The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSRBC) program in improving psychological and physical symptoms and ...quality of life among breast cancer survivors (BCSs) who completed treatment. Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe.
A total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects.
Results demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P < .01). Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC).
The MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes.
Background & Aims Crohn's disease commonly recurs after intestinal resection. We evaluated whether the administration of infliximab after resective intestinal surgery for Crohn's disease reduces ...postoperative recurrence. Methods We randomly assigned 24 patients with Crohn's disease who had undergone ileocolonic resection to receive intravenous infliximab (5 mg/kg), administered within 4 weeks of surgery and continued for 1 year, or placebo. The primary end point was the proportion of patients with endoscopic recurrence at 1 year. Secondary end points were clinical recurrence and remission and histologic recurrence. Results The rate of endoscopic recurrence at 1 year was significantly lower in the infliximab group (1 of 11 patients; 9.1%) compared with the placebo group (11 of 13 patients; 84.6%) ( P = .0006). There was a nonsignificant higher proportion of patients in clinical remission in the infliximab group (8 of 10; 80.0%) compared with the placebo group (7 of 13; 53.8%) ( P = .38). The histologic recurrence rate at 1 year was significantly lower in the infliximab group (3 of 11 patients; 27.3%) compared with the placebo group (11 of 13 patients; 84.6%) ( P = .01). The occurrence of adverse events was similar between the placebo and infliximab groups, and none occurred in the immediate postoperative period. Conclusions Administration of infliximab after intestinal resective surgery was effective at preventing endoscopic and histologic recurrence of Crohn's disease.
Treatment guidelines and U.S. Food and Drug Administration emergency use authorizations (EUAs) of monoclonal antibodies (mAbs) for treatment of high-risk outpatients with mild to moderate COVID-19 ...changed frequently as different SARS-CoV-2 variants emerged.
To evaluate whether early outpatient treatment with mAbs, overall and by mAb product, presumed SARS-CoV-2 variant, and immunocompromised status, is associated with reduced risk for hospitalization or death at 28 days.
Hypothetical pragmatic randomized trial from observational data comparing mAb-treated patients with a propensity score-matched, nontreated control group.
Large U.S. health care system.
High-risk outpatients eligible for mAb treatment under any EUA with a positive SARS-CoV-2 test result from 8 December 2020 to 31 August 2022.
Single-dose intravenous mAb treatment with bamlanivimab, bamlanivimab-etesevimab, sotrovimab, bebtelovimab, or intravenous or subcutaneous casirivimab-imdevimab administered within 2 days of a positive SARS-CoV-2 test result.
The primary outcome was hospitalization or death at 28 days among treated patients versus a nontreated control group (no treatment or treatment ≥3 days after SARS-CoV-2 test date).
The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio RR, 0.61 95% CI, 0.50 to 0.74). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively. In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual mAb products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71).
Observational study design, SARS-CoV-2 variant presumed by date rather than genotyping, no data on symptom severity, and partial data on vaccination status.
Early mAb treatment among outpatients with COVID-19 is associated with lower risk for hospitalization or death for various mAb products and SARS-CoV-2 variants.
None.
A previous randomized, placebo-controlled study showed that infliximab maintenance therapy prevented recurrence of Crohn's disease 1 year after an ileocolonic resection. We evaluated recurrence of ...Crohn's disease, on the basis of endoscopic examination and/or the need for additional surgical resection, beyond the first postoperative year.
In a prospective, open-label, long-term follow-up study, 24 patients previously randomly assigned to receive infliximab for 1 year after an ileocolonic resection were given the option to continue, stop, or start infliximab therapy. The primary end point was the time to recurrence of Crohn's disease, on the basis of endoscopic evidence (endoscopic recurrence), from the initial assignment to postoperative infliximab or placebo. Secondary end points were rate of endoscopic recurrence, time to reoperation, and rate of surgical recurrence in relation to the total time on infliximab.
All patients were followed for at least 5 years after surgery. Patients assigned to the infliximab group in the first year after surgery had a longer mean time to first endoscopic recurrence (1231 ± 747 days) than patients originally assigned to the placebo group (460 ± 121 days, P = .003). Colonoscopies identified Crohn's disease recurrence in 22.2% of patients who received long-term infliximab and in 93.9% of those not on infliximab (P < .0001). Compared with no infliximab, the adjusted rate ratio for being in endoscopic remission while on infliximab was 13.47 (95% confidence interval, 3.52-61.53; P = .0001). Patients originally assigned to the infliximab group had a mean longer time to surgery (1798 ± 359 days) than patients originally assigned to the placebo group (1058 ± 529 days, P = .04). The rate of surgical recurrence (required additional surgical resection) was significantly lower among patients who received infliximab for most of the follow-up period than patients who received it for shorter periods (20.0% vs 64.3%, P = .047).
