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1.
Objectives
To date, the relationship between C-reactive protein (CRP) level and diabetic retinopathy (DR) remains controversial. Therefore, a systematic review and meta-analysis was used to reveal the potential relationship between CRP level and DR.Methods
A systematic search of PubMed, Embase.com, and Web of Science was performed to identify all comparative studies that compared the CRP level of two groups (case group and control group). We defined that diabetic patients without retinopathy and /or matched healthy persons constituted the control group, and patients with DR were the case group.Results
Two cross sectional studies and twenty case control studies including a total of 3679 participants were identified. After pooling the data from all 22 studies, obvious heterogeneity existed between the studies, so a subgroup analysis and sensitivity analysis were performed. Removing the sensitivity studies, the blood CRP levels in the case group were observed to be higher than those in the control group [SMD = 0.22, 95% confidence interval (CI), 0.11–0.34], and the blood CRP levels in the proliferative diabetic retinopathy (PDR) group were also higher than those in the non-proliferative diabetic retinopathy (NPDR) group [SMD = 0.50, 95% CI, 0.30–0.70].Conclusions
The results from this current meta-analysis indicate that the CRP level might be used as a biomarker to determine the severity of DR. 相似文献2.
Sudha Basnet Arun Sharma Maria Mathisen Prakash Sunder Shrestha Ram Kumar Ghimire Dhiraj Man Shrestha Palle Valentiner-Branth Halvor Sommerfelt Tor A. Strand 《PloS one》2015,10(3)
Background
Pneumonia in young children is still the most frequent cause of death in developing countries. We aimed to identify predictors for recovery and treatment failure in children hospitalized with severe pneumonia.Methods
We enrolled 610 Nepalese children, aged 2 – 35 months from February 2006 to June 2008. Study participants were provided with standard treatment for pneumonia and followed up until discharge. Three multiple regression models representing clinical variables, clinical and radiological combined and all variables, including C-reactive protein (CRP) and viral etiology were used to assess the associations.Results
The median age of study participants was 6 months with 493 (82%) infants and 367 (61%) males. The median time (IQR) till recovery was 49 (31, 87) hours and treatment failure was experienced by 209 (35%) of the children. Younger age, hypoxia on admission and radiographic pneumonia were independent predictors for both prolonged recovery and risk of treatment failure. While wasting and presence of any danger sign also predicted slower recovery, Parainfluenza type 1 isolated from the nasopharynx was associated with earlier resolution of illness. Gender, being breastfed, stunting, high fever, elevated CRP, presence of other viruses and supplementation with oral zinc did not show any significant association with these outcomes.Conclusion
Age, hypoxia and consolidation on chest radiograph were significant predictors for time till recovery and treatment failure in children with severe pneumonia. While chest radiograph is not always needed, detection and treatment of hypoxia is a crucial step to guide the management of hospitalized children with pneumonia. 相似文献3.
Background
To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants.Methods
This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment.Results
Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6–9 days, n = 21) in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20,) in the control group (p = 0.11). However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02), and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14). Osteopathic treatment was tolerated well and no adverse events were observed.Conclusions
Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight)-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants.Trial registration
Clinical trials.gov: NCT02140710 相似文献4.
J. Carlos Flores-González Miguel A. Matamala-Morillo Patricia Rodríguez-Campoy Juan J. Pérez-Guerrero Belén Serrano-Moyano Paloma Comino-Vazquez Encarnación Palma-Zambrano Rocio Bulo-Concellón Vanessa Santos-Sánchez Alfonso M. Lechuga-Sancho Bronchiolitis of Cadiz Study group 《PloS one》2015,10(11)
Background and Aims
There is no evidence that the epinephrine-3% hypertonic saline combination is more effective than 3% hypertonic saline alone for treating infants hospitalized with acute bronchiolitis. We evaluated the efficacy of nebulized epinephrine in 3% hypertonic saline.Patients and Methods
We performed a randomized, double-blind, placebo-controlled clinical trial in 208 infants hospitalized with acute moderate bronchiolitis. Infants were randomly assigned to receive nebulized 3% hypertonic saline with either 3 mL of epinephrine or 3 mL of placebo, administered every four hours. The primary outcome measure was the length of hospital stay.Results
A total of 185 infants were analyzed: 94 in the epinephrine plus 3% hypertonic saline group and 91 in the placebo plus 3% hypertonic saline group. Baseline demographic and clinical characteristics were similar in both groups. Length of hospital stay was significantly reduced in the epinephrine group as compared with the placebo group (3.94 ±1.88 days vs. 4.82 ±2.30 days, P = 0.011). Disease severity also decreased significantly earlier in the epinephrine group (P = 0.029 and P = 0.036 on days 3 and 5, respectively).Conclusions
In our setting, nebulized epinephrine in 3% hypertonic saline significantly shortens hospital stay in hospitalized infants with acute moderate bronchiolitis compared to 3% hypertonic saline alone, and improves the clinical scores of severity from the third day of treatment, but not before.Trial Registration
EudraCT 2009-016042-57 相似文献5.
