scholarly journals Regression to the mean contributes to the apparent improvement in glycemia 3.8 years after screening – the ELSA-Brasil Study

2020 ◽  
Author(s):  
Maria Inês Schmidt ◽  
Paula Bracco ◽  
Scheine Canhada ◽  
Joanna MN Guimarães ◽  
Sandhi Maria Barreto ◽  
...  

<b>Objective </b> <p>Glycemic regression is common in real world settings, but the contribution of regression to the mean (RTM) has been little investigated. We aimed to estimate glycemic regression before and after adjusting for RTM in a free-living cohort of adults with newly ascertained diabetes and intermediate hyperglycemia (IH). </p> <p><b>Research Design and Methods</b></p> <p>ELSA-Brasil is a cohort study of 15,105 adults screened between 2008-2010 with standardized OGTT and HbA1c, repeated after 3.84 (0.42) years. After excluding those receiving medical treatment for diabetes, we calculated partial or complete regression before and after adjusting baseline values for RTM. </p> <p><b>Results</b></p> <p>Regarding newly ascertained diabetes, partial or complete regression was seen in 49.4% (95%CI 45.2 – 53.7); after adjustment for RTM, in 20.2% (95%CI 12.1 – 28.3). Regarding IH, regression to normal levels was seen in 39.5% (95%CI 37.9 – 41.3) or in 23.7% (95%CI 22.6% – 24.3%) depending on the WHO or the ADA definition, respectively; after adjustment, corresponding frequencies were 26.1% (95%CI 22.4 – 28.1) and 19.4% (95%CI 18.4 – 20.5). Adjustment for RTM reduced the number of cases detected at screening: 526 to 94 cases of diabetes; 3118 to 1986 cases of WHO-defined IH; and 6182 to 5711 cases of AD-defined IH. Weight loss ≥2.6% was associated with greater regression from diabetes (RR=1.52 95%CI 1.26-1.84) and IH (RR=1.30 95%CI 1.17-1.45). </p> <p><b>Conclusions</b></p> <p>In this quasi-real-world setting, regression from diabetes at ~4 years was common, less so for IH. Regression was frequently explained by RTM, but, in part, also related to improved weight loss and homeostasis over the follow-up. </p>

2020 ◽  
Author(s):  
Maria Inês Schmidt ◽  
Paula Bracco ◽  
Scheine Canhada ◽  
Joanna MN Guimarães ◽  
Sandhi Maria Barreto ◽  
...  

<b>Objective </b> <p>Glycemic regression is common in real world settings, but the contribution of regression to the mean (RTM) has been little investigated. We aimed to estimate glycemic regression before and after adjusting for RTM in a free-living cohort of adults with newly ascertained diabetes and intermediate hyperglycemia (IH). </p> <p><b>Research Design and Methods</b></p> <p>ELSA-Brasil is a cohort study of 15,105 adults screened between 2008-2010 with standardized OGTT and HbA1c, repeated after 3.84 (0.42) years. After excluding those receiving medical treatment for diabetes, we calculated partial or complete regression before and after adjusting baseline values for RTM. </p> <p><b>Results</b></p> <p>Regarding newly ascertained diabetes, partial or complete regression was seen in 49.4% (95%CI 45.2 – 53.7); after adjustment for RTM, in 20.2% (95%CI 12.1 – 28.3). Regarding IH, regression to normal levels was seen in 39.5% (95%CI 37.9 – 41.3) or in 23.7% (95%CI 22.6% – 24.3%) depending on the WHO or the ADA definition, respectively; after adjustment, corresponding frequencies were 26.1% (95%CI 22.4 – 28.1) and 19.4% (95%CI 18.4 – 20.5). Adjustment for RTM reduced the number of cases detected at screening: 526 to 94 cases of diabetes; 3118 to 1986 cases of WHO-defined IH; and 6182 to 5711 cases of AD-defined IH. Weight loss ≥2.6% was associated with greater regression from diabetes (RR=1.52 95%CI 1.26-1.84) and IH (RR=1.30 95%CI 1.17-1.45). </p> <p><b>Conclusions</b></p> <p>In this quasi-real-world setting, regression from diabetes at ~4 years was common, less so for IH. Regression was frequently explained by RTM, but, in part, also related to improved weight loss and homeostasis over the follow-up. </p>


