Comparison of smartwatch-based measures between participants with and without diabetes in the middle-aged and older participants of the electronic Framingham Heart Study (Preprint)

2021 ◽  
Author(s):  
Yuankai Zhang ◽  
Chathurangi H. Pathiravasan ◽  
Michael M. Hammond ◽  
Hongshan Liu ◽  
Honghuang Lin ◽  
...  

BACKGROUND Daily physical activities are related to the development of diabetes. However, traditional research methods are not optimal to document long-term daily routine patterns. mHealth offers an effective approach to collect users’ long-term daily activities and daily routine patterns. OBJECTIVE To evaluate cross-sectional associations of daily routine variables derived from a smartwatch with diabetes and prediabetes status in the electronic Framingham Heart Study (eFHS). METHODS At baseline, diabetes was defined as fasting blood glucose (FBG) ≥126 mg/dL or on self-report of glucose lowering medication; prediabetes as FBG 100-125 mg/dL; the rest were referents. Using smartwatch data, we calculated an average daily step count, and identified the first and last watch time on a given day. We compared average daily step counts and the intra-individual day-to-day variability of the first and last watch time in participants with diabetes and prediabetes to referents, adjusting for age, sex, and race/ethnicity. RESULTS We included 796 participants (mean age 53, 62% women, 41 diabetes, 209 prediabetes, and 546 referents) in up to 3-year of follow-up (median follow-up=219 days) since the baseline. On average, participants with diabetes took 1,611 fewer daily steps (95% CI=863, 2,360; p-value<0.001), and displayed 13 minutes (95% CI=6, 20; p-value<0.001) greater variation in their first watch time, 6 minutes (95% CI=2, 10; p-value=0.005) greater variation in their last watch time, compared to referents. Participants with prediabetes also walked fewer daily steps (p-value=0.04) and displayed larger variation in their first watch time (p-value=0.04) compared to referents. CONCLUSIONS Participants with diabetes on average walked significantly fewer daily steps and displayed larger variations in their morning and night watch time routines. These findings may shed light on the roles of physical activity and daily routine in diabetes management.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Medina-Inojosa ◽  
A Ladejobi ◽  
Z Attia ◽  
M Shelly-Cohen ◽  
B Gersh ◽  
...  

Abstract Background We have demonstrated that artificial intelligence interpretation of ECGs (AI-ECG) can estimate an individual's physiologic age and that the gap between AI-ECG and chronologic age (Age-Gap) is associated with increased mortality. We hypothesized that Age-Gap would predict long-term atherosclerotic cardiovascular disease (ASCVD) and that Age-Gap would refine the ACC/AHA Pooled Cohort Equations' (PCE) predictive abilities. Methods Using the Rochester Epidemiology Project (REP) we evaluated a community-based cohort of consecutive patients seeking primary care between 1998–2000 and followed through March 2016. Inclusion criteria were age 40–79 and complete data to calculate PCE. We excluded those with known ASCVD, AF, HF or an event within 30 days of baseline.A neural network, trained, validated, and tested in an independent cohort of ∼ 500,000 independent patients, using 10-second digital samples of raw, 12 lead ECGs. PCE was categorized as low&lt;5%, intermediate 5–9.9%, high 10–19.9%, and very high≥20%. The primary endpoint was ASCVD and included fatal and non-fatal myocardial infarction and ischemic stroke; the secondary endpoint also included coronary revascularization [Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG)], TIA and Cardiovascular mortality. Events were validated in duplicate. Follow-up was truncated at 10 years for PCE analysis. The association between Age-Gap with ASCVD and expanded ASCVD was assessed with cox proportional hazard models that adjusted for chronological age, sex and risk factors. Models were stratified by PCE risk categories to evaluate the effect of PCE predicted risk. Results We included 24,793 patients (54% women, 95% Caucasian) with mean follow up of 12.6±5.1 years. 2,366 (9.5%) developed ASCVD events and 3,401 (13.7%) the expanded ASCVD. Mean chronologic age was 53.6±11.6 years and the AI-ECG age was 54.5±10.9 years, R2=0.7865, p&lt;0.0001. The mean Age-Gap was 0.87±7.38 years. After adjusting for age and sex, those considered older by ECG, compared to their chronologic age had a higher risk for ASCVD when compared to those with &lt;−2 SD age gap (considered younger by ECG). (Figure 1A), with similar results when using the expanded definition of ASCVD (data not shown). Furthermore, Age-Gap enhanced predicted capabilities of the PCE among those with low 10-year predicted risk (&lt;5%): Age and sex adjusted HR 4.73, 95% CI 1.42–15.74, p-value=0.01 and among those with high predicted risk (&gt;20%) age and sex adjusted HR 6.90, 95% CI 1.98–24.08, p-value=0.0006, when comparing those older to younger by ECG respectively (Figure 1B). Conclusion The difference between physiologic AI-ECG age and chronologic age is associated with long-term ASCVD, and enhances current risk calculators (PCE) ability to identify high and low risk individuals. This may help identify individuals who should or should not be treated with newer, expensive risk-reducing therapies. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Mayo Clinic