Pavani K. Ram Margaret A. DiVita Kaniz Khatun-e-Jannat Manoshi Islam Kimberly Krytus Emily Cercone Badrul Munir Sohel Makhdum Ahmed Abid Mahmud Quaiyum Rahman Mustafizur Rahman Jihnhee Yu W. Abdullah Brooks Eduardo Azziz-Baumgartner Alicia M. Fry Stephen P. Luby 《PloS one》2015,10(6)
Rationale
There is little evidence for the efficacy of handwashing for prevention of influenza transmission in resource-poor settings. We tested the impact of intensive handwashing promotion on household transmission of influenza-like illness and influenza in rural Bangladesh.Methods
In 2009–10, we identified index case-patients with influenza-like illness (fever with cough or sore throat) who were the only symptomatic person in their household. Household compounds of index case-patients were randomized to control or intervention (soap and daily handwashing promotion). We conducted daily surveillance and collected oropharyngeal specimens. Secondary attack ratios (SAR) were calculated for influenza and ILI in each arm. Among controls, we investigated individual risk factors for ILI among household contacts of index case-patients.Results
Among 377 index case-patients, the mean number of days between fever onset and study enrollment was 2.1 (SD 1.7) among the 184 controls and 2.6 (SD 2.9) among 193 intervention case-patients. Influenza infection was confirmed in 20% of controls and 12% of intervention index case-patients. The SAR for influenza-like illness among household contacts was 9.5% among intervention (158/1661) and 7.7% among control households (115/1498) (SAR ratio 1.24, 95% CI 0.92–1.65). The SAR ratio for influenza was 2.40 (95% CI 0.68–8.47). In the control arm, susceptible contacts <2 years old (RRadj 5.51, 95% CI 3.43–8.85), those living with an index case-patient enrolled ≤24 hours after symptom onset (RRadj 1.91, 95% CI 1.18–3.10), and those who reported multiple daily interactions with the index case-patient (RRadj 1.94, 95% CI 1.71–3.26) were at increased risk of influenza-like illness.Discussion
Handwashing promotion initiated after illness onset in a household member did not protect against influenza-like illness or influenza. Behavior may not have changed rapidly enough to curb transmission between household members. A reactive approach to reduce household influenza transmission through handwashing promotion may be ineffective in the context of rural Bangladesh.Trial Registration
ClinicalTrials.gov NCT00880659 相似文献6.
Karlijn J. Barnhoorn J. Bart Staal Robert T. M. van Dongen Jan Paul M. Fr?lke Frank P. Klomp Henk van de Meent Han Samwel Maria W. G. Nijhuis-van der Sanden 《PloS one》2015,10(4)
Objective
To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy.Design
An explorative secondary analysis of a randomised controlled trial.Participants
Fifty-six patients with Complex Regional Pain Syndrome type 1.Interventions
The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline.Outcome measures
Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up.Results
The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation.Conclusion
The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment.Trial registration
International Clinical Trials Registry NCT00817128 相似文献7.
