Abstract 4143513: ECG-AI to Assist with the Classification of Low Ejection Fraction and Heart Failure with Preserved Ejection Fraction

Circulation, Volume 150, Issue Suppl_1, Page A4143513-A4143513, November 12, 2024. Background:There are delays on identification of people with low left ventricular ejection fraction (LVEF) and Heart Failure with preserved EF (HFpEF). There is a need for low cost and accessible tools to identify individuals who can benefit from more comprehensive exams such as echocardiogram (ECHO).Research GoalTo develop electrocardiographic artificial intelligence (ECG-AI) models that can classify low EF and HFpEF.Methods:We developed an ECG-AI model using convolutional neural networks to classify 12-lead ECG’s into four categories: rEF( LVEF

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Novembre 2024

Abstract 4140622: Systemic hypotension triggered by stretching of shoulder and upper back muscles: A possible basis for ‘stretch-syncope’ in humans

Circulation, Volume 150, Issue Suppl_1, Page A4140622-A4140622, November 12, 2024. Background:Stretch induced syncope (SIS) is a well-known but rare condition of uncertain pathophysiology. Proposed but unproven mechanisms include Valsalva-like straining, transient vertebral artery occlusion, carotid baroreceptor activation or a combination of these. We hypothesized that shoulder and upper back stretching, possibly acting through skeletal muscle mechanoreceptors, may trigger a hypotensive response, similar to that induced by stretch of other large skeletal muscles (e.g., legs and forearms), but opposite in direction.Objective:This study evaluated the impact of shoulder and upper back stretch on autonomic and hemodynamic findings in otherwise healthy patients with SIS by history compared to controls being evaluated for syncope or near syncope unrelated to stretch.Methods:The study comprised 18 otherwise healthy patients presenting for hemodynamic and autonomic evaluation of syncope or near-syncope. None had evidence of underlying structural cardiovascular disease or abnormal neurological findings on exam.Autonomic evaluation was performed in included i) heart rate (HR) and blood pressure (BP) responses during active standing (AS), ii) Valsalva maneuver, and iii) respiratory sinus arrhythmia. Suspected SIS patients also underwent carotid sinus massage while seated. In addition, seated patients were instructed to undertake active extension of the neck and shoulders for approximately 10 seconds while keeping their forearms still and breathing normally. HR and systolic and mean BPs were recorded using beat-by-beat non-invasive plethysmography.Results:The patient population comprised 5/18 patients with a history suggesting SIS and 13/18 controls. With stretching, both SIS and control patients exhibited decreased systolic and mean arterial pressure (MAP), and increased HR. Further, SIS patients had a greater decrease in SBP and MAP during stretch than controls (p=0.021 and 0.029). Syncope or near-syncope developed in four SIS patients (80%) during stretch while no control experienced syncope or near-syncope (p

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Novembre 2024

Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT)

Introduction
Differential target multiplexed spinal cord stimulation (DTM SCS) is a new stimulation paradigm for chronic pain management with the aim of modulating glial cells and neurons in order to rebalance their interactions. Animal studies revealed positive effects of this type of stimulation; however, studies in humans are still scarce, pointing towards the need for an evaluation of the effectiveness and safety of DTM SCS in clinical settings. Furthermore, the differential target multiplexed (DTM) algorithm consists of a combination of several programmes, which will presumably consume more energy from the spinal cord stimulation (SCS) battery. Therefore, the objective of DETECT is to investigate the feasibility, effectiveness and safety of DTM SCS in patients with Persistent Spinal Pain Syndrome Type II through a longitudinal cohort study.

Methods and analysis
DETECT is a prospective multicentre cohort study (n≥250) with a follow-up until 12 months after receiving DTM SCS. The study initiated in October 2021 and is currently still recruiting patients. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 6 and 12 months of DTM SCS. The primary effectiveness endpoint is overall pain intensity, measured with the visual analogue scale. Secondary effectiveness outcome measures are back pain intensity, leg pain intensity, disability, health-related quality of life, pain medication use, functional disability, clinical holistic responder status, self-management, impression of change, work status, pain catastrophising, symptoms of central sensitisation, anxiety, depression and healthcare utilisation. Time spent in different body postures and SCS stimulation parameters will be read out from the pulse generator. The prevalence of technical issues, recharge frequency, (serious) adverse events and the proportion of successful DTM trials will be collected as well. Longitudinal mixed models will be calculated to evaluate the effectiveness of DTM SCS over time.