Postoperative infliximab maintenance beyond 1 year prevents recurrence of Crohn's disease.
To determine the effect of self-reported clinical diagnosis of obstructive sleep apnea (OSA) on longitudinal changes in brain amyloid PET and CSF biomarkers (Aβ42, T-tau, and P-tau) in cognitively ...normal (NL), mild cognitive impairment (MCI), and Alzheimer's disease (AD) elderly.
Longitudinal study with mean follow-up time of 2.52 ± 0.51 years. Data were obtained from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database. Participants included 516 NL, 798 MCI, and 325 AD elderly. Main outcomes were annual rate of change in brain amyloid burden (i.e. longitudinal increases in florbetapir PET uptake or decreases in CSF Aβ42 levels); and tau protein aggregation (i.e. longitudinal increases in CSF total tau T-tau and phosphorylated tau P-tau). Adjusted multilevel mixed effects linear regression models with randomly varying intercepts and slopes was used to test whether the rate of biomarker change differed between participants with and without OSA.
In NL and MCI groups, OSA+ subjects experienced faster annual increase in florbetapir uptake (B = .06, 95% CI = .02, .11 and B = .08, 95% CI = .05, .12, respectively) and decrease in CSF Aβ42 levels (B = -2.71, 95% CI = -3.11, -2.35 and B = -2.62, 95% CI = -3.23, -2.03, respectively); as well as increases in CSF T-tau (B = 3.68, 95% CI = 3.31, 4.07 and B = 2.21, 95% CI = 1.58, 2.86, respectively) and P-tau (B = 1.221, 95% CI = 1.02, 1.42 and B = 1.74, 95% CI = 1.22, 2.27, respectively); compared with OSA- participants. No significant variations in the biomarker changes over time were seen in the AD group.
In both NL and MCI, elderly, clinical interventions aimed to treat OSA are needed to test if OSA treatment may affect the progression of cognitive impairment due to AD.
Abstract Context Breast cancer survivors (BCS) face adverse physical and psychological symptoms, often co-occurring. Biologic and psychological factors may link symptoms within clusters, ...distinguishable by prevalence and/or severity. Few studies have examined the effects of behavioral interventions or treatment of symptom clusters. Objectives The aim of this study was to identify symptom clusters among post-treatment BCS and determine symptom cluster improvement following the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR(BC)) program. Methods Three hundred twenty-two Stage 0–III post-treatment BCS were randomly assigned to either a six-week MBSR(BC) program or usual care. Psychological (depression, anxiety, stress, and fear of recurrence), physical (fatigue, pain, sleep, and drowsiness), and cognitive symptoms and quality of life were assessed at baseline, six, and 12 weeks, along with demographic and clinical history data at baseline. A three-step analytic process included the error-accounting models of factor analysis and structural equation modeling. Results Four symptom clusters emerged at baseline: pain, psychological, fatigue, and cognitive. From baseline to six weeks, the model demonstrated evidence of MBSR(BC) effectiveness in both the psychological (anxiety, depression, perceived stress and QOL, emotional well-being) ( P = 0.007) and fatigue (fatigue, sleep, and drowsiness) ( P < 0.001) clusters. Results between six and 12 weeks showed sustained effects, but further improvement was not observed. Conclusion Our results provide clinical effectiveness evidence that MBSR(BC) works to improve symptom clusters, particularly for psychological and fatigue symptom clusters, with the greatest improvement occurring during the six-week program with sustained effects for several weeks after MBSR(BC) training. Trial Registration Name and URL of Registry: ClinicalTrials.gov . Registration number: NCT01177124.
Sleep complaints are highly prevalent and associated with cardiovascular disease (CVD) morbidity and mortality. This is the first prospective study to report the association between commonly reported ...sleep symptoms and the development of the metabolic syndrome, a key CVD risk factor.
Participants were from the community-based Heart Strategies Concentrating on Risk Evaluation study. The sample was comprised of 812 participants (36% African American; 67% female) who were free of metabolic syndrome at baseline, had completed a baseline sleep questionnaire, and had metabolic syndrome evaluated 3 years after baseline. Apnea-hypopnea index (AHI) was measured cross-sectionally using a portable monitor in a subset of 290 participants. Logistic regression examined the risk of developing metabolic syndrome and its components according to individual sleep symptoms and insomnia syndrome.
