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MEPs elicited by multidirectional rotational-field TMS show marked differences compared to unidirectional Figure-of-8 and H7 coils

by Orit Wonderman Bar Sela, Shay Ofir Geva, Gaby S. Pell, Yiftach Roth, Jason Friedman, Afnan Muhana, Silvi Frenkel-Toledo, Nachum Soroker

Unidirectional transcranial magnetic stimulation (udTMS; e.g., via Figure-of-8 coil) depolarizes mainly neurons whose axonal orientation aligns with the direction of the induced electric field. A novel dual H-coil (T360°) TMS system (BrainsWayTM, Israel) generates a rotational magnetic field aimed to recruit a larger neuronal population by induction of a multidirectional electric field (rfTMS). This study aimed to comparatively assess the neurophysiological properties of motor evoked potentials (MEPs) elicited from the first dorsal interosseous (FDI) muscle following udTMS (via Figure-of-8 and H7 coils) vs. multidirectional rfTMS. In this study, 10 healthy adult subjects received TMS via the three coil configurations in a random order. The results showed that rfTMS elicited larger MEPs at a lower resting motor threshold (rMT) compared to the unidirectional coils. These findings suggest that rfTMS is likely to recruit larger populations of neurons compared to conventional udTMS coil configurations. This may be advantageous in efforts to enhance motor recovery following brain damage by treatments using TMS.

Prevalence of long covid symptoms in Tuscany, Italy: a population-representative cross-sectional telephone survey

Por: Bruschi · M. · Del Riccio · M. · Lorini · C. · Profili · F. · Zanobini · P. · Biagi · C. · Papini · E. · Floridia · M. · Onder · G. · Francesconi · P. · Bonaccorsi · G.
Objectives

Long covid affects over 36 million individuals in the European region, but its clinical profile is still poorly defined, particularly in the general population with less severe acute disease. This study aimed to assess the prevalence of a broad spectrum of symptoms potentially linked to long covid in the general population of Tuscany, Italy.

Methods

A cross-sectional study was conducted in January–February 2024 using Computer-Assisted Telephone Interviews in a representative population sample of Tuscany. Based on the WHO questionnaire long covid symptom list, data on 33 symptoms experienced in the past 6 months were collected, along with demographic and clinical characteristics. After excluding patients with COVID-19 within the past 6 months and those failing a screening cognitive test, symptom prevalence and ORs adjusted for sex, time since infection, smoking and concurrent diseases (aOR) were calculated according to COVID-19 history.

Results

After excluding 129 failing the cognitive test (6.4%) and 123 recent COVID cases (6.1%), among 1753 participants interviewed, 1013 (57.8%) had a history of COVID-19. The symptoms significantly more prevalent in individuals with previous COVID-19 were fatigue (12.8% vs 8.9%, aOR 1.6 (95% CI 1.2 to 2.2)), concentration impairment (5.5% vs 2.4%, aOR 2.2 (95% CI 1.3 to 3.8)) and skin rashes (4.5% vs 2.4%, aOR 1.9 (95% CI 1.1 to 3.3)). Prevalences and ORs were higher in more recent COVID-19 cases, particularly females and individuals with concurrent diseases.

Conclusions

We identified in a population-based study some symptoms significantly more common in individuals with previous COVID-19. This approach complements data collected in clinical settings and in patients selected by greater disease severity. The findings may help future surveillance efforts and targeted public health interventions directed at optimising care pathways and mitigating long-term consequences.

Site-randomised trial of a multilevel digital intervention to reduce maternal morbidity and mortality: a study protocol

Por: Kelpin · S. S. · Margerison · C. E. · McKay · A. S. · Vickers · E. · Crawford · M. K. · Spencer · J. · Sikorskii · A. · Ondersma · S. J.
Introduction

Compared with other high-income countries, the USA continues to have the highest rates of pregnancy-related and associated mortality and morbidity (PRAMM), particularly in rural areas and among non-Hispanic black pregnancies. Over 80% of pregnancy-related deaths are preventable; however, the intensity of existing interventions has proven difficult to broadly disseminate. Technology offers the potential to address such barriers. This study will develop a multilevel digital intervention to reduce PRAMM and evaluate its effects using a site-randomised trial.

