Background: Traumatic brain injury is a major health problem that frequently leads to deficits in executive function. Self-regulation processes, such as goal-setting, may become disordered after traumatic brain injury...Background: Traumatic brain injury is a major health problem that frequently leads to deficits in executive function. Self-regulation processes, such as goal-setting, may become disordered after traumatic brain injury, particularly when the frontal regions of the brain and their connections are involved. Such impairments reduce injured veterans' ability to return to work or school and to regain satisfactory personal lives. Understanding the neurologically disabling effects of brain injury on executive function is necessary for both the accurate diagnosis of impairment and the individual tailoring of rehabilitation processes to help returning service members recover independent function.Methods/design: The COMPASSgoal(Community Participation through Self-Efficacy Skills Development) program develops and tests a novel patient-centered intervention framework for community reintegration psychosocial research in veterans with mild traumatic brain injury. COMPASSgoal integrates the principles and best practices of goal self-management. Goal setting is a core skill in self-management training by which persons with chronic health conditions learn to improve their status and decrease symptom effects. Over a three-year period, COMPASSgoal will recruit 110 participants with residual executive dysfunction three months or more post-injury. Inclusion criteria combine both clinical diagnosis and standardized scores that are >1 SD from the normative score on the Frontal Systems Rating Scale. Participants are randomized into two groups: goal-management(intervention) and supported discharge(control). The intervention is administered in eight consecutive, weekly sessions. Assessments occur at enrollment, post-intervention/supported discharge, and three months post-treatment follow-up.Discussion: Goal management is part of the "natural language" of rehabilitation. However, collaborative goal-setting between clinicians/case managers and clients can be hindered by the cognitive deficits that follow brain injury. Re-training returning veterans with brain injury in goal management, with appropriate help and support, would essentially treat deficits in executive function. A structured approach to goal self-management may foster greater independence and self-efficacy, help veterans gain insight into goals that are realistic for them at a given time, and help clinicians and veterans to work more effectively as true collaborators.展开更多
Objective:The Consolidated Standards for Reporting of Trials(CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials(RCTs).However,most of the Chinese me...Objective:The Consolidated Standards for Reporting of Trials(CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials(RCTs).However,most of the Chinese medical journals have not endorsed the CONSORT statement.The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear.The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals.Methods:We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals(Journal type 1) without adoption of CONSORT and Chinese Journal of Evidence-based Medicine(Journal type 2) which adopted CONSORT in 2004.We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report,gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items.The reporting quality of RCT trials from 2001 to 2003(pre-adoption period) was compared with that from 2004 to 2006(post-adoption period).Results:The average reporting quality of RCTs was moderate(mean score,15.18),and the mean score of the 6 core items was low(mean score,1.09) in 5 leading journals.The difference in the total score and the score of the 6 core items between pre-adoption period(2001-2003) and post-adoption period(2004-2006) was statistically significant(P=0.003;P=0.000).Interaction between journal type and period was not significant(F=0.76;P=0.383).We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different.But as to the core items of sequence concealment and intention-to-treat analysis,the increases were greater for Journal type 2 when evaluated against Journal type 1(P=0.038;P=0.016).Conclusion:The reporting quality of RCT trials in 5 leading Chinese medical journals is improving.However,the lack of important items in RCT trials remains a serious problem.We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.展开更多
Background:Evidence regarding the effectiveness of prenatal nutritional supplements has mainly considered anthropometric pregnancy outcomes.The effect on markers of health and disease,such as offspring telomere length...Background:Evidence regarding the effectiveness of prenatal nutritional supplements has mainly considered anthropometric pregnancy outcomes.The effect on markers of health and disease,such as offspring telomere length(TL)and mitochondrial DNA content(mtDNAc)is unknown.Objectives:We assessed the efficacy of maternal multiple micronutrient(MMN)-fortified balanced-energy protein(BEP)and iron-folic acid(IFA)supplementation on newborn TL as a secondary outcome and mtDNAc as a non-declared outcome.Design:We conducted a randomized controlled trial in rural Burkina Faso,among pregnant females(15-40 years old)enrolled at<21 weeks of gestation.Mothers received either MMN-fortified BEP and IFA(intervention)or IFA only(control)throughout pregnancy.Whole arterial blood samples were collected from the umbilical cord of 104 control and 90 intervention group