2020 ◽  
Author(s):  
Anna-Leena Vuorinen ◽  
Elina Helander ◽  
Julia Pietilä ◽  
Ilkka Korhonen

BACKGROUND Frequent self-weighing is associated with successful weight loss and weight maintenance during and after weight loss interventions. Less is known about self-weighing behaviors and associated weight change in free-living settings. OBJECTIVE This study aimed to investigate the association between the frequency of self-weighing and changes in body weight in a large international cohort of smart scale users. METHODS This was an observational cohort study with 10,000 randomly selected smart scale users who had used the scale for at least 1 year. Longitudinal weight measurement data were analyzed. The association between the frequency of self-weighing and weight change over the follow-up was investigated among normal weight, overweight, and obese users using Pearson’s correlation coefficient and linear models. The association between the frequency of self-weighing and temporal weight change was analyzed using linear mixed effects models. RESULTS The eligible sample consisted of 9768 participants (6515/9768, 66.7% men; mean age 41.5 years; mean BMI 26.8 kg/m2). Of the participants, 4003 (4003/9768, 41.0%), 3748 (3748/9768, 38.4%), and 2017 (2017/9768, 20.6%) were normal weight, overweight, and obese, respectively. During the mean follow-up time of 1085 days, the mean weight change was –0.59 kg, and the mean percentage of days with a self-weigh was 39.98%, which equals 2.8 self-weighs per week. The percentage of self-weighing days correlated inversely with weight change, <i>r</i>=–0.111 (<i>P</i>&lt;.001). Among normal weight, overweight, and obese individuals, the correlations were <i>r</i>=–0.100 (<i>P</i>&lt;.001), <i>r</i>=–0.125 (<i>P</i>&lt;.001), and <i>r</i>=–0.148 (<i>P</i>&lt;.001), respectively. Of all participants, 72.5% (7085/9768) had at least one period of ≥30 days without weight measurements. During the break, weight increased, and weight gains were more pronounced among overweight and obese individuals: 0.58 kg in the normal weight group, 0.93 kg in the overweight group, and 1.37 kg in the obese group (<i>P</i>&lt;.001). CONCLUSIONS Frequent self-weighing was associated with favorable weight loss outcomes also in an uncontrolled, free-living setting, regardless of specific weight loss interventions. The beneficial associations of regular self-weighing were more pronounced for overweight or obese individuals.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Oriel Spierer ◽  
Abraham Spierer

Abstract Background Different surgical methods have been suggested for the correction of intermittent exotropia. Unilateral lateral rectus recession has been described as a surgical alternative for small and moderate-angle exotropia. In general, previous studies did not focus on the outcomes of unilateral lateral rectus recession in young children with intermittent exotropia. The purpose of this study is to evaluate the surgical outcomes of unilateral lateral rectus recession in the treatment of moderate-angle exotropia (≤ 25 PD (prism diopters)) in children. Methods The charts of all patients younger than 12 years of age with moderate-angle exotropia (up to 25 PD) who were operated during the years 2006–2018 were retrospectively reviewed. Fifty-eight patients underwent unilateral lateral rectus recession and had a minimum follow up of 6 months. The angle of exotropia (PD) before and after surgery and the success rate were documented. Results Mean age at surgery was 6.4 ± 1.9 (range 3.5–11.0) years. Exotropia improved from a preoperative angle of 21.4 ± 4.0 PD to 3.5 ± 5.9 PD postoperatively (p < 0.001). Success rate, defined as deviation of ≤ 10 PD, was achieved in 86.2%. There were 2 (3.4%) cases of overcorrection (consecutive esotropia). There were no intra- or postoperative complications. The mean follow-up duration after surgery was 2.3 ± 1.7 years. Conclusions In children with moderate angle exotropia, good postoperative success rate was achieved by performing unilateral lateral rectus recession.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040819
Author(s):  
Pontus Rygh ◽  
Ina Asklund ◽  
Eva Samuelsson

ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months’ use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.