Denise M. D. ?zdemir-van Brunschot Giel G. Koning Kees C. J. H. M. van Laarhoven Mehmet Ergün Sharon B. C. E. van Horne Maroeska M. Rovers Michiel C. Warlé 《PloS one》2015,10(3)
Objective
To compare the effectiveness of different technique modifications in laparoscopic donor nephrectomy.Design
Systematic review and meta-analyses.Data Sources
Searches of PubMed, EMBASE, Web of Science and Central from January 1st 1997 until April 1st 2014.Study Design
All cohort studies and randomized clinical trials comparing fully laparoscopic donor nephrectomy with modifications of the standard technique including hand-assisted, retroperitoneoscopic and single port techniques, were included.Data-Extraction and Analysis
The primary outcome measure was the number of complications. Secondary outcome measures included: conversion to open surgery, first warm ischemia time, estimated blood loss, graft function, operation time and length of hospital stay. Each technique modification was compared with standard laparoscopic donor nephrectomy. Data was pooled with a random effects meta-analysis using odds ratios, weighted mean differences and their corresponding 95% confidence intervals. To assess heterogeneity, the I2 statistic was used. First, randomized clinical trials and cohort studies were analyzed separately, when data was comparable, pooled analysis were performed.Results
31 studies comparing laparoscopic donor nephrectomy with other technique modifications were identified, including 5 randomized clinical trials and 26 cohort studies. Since data of randomized clinical trials and cohort studies were comparable, these data were pooled. There were significantly less complications in the retroperitoneoscopic group as compared to transperitoneal group (OR 0.52, 95%CI 0.33–0.83, I2 = 0%). Hand-assisted techniques showed shorter first warm ischemia and operation times.Conclusions
Hand-assistance reduces the operation and first warm ischemia times and may improve safety for surgeons with less experience in laparoscopic donor nephrectomy. The retroperitoneoscopic approach was significantly associated with less complications. However, given the, in general, poor to intermediate quality and considerable heterogeneity in the included studies, further high-quality studies are required.Trial Registration
The review protocol was registered in the PROSPERO database before the start of the review process (CRD number 42013006565). 相似文献8.
Franck Maunoury Anastasiia Motrunich Maria Palka-Santini Stéphanie F. Bernatchez Stéphane Ruckly Jean-Fran?ois Timsit 《PloS one》2015,10(6)
Objective
To model the cost-effectiveness impact of routine use of an antimicrobial chlorhexidine gluconate-containing securement dressing compared to non-antimicrobial transparent dressings for the protection of central vascular lines in intensive care unit patients.Design
This study uses a novel health economic model to estimate the cost-effectiveness of using the chlorhexidine gluconate dressing versus transparent dressings in a French intensive care unit scenario. The 30-day time non-homogeneous markovian model comprises eight health states. The probabilities of events derive from a multicentre (12 French intensive care units) randomized controlled trial. 1,000 Monte Carlo simulations of 1,000 patients per dressing strategy are used for probabilistic sensitivity analysis and 95% confidence intervals calculations. The outcome is the number of catheter-related bloodstream infections avoided. Costs of intensive care unit stay are based on a recent French multicentre study and the cost-effectiveness criterion is the cost per catheter-related bloodstream infections avoided. The incremental net monetary benefit per patient is also estimated.Patients
1000 patients per group simulated based on the source randomized controlled trial involving 1,879 adults expected to require intravascular catheterization for 48 hours.Intervention
Chlorhexidine Gluconate-containing securement dressing compared to non-antimicrobial transparent dressings.Results
The chlorhexidine gluconate dressing prevents 11.8 infections /1,000 patients (95% confidence interval: [3.85; 19.64]) with a number needed to treat of 85 patients. The mean cost difference per patient of €141 is not statistically significant (95% confidence interval: [€-975; €1,258]). The incremental cost-effectiveness ratio is of €12,046 per catheter-related bloodstream infection prevented, and the incremental net monetary benefit per patient is of €344.88.Conclusions
According to the base case scenario, the chlorhexidine gluconate dressing is more cost-effective than the reference dressing.Trial Registration
This model is based on the data from the RCT registered with www.clinicaltrials.gov (NCT01189682). 相似文献9.
Objective
To compare the effects of stress dose hydrocortisone therapy with placebo on survival without neurodevelopmental impairments in high-risk preterm infants.Study Design
We recruited 64 extremely low birth weight (birth weight ≤1000g) infants between the ages of 10 and 21 postnatal days who were ventilator-dependent and at high-risk for bronchopulmonary dysplasia. Infants were randomized to a tapering 7-day course of stress dose hydrocortisone or saline placebo. The primary outcome at follow-up was a composite of death, cognitive or language delay, cerebral palsy, severe hearing loss, or bilateral blindness at a corrected age of 18–22 months. Secondary outcomes included continued use of respiratory therapies and somatic growth.Results
Fifty-seven infants had adequate data for the primary outcome. Of the 28 infants randomized to hydrocortisone, 19 (68%) died or survived with impairment compared with 22 of the 29 infants (76%) assigned to placebo (relative risk: 0.83; 95% CI, 0.61 to 1.14). The rates of death for those in the hydrocortisone and placebo groups were 31% and 41%, respectively (P = 0.42). Randomization to hydrocortisone also did not significantly affect the frequency of supplemental oxygen use, positive airway pressure support, or need for respiratory medications.Conclusions
In high-risk extremely low birth weight infants, stress dose hydrocortisone therapy after 10 days of age had no statistically significant effect on the incidence of death or neurodevelopmental impairment at 18–22 months. These results may inform the design and conduct of future clinical trials.Trial Registration
ClinicalTrials.gov NCT00167544 相似文献10.
