Spin of information and inconsistency between abstract and full text in RCTs investigating upper limb rehabilitation after stroke: An overview study.

BACKGROUND: Researchers may be tempted to favorably distort the interpretation of their findings when reporting the abstract (i.e., spin). Spin bias overemphasizes the beneficial effects of the intervention compared with the results shown in the full text. OBJECTIVE: To assess the occurrence of spin bias and incompleteness in reporting abstracts in post-stroke upper limb (UL) rehabilitation randomized clinical trials (RCTs). METHODS: A sample of 120 post-stroke UL rehabilitation RCTs (indexed in PEDro database), published in English between 2012 and 2020, was included. The completeness of reporting and spin were assessed using the Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) and the spin checklist. The relationship between CONSORT-A and spin checklist scores with RCT and journal characteristics was assessed. RESULTS: CONSORT-A and spin checklist scored 5.3±2.4 (max 15-points, higher scores indicating better reporting) and 5.5±2.0 (max 7-points, higher scores indicating presence of spin), respectively; Significant differences were detected between abstract and full-text scores in the CONSORT-A checklist (p < 0.01) and the spin checklist (p < 0.01). Items of the CONSORT-A checklist in the abstracts and full text showed a fair agreement (k = 0.31), while a moderate agreement (k = 0.59) for the spin checklist was detected. Completeness of abstract was associated (R2 = 0.46) with journal Impact Factor (p < 0.01), CONSORT Guideline endorsement (p = 0.04), and abstract word number (p = 0.02). A lower spin was associated with a higher journal Impact Factor (p = 0.01) and CONSORT Guideline endorsement (p = 0.01). CONCLUSIONS: Post-stroke UL rehabilitation RCTs abstracts were largely incomplete showing spin. Authors, reviewers, publishers, and stakeholders should be aware of this phenomenon. Publishers should consider allowing more words in abstracts to improve the completeness of reporting abstracts. Although we have investigated only stroke rehabilitation, our results suggest that health care professionals of all disciplines should avoid clinical decision-making based solely upon abstracts.

Post-operative heparin reduces early venous thrombotic complications after orthotopic paediatric liver transplantation.

BACKGROUND: Despite significant improvements in surgical techniques and medical care, thrombotic complications still represent the primary cause of early graft failure and re-transplantation following paediatric liver transplantation. There is still no standardized approach for thrombosis prevention. MATERIALS AND METHODS: The study aimed to evaluate the effectiveness of early intravenous unfractionated heparin started 12 hours postoperatively at 10 UI/kg per hour and used a retrospective "before and after" design to compare the incidence of early thrombotic complications prior to (2002-2010) and after (2011-2016) the introduction of heparin in our institute. RESULTS: From 2002 to 2016, 479 paediatric patients received liver transplantation in our institution with an overall survival rate over one year of 0.91 (95% CI: 0.87-0.94). Of 365 eligible patients, 244 did not receive heparin while 121 did receive heparin. We reported a lower incidence of venous thrombosis (VT) in the group treated with heparin: 2.5% (3/121) vs 7.9% (19/244) (p=0.038). All clinical and laboratory variables considered potential risk factors for VT were studied. By multivariate stepwise Cox proportional hazards models, heparin prophylaxis resulted significantly associated to a reduction in VT (HR=0.29 [95% CI: 0.08-0.97], p=0.045), while age <1 year was found to be an independent risk factor for VT (HR=2.62 [95% CI: 1.11-6.21]; p=0.028). DISCUSSION: Early postoperative heparin could be considered a valid and safe strategy to prevent early VT after paediatric liver transplantation without a concomitant increase in bleeding. A future randomised control trial is mandatory in order to strengthen this conclusion.

Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial.

INTRODUCTION: Some evidence indicates that exogenous surfactant therapy may be effective in infants with acute viral bronchiolitis, even though more confirmatory data are needed. To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV). METHODS AND ANALYSIS: This is a multicentre randomised, placebo-controlled, double-blind study, performed in 19 Italian paediatric intensive care units (PICUs). Eligible participants are infants under the age of 12 months hospitalised in a PICU, suffering from severe acute hypoxaemic bronchiolitis, requiring IMV. We adopted a more restrictive definition of bronchiolitis, including only infants below 12 months of age, to maintain the population as much homogeneous as possible. The primary outcome is to evaluate whether exogenous surfactant therapy (Curosurf, Chiesi Pharmaceuticals, Italy) is effective compared with placebo (air) in reducing the duration of IMV in the first 14 days of hospitalisation, in infants suffering from acute hypoxaemic viral bronchiolitis. Secondary outcomes are duration of non-invasive mechanical ventilation in the post-extubation phase, number of cases requiring new intubation after previous extubation within 14 days from randomisation, PICU and hospital length of stay (LOS), duration of oxygen dependency, effects on oxygenation and ventilatory parameters during invasive mechanical respiratory support, need for repeating treatment within 24 hours of first treatment, use of other interventions (eg, high-frequency oscillatory ventilation, nitric oxide, extracorporeal membrane oxygenation), mortality within the first 14 days of PICU stay and before hospital discharge, side effects and serious adverse events. ETHICS AND DISSEMINATION: The trial design and protocol have received approval by the Italian National Agency for Drugs (AIFA) and by the Regional Ethical Committee of Verona University Hospital (1494CESC). Findings will be disseminated through publication in peer-reviewed journals, conference/meeting presentations and media. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, issue date 22 May 2019. NCT03959384.