infants,respectively.Average relative TL and mtDNAc were measured using quantitative polymerase chain reaction.Linear regression models were fitted to assess TL and mtDNAc differences across trial arms.Results:We found that a combined daily MMN-fortified BEP supplement and IFA tablet did not affect newborn TL[β=-0.010(95%CI:-0.057,0.036);P=0.662]or mtDNAc[β=0.065(95%CI:-0.203,0.073);P=0.354],as compared to an IFA tablet alone.These findings were confirmed(P>0.05)by adjusting the regression models for potential prognostic factors of study outcomes at enrollment.Exploratory analyses indicated higher,but non-significantly different mtDNAc among children born either small-for-gestational age,low birthweight,or preterm.Conclusion:Newborns from mothers who received daily nutritional supplements across gestation did not have different relative TL or mtDNAc.展开更多
Numerous studies currently compare the lipid metabolism in patients with cardiovascular disease(CVD)and healthy individuals to identify lipid markers for predicting CVD.In this study,multidimensional mass spectrometry...Numerous studies currently compare the lipid metabolism in patients with cardiovascular disease(CVD)and healthy individuals to identify lipid markers for predicting CVD.In this study,multidimensional mass spectrometry-based shotgun lipidomics was used to examine the serum lipidomics of participants in a clinical randomized controlled feeding trial undergoing olive oil(OO),camellia seed oil(CSO),and soybean oil(SO)dietary interventions.189 lipid molecules are identified,including 14 species of phosphatidylinositol,45 species of ethanolamine glycerols(PE),47 species of choline glycerophospholipids(PC),39 species of triacylglycerols(TAG),18 species of lysophosphatidylcholine,and 26 species of sphingomyelin.After screening,10 lipid markers are found,among which 18:2 fatty acid(FA),16:1 FA,C54:4/C55:11,C54:3/C55:10,and C52:3/C53:10 in TAG pool,p18:0/20:0 and a18:0/18:1 in PC pool,and p18:1/20:4 in PE pool have differential regulation in the SO group compared to OO and CSO.The d16:0/18:1 in PC pool and C52:2/C53:9 in TAG pool are differentially regulated by OO and CSO.The C52:2/C53:9 in TAG pool has a significant negative correlation with aspartate aminotransferase(r=-0.363,P=0.048)and high-density lipoprotein cholesterol(r=-0.519,P<0.01).This study provides a reference for researching the effect of dietary fat on blood lipid metabolism.展开更多
Background The clinical efficacy and safety of adjunctive thrombus aspiration （TA） in patients with ST-segment elevation myocardial infarction （STEMI） during percutaneous coronary intervention （PCI） remain contr...Background The clinical efficacy and safety of adjunctive thrombus aspiration （TA） in patients with ST-segment elevation myocardial infarction （STEMI） during percutaneous coronary intervention （PCI） remain controversial. Methods Twenty five eligible randomized controlled trials were included to compare the use of thrombus aspiration （TA） with PCI and PCI-only for STEMI. The primary endpoint was all-cause mortality and death. The secondary endpoints were major adverse cardiac events （MACE）, recurrent infarction （RI）, target vessel revascularization （TVR）, stent thrombosis （ST）, perfusion surrogate markers and stroke. Results TIMI flow grade 3 and MBG 2-3 were significantly increased in the TA plus PCI arm compared with the PCI-only arm [relative risk （RR）： 1.05, 95% confidence intervals （CI）： 1.02-1.09, P = 0.004] and （RR： 1.68, 95% CI： 1.40-2.00, P 〈 0.001）, respectively. There were no significant differences in all-cause mortal- ity, MACEs, TVR and ST rates between the two groups. The RI rate was lower in the TA plus PCI arm than that in the PCI-only arm with short-term follow-up duration （RR： 0.60, 95% CI： 0.38-0.96, P = 0.03）, but there was no significant difference in RI incidence over the me- diumor long-term follow-up periods （RR： 1.00, 95% CI： 0.77-1.29, P = 0.98）, and （RR： 0.96, 95% CI： 0.81-1.15, P = 0.69）, respectively. There were statistically significant differences in the rates of crude stroke and stroke over the medium- or long-term follow-up periods and the crude stroke rate in the TA plus PCI （RR： 1.60, 95% CI： 1.08-2.38, P = 0.02） and （RR： 1.43, 95% CI： 1.03-1.98, P = 0.03）, respectively; this was not observed between the two arms during the short-term follow-up period （RR： 1.47, 95% CI： 0.97-2.21, P = 0.07）. Conclusions Routine TA-assisted PCI in STEMI patients can improve myocardial reperfusion and get limited benefits related to the clinical endpoints, which may be associated with stroke risk.展开更多
基金supported by Merit Review Award#I 01 RX000637-01A3 from the United States Department of Veterans Af airs Rehabilitation Research and Development Service Programsupport for the preparatory phase of the project was provided through the Med Star Health Research Institute,a component of the Georgetown Howard Universities Center for Clinical and Translational Sciencesupported by Grant U54 RR026076-01 from the National Center for Research Resources,a component of the National Institutes of Health