Catherine M. Pound Katherine Moreau Kristina Rohde Nick Barrowman Mary Aglipay Ken J. Farion Amy C. Plint 《PloS one》2015,10(3)
Objectives
Neonatal jaundice is the most common problem in full-term infants during the immediate post-natal period. We examined the effect of a lactation support intervention on breastfeeding duration in hospitalized jaundiced infants.Study Design
We conducted a randomized controlled trial with a qualitative component involving mothers of hospitalized jaundiced breastfed infants <4 weeks of age. Mothers receiving the intervention met with an International Board-Certified Lactation Consultant in hospital and 1–3 times post discharge. Both groups received the standard care for jaundice. The primary outcome was exclusive breastfeeding at 3 months. To the exception of research assistants enrolling participants and completing qualitative interviews, all research staff, investigators and statisticians were blinded to group assignment. Qualitative interviews elicited feedback on breastfeeding experiences for both groups.Results
99 participants were recruited, and 86 analyzed for primary outcome. There was no difference in exclusive breastfeeding at 3 months between groups (RR 0.84, 95% CI 0.56–1.24, p = 0.40) or in the secondary outcomes. 31 participants were included in the qualitative analysis. Participants in the intervention group described an increase in comfort and confidence levels with breastfeeding. Participants in the control group reported limited lactation support.Conclusions
Our hospital-based lactation support program did not result in a higher proportion of mothers exclusively breastfeeding at 3 months compared to current hospital standard care. Qualitative feedback from the intervention group suggests that mothers’ confidence was increased, which is linked to breastfeeding duration. The decision to breastfeed is multifactorial and hospital-based lactation support may be only a small piece of the puzzle in hospitalized jaundiced infants. Further studies may be needed to fully elucidate the impact of an in-hospital lactation support program on successful breastfeeding for these infants.Trial Registration
ClinicalTrials.gov NCT00966719 https://www.clinicaltrials.gov/ct2/show/NCT00966719?term=Lactation+Support+and+Breastfeeding+Duration+in+Jaundiced+Infants%3A+a+Randomized+Controlled+Trial&rank=1 相似文献11.
Ling-Xiao Chen Guang-Zhi Ning Zhi-Rui Zhou Yu-Lin Li Di Zhang Qiu-Li Wu Tian-Song Zhang Lei Cheng Shi-Qing Feng 《PloS one》2015,10(4)
Context
Alendronate may relate to the incidence of cancers, especially esophageal and colon cancer. But the results are inconsistent in different studies.Objective
To quantify the association between the use of alendronate and the occurrence of different types of cancer.Data Sources
We searched Embase, Pubmed, CENTRAL, SIGLE and clinicaltrials.gov, up to 2014 June.Study Selection
Cohort studies reporting association between alendronate or bisphosphonate therapy including alendronate in patients with osteoporosis and risk of cancer were selected by two authors.Data Extraction
Two authors independently extracted the data. The Chi-square test and the I-square test were used for testing heterogeneity between studies.Data Synthesis
Eight cohort studies were included in the meta-analysis. Meta-analysis result manifested that alendronate significantly increased the incidence of lung cancer (HR 1.23, 95%CI 1.03 to 1.47, P value = 0.03), nevertheless, there was no significant difference after we excluded either Lee’s 2012 study (HR 1.17, 95%CI 0.95 to 1.44, P value = 0.13) or Chiang’s 2012 study (HR 1.47, 95%CI 1 to 2.17, P value = 0.05). For the incidence of colorectal cancer, no significant difference occurred (HR 0.91, 95%CI 0.74 to 1.13, P value = 0.39), but there was a positive relationship when we used fixed model (HR 0.85, 95%CI 0.78 to 0.93, P value = 0.004). For the incidence of liver cancer, there was no significant difference (HR 1.36, 95%CI 0.9 to 2.04, P value = 0.14), however, the result changed after we excluded Chiang’s 2012 study (HR 1.69, 95%CI 1.03 to 2.77, P value = 0.04). There was no significant difference in other types of cancer.Conclusion
Based on current evidences, alendronate therapy may be associated with a high risk of lung cancer, may with an excess risk of liver cancer, a low risk of colorectal and no related risk of other cancers. 相似文献12.