Pressure support ventilation, sigh adjunct to pressure support ventilation, and neurally adjusted ventilatory assist in infants after cardiac surgery: A physiologic crossover randomized study.

OBJECTIVES: We sought to compare gas exchange, respiratory mechanics, and asynchronies during pressure support ventilation (PSV), sigh adjunct to PSV (PSV SIGH), and neurally adjusted ventilatory assist (NAVA) in hypoxemic infants after cardiac surgery. DESIGN: Prospective, single-center, crossover, randomized physiologic study. SETTING: Tertiary-care pediatric intensive care unit. PATIENTS: Fourteen hypoxemic infants (median age 11.5 days [8.7-74]). INTERVENTIONS: The protocol begins with a 1 hour step of PSV, followed by two consecutive steps in PSV SIGH and NAVA in random order, with a washout period of 30 minutes (PSV) between them. MAIN RESULTS: Three infants presented an irregular Eadi signal because of diaphragmatic paralysis and were excluded from analysis. For the remaining 11 infants, PaO2 /FiO 2 and oxygenation index improved in PSV SIGH compared with PSV (P < 0.05) but not in NAVA compared with PSV. PSV SIGH showed increased tidal volumes and lower respiratory rate than PSV (P < 0.05), as well as a significant improvement in compliance with respiratory system indexed to body weight when compared with both PSV and NAVA (P < 0.01). No changes in mean airway pressure was registered among steps. Inspiratory time resulted prolonged for both PSV SIGH and NAVA than PSV (P < 0.05). NAVA showed the higher coefficient of variability in respiratory parameters and a significative decrease in asynchrony index when compared with both PSV and PSV SIGH (P < 0.01). CONCLUSIONS: The adjunct of one SIGH per minute to PSV improved oxygenation and lung mechanics while NAVA provided the best patient-ventilator synchrony in infants after cardiac surgery.

Sevoflurane improves respiratory mechanics and gas exchange in a case series of infants with severe bronchiolitis-induced acute respiratory distress syndrome.

This report describes the successful use of a new intervention to improve respiratory mechanics and gas exchange in a relatively homogeneous group of infants with severe bronchiolitis-induced PARDS after failure of conventional treatment. These results may open a new interesting area of research and management for PARDS patients.

The effects of anesthesia, muscle paralysis, and ventilation on the lung evaluated by lung diffusion for carbon monoxide and pulmonary surfactant protein B.

BACKGROUND: An increased alveolar-arterial oxygen tension difference is frequent in anesthetized patients. In this study, we evaluated the effect on the lung of anesthesia, muscle paralysis, and a brief course of mechanical ventilation. METHODS: Lung diffusion for carbon monoxide (DLCO), including pulmonary capillary blood volume (Vc) and conductance of the alveolar-capillary membrane (DM), and pulmonary surfactant protein type B (a marker of alveolar damage) were measured in 45 patients without pulmonary disease undergoing extrathoracic surgery. RESULTS: Anesthesia, muscle paralysis, and mechanical ventilation led to impairment of gas exchange, with a reduction of DLCO values immediately after anesthetic induction due to a concomitant reduction of both DM and Vc. While changes in DM were due to the reduction of lung volume, changes in Vc were not limited to volume loss, since the Vc/alveolar volume ratio decreased significantly. Although DLCO and its components decreased immediately after induction, none of the values decreased further at 1 and 3 hours. Surfactant protein type B, however, was unchanged immediately after anesthesia but increased at 1 hour after induction and further increased after 3 hours of anesthesia. The level of alveolar damage correlated with the reduction of lung perfusion and lung dynamic strain (i.e., ratio between tidal volume and end-expiratory lung volume). CONCLUSIONS: A brief course of anesthesia and controlled ventilation leads to: (1) alveolar damage, which is correlated with lung strain and perfusion, and (2) impaired gas exchange mainly due to volume loss but also to reduced aerated lung perfusion.

Acute high-altitude exposure reduces lung diffusion: data from the HIGHCARE Alps project.

