tbuckley/cabot-search huggingface dataset:
Association of Lumbar Spine Radiographic Changes With Severity of Back Pain–Related Disability Among Middle-aged, Community-Dwelling Women
Authors: Lingxiao Chen, Romain S. Perera, Maja R. Radojcic, Paula R. Beckenkamp, Paulo H. Ferreira, Deborah J. Hart, Tim D. Spector, Nigel K. Arden, Manuela L. Ferreira
Journal: JAMA Network Open (2021)

Previous studies, using mostly cross-sectional data, provide conflicting evidence of an association between lumbar spine radiographic changes and the severity of back pain-related disability. Such conflicting evidence may be associated with widely unnecessary diagnostic imaging of the lumbar spine.To examine both cross-sectional and longitudinal associations between lumbar spine radiographic changes and the severity of back pain-related disability among middle-aged, community-dwelling women.This population-based prospective cohort study used data from the Chingford 1000 Women Study. Analyses included data collected from year 6 (1994-1996; physical activity was measured), year 9 (1997-1999; treated as baseline), and year 15 (2003-2005), with a total length of follow-up for longitudinal analyses of 6 years. Data were analyzed from April 17 to November 3, 2020.Primary exposure was lumbar spine radiographic changes, defined using the Kellgren-Lawrence (K-L) grade. Secondary exposures were defined using presence of osteophytes and disc space narrowing. The composite score combined the number of lumbar spine segments with definite changes detected on radiographic images (ie, radiographic changes) (K-L grade ≥2, which means at least definite osteophyte and possible narrowing of disc space are present; osteophyte and disc space narrowing grade ≥1, which means at least mild or definite changes are present).Self-reported back pain-related disability measured in years 9 and 15 assessed by the St Thomas disability questionnaire.Among 650 women (mean [SD] age, 61.3 [5.9] years) in cross-sectional analyses and 443 women (mean [SD] age, 60.6 [6.0] years) in longitudinal analyses, there was no evidence to support an association between higher number of lumbar segments with radiographic changes (K-L grade, osteophytes, and disc space narrowing) and more severe back pain-related disability (eg, cross-sectional analyses using the K-L grade; 1 segment vs 0 segment: adjusted odds ratio, 1.22 [95% CI, 0.76-1.96]). No interactions were found of an association between lumbar spine radiographic changes and the severity of back pain-specific disability with age, body mass index, or smoking status.In this cohort of middle-aged, community-dwelling women, there was no evidence to support an association between a higher number of lumbar segments with radiographic changes (K-L grade, osteophytes, and disc space narrowing) and more severe back pain-related disability cross-sectionally or over time. These findings provide further evidence against routinely using diagnostic imaging of the lumbar spine.
Heberden Oration, 1965. Reflections on the Controlled Trial
Authors: Austin Bradford Hill
Journal: Annals of the Rheumatic Diseases (1966)

I cannot claim to be by nature "bloody, bold and resolute".My audacity in accepting the honour of giving the Heberden Oration for 1965 was, rather, the product of two environmental factors-my knowledge of rheumatologists and the statistical views of the poet William Cowper.Under the first heading one of the more euphoric side-effects of nearly twenty years of work in clinical trials has b en my contact with many of the leaders of your profession-and with the great advantage that I have not had to consult them professionally.In no speciality have I been more kindly received, and in none have I made more friends than in the field of rheumatology.That was, indeed, a source of courage.I could rely upon a continuing charity.And then, having talked much in my time of clinical trials, I was emboldened by William Cow- per's sagacious couplet: "Tis hard if all is false that I advance A fool must now and then be right by chance."Who knows?Perhaps it could be today that the 0 05 level would turn up. THE GROWTH OF THE CONTROLLED TRIALIt is not far off twenty years since the Medical Research Council published the results of its trial of the new antibiotic streptomycin in the treatment of pulmonary tuberculosis (M.R.C., 1948).This it was that set off the population explosion in controlled trials until now they appear in a continual and widely ranging stream in the weekly and specialist medical journals.Limiting attention merely to the weekly journals and to the last twelve months, controlled trials have * Delivered on November 12, 1965.
Functional Electrical Stimulation of Peroneal Muscles on Balance in Healthy Females
Authors: Zoe A. Bamber, Wei Sun, Rhea S. Menon, Patrick C. Wheeler, Ian D. Swain, Daniel T. P. Fong
Journal: Cyborg and Bionic Systems (2021)