Ethics and dissemination
The study protocol was approved by the central Ethics Committee of the Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (B.U.N.1432021000563) and the Ethics Committees of each participating centre. Research findings will be disseminated to key stakeholders through peer-reviewed publications in scientific journals and presentations to clinical audiences.

Trial registration number
NCT05068011.

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Novembre 2024

Acupuncture combined with Chinese herbal medicine for discogenic low back pain: protocol for a multicentre, randomised controlled trial

Introduction
Discogenic low back pain is a common form of chronic low back pain. In traditional Chinese medicine, combinations of acupuncture and herbal medicine are frequently used to manage this condition. However, evidence for the efficacy of a combined approach remains scarce. To address this gap, we designed a multicentre, randomised controlled trial to compare the effects of the combined use of acupuncture and Chinese herbal medicine, and their separate applications along with non-steroidal anti-inflammatory drugs, in treating discogenic low back pain.

Methods and analysis
This is a multicentre, prospective, randomised, four-arm, parallel-controlled trial involving patients with discogenic low back pain. Patients will be randomly divided into four groups (acupuncture combined with herbal medicine, acupuncture, herbal medicine and positive drug control) at a 1:1:1:1 ratio. All patients will undergo a 4-week treatment regimen consisting of acupuncture (active or sham acupuncture) and oral medication (herbal medicine or placebo granules and celecoxib or placebo capsules), as well as a 3-month follow-up assessment. The primary outcome measure will be pain intensity, measured using the Visual Analogue Scale after a 4-week treatment period. Secondary outcome measures will include the lumbar pressure pain threshold, pain-related disability measured using the Oswestry Disability Index, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, 36-Item Short-Form Health Survey and incidence of adverse events. Assuming an SD of 1.8, minimal clinically important difference of 1.5 and a 10% dropout rate, at least 97 participants per group are needed, totalling 388 participants.

Ethics and dissemination
The study was approved by the Ethics Committee of Dongzhimen Hospital Affiliated with Beijing University of Chinese Medicine (approval number: 2024DZMEC-083-03) and the other seven participating subcentres. All participants will provide written informed consent. This trial will be conducted in accordance with the principles outlined in the Declaration of Helsinki and its amendments. This work will be disseminated through the publication of peer-reviewed manuscripts.

Trial registration number
ChiCTR2400082428.

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Novembre 2024

Postoperative pain management practice and associated factors among nurses working at public hospitals, in Oromia region, Ethiopia, 2021: an institution-based cross-sectional study

Background
Management of postoperative pain leads to positive patient progress and shortens the duration of hospital stay. There is a lack of information on nurse’s postoperative pain management practice and its associated factors.

Objective
To assess postoperative pain management practice and associated factors among nurses working in public hospitals of West Shoa Zone, Oromia, Ethiopia, 2021.

Design
An institutional-based cross-sectional study was employed.

Setting
Study was conducted among eight public hospitals (two tertiary hospitals and six secondary hospitals), which were located in West Shoa Zone in Oromia, Ethiopia.

Participants
Totally 377 participants were selected by using simple random sampling. From this, 277 were men and 100 participants were women. All nurses who were worked in surgical ward, medical wards, minor operation room and major operation room, recovery rooms, emergency, obstetrics and gynaecology wards were included.

Methods
Data were collected by distributing structured self-administered questionnaires that adapted from different literatures and were entered into Epi data V.3.1 and exported to SPSS V.22 for analysis. Variables with significant association in the bivariate analyses were entered into a multivariable regression analysis to identify the independent factors associated with nurses’ postoperative pain management practice. Significant factors were declared at p

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Novembre 2024

Efficacy of an mHealth intervention to support pain self-management and improve analgesia in patients with rib fractures: protocol for a randomised controlled trial

Introduction
In light of the risks of over-reliance on opioid analgesia during recovery from rib fractures, there is increased interest in the efficacy of non-pharmacological approaches to pain management. This paper describes the protocol for a double-blind randomised controlled trial to evaluate the efficacy of an mHealth intervention for reducing pain intensity, pain-related distress and opioid use during early recovery from rib fractures.

Methods and analysis
Adults (N=120) with isolated rib fractures will be recruited within 24 hours of admission to a large public hospital in Sydney, Australia (single site), and randomised (1:1 allocation) to an intervention or active control group. Clinicians, participants and statisticians will be blind to participants’ group allocation. The intervention (PainSupport) consists of a brief pain self-management educational video, followed by twice daily supportive Short Message Service (SMS) text messages for 14 days. Participants in the active control group receive the same video but not the supportive text messages. Participants in both groups continue to receive usual care throughout the trial. The primary outcome will be self-reported pain intensity on respiration measured using a Numerical Rating Scale. Secondary outcomes will include opioid use, pain-related distress, adherence to behavioural pain management strategies and the acceptability and feasibility of the intervention. Participants will complete questionnaires at baseline and then on days 1–7 and day 14 of the trial. A feedback survey will be completed at the end of the trial (day 15). Linear mixed models will be used to evaluate the main effect of the group on the primary and secondary outcomes and to explore differences between outcome trends recorded over the trial. Analyses will be based on the intention-to-treat principle to minimise bias secondary to missing data or dropouts.