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
A Hooker ◽  
R A Leeuw ◽  
J Twisk ◽  
H Brolmann ◽  
J Huirne

Abstract Study question Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs. Summary answer Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs. What is known already The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance. Study design, size, duration This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8–12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization. Participants/materials, setting, methods Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded. Main results and the role of chance In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value &lt;0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups. Limitations, reasons for caution In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol. Wider implications of the findings As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered. Trial registration number Netherlands Trial Register NTR 3120.


2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively


2020 ◽  
Vol 31 (4) ◽  
pp. 513-518
Author(s):  
Antti I Lehtomäki ◽  
Riikka M Nevalainen ◽  
Vesa J Toikkanen ◽  
Emilia S Pohja ◽  
Jaakko J Nieminen ◽  
...  

Abstract OBJECTIVES Patients with pleural infections frequently have several comorbidities and inferior long-term survival. We hypothesized that these patients represent a vulnerable cohort with high rates of hospitalization and frequent use of healthcare services. This study aims to ascertain the need for and causes of treatment episodes after pleural infections during long-term follow-up. METHODS Patients treated for pleural infections at Tampere University Hospital between January 2000 and December 2008 (n = 191, 81% males, median age 58 years) were included and compared to a demographically matched population-based random sample of 1910 controls. Seventy percent of the pleural infections were caused by pneumonias and 80% of the patients underwent surgery. Information regarding later in-hospital periods and emergency room and out-patient clinic visits, as well as survival data, was obtained from national registries and compared between patients and controls. RESULTS Patients treated for pleural infections had significantly higher rates of hospitalizations (8.19 vs 2.19), in-hospital days (88.5 vs 26.6), emergency room admissions (3.18 vs 1.45), out-patient clinic visits (41.1 vs 11.8) and procedures performed (1.26 vs 0.55) per 100 patient-months when compared to controls during 5-year follow-up, in addition to having increased mortality (30% vs 11%), P-value &lt;0.00001 each. Particularly, episodes due to respiratory and digestive diseases, malignancies and mental disorders were more frequent. The patients’ comorbidities, such as alcoholism or chronic pulmonary disease, were associated with more frequent use of healthcare services. CONCLUSIONS Patients treated for pleural infections have high rates of hospitalizations, emergency room admissions and out-patient clinic visits during follow-up.


Author(s):  
Matthew A. Siegel ◽  
Michael J. Patetta ◽  
Angie M. Fuentes ◽  
Armaan S. Haleem ◽  
Craig W. Forsthoefel ◽  
...  

AbstractKnee range of motion (ROM) is an important postoperative measure of total knee arthroplasty (TKA). There is conflicting literature whether patients who are obese have worse absolute ROM outcomes than patients who are not obese. This study analyzed whether preoperative body mass index (BMI) influences knee ROM after patients' primary TKA. A retrospective investigation was performed on patients, who underwent primary TKA at an academic institution, by one of three fellowship-trained adult reconstruction surgeons. Patients were stratified according to their preoperative BMI into nonobese (BMI < 30.0 kg/m2) and obese (BMI ≥ 30.0 kg/m2) classifications. Passive ROM was assessed preoperatively as well as postoperatively at patients' most recent follow-up visit that was greater than 2 years. Mann–Whitney U tests were performed to determine statistical significance at p-value <0.05 for ROM outcomes. No statistically significant differences were observed when ROM in the nonobese group was compared with ROM in the obese group both preoperatively (105.73 ± 11.58 vs. 104.14 ± 13.58 degrees, p-value = 0.417) and postoperatively (105.83 ± 14.19 vs. 104.49 ± 13.52 degrees, p-value = 0.777). Mean follow-up time for all patients was 4.49 ± 1.92 years. In conclusion, long-term postoperative ROM outcomes were similar between patients who were nonobese and patients who were obese.


