Purpose:This study aimed to describe the effects of a 1-year lifestyle intervention on hemoglobin A1c(HbA1c)and cardiovascular risk factors5 years after cessation of the lifestyle intervention in persons with type 2 d...Purpose:This study aimed to describe the effects of a 1-year lifestyle intervention on hemoglobin A1c(HbA1c)and cardiovascular risk factors5 years after cessation of the lifestyle intervention in persons with type 2 diabetes(T2D).Methods:From April 2015 to August 2016,98 persons with T2D(duration<10 years)were randomly allocated(2:1,stratified by sex)to a 1-year lifestyle intervention group(INT)(n=64)or a standard care group(StC)(n=34).All participants received standard care with blinded,targetdriven medical therapy.INT included up to 5-6 weekly supervised aerobic and strength training sessions and dietary plans targeting a body mass index≤25 kg/m^(2).No intervention was given during the follow-up period.Forty-nine(77%)and 19(56%)participants in INT and StC attended the 6-year follow-up.Based on the original intention-to-treat population,the primary outcome was the change in HbA1c from baseline to 6-year follow-up.Secondary outcomes included weight,Low density lipoprotein(LDL)cholesterol,blood pressure(BP),and cardiorespiratory fitness.Results:Ninety-eight participants(mean age=54.6 years;46%women;mean baseline Hemoglobin A1c(HbA1c)=49.8 mmol/mol)were analyzed.HbA1c changed 6%and 13%in the INT and StC from baseline to 6-year follow-up(between group difference=-6%(95%confidence interval(95%CI):-14%to 3%);p=0.18).While no differences were observed for most secondary outcomes,the diastolic BP decreased6.0(95%CI:2.1 to 9.8)mmHg more in the StC compared to INT.Conclusion:The sustained effect of the lifestyle intervention on glycemic control and cardiovascular risk factors was marginal,and it was surprisingly associated with inferior diastolic BP regulation.展开更多
Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content...Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content. The objective of this study was to compare the combined measurement properties of two fatigue scales, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and SF-36 vitality (VT) scale using item response theory (IRT). Methods: The FACIT-Fatigue and SF-36v2 were administered at baseline and weeks 2, 4, 7, 12, and 16 to rheumatoid arthritis (RA) patients (n = 237) enrolled in a 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy and safety of subcutaneous secukinumab administered to pa- tients with active RA. Confirmatory factor analysis (CFA) was used to investigate unidimensionality among FACIT- Fatigue and VT items. A generalized partial credit IRT model was used to cross-calibrate the FACIT-Fatigue and VT items and weighted maximum-likelihood estimation was used to score a composite fatigue index. Analysis of variance was used to compare the composite fatigue index with the original scales in responding to ACR improvement and treatment effects. Results: CFA found less than adequate fit to a unidimensional model. However, specifications of alternative multidimensional models were insufficient in explaining the common variance among items. An IRT model was successfully fitted and the composite fatigue index score was found to be more responsive than the original scales to ACR improvement and treatment effects. Effect sizes and significance tests for changes in scores on the composite index were generally larger than those observed with the original scales. Conclusion: IRT methods offer a promising approach to combining items from different scales measuring the same concept that could improve the detection of treatment effects in clinical studies of RA.展开更多
基金funding from TrygFondenThe Centre for Physical Activity Research(CFAS)is supported by a grant from TrygFonden+4 种基金support for this work was provided by a grant from the Danish Diabetes Academyfunded by the Novo Nordisk Foundation(MR-L)and a grant from Rigshospitalet(MYJ)supported by the Canadian Institutes of Health Research(MFE-176582)the Section for Biostatistics and Evidence-Based Research,the Parker Institute,Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation(OCAY-18-774-OFIL)the strategic research alliance Excellence of Diabetes Research in Sweden(EXODIAB)funded by the Swedish Research Council(EXODIAB,2009-1039,2018-02837)。
文摘Purpose:This study aimed to describe the effects of a 1-year lifestyle intervention on hemoglobin A1c(HbA1c)and cardiovascular risk factors5 years after cessation of the lifestyle intervention in persons with type 2 diabetes(T2D).Methods:From April 2015 to August 2016,98 persons with T2D(duration<10 years)were randomly allocated(2:1,stratified by sex)to a 1-year lifestyle intervention group(INT)(n=64)or a standard care group(StC)(n=34).All participants received standard care with blinded,targetdriven medical therapy.INT included up to 5-6 weekly supervised aerobic and strength training sessions and dietary plans targeting a body mass index≤25 kg/m^(2).No intervention was given during the follow-up period.Forty-nine(77%)and 19(56%)participants in INT and StC attended the 6-year follow-up.Based on the original intention-to-treat population,the primary outcome was the change in HbA1c from baseline to 6-year follow-up.Secondary outcomes included weight,Low density lipoprotein(LDL)cholesterol,blood pressure(BP),and cardiorespiratory fitness.Results:Ninety-eight participants(mean age=54.6 years;46%women;mean baseline Hemoglobin A1c(HbA1c)=49.8 mmol/mol)were analyzed.HbA1c changed 6%and 13%in the INT and StC from baseline to 6-year follow-up(between group difference=-6%(95%confidence interval(95%CI):-14%to 3%);p=0.18).While no differences were observed for most secondary outcomes,the diastolic BP decreased6.0(95%CI:2.1 to 9.8)mmHg more in the StC compared to INT.Conclusion:The sustained effect of the lifestyle intervention on glycemic control and cardiovascular risk factors was marginal,and it was surprisingly associated with inferior diastolic BP regulation.
文摘Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content. The objective of this study was to compare the combined measurement properties of two fatigue scales, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and SF-36 vitality (VT) scale using item response theory (IRT). Methods: The FACIT-Fatigue and SF-36v2 were administered at baseline and weeks 2, 4, 7, 12, and 16 to rheumatoid arthritis (RA) patients (n = 237) enrolled in a 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy and safety of subcutaneous secukinumab administered to pa- tients with active RA. Confirmatory factor analysis (CFA) was used to investigate unidimensionality among FACIT- Fatigue and VT items. A generalized partial credit IRT model was used to cross-calibrate the FACIT-Fatigue and VT items and weighted maximum-likelihood estimation was used to score a composite fatigue index. Analysis of variance was used to compare the composite fatigue index with the original scales in responding to ACR improvement and treatment effects. Results: CFA found less than adequate fit to a unidimensional model. However, specifications of alternative multidimensional models were insufficient in explaining the common variance among items. An IRT model was successfully fitted and the composite fatigue index score was found to be more responsive than the original scales to ACR improvement and treatment effects. Effect sizes and significance tests for changes in scores on the composite index were generally larger than those observed with the original scales. Conclusion: IRT methods offer a promising approach to combining items from different scales measuring the same concept that could improve the detection of treatment effects in clinical studies of RA.