Ethics and dissemination
The study protocol has been reviewed and approved by the Northern Sydney Local Health District Human Research Ethics Committee (Australia). Informed consent is a requirement for participation in the study. Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.

Trial registration number
ACTRN12623000006640.

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Novembre 2024

Variation in organisational factors across high- and low-performing hospitals with regard to spontaneous vaginal birth for Black women in four states: a cross-sectional descriptive study

Objective
To describe variation in hospital organisational factors across high- and low-performing hospitals with regard to spontaneous vaginal birth (SVB) for Black women.

Design
Cross-sectional descriptive.

Setting
We conducted a cross-sectional study using three datasets in four states from 2016, including the American Hospital Association Annual Survey, administrative discharge abstracts and a survey in which nurses served as informants about the organisational factors in their hospitals. Hospitals were categorised based on whether they achieved (1) the SVB rate target for Black women at low risk for caesarean birth, (2) the SVB rate target for Black women at low risk for caesarean birth and equivalent SVB rates between Black and White women at low risk for caesarean birth, or (3) neither of these metrics. The first two categories above were considered ‘high performing’ and the third ‘low performing’. Analysis of variances were used to compare organisational factors between hospital categories.

Participants
There were 257 hospitals in the sample.

Primary and secondary outcome measures
Outcomes were meeting the SVB rate targets for Black women at low risk for caesarean birth and SVB rate equivalence between Blacks and White patients.

Results
High-performing hospitals had better nurse work environments (2.84 vs 2.695, p =0.04), including better nurse-physician relationships (2.77 vs 2.695, p =0.02). There were statistically significantly more advanced practice nurses (APNs) on average in maternity units in high-performing hospitals compared with low performing (3.51 to 2.76; p=0.003).

Conclusions
Better rated nurse work environments and the presence of APNs were distinguishing characteristics of high-performing hospitals. These organisational factors may be system-level targets for hospital-level interventions to improve SVB rates and equity therein.

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Novembre 2024

Long-term effects of pelvic floor training in male chronic pelvic pain, correlation between subjective and objective outcomes: a study protocol for a randomised controlled trial

Introduction
Chronic primary pelvic pain syndrome (CPPPS) is a condition characterised by pain in the pelvic area together with lower urinary tract symptoms. Pathophysiology remains largely unclear. Common treatment modalities show unsatisfactory results. This randomised controlled trial aims to establish the long-term effect of pelvic floor re-education using biofeedback and home training for men with CPPPS evaluated with the National Institute of Health–Chronic Prostatitis Symptom Index (NIH-CPSI) and to explore if outcomes can be correlated to changes in objective urodynamic measures.

Methods and analysis
After inclusion all study participants will go through baseline testing consisting of urodynamic evaluation, assessment of the pelvic floor muscles and the NIH-CPSI questionnaire, thereafter, randomised to intervention or control group. Intervention consists of short daily session of pelvic floor muscle training, during 6 months. Parallelly with starting up, the intervention group will attend four bio-feedback sessions, to guide and facilitate the training. The training will initially aim on how to correctly activate and relax the pelvic floor muscles with functional enhancement further on. The control group will be offered to enter the intervention group after the 6-month assessment. The outcome will be assessed by repeating the baseline tests at 3, 6 and 12 months.
To compare the primary outcome, the NIH-CPSI questionnaire between and within the two groups will be analysed. Secondary outcomes are the differences in sub-score reduction according to the domains in the NIH-CPSI questionnaire, the manual assessment of the pelvic floor muscles and numerical results from the urodynamic testing. The correlation between subjective and objective outcomes will be analysed.

Ethics and dissemination
The study obtained ethical approval from the Swedish Ethical Review Authority (2023-00286-01). The study result will be published in a peer-reviewed medical journal and presented at an international conference.

Trial registration number
This trial is registered at Clinicaltrials.gov (NCT06115083).