Balance improvement could contribute to ankle stability for the prevention of ankle sprains. Functional electrical stimulation (FES) is an effective way of augmenting muscle activity and improving balance. This study investigated the effect of FES of peroneal muscles on single-and double-leg balance. Fifteen healthy females (age = 23.1 ± 1.6 years, height = 1.63 ± 0.07 m, and weight = 63.7 ± 9.9 kg) performed single- and double-leg standing balance tests with eyes open and closed before and after 15-minute FES intervention during treadmill running at a comfortable, self-selected pace. FES of peroneal muscles was provided bilaterally, using an Odstock Dropped Foot Stimulator. The total excursion of the centre of pressure (COP) was calculated to assess the standing balance control ability. The total excursion of COP in single- and double-leg stance with eyes open reduced significantly after FES intervention by 14.7% (p < 0.001) and 5.9% (p = 0.031), respectively. The eyes-closed condition exhibited a 12.7% (p = 0.002) reduction in single-leg stance but did not significantly change in double-leg stance (p > 0.05). Limb preference did not account for balance postintervention. No significant difference in total excursion of COP was found between preferred and less preferred limbs with both visual conditions (p > 0.05). FES of peroneal muscles improved standing balance control with eyes open in double-leg and single-leg stance and with eyes closed in double-leg stance. The improvements in balance control with FES treatment did not vary concerning limb preference.
Characteristics Associated With Multisystem Inflammatory Syndrome Among Adults With SARS-CoV-2 Infection
Authors: Giovanni E. Davogustto, Daniel E. Clark, Edward Hardison, Ahmad H. Yanis, Brandon D. Lowery, Natasha B. Halasa, Quinn S. Wells
Journal: JAMA Network Open (2021)

This cohort study describes the clinical characteristics and outcomes of patients with multisystem inflammatory syndrome among adults with laboratory-confirmed SARS-CoV-2 infection at a single US tertiary care medical center.
Abstract P194: Psychosocial Stressors And Cardiovascular Disease Risk Factors In Young African American Women: A Systematic Review
Authors: Latesha K Harris, Diane C Berry, Yamnia I Cortes
Journal: Circulation (2021)

Background: Emerging evidence suggests that psychosocial factors are related to morbidity and mortality due to cardiovascular disease (CVD). African American women experience a unique multitude of psychosocial stressors, including racism, discrimination, poverty, neighborhood stress, anxiety, and depression. The impact of these stressors on CVD risk in African American women during early adulthood (age 19-24 years) is limited. Objective: In this systematic review, we synthesized and evaluated the existing evidence on the relationship between psychosocial stress and CVD risk in young adult African American women. Methods: We conducted a comprehensive search of the literature in PubMed, APA PsycINFO, and CINAHL for studies published between January 1975 and May 2020 that examined psychosocial stress and CVD risk factors in young adult African American women. Eligible studies measured at least one psychosocial stress exposure, a CVD risk factor, or subclinical CVD outcome (e.g., body mass index, blood pressure, carotid intima-media thickness), and included African American women age 19-24 years or reported sex-stratified analyses. We excluded reviews, editorials, case studies, and gray literature. Two reviewers independently screened studies for eligibility and appraised the quality of the included studies using the Newcastle-Ottawa Scale. Results: The literature search yielded 1,100 potentially relevant articles for review. Of these, we identified nine studies that met our inclusion criteria: six cross-sectional and three prospective cohort studies. The mean age of participants ranged from 19 to 22 years. Of the nine studies, eight found that stress (i.e., perceived stress, racial discrimination, internalized racism, depression) was related to higher body mass index and blood pressure. In one longitudinal study, a greater frequency of everyday discrimination was associated with a nearly 2-fold higher odds of excessive weight gain (&gt;40 pounds) during pregnancy. Overall, the majority of studies (n=6) were rated as excellent ; the remainder were good and fair. The lowest risk of bias was the selection and outcome measurement. Conclusion: This systematic review found sufficient evidence to support a relationship between psychosocial stress and CVD risk factors in young adult African American women. However, future studies that follow women from childhood to early adulthood are needed to gain a better understanding of the impact of psychosocial stress on the progression of CVD risk. Further investigation on specific stressors relevant to early adulthood, including self-identity and social role stress, are needed to understand the full extent to which psychosocial stress impacts CVD risk in young African American women.
Abstract 065: Ultra-processed Food And Hypertension Incidence In The Regards Cohort
Authors: Carol R Oladele, Neha Khandpur, Timothy B Plante, Ya Yuan, Gina S Lovasi, Suzanne E Judd
Journal: Circulation (2021)

