Circulation, Volume 146, Issue Suppl_1, Page A9867-A9867, November 8, 2022. Introduction:Pain is present in 37%-68.9% of hospitalized patients with heart failure (HF), but little is known about how pain at discharge influences transition from hospital to home or 12-month mortality. The aims were to examine if pain at discharge predicts 1) return to home status and 2) 12-month mortality among hospitalized patients with HF.Methods:In this prospective study, data were obtained from a dataset of 1,475 patients with HF hospitalized at 3 tertiary-care hospitals from 2009-2017. Pain at discharge (yes/no) was obtained from medical records using ICD-9 or ICD-10 codes. Return to home status (yes/no) and all-cause 12-month mortality were obtained from medical records. Descriptive statistics, independent samples t-tests, and χ2were used to describe the sample. Logistic regression was computed to address the aims.Results:The sample was 59.5% women and 40.5% men. The mean age was 68.6 (SD 13.6) years. Race was 53.6% Black and 46.4% White. Of 1,475 patients, 239 (16.2%) had pain documented at discharge. Patients with pain documented at discharge were younger compared to patients without pain (p
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Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial)
Introduction
Alcohol use disorder is a difficult-to-treat psychiatric disorder and a major burden on public health. Existing treatment efficacy is moderate, and relapse rates are high. Preliminary findings suggest that psilocybin, a psychedelic compound, can safely and reliably occasion highly meaningful experiences that may spur a positive change in drinking behaviour when administered in a therapeutic context. However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown.
Methods and analysis
To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. Ninety treatment-seeking patients, aged 20–70 years, diagnosed with alcohol use disorder will be recruited from the community via advertisement and referrals from general practitioners or specialised treatment units. The psilocybin or placebo will be administered in accordance with a protocol for psychological support before, during and after the dosing. Outcome assessments will be carried out 1, 4, 8 and 12 weeks postdosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes are as follows: (1) total alcohol consumption, (2) phosphatidyl-ethanol, an objective biomarker for alcohol, (3) plasma psilocin, the active metabolite, to establish a possible therapeutic range, (4) the acute subjective drug experience as a possible predictor of treatment outcome and (5) neuronal response to alcohol cues and cognitive flexibility within corticostriatal pathways by use of functional MR brain imaging 1-week postdosing.
Ethics and dissemination
Ethical approval has been obtained from the Committee on Health Research Ethics of the Capital Region of Denmark (H-20043832). All patients will be provided oral and written information about the trial before screening. The study results will be disseminated by peer-review publications and conference presentations.
Trial registration number
EudraCT 2020-000829-55 and NCT05416229.
Inequalities in healthcare disruptions during the COVID-19 pandemic: evidence from 12 UK population-based longitudinal studies
Objectives
We investigated associations between multiple sociodemographic characteristics (sex, age, occupational social class, education and ethnicity) and self-reported healthcare disruptions during the early stages of the COVID-19 pandemic.
Design
Coordinated analysis of prospective population surveys.
Setting
Community-dwelling participants in the UK between April 2020 and January 2021.
Participants
Over 68 000 participants from 12 longitudinal studies.
Outcomes
Self-reported healthcare disruption to medication access, procedures and appointments.
Results
Prevalence of healthcare disruption varied substantially across studies: between 6% and 32% reported any disruption, with 1%–10% experiencing disruptions in medication, 1%–17% experiencing disruption in procedures and 4%–28% experiencing disruption in clinical appointments. Females (OR 1.27; 95% CI 1.15 to 1.40; I2=54%), older persons (eg, OR 1.39; 95% CI 1.13 to 1.72; I2=77% for 65–75 years vs 45–54 years) and ethnic minorities (excluding white minorities) (OR 1.19; 95% CI 1.05 to 1.35; I2=0% vs white) were more likely to report healthcare disruptions. Those in a more disadvantaged social class were also more likely to report healthcare disruptions (eg, OR 1.17; 95% CI 1.08 to 1.27; I2=0% for manual/routine vs managerial/professional), but no clear differences were observed by education. We did not find evidence that these associations differed by shielding status.
Conclusions
Healthcare disruptions during the COVID-19 pandemic could contribute to the maintenance or widening of existing health inequalities.
Association between the interval of worksite dental check-ups and dental and medical expenditures: a single-site, 12-year follow-up study in Japan
Objectives
The purpose of this study was to identify the effective intervals of worksite dental check-ups to reduce cumulative dental expenditures (CDEs) and cumulative medical expenditures (CMEs), based on 12 years of follow-up dental check-ups.