Usha Ramakrishnan Amanda Stinger Ann M. DiGirolamo Reynaldo Martorell Lynnette M. Neufeld Juan A. Rivera Lourdes Schnaas Aryeh D. Stein Meng Wang 《PloS one》2015,10(8)
Objective
We evaluated the effects of prenatal docosahexaenoic acid (DHA) supplementation on offspring development at 18 months of age.Design
Randomized placebo double-blind controlled trial.Settings
Cuernavaca, Mexico.Participants and Methods
We followed up offspring (n = 730; 75% of the birth cohort) of women in Mexico who participated in a trial of DHA supplementation during the latter half of pregnancy. We assessed the effect of the intervention on child development and the potential modifying effects of gravidity, gender, SES, and quality of the home environment.Interventions or Main Exposures
400 mg/day of algal DHA.Outcome Measures
Child development at 18 months of age measured using the Spanish version of the Bayley Scales of Infant Development-II. We calculated standardized psychomotor and mental development indices, and behavior rating scale scores.Results
Intent-to-treat differences (DHA-control) were: Psychomotor Developmental Index -0.90 (95% CI: -2.35, 0.56), Mental Developmental Index -0.26 (95% CI: -1.63, 1.10) and Behavior Rating Scale -0.01 (95% CI: -0.95, 0.94). Prenatal DHA intake attenuated the positive association between home environment and psychomotor development index observed in the control group (p for interaction = 0.03) suggesting potential benefits for children living in home environments characterized by reduced caregiver interactions and opportunities for early childhood stimulation.Conclusions
Prenatal DHA supplementation in a population with low intakes of DHA had no effects on offspring development at 18 months of age although there may be some benefit for infants from poor quality home environments.Trial Registration
Clinicaltrials.gov NCT00646360 相似文献13.
Bernhard Schwaberger Gerhard Pichler Alexander Avian Corinna Binder-Heschl Nariae Baik Berndt Urlesberger 《PloS one》2015,10(9)
Background
Sustained lung inflations (SLI) during neonatal resuscitation may promote alveolar recruitment in preterm infants. While most of the studies focus on respiratory outcome, the impact of SLI on the brain hasn’t been investigated yet.Objective
Do SLI affect cerebral blood volume (CBV) in preterm infants?Methods
Preterm infants of gestation 28 weeks 0 days to 33 weeks 6 days with requirement for respiratory support (RS) were included in this randomized controlled pilot trial. Within the first 15 minutes after birth near-infrared spectroscopy (NIRS) measurements using ‘NIRO-200-NX’ (Hamamatsu, Japan) were performed to evaluate changes in CBV and cerebral tissue oxygenation. Two groups were compared based on RS: In SLI group RS was given by applying 1–3 SLI (30 cmH2O for 15 s) continued by respiratory standard care. Control group received respiratory standard care only.Results
40 infants (20 in each group) with mean gestational age of 32 weeks one day (±2 days) and birth weight of 1707 (±470) g were included. In the control group ΔCBV was significantly decreasing, whereas in SLI group ΔCBV showed similar values during the whole period of 15 minutes. Comparing both groups within the first 15 minutes ΔCBV showed a tendency toward different overall courses (p = 0.051).Conclusion
This is the first study demonstrating an impact of SLI on CBV. Further studies are warranted including reconfirmation of the present findings in infants with lower gestational age. Future investigations on SLI should not only focus on respiratory outcome but also on the consequences on the developing brain.Trial Registration
German Clinical Trials Register DRKS00005161 https://drks-neu.uniklinik-freiburg.de/drks_web/setLocale_EN.do 相似文献14.