Background: A growing body of evidence demonstrates that diets high in ultra-processed food products (UPF)—ready-to-eat formulations of processed substances that have been extracted or refined from whole foods and that typically contain added flavors, colors, and other cosmetic additives -- lack nutrient quality and contribute to energy imbalance. However, few studies have examined the impact on hypertension, a diet-sensitive condition characterized by racial disparities across the disease spectrum. We sought to determine black-white differences in UPF consumption and associations with incident hypertension. Methods: Data from the Reasons for Geographic and Racial Disparities in Stroke (REGARDS) Cohort Study was used. Participants free of hypertension at baseline (2003-2007) who had complete food intake data and completed visit 2 (2013-2017) were included. The NOVA classification system was used to categorize participants food and drink into categories according to their level of processing, from 1 (minimally processed) to 4 (ultra-processed). The percent gram contribution of UPF to total grams consumed was calculated and used to create quartiles of UPF intake. The outcome, incident hypertension, was defined as systolic blood pressure of =&gt;140 mm Hg or diastolic pressure =&gt;90 mm Hg or taking antihypertensive medication at visit 2. Summary statistics were used to examine participant demographics by UPF consumption. Multivariable logistic regression was used to assess the hypothesis that UPF consumption is associated with incident hypertension and that the association varies by race. Results: A total of 5,957 participants were included in analyses, 23 percent were Black and 77 White. Black participants had higher UPF intake compared to White participants. Thirty-eight percent of Black participants were in the top quartile of UPF consumption compared to 21 percent among White participants. Women, those with lower educational attainment, lower physical activity, and income below 35K were more likely to be in the top quartile of UPF consumption. Regression model results showed individuals in the top quartile of UPF consumption had 38 percent greater odds of incident hypertension (CI=1.11-1.53) after adjustment for sociodemographic characteristics. Race-stratified model results showed that Blacks in the top quartile had 47 percent greater odds (CI=1.06-2.03) of incident hypertension. UPF consumption was not significantly associated with incident hypertension among Whites (OR=1.19, CI=0.99-1.43). Conclusions: Findings demonstrate racial disparities in consumption of UPF and that disparities contribute to higher incident hypertension among Black persons. Results contribute to the growing evidence base needed to inform equitable food system policies, support healthier dietary consumption, and address hypertension disparities.
Abstract MP28: Social Isolation, Loneliness, And Cardiovascular Disease Among Older Women In The Women’S Health Initiative
Authors: Natalie M Golaszewski, Andrea Z Lacroix, Michael J Lamonte, John Bellettiere
Journal: Circulation (2021)