Setting, design and participants
A longitudinal study was conducted between 2002 and 2014 fiscal years. A total of 2691 full-time employees (2099 males and 592 females) aged 20–59 years in a manufacturing company in Japan were recruited.
Primary and secondary outcome measures
Based on the follow-up of 12-year dental check-ups, the interval of dental check-ups visits was classified into the following categories: ‘Once per year’ as the regular group, ‘At least once per 2 years’ as the subregular group and others as the irregular group. CDEs and CMEs per capita were examined by the three groups of dental check-ups interval after adjustment for sex, age, occupation and total CMEs at baseline. For sensitivity analysis, decayed teeth, missing teeth and Community Periodontal Index were added as adjustment factors.
Results
Compared with the irregular group, the pooled CDEs (including dental check-ups fee) per capita in the subregular group (OR 0.91, 95% CI 0.85 to 0.98) and regular group (OR 0.87, 95% CI 0.81 to 0.93) were significantly lower overall. The younger adults in the subregular group and younger-aged and middle-aged adults in the regular group had significantly lower CDEs. Sensitivity analysis confirmed these findings.
Conclusions
Our findings suggest that regular and subregular worksite dental check-ups were related to reduction of CDEs. It is important to promote a yearly interval between dental check-ups.
In migraine with previous treatment failures, eptinezumab safely reduced migraine days at 1 to 12 wk
Annals of Internal Medicine, Volume 175, Issue 10, Page JC117, October 2022.
In active Crohn disease, risankizumab increased clinical remission and endoscopic response at 12 wk
Annals of Internal Medicine, Ahead of Print.
Da lunedì i vaccini per Omicron 4-5, disponibili anche per le quarte dosi degli over 12
Dopo quelli per Omicron 1 al via anche i vaccini per Omicron 4-5, le sottovarianti al momento prevalenti in Italia. In arrivo da lunedì 6 milioni di dosi
Prevalence, incidence and longevity of antibodies against SARS-CoV-2 among primary healthcare providers in Belgium: a prospective cohort study with 12 months of follow-up
Objectives
To estimate the prevalence, incidence and longevity of antibodies against SARS-CoV-2 among primary healthcare providers (PHCPs).
Design
Prospective cohort study with 12 months of follow-up.
Setting
Primary care in Belgium.
Participants
Any general practitioner (GP) working in primary care in Belgium and any other PHCP from the same GP practice who physically manages (examines, tests, treats) patients were eligible. A convenience sample of 3648 eligible PHCPs from 2001 GP practices registered for this study (3044 and 604 to start in December 2020 and January 2021, respectively). 3390 PHCPs (92,9%) participated in their first testing time point (2820 and 565, respectively) and 2557 PHCPs (70,1%) in the last testing time point (December 2021).
Interventions
Participants were asked to perform a rapid serological test targeting IgM and IgG against the receptor binding domain of SARS-CoV-2 and to complete an online questionnaire at each of maximum eight testing time points.
Primary and secondary outcome measures
The prevalence, incidence and longevity of antibodies against SARS-CoV-2 both after natural infection and after vaccination.
Results
Among all participants, 67% were women and 77% GPs. Median age was 43 years. The seroprevalence in December 2020 (before vaccination availability) was 15.1% (95% CI 13.5% to 16.6%), increased to 84.2% (95% CI 82.9% to 85.5%) in March 2021 (after vaccination availability) and reached 93.9% (95% CI 92.9% to 94.9%) in December 2021 (during booster vaccination availability and fourth (delta variant dominant) COVID-19 wave). Among not (yet) vaccinated participants the first monthly incidence of antibodies against SARS-CoV-2 was estimated to be 2.91% (95% CI 1.80% to 4.01%). The longevity of antibodies is higher in PHCPs with self-reported COVID-19 infection.
Conclusions
This study confirms that occupational health measures provided sufficient protection when managing patients. High uptake of vaccination resulted in high seroprevalence of SARS-CoV-2 antibodies in PHCPs in Belgium. Longevity of antibodies was supported by booster vaccination and virus circulation.
Trial registration number
NCT04779424.
Describing, predicting and explaining adherence to total skin self-examination (TSSE) in people with melanoma: a 12-month longitudinal study
Objectives
To describe trajectories in melanoma survivors’ adherence to monthly total skin self-examination (TSSE) over 12 months, and to investigate whether adherence trajectories can be predicted from demographic, cognitive or emotional factors at baseline.