Objective
To investigate the developmental effects of clozapine and other atypical antipsychotics on infants who were exposed to as fetus.Method
The developmental progress of 33 infants who were exposed to clozapine as fetus was compared to 30 infants who were exposed to risperidone, olanzapine or quetiapine as fetus by assessing Apgar scoring, birth weight at birth, body weight, height, and the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) at months 2, 6 and 12 of age. Five subscale scores of BSID-III including cognitive, language, motor, social-emotional, and adaptive behavior were also compared. Student’s t test and Chi-square analysis were used as appropriate. Repeated measurements were evaluated by analysis of covariance.Results
Of the 63 infants, 58 (92.1%) completed a 12-month study period. At the age of 2 and 6 months, mean adaptive behavior scores of BSID-III were significantly lower in clozapine-exposed infants than infants who exposed to other atypical antipsychotic at 2 and 6 months of age. More clozapine-exposed infants had delayed development (defined as the subscale score of <85) for adaptive behavior at 2 and 6 months of age. There was no difference between the two groups for cognitive, language, motor, social and emotional at 2, 6 and 12 months of age. More infants who were exposed to clozapine as fetus (25 of 33, 75.8%) had disturbed sleep and a labile state than those who were exposed to other atypical antipsychotics (8 of 30, 26.7%) during 2 months of age (P<0.001).Conclusion
These results suggest that clozapine has more adaptive behavior effects on infants who were exposed to as a fetus than other atypical antipsychotics at 2 and 6 months of age.Trial Registration
ClinicalTrials.gov NCT01479400 相似文献15.
Sonia Gaucher Isabelle Boutron Florence Marchand-Maillet Gabriel Baron Richard Douard Jean-Pierre Béthoux AMBUPROG Group Investigators 《PloS one》2016,11(2)
Objectives
To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial).Design
Multicenter, two-arm, parallel-group, open-label randomized controlled trial.Setting
11 university hospital ambulatory surgery units in Paris, France.Participants
Patients scheduled for ambulatory surgery and able to be reached by telephone.Intervention
A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults), was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone.Main Outcome Measures
Rate of cancellation on the day of surgery or the day before.Results
The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6%) vs. 113 (5.8%), adjusted odds ratio [95% confidence interval] = 0.91 [0.65–1.29], (p = 0.57)). Checklist administration revealed that 355 patients (28.0%) had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0%) still had questions concerning the fasting state.Conclusions
A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes.Trial Registration
ClinicalTrials.gov NCT01732159相似文献16.
Jessica A. Hartmann Marieke Wichers Claudia Menne-Lothmann Ingrid Kramer Wolfgang Viechtbauer Frenk Peeters Koen R. J. Schruers Alex L. van Bemmel Inez Myin-Germeys Philippe Delespaul Jim van Os Claudia J. P. Simons 《PloS one》2015,10(6)
Objectives
Positive affect (PA) plays a crucial role in the development, course, and recovery of depression. Recently, we showed that a therapeutic application of the experience sampling method (ESM), consisting of feedback focusing on PA in daily life, was associated with a decrease in depressive symptoms. The present study investigated whether the experience of PA increased during the course of this intervention.Design
Multicentre parallel randomized controlled trial. An electronic random sequence generator was used to allocate treatments.Settings
University, two local mental health care institutions, one local hospital.Participants
102 pharmacologically treated outpatients with a DSM-IV diagnosis of major depressive disorder, randomized over three treatment arms.Intervention
Six weeks of ESM self-monitoring combined with weekly PA-focused feedback sessions (experimental group); six weeks of ESM self-monitoring combined with six weekly sessions without feedback (pseudo-experimental group); or treatment as usual (control group).Main outcome
The interaction between treatment allocation and time in predicting positive and negative affect (NA) was investigated in multilevel regression models.Results
102 patients were randomized (mean age 48.0, SD 10.2) of which 81 finished the entire study protocol. All 102 patients were included in the analyses. The experimental group did not show a significant larger increase in momentary PA during or shortly after the intervention compared to the pseudo-experimental or control groups (χ2 (2) =0.33, p=.846). The pseudo-experimental group showed a larger decrease in NA compared to the control group (χ2 (1) =6.29, p=.012).Conclusion
PA-focused feedback did not significantly impact daily life PA during or shortly after the intervention. As the previously reported reduction in depressive symptoms associated with the feedback unveiled itself only after weeks, it is conceivable that the effects on daily life PA also evolve slowly and therefore were not captured by the experience sampling procedure immediately after treatment.Trial Registration
Trialregister.nl/trialreg/index.asp. NTR1974 相似文献17.