Background: Now more than ever is a critical time to understand the independent contributions social isolation and loneliness have on cardiovascular disease (CVD) events. This study examined the unique contribution social isolation and loneliness have on incidence of CVD among a large, diverse sample of postmenopausal women. Further, we examined whether levels of social support modified these relationships. Methods: Women with no prior history of CVD events (n=57,825; age 79±6) self-reported social activities, living alone, marital status, loneliness, and social support from 2014-2015 and were followed up-to 4 years for incident major CVD (myocardial infarction, stroke, and CVD death). Hazard ratios (HR) and 95% confidence intervals (CIs) for CVD were estimated for 1-interquartile range (IQR) increment in social isolation and loneliness using 3 progressively adjusted Cox proportional hazard models. Social support was tested as an effect modifier using a multiplicative interaction term in model 2 (see Table) separately for social isolation and loneliness. Results: Over a cumulative follow-up time of 186,762 person-years, 1,599 incident major CVD events were observed. In fully adjusted models containing both social isolation and loneliness, HRs (95% CIs) for 1-IQR increment in social isolation 1.07 (1.03 - 1.12) and loneliness 1.05 (1.01 - 1.09) (see Table). Social support was not an effect modifier of either association (p’s &gt; .05). Conclusions: Higher social isolation and loneliness were each independently associated with higher risk for incident CVD events among older women and associations were not significantly different among those with high and low social support. Findings support emerging evidence regarding the importance of social connection on heart health. Future studies need to explore ways to reduce feelings of social isolation and loneliness, and the mechanisms through which that affects healthy cardiovascular aging and resiliency.
Benralizumab improves symptoms of patients with severe, eosinophilic asthma with a diagnosis of nasal polyposis
Authors: Giorgio Walter Canonica, Tim W. Harrison, Pascal Chanez, Francesco Menzella, Renaud Louis, Borja G. Cosio, Njira L. Lugogo, Arjun Mohan, Annie Burden, Esther Garcia Gil
Journal: Allergy (2021)

Clinically meaningful improvement in the Sino-Nasal Outcome Test-22 (SNOT-22) was observed in patients with severe, eosinophilic asthma, and nasal polyposis (NP) treated with benralizumab in the ANDHI trial. A post hoc assessment of the effects of benralizumab on SNOT-22 response and asthma efficacy measures in these patients was conducted for further characterization of the efficacy and safety of benralizumab for patients with severe asthma and NP.Adults with severe, eosinophilic asthma who had experienced ≥2 prior-year exacerbations despite high-dosage inhaled corticosteroid plus additional controller[s] were randomized to 24 weeks of benralizumab or placebo. Patients with physician-diagnosed chronic rhinosinusitis with NP of any severity ongoing at baseline who consented to participate were included in the current ANDHI NP substudy population. Effect on NP symptoms was assessed by the SNOT-22, with an improvement of at least 8.9 defined as clinically significant (responder). Effects on chronic asthma outcomes were assessed by means of annualized asthma exacerbation rate (AER), St. George's Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in one second (FEV1 ), and Asthma Control Questionnaire-6 (ACQ-6). All p-values were nominal.Of the ANDHI population (n = 656), 23% (n = 153) participated in the NP substudy (n = 96 benralizumab; n = 57 placebo). Patients were 50% female, with mean age of 53 years, had prior-year AER = 3.3; mean pre-bronchodilator FEV1 = 55% predicted; and median blood eosinophil count ​= 510 cells/µl. For patients with high baseline SNOT-22 scores (>30), benralizumab treatment improved symptoms of NP as measured by SNOT-22 from baseline to Week 24 compared with placebo (Week 24: -10.44 [p = .0176]). Percentage of responders to SNOT-22 was greater for benralizumab vs. placebo (71.3% vs. 45.5%; p = .0036), and effect was enhanced for patients with high baseline SNOT-22 scores (>30). A 69% reduction vs. placebo in annualized AER (0.77 vs. 2.47; p < .0001) and greater clinically meaningful improvements from baseline in SGRQ total score (-16.7), FEV1 (+0.32 L), and ACQ-6 (-0.88) were observed (p < .0001). Benralizumab was well-tolerated. Frequency of adverse events (AEs) was similar for benralizumab (76.0%) and placebo (73.7%) groups. Most common AEs (frequency ≥5%) reported at a greater frequency in benralizumab vs. placebo included headache, sinusitis, pyrexia, and influenza.These substudy data from ANDHI demonstrated the efficacy profile of benralizumab for patients with severe, eosinophilic asthma and NP, with improvement in SNOT-22 and asthma outcomes.
Abstract P066: Rationale And Design Of A Study To Test The Effect Of Personal Protective Aids On Hypertension And Diabetes In People Exposed To High Levels Of Air Pollution
Authors: Dweep Barbhaya, Aditya Khetan, Jennifer Tran, Supreme Jain, Anubha Goel
Journal: Circulation (2021)