Design
A longitudinal observational study nested within the intervention arm of the ASICA (Achieving Self-Directed Integrated Cancer Aftercare) randomised controlled trial.
Setting
Follow-up secondary care in Aberdeen and Cambridge UK.
Participants
n=104 adults (48 men/56 women; mean age 58.83 years, SD 13.47, range 28–85 years; mean Scottish Index of Multiple Deprivation score 8.03, SD 1.73, range 2–10) who had been treated for stage 0–IIC primary cutaneous melanoma in the preceding 60 months and were actively participating in the intervention arm of the ASICA trial.
Interventions
All participants were using the ASICA intervention—a tablet-based intervention designed to support monthly TSSE.
Primary and secondary outcome measures
The primary outcome was adherence to guideline recommended (monthly) TSSE over 12 months. This was determined from time-stamped TSSE data recorded by the ASICA intervention app.
Results
Latent growth mixture models identified three TSSE adherence trajectories (adherent –41%; drop-off –35%; non-adherent –24%). People who were non-adherent were less likely to intend to perform TSSE as recommended, intending to do it more frequently (OR=0.21, 95% CI 0.06 to 0.81, p=0.023) and were more depressed (OR=1.31, 95% CI 1.06 to 1.61, p=0.011) than people who were adherent. People whose adherence dropped off over time had less well-developed action plans (OR=0.78, 95% CI 0.63 to 0.96, p=0.016) and lower self-efficacy about TSSE (OR=0.92, 95% CI 0.86 to 0.99, p=0.028) than people who were adherent.
Conclusions
Adherence to monthly TSSE in people treated for melanoma can be differentiated into adherent, drop-off and non-adherent trajectories. Collecting information about intentions to engage in TSSE, depression, self-efficacy and/or action planning at outset may help to identify those who would benefit from additional intervention.
Trial registration number
ClinicalTrials.gov Registry (NCT03328247).
Association of occupations with decreased semen quality in eastern China: a cross-sectional study of 12 301 semen donors
Objectives
This study aims to examine the association between occupational factors and semen quality in semen donors in eastern China.
Methods
We recruited 12 301 semen donors from 2006 to 2020 as the studying population. A self-designed questionnaire was applied for collecting lifestyle and work style information. Semen samples were analysed according to WHO guidelines. A crude and adjusted linear regression model was used to analyse the association between occupational factors and semen quality.
Results
College students accounted for 36.2% of all semen donors. The majority (81.3%) of semen donors were between 18 year and 30 years. Soldiers or the police had the highest semen volume (the median value=3.8 mL), however, they had the lowest sperm concentration (53.6×106/ml) and sperm motility (45.5%). Workers in finance or insurance had an elevated risk of low semen volume, sperm concentration and total sperm count (OR=1.43, 1.57 and 1.98, respectively). Unemployed men had a high risk of low sperm concentration and low total sperm count (OR=1.84 and 1.58, respectively). Working in the information technology industry had a deleterious effect on the progressive motility of sperm (OR=1.27, 95% CI 1.03 to 1.57).
Conclusion
Our study indicated that sedentary work style and intensive sports in certain professions might be associated with decreased semen quality. We reported evidence of becoming unemployed on the damage to semen quality. Hence, we advocate a healthy work style to improve semen quality in eastern China.
Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: secondary analysis of a 12-month randomised controlled trial
Objectives
The aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and vitamin D supplementation on cognition in men with prostate cancer treated with androgen deprivation therapy (ADT).
Design
12-month, two-arm, randomised controlled trial.
Setting
University clinical exercise centre.
Participants
70 ADT-treated men were randomised to exercise-training plus supplementation (Ex+ Suppl, n=34) or usual care (control, n=36).
Intervention
Men allocated to Ex + Suppl undertook thrice weekly resistance training with weight-bearing exercise training plus daily whey protein (25 g), calcium (1200 mg) and vitamin D (2000 IU) supplementation.
Primary and secondary outcome measures
Cognition was assessed at baseline, 6 and 12 months via a computerised battery (CogState), Trail-making test, Rey auditory-verbal learning test and Digit span. Data were analysed with linear mixed models and an intention-to-treat and prespecified per-protocol approach (exercise-training: ≥66%, nutritional supplement: ≥80%).