Background
Recently, using the patient’s genotype to guide warfarin dosing has gained interest; however, whether pharmacogenetics-based dosing (PD) improves clinical outcomes compared to conventional dosing (CD) remains unclear. Thus, we performed a meta-analysis to evaluate these two strategies.Methods
The PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese VIP and Chinese Wan-fang databases were searched. The Cochrane Collaboration’s tool was used to assess the risk of bias in randomized controlled trials (RCTs). The primary outcome was time within the therapeutic range (TTR); the secondary end points were the time to maintenance dose and time to first therapeutic international normalized ratio (INR), an INR greater than 4, adverse events, major bleeding, thromboembolism and death from any cause.Results
A total of 11 trials involving 2,678 patients were included in our meta-analysis. The results showed that PD did not improve the TTR compared to CD, although PD significantly shortened the time to maintenance dose (MD = -8.80; 95% CI: -11.99 to -5.60; P<0.00001) and the time to first therapeutic INR (MD = -2.80; 95% CI: -3.45 to -2.15; P<0.00001). Additionally, PD significantly reduced the risk of adverse events (RR = 0.86; 95% CI: 0.75 to 0.99; P = 0.03) and major bleeding (RR = 0.36; 95% CI: 0.15 to 0.89, P = 0.03), although it did not reduce the percentage of INR greater than 4, the risk of thromboembolic events and death from any cause. Subgroup analysis showed that PD resulted in a better improvement in the endpoints of TTR and over-anticoagulation at a fixed initial dosage rather than a non-fixed initial dosage.Conclusions
The use of genotype testing in the management of warfarin anticoagulation was associated with significant improvements in INR-related and clinical outcomes. Thus, genotype-based regimens can be considered a reliable and accurate method to determine warfarin dosing and may be preferred over fixed-dose regimens.Trial Registration PROSPERO
Database registration: CRD42015024127. 相似文献18.
Xingsheng Hu Li Zhang Yuankai Shi Caicun Zhou Xiaoqing Liu Dong Wang Yong Song Qiang Li Jifeng Feng Shukui Qin Nong Xv Jianying Zhou Li Zhang Chunhong Hu Shucai Zhang Rongcheng Luo Jie Wang Fenlai Tan Yinxiang Wang Lieming Ding Yan Sun 《PloS one》2015,10(11)
Background
Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.Methods
Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety.Results
From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9–6.6 m) and 5.4 months (95%CI 3.1–7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127).Conclusions
In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy.Trial Registration
ClinicalTrials.gov NCT02486354 相似文献19.
Gabriella d’Ettorre Giancarlo Ceccarelli Noemi Giustini Sara Serafino Nina Calantone Gabriella De Girolamo Luigi Bianchi Valeria Bellelli Tommaso Ascoli-Bartoli Sonia Marcellini Ombretta Turriziani Jason M. Brenchley Vincenzo Vullo 《PloS one》2015,10(9)
Background
HIV infection results in damage to the gastrointestinal (GI) tract, microbial translocation and immune activation. These are not completely normalized with combined antiretroviral therapy (cART). Moreover, increate morbidity and mortality of cART-treated HIV-infected individuals is associated with inflammation.Methods
In order to enhance GI tract immunity, we recruited and treated 20 HIV-infected humans with cART supplemented with probiotics and followed inflammation and immunological parameters (clinical trial number NCT02164344). 11 HIV seronegative subjects were included as control group. The enumeration of CD4+, CD8+, CD38+ and HLA-DR+ lymphocytes were evaluated on peripheral blood; HIV-RNA levels, sCD14, d-dimer, C-reactive protein (CRP) high sensitivity C-reactive protein (hsCRP), IL-6 and Lipopolysaccharide Binding Protein (LBP) were assayed on plasma.Results
We observe that cART does not normalize the levels of immune activation in HIV positive patients anyway inflammation and markers of microbial translocation were significantly reduced with probiotic supplementation. Patients show a clear and statistically significant reduction in the levels of immune activation on CD4 T-lymphocytes, for both markers CD38 and HLA-DR and their simultaneous expression, LBP and hsCRP plasma levels after probiotic diet supplementation settling to values comparable to controls.Conclusions
Supplementing cART with probiotics in HIV-infected individuals may improve GI tract immunity and there by mitigate inflammatory sequelae, ultimately improving prognosis.Trial Registration
ClinicalTrials.gov NCT02164344 相似文献20.
Anita S. Iyer Noor M. Khaskhely David J. Leggat Jennifer A. Ohtola Jessica L. Saul-McBeth Sadik A. Khuder M. A. Julie Westerink 《PloS one》2016,11(3)