Background: Air pollution is the largest environmental cause of disease and premature death in the world today, disproportionally affecting low- and middle-income countries (LMICs) such as India. Numerous studies have shown that exposure to particulate matter &lt;2.5 μm (PM2.5) can contribute to cardiovascular disease and mortality, which is partially attributable to the development of cardiometabolic conditions such as hypertension and diabetes. We hypothesize that the use of personal protective aids (home air-purifier and N-95 mask) can decrease systolic blood pressure (SBP) in people with hypertension and decrease fasting blood glucose (FBG) in those with diabetes. Method: This is a prospective randomized cross-over study in Dalkhola, India- an area of high ambient PM2.5 levels. Participants between 18 and 70 years of age with hypertension (n=130) and diabetes (n=33) will be invited to participate in the study. They will be randomized to either an intervention or control arm for 4 weeks, after which they will cross over to the other arm following a 2-week washout period. The intervention period will consist of using an indoor air-purifier at night and an N-95 mask when outdoors. Control period will involve using an identical air purifier and facemask, with the filter removed (sham filtration). Participants and outcome assessors will be blinded. Outcome evaluation: The primary outcome of the study is the absolute reduction in SBP among people with hypertension and absolute reduction in FBG among people with diabetes. Discussion: This is the first randomized controlled trial to evaluate personal protective aids as a therapeutic measure in people with hypertension and diabetes exposed to high levels of PM2.5. Given the high burden of air pollution in LMICs, there is an urgent need for adaptation measures targeting people at high risk for mortality from this exposure. The results of our study will demonstrate if personal protective aids can be a viable adaptation measure for people living with hypertension and diabetes in areas with a high burden of air pollution.
Abstract 15510: Trials of Dual Antiplatelet Therapy Do Not Include Evidence-Based Strategies for Gastrointestinal Bleeding Prevention
Authors: Jacob E Kurlander, Geoffrey Barnes, Devraj Sukul, Danielle Helminski, Alex Kokaly, Kevin Platt, Hitinder S Gurm, Sameer Saini
Journal: Circulation (2020)

Background: Proton pump inhibitors (PPIs) substantially reduce the risk of upper gastrointestinal bleeding (GIB) and are recommended for high-risk patients by professional cardiology societies but remain underused in clinical practice. By reducing hemorrhagic risk associated with dual antiplatelet therapy (DAPT), PPIs may affect the risk-benefit equation of varying durations of DAPT and should be considered in such clinical trials. We sought to determine the extent to which randomized controlled trials (RCTs) evaluating DAPT after percutaneous coronary intervention (PCI) provide guidance on the use of PPIs for GIB prevention. Methods: A previously completed systematic review was updated to identify all RCTs comparing varying durations of DAPT between June 1983 and October 2019. Primary publications, online supplements, clinical trial registries and additional publications linked to the trial registration number were reviewed for protocol information. Results: Of 21 included studies (n=58,625; Figure), none of the study protocols provided guidance on the use of PPIs by trial participants. One study stated that the decision to use PPIs was left to the discretion of the treating physician. Two studies specified that treating physicians could prescribe non-mandated medications concordant with standard of care but did not specifically mention PPIs. Only 5 studies reported rates of PPI use, which ranged from 25.6-69.1%. Conclusions: Trials of DAPT regimens did not provide guidance on the use of PPI gastroprotection, a guideline-supported strategy for prevention of bleeding from the GI tract, the most common site of bleeding in patients using DAPT. Guidance on and reporting of PPI use should be mandatory in future antithrombotic trials to enhance their safety and interpretability. Figure 1. PRISMA flow diagram