The causes and development of lung fluid, as well as the integrity of the alveolar-capillary membrane at high altitude, are undefined. This study was conceived to see whether fluid accumulates within the lung with acute high altitude exposure, and whether this is associated with alveolar capillary membrane damage. We studied lung carbon monoxide diffusion (DLCO), its components - membrane diffusion (DM) and capillary volume (VC) and alveolar volume (VA) measured in 43 healthy subjects in Milan (122 m) and after 1 and 3 days at Capanna Regina Margherita (4559 m). DLCO measurement was adjusted for hemoglobin and inspired oxygen. We also measured plasma surfactant derived protein B (SPB) and Receptor of Advanced Glycation End-products (RAGE) as markers of alveolar-capillary membrane damage, and ultrasound lung comets as a marker of extravascular lung water. 21 subjects received acetazolamide and 22 placebo. DLCO was lower at Capanna Regina Margherita (day 1: 24.3 ± 4.7 and day 3: 23.6 ± 5.4 mL/mmHg/min), than in Milan (25.8 ± 5.5; p<0.001 vs. day 1 and 3) due to DM reduction (Milan: 50.5 ± 14.6 mL/mmHg/min, Capanna Regina Margherita day 1: 45.1 ± 11.5 mL/mmHg/min, day 3: 43.2 ± 13.9 mL/mmHg/min; p<0.05 Milan vs. day 3) with a partially compensatory VC increase (Milan: 96 ± 37 mL, Capanna Regina Margherita day 1: 152 ± 66 mL, day 3: 153 ± 59 mL; p<0.001 Milan vs. day 1 and day 3). Acetazolamide did not prevent the fall in DLCO albeit, between day 1 and 3, such a trend was observed. Regardless of treatment lung comets increased from 0 to 7.2 ± 3.6 (p<0.0001). SPB and RAGE were unchanged. Lung fluid increased at high altitude without evidence from plasma measurements, supporting alveolar-capillary damage.

Effects of slow deep breathing at high altitude on oxygen saturation, pulmonary and systemic hemodynamics.

Slow deep breathing improves blood oxygenation (Sp(O2)) and affects hemodynamics in hypoxic patients. We investigated the ventilatory and hemodynamic effects of slow deep breathing in normal subjects at high altitude. We collected data in healthy lowlanders staying either at 4559 m for 2-3 days (Study A; N = 39) or at 5400 m for 12-16 days (Study B; N = 28). Study variables, including Sp(O2) and systemic and pulmonary arterial pressure, were assessed before, during and after 15 minutes of breathing at 6 breaths/min. At the end of slow breathing, an increase in Sp(O2) (Study A: from 80.2±7.7% to 89.5±8.2%; Study B: from 81.0±4.2% to 88.6±4.5; both p<0.001) and significant reductions in systemic and pulmonary arterial pressure occurred. This was associated with increased tidal volume and no changes in minute ventilation or pulmonary CO diffusion. Slow deep breathing improves ventilation efficiency for oxygen as shown by blood oxygenation increase, and it reduces systemic and pulmonary blood pressure at high altitude but does not change pulmonary gas diffusion.

High-altitude exposure of three weeks duration increases lung diffusing capacity in humans.

BACKGROUND: high-altitude adaptation leads to progressive increase in arterial Pa(O2). In addition to increased ventilation, better arterial oxygenation may reflect improvements in lung gas exchange. Previous investigations reveal alterations at the alveolar-capillary barrier indicative of decreased resistance to gas exchange with prolonged hypoxia adaptation, but how quickly this occurs is unknown. Carbon monoxide lung diffusing capacity and its major determinants, hemoglobin, alveolar volume, pulmonary capillary blood volume, and alveolar-capillary membrane diffusion, have never been examined with early high-altitude adaptation. METHODS AND RESULTS: lung diffusion was measured in 33 healthy lowlanders at sea level (Milan, Italy) and at Mount Everest South Base Camp (5,400 m) after a 9-day trek and 2-wk residence at 5,400 m. Measurements were adjusted for hemoglobin and inspired oxygen. Subjects with mountain sickness were excluded. After 2 wk at 5,400 m, hemoglobin oxygen saturation increased from 77.2 ± 6.0 to 85.3 ± 3.6%. Compared with sea level, there were increases in hemoglobin, lung diffusing capacity, membrane diffusion, and alveolar volume from 14.2 ± 1.2 to 17.2 ± 1.8 g/dl (P < 0.01), from 23.6 ± 4.4 to 25.1 ± 5.3 ml·min(-1)·mmHg(-1) (P < 0.0303), 63 ± 34 to 102 ± 65 ml·min(-1)·mmHg(-1) (P < 0.01), and 5.6 ± 1.0 to 6.3 ± 1.1 liters (P < 0.01), respectively. Pulmonary capillary blood volume was unchanged. Membrane diffusion normalized for alveolar volume was 10.9 ± 5.2 at sea level rising to 16.0 ± 9.2 ml·min(-1)·mmHg(-1)·l(-1) (P < 0.01) at 5,400 m. CONCLUSIONS: at high altitude, lung diffusing capacity improves with acclimatization due to increases of hemoglobin, alveolar volume, and membrane diffusion. Reduction in alveolar-capillary barrier resistance is possibly mediated by an increase of sympathetic tone and can develop in 3 wk.