2020 ◽  
Vol 9 (7) ◽  
pp. 2275
Author(s):  
Juan J. Gorgojo-Martínez ◽  
Manuel A. Gargallo-Fernández ◽  
Alba Galdón Sanz-Pastor ◽  
Teresa Antón-Bravo ◽  
Miguel Brito-Sanfiel ◽  
...  

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.


Author(s):  
Juan Vivanco‐Suarez ◽  
Alan Mendez‐Ruiz ◽  
Farooqui Mudassir ◽  
Cynthia B Zevallos ◽  
Milagros Galecio‐Castillo ◽  
...  

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.


2021 ◽  
Vol 36 (6) ◽  
pp. 1187-1188
Author(s):  
Jason A Blake ◽  
Brandon Mitchell ◽  
Staci McKay ◽  
Gitendra Uswatte ◽  
Edward Taub

Abstract Objective Currently, the majority of cognitive training research measures treatment efficacy using in-laboratory measures, with minimal focus on real-world treatment changes. This case series demonstrates the feasibility of transferring cognitive improvements from the laboratory into the everyday life setting. Method This case series includes 6 chronic post-stroke participants; mild to moderate cognitive impairment. The intervention combines cognitive training with behavioral techniques, known as the Transfer Package (TP). The TP involves components that target functionality on IADLs in the real-world. Performance on cognitively-based IADLs in the real world are measured pre-treatment, post, and 6-month follow-up. Measures of real-world ability are the: Canadian Occupational Performance Measure (COPM), Cognitive Task Activity Log (CTAL) and Inventory of Improved and New Abilities (INCA). In-laboratory measures included the D-KEFS and Timed IADL assessments. Results The real-world outcome measures used in this study were the COPM and two measures developed for this study, the CTAL and INCA. The mean change from pre to post on the COPM Performance Scale was 2.18 (SD = 1.33) and the mean change on the COPM Satisfaction Scale was 2.70 (SD = 1.27). The mean change on the CTAL was 1.96 (SD = 0.93). On the INCA, the mean number of improved real-world cognitive activities was 11.8 (SD = 4.9) and the mean number of new cognitive activities was 7.6 (SD = 3.9). Follow-up reported near-perfect retention on CTAL and continued improvement on the INCA. There were minimal changes on in-laboratory measures. Conclusions This case series provides a framework for achieving the transfer of cognitive training treatment effects in the real-world life situation by overcoming behavioral barriers to functioning.


2021 ◽  
Vol 10 (18) ◽  
pp. 4062
Author(s):  
François-Victor Prigent ◽  
Kévin Guillen ◽  
Pierre-Olivier Comby ◽  
Julie Pellegrinelli ◽  
Nicolas Falvo ◽  
...  

Selective arterial embolization (SAE) for renal angiomyolipoma (rAML) is effective to treat or prevent bleeding. We report our experience using a cyanoacrylate–Lipiodol mixture. We performed a single-center retrospective review of all rAMLs embolized with cyanoacrylate glue between July 2014 and June 2020. Demographics, tuberous sclerosis complex (TSC) status, clinical presentation, angiography features, and follow-up data were recorded. Pre- and post-procedure rAML sizes and volumes were estimated from computed tomography (CT) or magnetic resonance imaging (MRI) studies. Kidney function was assessed before and after the procedure. We identified 24 patients (22 females and 2 males, mean age 51 years) treated for 27 AMLs, either prophylactically (n = 20) or as an emergency (n = 4). Technical success was achieved for 25/27 AMLs; two patients, each with a single AML, required nephrectomy and repeated embolization, respectively. Major complications occurred in three patients and minor complications such as postembolization syndrome in 15 patients. AML volume reduction after embolization was 55.1% after a mean follow-up of 15 months (range, 1–72 months). Factors associated with greater volume reduction were a smaller percentage of fat (p = 0.001), larger initial rAML volume (p = 0.014), and longer follow-up (p = 0.0001). The mean creatinine level did not change after SAE. Embolization of rAMLs with a mixture of cyanoacrylate and Lipiodol is feasible, safe, and effective in significantly decreasing tumor volume.