Results
Sixty (86%) men completed the trial (Ex + Suppl, n=31; control, n=29). Five (7.1%) men were classified as having mild cognitive impairment at baseline. Median (IQR) adherence to the exercise and supplement was 56% (37%–82%) and 91% (66%–97%), respectively. Ex + Suppl had no effect on cognition at any time.
Conclusions
A 12-month multicomponent exercise training and supplementation intervention had no significant effect on cognition in men treated with ADT for prostate cancer compared with usual care. Exercise training adherence below recommended guidelines does not support cognitive health in men treated with ADT for prostate cancer.
Trial registration number
Australian and New Zealand Clinical Trial Registry (ACTRN12614000317695, registered 25/03/2014) and acknowledged under the Therapeutic Goods Administration Clinical Trial Notification Scheme (CT-2015-CTN-03372-1 v1).
Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research
Introduction
Rural communities bear a disproportionate share of the opioid and methamphetamine use disorder epidemics. Yet, rural people who use drugs (PWUD) are rarely included in trials testing new drug use prevention and treatment strategies. Numerous barriers impede rural PWUD trial engagement and advancing research methods to better retain rural PWUD in clinical trials is needed. This paper describes the Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2) study protocol to test the effectiveness of a peer-driven intervention to improve study retention among rural PWUD.
Methods and analysis
The PROUD-R2 study is being implemented in 21 rural counties in three states (Kentucky, Ohio and Oregon). People who are 18 years or older, reside in the study area and either used opioids or injected any drug to get high in the past 30 days are eligible for study inclusion. Participants are allocated in a 1:1 ratio to two arms, stratified by site to assure balance at each geographical location. The trial compares the effectiveness of two retention strategies. Participants randomised to the control arm provide detailed contact information and receive standard retention outreach by study staff (ie, contacts for locator information updates, appointment reminders). Participants randomised to the intervention arm are asked to recruit a ‘study buddy’ in addition to receiving standard retention outreach. Study buddies are invited to participate in a video training and instructed to remind their intervention participant of follow-up appointments and encourage retention. Assessments are completed by intervention, control and study buddy participants at 6 and 12 months after enrolment.
Ethics and dissemination
The protocol was approved by a central Institutional Review Board (University of Utah). Results of the study will be disseminated in academic conferences and peer-reviewed journals, online and print media, and in meetings with community stakeholders.
Trial registration number
NCT03885024
Ad un passo dal vaccino contro il tumore al fegato
Abstract 34: A Stroke Transition Of Care Intervention With Stroke Nurse Navigator And Early Stroke Clinic Follow-up Reduces Readmissions For Stroke At 12 Months
Stroke, Volume 53, Issue Suppl_1, Page A34-A34, February 1, 2022. Introduction:Stroke is a leading cause of disability in the United States, and one in four occur in people who have already had a stroke. Preventable hospital readmissions contribute to the high medical costs of stroke. Transition of care programs have been successful in reducing hospital readmissions in other diseases, but the data on such programs for stroke is mixed. A transition of care program was implemented at a large urban stroke center, utilizing interventions shown to be effective in the literature, with the goal of reducing recurrent strokes and hospital readmissions.Methods:The transition of care program consisted of: two Stroke Nurse Navigators, personalized stroke education in the hospital, two-day phone call reinforcing education and reviewing medications, early follow-up within 7-10 business days with a Stroke Neurologist, and further education on personalized risk factors in the clinic. Baseline data from the year prior to intervention, and each quarter of the three-year project period were obtained on the following measures: Rate of recurrent stroke admissions within one year, all-cause readmission within one year, all-cause readmission within 30 days, patient scheduled for initial follow-up within 7-10 days, compliance with follow up in the stroke clinic, and percent of patients receiving two-day post discharge phone call. Discharge data were reviewed on 949 patients in 2016 (year 0) and on 2,328 patients in the three-year project period (starting in July 2017).Results:The rate of readmission for stroke was 8.5%, 9.0%, 6.6%, and 4.2% for year 0, 1, 2, and 3, respectively. This represents a reduction of 50% from the year prior to the intervention to year 3 of the grant. All-cause readmission remained stable, at 38.9%, 42.6%, 36.6%, and 37.4% for year 0, 1, 2, and 3 respectively. An improvement was seen in process measures: patients scheduled for early follow up in the stroke clinic, adherence to follow-up, and two-day post-discharge phone calls.Conclusions:In conclusion, the transition of care intervention led to a reduction from baseline in readmissions for stroke within one year, but did not impact all cause readmission at one year or 30 days. This is a meaningful outcome for those who have suffered strokes. This program can serve as a model.