2000 ◽  
Vol 28 (1) ◽  
pp. 71-85 ◽  
Author(s):  
Jillian Ball ◽  
Brian Kearney ◽  
Kay Wilhelm ◽  
Jodie Dewhurst-Savellis ◽  
Belinda Barton

Longitudinal evaluations were conducted on 61 adults who were referred to a Mood Disorders Unit with a history of depression (all index episodes reached criteria for DSM-III-R major depression or dysthymia) and who had completed a cognitive behavioural therapy group either on its own or in combination with an assertion training group. Assessment of personality was made using DSM-III-R Axis II personality disorder categories. These categories were aggregated to form three groups: (i) no personality disorder; (ii) Cluster B (dramatic-erratic); and (iii) Cluster C (anxious-fearful), and were used to identify responsiveness to treatment and outcome at long-term follow-up. A battery of self-report measures were administered pretreatment, posttreatment and at long-term follow-up (1–3 years later). Both groups showed significant improvements in mean scores during treatment and these gains were maintained over the follow-up period. However, improvement in those patients without personality disorders was greater at posttreatment and at long-term follow-up, both in level of depressive symptomatology and proportion of cases meeting criteria for recovery. The treatment implications of these results are discussed.


2019 ◽  
Vol 39 (10) ◽  
pp. 1159-1162
Author(s):  
Candace S. Brown ◽  
Richard Sloane ◽  
Miriam C. Morey

Behavior change theory was used to explore predictors of long-term adherence (≥2 years) to exercise. A retrospective analysis of data from participants ( N = 97) who reached a 6-month follow-up, which served as the baseline, was evaluated for completion of yearly follow-up surveys. Variables examined at baseline, which included age, race, gender, body mass index (BMI), and self-report of comorbidities, symptoms, physical function, and a Barriers Specific Self-Efficacy Scale, were examined with significance set at p < .05. Lower BMI (29.1 ± 5.1 vs. 31.6 ± 6.5, p = .047) and higher self-efficacy to overcome environmental barriers ( p = .016) and social isolation ( p = .05) were associated with long-term adherence. Self-efficacy to overcome environmental and social barriers, such as inclement weather, access to exercise site, and opportunities for group-based exercise, should be addressed to promote long-term adherence to exercise among older adults.


2016 ◽  
Vol 31 (12) ◽  
pp. 1223-1229 ◽  
Author(s):  
Priyanka Jain ◽  
Goodarz Danaei ◽  
James M. Robins ◽  
JoAnn E. Manson ◽  
Miguel A. Hernán

2018 ◽  
Vol 21 (16) ◽  
pp. 2998-3010 ◽  
Author(s):  
Adela Hruby ◽  
Paul F Jacques

AbstractObjectiveDietary protein plays a role in counteracting age-related muscle loss. However, limited long-term data exist on protein intake and markers of cardiometabolic health, which tend to deteriorate with age.DesignProspective cohort study. FFQ-derived protein intake (g/d) and cardiometabolic markers were assessed up to five times across 20 years. Markers included systolic (SBP) and diastolic (DBP) blood pressures, circulating lipids (total, HDL and LDL cholesterol; TAG), estimated glomerular filtration rate (eGFR), fasting glucose (FG), weight and waist circumference (WC). Mixed models accounting for repeated measures were used to estimate adjusted mean annualized changes in outcomes per quartile category of protein.SettingFramingham Heart Study Offspring cohort, USA.SubjectsParticipants (n 3066) with 12 333 unique observations, baseline (mean (sd)) age=54·0 (9·7) years, BMI=27·4 (4·9) kg/m2, 53·5 % female.ResultsIn fully adjusted models, there were favourable associations (mean (se)) of total protein with annualized changes in SBP (lowest v. highest intake: 0·34 (0·06) v. 0·04 (0·06) mmHg, P trend=0·001) and eGFR (−1·03 (0·06) v. −0·87 (0·05) ml/min per 1·73 m2, P trend=0·046), unfavourable associations with changes in FG (0·013 (0·004) v. 0·028 (0·004) mmol/l, P trend=0·004) and no associations with weight, WC, DBP or lipids. Animal protein was favourably associated with SBP and unfavourably with FG and WC; plant protein was favourably associated with FG and WC.ConclusionsThe present study provides evidence that protein intake may influence changes in cardiometabolic health independent of change in weight in healthy adults and that protein’s role in cardiometabolic health may depend on the protein source.


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