2018 ◽  
Vol 30 (1) ◽  
pp. 162-167 ◽  
Author(s):  
Dina H Hassanein ◽  
Ahmed Awadein ◽  
Hala Elhilali

Purpose: To analyze the risk factors associated with early and late failure after goniotomy for primary pediatric glaucoma. Methods: A retrospective study was done on infants who underwent goniotomy as the initial surgical procedure for primary pediatric glaucoma, and had a follow-up period ⩾48 months after surgery. Early and late failures were defined as intraocular pressure ⩾18 mmHg or signs of glaucoma progression before and after the end of first year, respectively. Results: A total of 81 eyes of 47 children were included. The mean age at the time of surgery was 6.1 ± 6.7 months, 34 children (72.3%) were bilateral. The mean follow-up was 5.9 ± 2.8 years. Of the included eyes, 41 eyes (50.6%) showed success, 25 eyes (30.9%) showed an early failure, and 15 eyes (18.5%) showed a late failure. The mean survival time was 43 months. However, only surgery before the end of the first month and positive consanguinity of the parents (P < 0.01 for both) were independent risk factors for early and late failure of goniotomy for primary pediatric glaucoma. Patients with late failure showed a statistically significant lower preoperative intraocular pressure (P = 0.02). A larger preoperative corneal diameter and a male gender were associated with higher but statistically insignificant failure rates. There were no differences in the early or late failure rates between unilateral and bilateral cases. Conclusion: A positive consanguinity of the parents and surgery before the end of the first month are the major predictors of failure of goniotomy.


Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Ebenezer T Oni ◽  
Ehimen Aneni ◽  
Maribeth Rouseff ◽  
Thinh Tran ◽  
Henry Guzman ◽  
...  

Negative impact of CVD as the leading cause of death in the US is worsened by the significant burden of obesity and associated morbidity and concerns about the growing population inactivity. The American Heart Association has emphasized worksite-based interventions to improve CV health. We evaluated the benefits of improved physical activity(PA) and weight loss(WL) among employees of the Baptist Health South Florida enrolled in a wellness intervention program. Methods: Employees with two or more Cardio-metabolic risk factors , such as total cholesterol ≥ 200 mg/dl, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, hemoglobin A1C ≥ 6.5%, and body mass index (BMI) ≥ 30 were enrolled in an intervention program themed “My unlimited potential”. Interventions were focused on diet and PA modifications. We defined improved physical activity as the difference in the metabolic equivalents (METs) at 12 weeks follow-up and at baseline. WL (lbs) was the difference in weight at follow-up. The relationship between WL and changes in METs was explored in an ordered logistic regression. Results: Overall 203 (48±10 years, 78% females) employees were enrolled with a retention rate of 89% (n=181) at 12 weeks follow-up. At baseline the median weights was 211 lbs., and mean METs- 8.6, while at follow-up the median weight was 200 lbs, and the mean METs 11. At 12 weeks follow up 38% had significant WL (lost >5% of baseline weight). The median WL was 8.4 (IQR 4.8-13.0) lbs and the mean change in METs was 2.4±1.8. Median WL increased with increasing tertiles of METs change; tertile1- 6.5(4-11) lbs., tertile2- 9(6-13)lbs. tertile3- 11(7-15)lbs. Increased PA was related to increased WL across BMI categories adjusting for age, gender and baseline weight. Conclusion: This study points strongly toward the benefit of increasing PA among other lifestyle modification interventions in controlling weight. Although further follow-up of this population to evaluate sustainability of change is needed, our results clearly relate improved PA and health.


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