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Novembre 2024

Independence of Lipoprotein(a) and Low-Density Lipoprotein Cholesterol–Mediated Cardiovascular Risk: A Participant-Level Meta-Analysis

Circulation, Ahead of Print. BACKGROUND:Low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a]) levels are independently associated with atherosclerotic cardiovascular disease (ASCVD). However, the relationship between Lp(a) level, LDL-C level, and ASCVD risk at different thresholds is not well defined.METHODS:A participant-level meta-analysis of 27 658 participants enrolled in 6 placebo-controlled statin trials was performed to assess the association of LDL-C and Lp(a) levels with risk of fatal or nonfatal coronary heart disease events, stroke, or any coronary or carotid revascularization (ASCVD). The multivariable-adjusted association between baseline Lp(a) level and ASCVD risk was modeled continuously using generalized additive models, and the association between baseline LDL-C level and ASCVD risk by baseline Lp(a) level by Cox proportional hazards models with random effects. The joint association between Lp(a) level and statin-achieved LDL-C level with ASCVD risk was evaluated using Cox proportional hazards models.RESULTS:Compared with an Lp(a) level of 5 mg/dL, increasing levels of Lp(a) were log-linearly associated with ASCVD risk in statin- and placebo-treated patients. Among statin-treated individuals, those with Lp(a) level >50 mg/dL (≈125 nmol/L) had increased risk across all quartiles of achieved LDL-C level and absolute change in LDL-C level. Even among those with the lowest quartile of achieved LDL-C level (3.1–77.0 mg/dL), those with Lp(a) level >50 mg/dL had greater ASCVD risk (hazard ratio, 1.38 [95% CI, 1.06–1.79]) than those with Lp(a) level ≤50 mg/dL. The greatest risk was observed with both Lp(a) level >50 mg/dL and LDL-C level in the fourth quartile (hazard ratio, 1.90 [95% CI, 1.46–2.48]).CONCLUSIONS:These findings demonstrate the independent and additive nature of Lp(a) and LDL-C levels for ASCVD risk, and that LDL-C lowering does not fully offset Lp(a)-mediated risk.

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Novembre 2024

Patient-controlled analgesia in cancer pain management across African healthcare settings: a scoping review protocol

Background
Cancer pain management is critical, especially at advanced stages. This is particularly important in Africa as most cancers are typically diagnosed at advanced stages. Given the central role of adequate pain management in advanced cancer care, this scoping review aims to examine the utilisation of patient-controlled analgesia (PCA) in cancer pain management within African healthcare settings.

Methods and analysis
This scoping review will apply the Arksey and O’Malley framework. A systematic search will be conducted in PubMed, African Journals Online and Google Scholar, focusing on studies conducted in Africa involving PCA and cancer pain. A two-step screening process will be used, title/abstract screening and full-text screening, with inclusion criteria emphasising relevance to cancer pain, PCA usage and African context. A thematic analysis approach will categorise data into themes related to PCA utilisation, effectiveness, barriers and outcomes. Tables and figures will be used for presentation.

Ethics and dissemination
This review will involve a secondary analysis of already published literature; therefore, ethical approval is not required. The findings of our scoping review will be published in an open-access, peer-reviewed journal on completion.

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Novembre 2024

Effectiveness of non-pharmacological interventions for pain management in patients with cancer:a protocol for systematic review and network meta-analysis

Introduction
Pain management in patients with cancer is a critical aspect of oncological care, yet remains challenging with current pharmacological therapies. Non-pharmacological interventions, offering potential benefits without the adverse effects of drugs, have gained attention. However, the effectiveness of these diverse non-pharmacological interventions is not well understood, creating a gap in clinical practice. This study aims to conduct a systematic review and network meta-analysis (NMA) to evaluate the efficacy of various non-pharmacological interventions for pain management in patients with cancer, providing evidence-based guidance for clinicians and patients.

Methods and analysis
A systematic review and Bayesian NMA will be performed. To assess the efficacy of interventions for cancer pain, we will search six electronic databases: Cochrane Library, Web of Science, PubMed, EMBASE, PsycINFO and the Cumulative Index to Nursing and Allied Health Literature, focusing on identifying randomised controlled trials. Literature screening should be independently performed by two reviewers. A NMA will evaluate the efficacy of various non-pharmacological interventions for cancer pain. A second NMA will compare the efficacy of different non-pharmacological interventions in relieving pain interference in patients with cancer pain. Bayesian 95% credible intervals will be used to estimate the pooled mean effect size for each treatment, and the surface under the cumulative ranking area will be employed to rank the effectiveness of the treatments.

Ethics and dissemination
Ethical approval is not required for this systematic review of the published data. Findings will be disseminated via peer-reviewed publication.

PROSPERO registration number
CRD42024483025.

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Novembre 2024