Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: A quality improvement project

Purpose: Prolonged periods of mechanical ventilation are associated with significant physical and psychosocial adverse effects. Despite increasing evidence supporting early rehabilitation strategies, uptake and delivery of such interventions in Europe have been variable. The objective of this study was to evaluate the impact of an early and enhanced rehabilitation program for mechanically ventilated patients in a large tertiary referral, mixed-population intensive care unit (ICU). Method: A new supportive rehabilitation team was created within the ICU in April 2012, with a focus on promoting early and enhanced rehabilitation for patients at high risk for prolonged ICU and hospital stays. Baseline data on all patients invasively ventilated for at least 5 days in the previous 12 months (n = 290) were compared with all patients ventilated for at least 5 days in the 12 months after the introduction of the rehabilitation team (n = 292). The main outcome measures were mobility level at ICU discharge (assessed via the Manchester Mobility Score), mean ICU, and post-ICU length of stay (LOS), ventilator days, and in-hospital mortality. Results: The introduction of the ICU rehabilitation team was associated with a significant increase in mobility at ICU discharge, and this was associated with a significant reduction in ICU LOS (16.9 vs 14.4 days, P = .007), ventilator days (11.7 vs 9.3 days, P < .05), total hospital LOS (35.3 vs 30.1 days, P < .001), and in-hospital mortality (39% vs 28%, P < .05). Conclusion: A quality improvement strategy to promote early and enhanced rehabilitation within this European ICU improved levels of mobility at critical care discharge, and this was associated with reduced ICU and hospital LOS and reduced days of mechanical ventilation

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

OBJECTIVES Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist. DESIGN Repeated cross sectional study. SETTING Swiss, German and Canadian research ethics committees (RECs). PARTICIPANTS RCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292). PRIMARY AND SECONDARY OUTCOME MEASURES The primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items. We compared these outcomes in protocols approved in 2012 and 2016, and built regression models to explore factors associated with adherence to SPIRIT. For each protocol, we also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reported RESULTS: The median proportion of reported SPIRIT items among RCT protocols showed a non-significant increase from 72% (IQR, 63%-79%) in 2012 to 77% (IQR, 68%-82%) in 2016. However, in a preplanned subgroup analysis, we detected a significant improvement in investigator-sponsored protocols: the median proportion increased from 64% (IQR, 55%-72%) in 2012 to 76% (IQR, 64%-83%) in 2016, while for industry-sponsored protocols median adherence was 77% (IQR 72%-80%) for both years. The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship. CONCLUSIONS In 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis

BACKGROUND We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. METHODS AND FINDINGS We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. CONCLUSIONS We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research

Early mobilization in the critical care unit: A review of adult and pediatric literature.

Early mobilization of critically ill patients is beneficial, suggesting that it should be incorporated into daily clinical practice. Early passive, active, and combined progressive mobilizations can be safely initiated in intensive care units (ICUs). Adult patients receiving early mobilization have fewer ventilator-dependent days, shorter ICU and hospital stays, and better functional outcomes. Pediatric ICU data are limited, but recent studies also suggest that early mobilization is achievable without increasing patient risk. In this review, we provide a current and comprehensive appraisal of ICU mobilization techniques in both adult and pediatric critically ill patients. Contraindications and perceived barriers to early mobilization, including cost and health care provider views, are identified. Methods of overcoming barriers to early mobilization and enhancing sustainability of mobilization programs are discussed. Optimization of patient outcomes will require further studies on mobilization timing and intensity, particularly within specific ICU populations

Simulation of precipitation in V-containing hsla steel for the strengthening enhancement

The precipitation of the microalloying elements in high strength low alloyed (HSLA) steel controls the strength of the steel greatly through grain refinement and particle hardening mechanisms. The current work simulates the precipitation of vanadium a hot rolling process for the optimized strengthening effect in a microalloyed steel. Taking into account the effect of deformation, cause of the drastic increase in the dislocation density, namely higher nucleation site density, it can be clearly seen that the precipitation of all species at dislocations, dominate the precipitation kinetics. The diffuse interface effect on the interfacial energy as well as a volumetric misfit of AlN at dislocations is also taken into account. The latter is because of its significant difference in the lattice parameter from the matrix. The presence of AlN at dislocations does not override that of V(C, N) as found in other cases with low density of dislocation. Slow cooling rate in the process ensures the consumption of the microalloying elements which in turn strengthen the product and minimise the production cost. The experimental verifications for the precipitates are performed by scanning transmission electron microscopy (STEM) as well as X-ray absorption spectroscopy (XAS) from synchrotron radiation

Improvement in adhesion of sputtered TiB2 coating onto high speed steel by a chromium interlayer.