Specific symptoms of insomnia (difficulty falling asleep DFA and "unrefreshing" sleep), but not a syndromal definition of insomnia, were significant predictors of the development of metabolic syndrome. Loud snoring more than doubled the risk of developing the metabolic syndrome and also predicted specific metabolic abnormalities (hyperglycemia and low high-density lipoprotein cholesterol). With further adjustment for AHI or the number of metabolic abnormalities at baseline, loud snoring remained a significant predictor of metabolic syndrome, whereas DFA and unrefreshing sleep were reduced to marginal significance.
Difficulty falling asleep, unrefreshing sleep, and, particularly, loud snoring, predicted the development of metabolic syndrome in community adults. Evaluating sleep symptoms can help identify individuals at risk for developing metabolic syndrome.
ObjectivesAmong primary prevention-type adults not on lipid-lowering therapy, conflicting results exist on the relationship between low-density lipoprotein cholesterol (LDL-C) and long-term ...mortality. We evaluated this relationship in a real-world evidence population of adults.DesignRetrospective cohort study.SettingElectronic medical record data for adults, from 4 January 2000 through 31 December 2022, were extracted from the University of Pittsburgh Medical Center healthcare system.ParticipantsAdults without diabetes aged 50–89 years not on statin therapy at baseline or within 1 year and classified as primary prevention-type patients. To mitigate potential reverse causation, patients who died within 1 year or had baseline total cholesterol (T-C) ≤120 mg/dL or LDL-C <30 mg/dL were excluded.Main exposure measureBaseline LDL-C categories of 30–79, 80–99, 100–129, 130–159, 160–189 or ≥190 mg/dL.Main outcome measureAll-cause mortality with follow-up starting 365 days after baseline cholesterol measurement.Results177 860 patients with a mean (SD) age of 61.1 (8.8) years and mean (SD) LDL-C of 119 (31) mg/dL were evaluated over a mean of 6.1 years of follow-up. A U-shaped relationship was observed between the six LDL-C categories and mortality with crude 10-year mortality rates of 19.8%, 14.7%, 11.7%, 10.7%, 10.1% and 14.0%, respectively. Adjusted mortality HRs as compared with the referent group of LDL-C 80–99 mg/dL were: 30–79 mg/dL (HR 1.23, 95% CI 1.17 to 1.30), 100–129 mg/dL (0.87, 0.83–0.91), 130–159 mg/dL (0.88, 0.84–0.93), 160–189 mg/dL (0.91, 0.84–0.98) and ≥190 mg/dL (1.19, 1.06–1.34), respectively. Unlike LDL-C, both T-C/HDL cholesterol (high-density lipoprotein cholesterol) and triglycerides/HDL cholesterol ratios were independently associated with long-term mortality.ConclusionsAmong primary prevention-type patients aged 50–89 years without diabetes and not on statin therapy, the lowest risk for long-term mortality appears to exist in the wide LDL-C range of 100–189 mg/dL, which is much higher than current recommendations. For counselling these patients, minimal consideration should be given to LDL-C concentration.
We aimed to assess racial differences in air pollution exposures to ambient fine particulate matter (particles with median aerodynamic diameter <2.5 µm PM
) and black carbon (BC) and their ...association with cardiovascular disease (CVD) risk factors, arterial endothelial function, incident CVD events, and all-cause mortality.
Data from the HeartSCORE study (Heart Strategies Concentrating on Risk Evaluation) were used to estimate 1-year average air pollution exposure to PM
and BC using land use regression models. Correlates of PM
and BC were assessed using linear regression models. Associations with clinical outcomes were determined using Cox proportional hazards models, adjusting for traditional CVD risk factors. Data were available on 1717 participants (66% women; 45% blacks; 59±8 years). Blacks had significantly higher exposure to PM
(mean 16.1±0.75 versus 15.7±0.73µg/m
;
=0.001) and BC (1.19±0.11 versus 1.16±0.13abs;
=0.001) compared with whites. Exposure to PM
, but not BC, was independently associated with higher blood glucose and worse arterial endothelial function. PM
was associated with a higher risk of incident CVD events and all-cause mortality combined for median follow-up of 8.3 years. Blacks had 1.45 (95% CI, 1.00-2.09) higher risk of combined CVD events and all-cause mortality than whites in models adjusted for relevant covariates. This association was modestly attenuated with adjustment for PM
.
PM
exposure was associated with elevated blood glucose, worse endothelial function, and incident CVD events and all-cause mortality. Blacks had a higher rate of incident CVD events and all-cause mortality than whites that was only partly explained by higher exposure to PM
.
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