdose time point were conducted in the intent-to-treat population using a mixed linear model. Secondary end-points included PERMP problems attempted and answered correctly and ADHD-RS-IV scores based on clinician ratings of counselor observations using the Time Segment Rating System and participant self-report. Tolerability assessments included treatment-emergent adverse events (TEAEs) and vital signs.

Results: Least squares mean (95% CI) treatment differences (combined 50/75 mg SHP465 MAS–placebo) significantly favored SHP465 MAS over placebo for PERMP total score averaged across all postdose assessments (18.38 [11.28, 25.47]; P < .0001) and at each postdose assessment (all P < .02). Nominal superiority of MAS IR over placebo for PERMP total score averaged across all postdose assessments was observed (nominal P = .0001); treatment differences between SHP465 MAS and MAS IR were not significant (nominal P = .2443). The two most frequently reported TEAEs associated with SHP465 MAS were insomnia (36.5%) and anorexia (21.2%). Mean increases in pulse and blood pressure with SHP465 MAS exceeded those of placebo.

Conclusions: SHP465 MAS (combined 50/75 mg) significantly improved PERMP total score versus placebo, with superiority observed from 2 to 16 h postdose. The tolerability profile of SHP465 MAS was similar to previous reports of SHP465 MAS in adults with ADHD.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT00928148 identifier is NCT00928148.     

Multimodal physiotherapy treatment based on a biobehavioral approach for patients with chronic cervico-craniofacial pain: a prospective case series

The purpose of this prospective case series was to observe and describe changes in patients with chronic cervico-craniofacial pain of muscular origin treated with multimodal physiotherapy based on a biobehavioral approach. Nine patients diagnosed with chronic myofascial temporomandibular disorder and neck pain were treated with 6 sessions over the course of 2 weeks including: (1) orthopedic manual physiotherapy (joint mobilizations, neurodynamic mobilization, and dynamic soft tissue mobilizations); (2) therapeutic exercises (motor control and muscular endurance exercises); and (3) patient education. The outcome measures of craniofacial (CF-PDI) and neck disability (NDI), kinesiophobia (TSK-11) and catastrophizing (PCS), and range of cervical and mandibular motion (ROM) and posture were collected at baseline, and at 2 and 14 weeks post-baseline. Compared to baseline, statistically significant (p < 0.01) and clinically meaningful improvements that surpassed the minimal detectable change were observed at 14 weeks in CF-PDI (mean change, 8.11 points; 95% confidence interval (CI): 2.55 to 13.69; d = 1.38), in NDI (mean change, 5 cm; 95% CI: 1.74–8.25; d = 0.98), and in the TSK-11 (mean change, 6.55 cm; 95% CI: 2.79–10.32; d = 1.44). Clinically meaningful improvements in self-reported disability, psychological factors, ROM, and craniocervical posture were observed following a multimodal physiotherapy treatment based on a biobehavioral approach.