文摘Background: Traumatic brain injury is a major health problem that frequently leads to deficits in executive function. Self-regulation processes, such as goal-setting, may become disordered after traumatic brain injury, particularly when the frontal regions of the brain and their connections are involved. Such impairments reduce injured veterans' ability to return to work or school and to regain satisfactory personal lives. Understanding the neurologically disabling effects of brain injury on executive function is necessary for both the accurate diagnosis of impairment and the individual tailoring of rehabilitation processes to help returning service members recover independent function.Methods/design: The COMPASSgoal(Community Participation through Self-Efficacy Skills Development) program develops and tests a novel patient-centered intervention framework for community reintegration psychosocial research in veterans with mild traumatic brain injury. COMPASSgoal integrates the principles and best practices of goal self-management. Goal setting is a core skill in self-management training by which persons with chronic health conditions learn to improve their status and decrease symptom effects. Over a three-year period, COMPASSgoal will recruit 110 participants with residual executive dysfunction three months or more post-injury. Inclusion criteria combine both clinical diagnosis and standardized scores that are >1 SD from the normative score on the Frontal Systems Rating Scale. Participants are randomized into two groups: goal-management(intervention) and supported discharge(control). The intervention is administered in eight consecutive, weekly sessions. Assessments occur at enrollment, post-intervention/supported discharge, and three months post-treatment follow-up.Discussion: Goal management is part of the "natural language" of rehabilitation. However, collaborative goal-setting between clinicians/case managers and clients can be hindered by the cognitive deficits that follow brain injury. Re-training returning veterans with brain injury in goal management, with appropriate help and support, would essentially treat deficits in executive function. A structured approach to goal self-management may foster greater independence and self-efficacy, help veterans gain insight into goals that are realistic for them at a given time, and help clinicians and veterans to work more effectively as true collaborators.
文摘Objective:The Consolidated Standards for Reporting of Trials(CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials(RCTs).However,most of the Chinese medical journals have not endorsed the CONSORT statement.The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear.The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals.Methods:We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals(Journal type 1) without adoption of CONSORT and Chinese Journal of Evidence-based Medicine(Journal type 2) which adopted CONSORT in 2004.We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report,gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items.The reporting quality of RCT trials from 2001 to 2003(pre-adoption period) was compared with that from 2004 to 2006(post-adoption period).Results:The average reporting quality of RCTs was moderate(mean score,15.18),and the mean score of the 6 core items was low(mean score,1.09) in 5 leading journals.The difference in the total score and the score of the 6 core items between pre-adoption period(2001-2003) and post-adoption period(2004-2006) was statistically significant(P=0.003;P=0.000).Interaction between journal type and period was not significant(F=0.76;P=0.383).We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different.But as to the core items of sequence concealment and intention-to-treat analysis,the increases were greater for Journal type 2 when evaluated against Journal type 1(P=0.038;P=0.016).Conclusion:The reporting quality of RCT trials in 5 leading Chinese medical journals is improving.However,the lack of important items in RCT trials remains a serious problem.We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.
基金supported by the Bill&Melinda Gates Foundation(OPP1175213)supported by the Research Foundation Flanders(12X9620N and 12X9623N)the European Research Council(ERC)under the European Union’s Horizon 2020 research and innovation program(946192,HUMYCO)。
文摘Background:Evidence regarding the effectiveness of prenatal nutritional supplements has mainly considered anthropometric pregnancy outcomes.The effect on markers of health and disease,such as offspring telomere length(TL)and mitochondrial DNA content(mtDNAc)is unknown.Objectives:We assessed the efficacy of maternal multiple micronutrient(MMN)-fortified balanced-energy protein(BEP)and iron-folic acid(IFA)supplementation on newborn TL as a secondary outcome and mtDNAc as a non-declared outcome.Design:We conducted a randomized controlled trial in rural Burkina Faso,among pregnant females(15-40 years old)enrolled at<21 weeks of gestation.Mothers received either MMN-fortified BEP and IFA(intervention)or IFA only(control)throughout pregnancy.Whole arterial blood samples were collected from the umbilical cord of 104 control and 90 intervention group infants,respectively.Average relative TL and mtDNAc were measured using quantitative polymerase chain reaction.Linear regression models were fitted to assess TL and mtDNAc differences across trial arms.Results:We found that a combined daily MMN-fortified BEP supplement and IFA tablet did not affect newborn TL[β=-0.010(95%CI:-0.057,0.036);P=0.662]or mtDNAc[β=0.065(95%CI:-0.203,0.073);P=0.354],as compared to an IFA tablet alone.These findings were confirmed(P>0.05)by adjusting the regression models for potential prognostic factors of study outcomes at enrollment.Exploratory analyses indicated higher,but non-significantly different mtDNAc among children born either small-for-gestational age,low birthweight,or preterm.Conclusion:Newborns from mothers who received daily nutritional supplements across gestation did not have different relative TL or mtDNAc.
