Evidence For Sustained Effect Research Articles

Pictorial information about subclinical atherosclerosis reduces the CVD risk: Results from the VIPVIZA RCT

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Region Västerbotten and the Swedish Research Council Background The VIPVIZA trial has previously shown beneficial effects on cardiovascular disease (CVD) risk scores 1 year after sending pictorial information of carotid ultrasound imaging (Picture 1) to individuals and their physicians Purpose To investigate whether the beneficial effects on CVD-risk observed at 1-year were sustained over three years Methods VIPVIZA is a pragmatic prospective open-label randomized controlled trial with blinded evaluators performed within a CVD prevention programme integrated in the regular primary health care in Västerbotten County, Sweden. Individuals aged 40, 50 or 60 years old with one CVD risk factor were enrolled and randomised 1:1 to intervention (n = 1749, pictorial information about subclinical atherosclerosis provided to participants and physicians, Picture 1) or control group(n = 1783, no information to participants or physicians). Intervention participants also recieved a follow-up phone call and the corresponding physicians written guideline-based information about the clinical significance of carotid ultrasound results. Participants were examined at baseline (2013-2016), after one and at three years Results A significant beneficial effect on cardiovascular risk was observed at the 3-year follow-up; Framingham Risk Score (FRS) was 13.38 for the intervention group and 14.08 for the control group(p = 0.047) and SCORE was 1.69 vs. 1.82(p = 0.022) respectively. The 3-year results adjusted for sex and educational level showed significant differences between the intervention and control group in FRS, SCORE, P-Total-Cholesterol, P-LDL-Cholesterol and waist circumference in favour of the intervention group. Analysis by sex showed difference in differences(DID) in FRS for men -1.19(95% CI -2.01 to -0.37) and -0.50(95% CI -0.93 to -0.07) for women and in SCORE for men -0.20(95% CI -0.33 to -0.06) and -0.08 (95% CI -0.13 to -0.04) for women, between the two groups over 3 years. Similarly, there were significant differences in DID in all educational groups. Further stratification by baseline FRS and SCORE risk category, showed a beneficial pattern of the intervention in all risk groups, however the DID at the 3-year follow-up was statistically significant only in the intermediate risk group for both FRS -1.34(95% CI -2.13 to -0.56) and SCORE -0.19(95% CI -0.32 to -0.05) Conclusions This study provides evidence of sustained effects over three years of pictorial information of subclinical carotid atherosclerosis on the reduction of cardiovascular risk regardless of sex and educational level. Importantly, a statistically significant intervention effect was seen in the intermediate risk group, where the majority of CVD events occur. Visualization of subclinical atherosclerosis may be one way to approach individuals at intermediate risk of CVD, a group where sufficient prevention is often overlooked. However, further studies are needed to investigate the intervention effect on hard end points as CVD-events and death. Abstract Figure. Picture 1

Long-term metformin treatment in adolescents with obesity and insulin resistance, results of an open label extension study

Background/ObjectivesOff-label metformin is nowadays frequently used for the treatment of obesity in adolescents. However, studies on long-term metformin treatment in adolescents with obesity are scarce. Therefore, an 18 month open label extension study following an 18 months randomized placebo-controlled trial (RCT) on the efficacy, safety, and tolerability of metformin in adolescents with obesity and insulin resistance was performed.Subjects/MethodsAfter completion of the RCT, metformin was offered to all participants with a body mass index standard deviation score (BMI-sds) > 2.3 and Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) ≥ 3.4. Endpoints were change in BMI and HOMA-IR.ResultsOverall, 31/42 participants completed the extension study (74% girls, median age 14.8 (11.6 – 17.9), BMI 31.2 (22.3 – 45.1), HOMA-IR 3.4 (0.2 – 8.8)). At start, 22/42 (52.4%) participants were eligible for metformin of which 13 (59.0%) agreed with treatment. In participants who continued metformin, an increase was observed in BMI (+2.2 (+0.2 to +9.0)) and HOMA-IR (+13.7 (+1.6 to +48.3)). In metformin naive participants, BMI stabilized after an initial decrease (+0.5 (−2.1 to +5.1)). For HOMA-IR, a decrease was observed (−1.1 (−4.6 to +1.4)).ConclusionWhile metformin treatment in metformin naive participants seems to result in an initial decrease in BMI and HOMA-IR, there is no evidence for sustained effect after prolonged use in adolescents. Limited compliance and/or insufficient dose may explain the differences in long-term effects between adolescents and adults.

Still no Evidence for Sustained Effects of Multisensory Integration of Duration.

In studies on temporal order perception, immediate as well as sustained effects of multisensory integration have been demonstrated repeatedly. Regarding duration perception, the corresponding literature reports clear immediate effects of multisensory integration, but evidence on sustained effects of multisensory duration integration is scarce. In fact, a single study [Heron, J. et al. (2013). Aneural hierarchy for illusions of time: Duration adaptation precedes multisensory integration, J.Vis. 13, 1-12.] investigated adaptation to multisensory conflicting intervals, and found no sustained effects of the audiovisual conflict on perceived duration of subsequently presented unimodal visual intervals. In two experiments, we provide independent evidence in support of this finding. In Experiment1, we demonstrate that adaptation to audiovisual conflict does not alter perceived duration of subsequently presented visual test intervals. Thus, replicating the results of Heron et al. (2013), we observed no sustained effect of multisensory duration integration. However, one might argue that the prolonged exposure to consistent multisensory conflict might have prevented or hampered multisensory integration per se. In Experiment2, we rule out this alternative explanation by showing that multisensory integration of audiovisual conflicting intervals is still effective after exposure to audiovisual conflict. This further strengthens the conclusion that multisensory integration of interval duration affects perception in an immediate, but not in a sustained manner.

Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping

IntroductionTinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus. Bimodal neuromodulation is emerging as a promising treatment for this condition. The main objectives of...

2GETHER - The Dual Protection Project: Design and rationale of a randomized controlled trial to increase dual protection strategy selection and adherence among African American adolescent females

BackgroundAfrican American adolescent females are at elevated risk for unintended pregnancy and sexually transmitted infections (STIs). Dual protection (DP) is defined as concurrent prevention of pregnancy and STIs. This can be achieved by abstinence, consistent condom use, or the dual methods of condoms plus an effective non-barrier contraceptive. Previous clinic-based interventions showed short-term effects on increasing dual method use, but evidence of sustained effects on dual method use and decreased incident pregnancies and STIs are lacking. Methods/designThis manuscript describes the 2GETHER Project. 2GETHER is a randomized controlled trial of a multi-component intervention to increase dual protection use among sexually active African American females aged 14–19years not desiring pregnancy at a Title X clinic in Atlanta, GA. The intervention is clinic-based and includes a culturally tailored interactive multimedia component and counseling sessions, both to assist in selection of a DP method and to reinforce use of the DP method. The participants are randomized to the study intervention or the standard of care, and followed for 12months to evaluate how the intervention influences DP method selection and adherence, pregnancy and STI incidence, and participants' DP knowledge, intentions, and self-efficacy. DiscussionThe 2GETHER Project is a novel trial to reduce unintended pregnancies and STIs among African American adolescents. The intervention is unique in the comprehensive and complementary nature of its components and its individual tailoring of provider-patient interaction. If the trial interventions are shown to be effective, then it will be reasonable to assess their scalability and applicability in other populations.