Abstract 12: CT Perfusion For Lesion-Symptom Mapping In Emergent Large Vessel Occlusion
Stroke, Volume 53, Issue Suppl_1, Page A12-A12, February 1, 2022. Introduction:Selection criteria for endovascular thrombectomy (EVT) for emergent large-vessel occlusion (ELVO) stroke increasingly rely on CT perfusion (CTP) findings at presentation. While perfusion imaging is used to estimate the likelihood of deriving long-term functional benefit from EVT, there is comparatively little data on how perfusion deficits relate to domains of neurological function. Here, we investigated region-specific hypoperfusion as a driver of neurological dysfunction through correspondence between NIHSS items and CTP.Methods:We included 169 patients with ELVO presenting to Mayo Clinic Rochester or Jacksonville, who had baseline CTP and itemised NIHSS data. Perfusion was quantified as mean transit time using e-CTP (Brainomix Ltd., Oxford, UK) and thresholded to ≥5 s for lesion masking. Voxel-wise lesion-symptom mapping (VLSM) was performed using sparse canonical correlations analysis (Lesymap package, R).Results:Total NIHSS was most strongly predicted by left MCA territory hypoperfusion, corresponding to language-eloquent cortical areas and dominant hemisphere motor tracts (figure 1). Contralateral limb motor deficits (NIHSS 5 and 6) were mainly associated with subcortical and white matter hypoperfusion; there was an additional strong signal for left frontal cortex in language function (NIHSS 9). The remaining NIHSS items were less well localised.Conclusions:Expanding on previous pilot data, our results provide further evidence for the feasibility of hypoperfusion-to-symptom mapping in ELVO. This could allow for more nuanced clinical-imaging mismatch determination, and selection of patients based on specific neurological deficits that may be reversible.
Abstract TP232: Post-stroke Suppression Of Matrix Metalloproteinase-12 Attenuates The Expression Of M1 And M2 Markers And Prevents The Elevation Of Other Matrix Metalloproteinases
Stroke, Volume 53, Issue Suppl_1, Page ATP232-ATP232, February 1, 2022. Introduction:We previously reported a marked elevation of matrix metalloproteinases (MMP-1, MMP-7, MMP-8, MMP-9, MMP-11, MMP-12, and MMP-14) in the ischemic brain on day 3 after ischemic stroke in a rodent model. Also, we showed that MMP-12 suppression after ischemic stroke attenuates blood-brain barrier (BBB) disruption. The aim of the present study was to examine the effects of MMP-12 suppression on the expression of elevated M1 and M2 microglia/macrophage phenotypes and other MMPs in the ischemic brain. We hypothesized that MMP-12 suppression, by attenuating infiltrating leucocytes (especially monocytes), would decrease the expression of both M1 and M2 markers as well as other MMPs, since activated monocytes are the primary source of elevated MMPs in the ischemic brain.Methods:Young adult male Sprague-Dawley rats (n=6/group) were subjected to 2-h transient middle cerebral artery occlusion and received either MMP-12 shRNA (M12sh) expressing plasmids (1 mg/kg, i.v.; formulated as nanoparticles) within 30 min of reperfusion or no treatment. M12sh-treated and untreated ischemia-induced rats along with sham surgery rats were euthanized on day 3 after ischemia and brain tissues were collected for quantitative real-time PCR analysis of specific M1/M2 markers and various MMPs.Results:In untreated ischemia-induced animals, the expression of both M1 markers (CD16, CD68, IL-1β, IL-6, and TNFα) and M2 markers (CD163, CD206, Arg1, TGFβ, and IL-10) was increased approximately 10-150 fold over sham operated animals. Similarly, the expression of all MMPs studied (MMP-1, MMP-7, MMP-8, MMP-9, MMP-11, and MMP-14) was elevated approximately 10-30 fold in untreated ischemia-induced animals. M12sh treatment reduced the expression of most M1/M2 markers, notably CD68, IL-10, Arg1, and TGFβ, compared to no treatment. M12sh treatment also strongly reduced the elevated levels of MMP-7, MMP-9, MMP-11, and MMP-14.Conclusions:Suppression of MMP-12 leads to a general downregulation of M1/M2 markers and MMPs in the ischemic brain. We attribute these effects to reduced monocyte infiltration and subsequent inflammation. Suppression of MMP-12 could prove to be a promising therapy for ischemic stroke.