基金funded by the“Pioneer”and“Leading Goose”R&D Program of Zhejiang Province(2023C02044)the Key Research and Development Program for Science and Technology Projects of Zhejiang Province(2017C02003)The funding sources played no role in the study design,study implementation,data analysis,or manuscript preparation.Science and Technology Projects of Zhejiang Province(2017C02003).
文摘Numerous studies currently compare the lipid metabolism in patients with cardiovascular disease(CVD)and healthy individuals to identify lipid markers for predicting CVD.In this study,multidimensional mass spectrometry-based shotgun lipidomics was used to examine the serum lipidomics of participants in a clinical randomized controlled feeding trial undergoing olive oil(OO),camellia seed oil(CSO),and soybean oil(SO)dietary interventions.189 lipid molecules are identified,including 14 species of phosphatidylinositol,45 species of ethanolamine glycerols(PE),47 species of choline glycerophospholipids(PC),39 species of triacylglycerols(TAG),18 species of lysophosphatidylcholine,and 26 species of sphingomyelin.After screening,10 lipid markers are found,among which 18:2 fatty acid(FA),16:1 FA,C54:4/C55:11,C54:3/C55:10,and C52:3/C53:10 in TAG pool,p18:0/20:0 and a18:0/18:1 in PC pool,and p18:1/20:4 in PE pool have differential regulation in the SO group compared to OO and CSO.The d16:0/18:1 in PC pool and C52:2/C53:9 in TAG pool are differentially regulated by OO and CSO.The C52:2/C53:9 in TAG pool has a significant negative correlation with aspartate aminotransferase(r=-0.363,P=0.048)and high-density lipoprotein cholesterol(r=-0.519,P<0.01).This study provides a reference for researching the effect of dietary fat on blood lipid metabolism.
文摘Background The clinical efficacy and safety of adjunctive thrombus aspiration （TA） in patients with ST-segment elevation myocardial infarction （STEMI） during percutaneous coronary intervention （PCI） remain controversial. Methods Twenty five eligible randomized controlled trials were included to compare the use of thrombus aspiration （TA） with PCI and PCI-only for STEMI. The primary endpoint was all-cause mortality and death. The secondary endpoints were major adverse cardiac events （MACE）, recurrent infarction （RI）, target vessel revascularization （TVR）, stent thrombosis （ST）, perfusion surrogate markers and stroke. Results TIMI flow grade 3 and MBG 2-3 were significantly increased in the TA plus PCI arm compared with the PCI-only arm [relative risk （RR）： 1.05, 95% confidence intervals （CI）： 1.02-1.09, P = 0.004] and （RR： 1.68, 95% CI： 1.40-2.00, P 〈 0.001）, respectively. There were no significant differences in all-cause mortal- ity, MACEs, TVR and ST rates between the two groups. The RI rate was lower in the TA plus PCI arm than that in the PCI-only arm with short-term follow-up duration （RR： 0.60, 95% CI： 0.38-0.96, P = 0.03）, but there was no significant difference in RI incidence over the me- diumor long-term follow-up periods （RR： 1.00, 95% CI： 0.77-1.29, P = 0.98）, and （RR： 0.96, 95% CI： 0.81-1.15, P = 0.69）, respectively. There were statistically significant differences in the rates of crude stroke and stroke over the medium- or long-term follow-up periods and the crude stroke rate in the TA plus PCI （RR： 1.60, 95% CI： 1.08-2.38, P = 0.02） and （RR： 1.43, 95% CI： 1.03-1.98, P = 0.03）, respectively; this was not observed between the two arms during the short-term follow-up period （RR： 1.47, 95% CI： 0.97-2.21, P = 0.07）. Conclusions Routine TA-assisted PCI in STEMI patients can improve myocardial reperfusion and get limited benefits related to the clinical endpoints, which may be associated with stroke risk.