This work addresses at the development of the use of interlayer of different materials for TiB2 coatings with increased adhesion to the substrate and retained high hardness. Ti and Cr were deposited on stationary high speed steel and silicon wafer substrates by magnetron sputtering as an interlayer material. The resultant coatings were evaluated with respect to fundamental properties such as structure, coating roughness, hardness, modulus and adhesion. It was found that the adhesion of resultant TiB2 coatings was increased tremendously with Cr interlayer, whilst the hardness was slightly increased

Patient characteristics and outcomes of a home mechanical ventilation program in a developing country

Background: There are limited data on home mechanical ventilation (HMV) in developing countries. This study aimed to describe the patient characteristics, feasibility, and outcomes of an HMV program at a university hospital in Thailand. Materials and Methods: Data were collected on all patients who were discharged with HMV between October 2014 and August 2015 at Thammasat University Hospital. Results: Twelve patients (eight men and four women) underwent HMV. They were aged 71.5 ± 17.6 years; mean ± standard deviation. Indications for HMV were 6 neurologic diseases (4 amyotrophic lateral sclerosis, 1 multiple system atrophy, and 1 stroke), 2 chronic obstructive pulmonary disease (COPD), 1 tracheomalacia, and 3 combined neurologic diseases and respiratory diseases (2 stroke and COPD, 1 stroke and tracheomalacia). The duration of follow-up was 799.5 ± 780.5 days. The ratio of family income to cost of HMV usage was 77.2:1 ± 5.5:1. All patients had tracheostomies. Modes of HMV were biphasic positive airway pressure (66.7%), pressure-controlled ventilation (16.7%), pressure-support ventilation (8.3%), and volume-controlled ventilation (8.3%). Complications occurred in ten patients (83.3%), including tracheobronchitis (20 events) and ventilator-associated pneumonia (12 events). Overall mortality was 41.7% (5/12 patients), including two patients who died due to ventilator-associated pneumonia. There were no instances of ventilator malfunction. Conclusions: HMV is feasible for patients with neurological diseases and COPD in a developing country. The relatively high rate of complications indicates the need for more comprehensive clinical services for chronic ventilator-dependent patients in this setting

Metabolic Disorders in HIV-Infected Adolescents Receiving Protease Inhibitors

Protease inhibitor (PI) may cause abnormal glucose metabolism, abnormal lipid metabolism, and metabolic syndrome in HIV-infected adults but less well studied in Asian adolescents. This cross-sectional study evaluated anthropometric factors, oral glucose tolerance test, and lipid profiles of perinatally HIV-infected Thai adolescents who had received PI-based antiretroviral therapy for at least 6 months. Eighty adolescents were enrolled [median (IQR) age 16.7 (14.6–18.0) years, 42 males]. Metabolic syndrome, prediabetes, and type 2 diabetes mellitus (T2DM) were found in 8 (10%), 17 (22.1%), and 3 (3.8%) adolescents, respectively. Dyslipidemia was found in 56 (70%) adolescents, with hypertriglyceridemia being the most common type. In multivariate analysis, presence of lipohypertrophy (OR: 25.7, 95% CI: 3.2–202.8; p=0.002) and longer duration of PI use (OR: 1.04, 95% CI: 1.00–1.08; p=0.023) were associated with metabolic syndrome. Obesity (OR: 7.71, 95% CI: 1.36–43.7; p=0.021), presence of lipohypertrophy (OR: 62.9, 95% CI: 4.97–795.6; p=0.001), and exposure to stavudine for ≥6 months (OR: 8.18, 95% CI: 1.37–48.7; p=0.021) were associated with prediabetes/T2DM, while exposure to tenofovir for ≥6 months reduced the risk (OR: 0.17, 95% CI: 0.04–0.78; p=0.022). Metabolic disorders were commonly found in adolescents receiving PI. Careful monitoring and early intervention to modify cardiovascular risk should be systematically implemented in this population particularly those with exposure to stavudine