Methods and analysis

The Michigan Healthy Mom (MI MOM) intervention will be developed using a community-partnered approach and will seek to address PRAMM risks at four distinct levels: individual, support system, provider and community. Pregnant participants and up to three members of their personal support system will receive an initial brief interactive session through a mobile web app and will thereafter receive a series of text messages with links to extended content. Healthcare providers will receive biweekly text messages and/or flyers distributed in clinic staff areas, and community health workers—who can facilitate access to local services—will be available via secure live chat text access. MI MOM effects will be evaluated using a cluster-randomised trial in 10 antenatal care clinics throughout Michigan (N=500 pregnant participants aged 18+ years receiving Medicaid). We will compare intervention and control arms on two coprimary outcomes: total PRAMM through 1 year post partum as measured using a universally collected linked dataset of Medicaid claims and vital records and an index of PRAMM risk factors directly targeted by MI MOM.

Ethics and dissemination

The Michigan State University Institutional Review Board has provided ethical approval (STUDY00011005). Results will be disseminated via presentations at academic conferences and community forums, as well as publications in peer-reviewed journals.

Trial registration number

NCT07213284.

Study protocol for the investigator-initiated Danish pragmatic randomised STENO INTEN-CT trial: does screening and intervention for subclinical coronary artery disease in type 2 diabetes reduce cardiovascular events?

Por: Funck · K. L. · Borregaard · B. · Egstrup · K. · Fredslund · E. K. · Hansen · T. W. · Kallestrup · P. · Olsen · M. H. · Reventlow · S. · Rossing · P. · Sandbaek · A. · Sondergaard · J. · Thomsen · J. L. · Vestergaard · P. · Poulsen · P. L. · Diederichsen · A.
Introduction

Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).

Methods and analysis

The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.

Ethics and dissemination

The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.

Trial registration number

NCT05700877.

Community advisory boards to inform behavioural health research in primary care: protocol for a scoping review

Por: McDermott · K. A. · Vonderheide · C. C. · Cronin · A. E. · Vranceanu · A.-M. · Plys · E.
Introduction

Most patients receive behavioural healthcare (BH) in a primary care setting, yet much of the BH research was not developed to account for eventual implementation. Areas of research and intervention that are considered priorities to patients may be absent from our existing knowledge base. Engaging the community in the research process can facilitate translation and uptake. A key strategy for community engagement is to employ a Community Advisory Board (CAB). CABs can assist in a number of research processes, including guiding research questions to fit the priorities of the community and creating research materials that are tailored to the patient population and healthcare setting. There is variability in practices and reporting standards for CABs. The field would benefit from a summary of the state of the current literature on CAB utilisation for BH research in primary care. To fill this gap, we will conduct a scoping review to answer the question, ‘What is known about the use of CABs in behavioural health studies in primary care?’.

Methods and analysis

We will use the guidelines for scoping reviews outlined by Arksey and O’Malley: (1) identifying the research question; (2) identifying relevant studies; (3) study selection; (4) charting the data and (5) collating, summarising and reporting the results. Our reporting of the results will be guided by the Arnos and colleagues Toolkit for Project-Based Community Advisory Boards, a set of practical guidelines for employing a CAB. To this end, we will report on how well CABs currently employed in BH primary care research match existing guidelines and what gaps need to be filled by future research.

Ethics and dissemination

This review does not require ethics board approval, as no patient data will be collected. We will disseminate findings primarily through journal publications and conference presentations.

Trial registration number

This scoping review protocol was registered on the Open Science Framework (https://osf.io/pa3rz/?view_only=31c558eb395a4a9482ee9c5b57ca1c4c)

Transforming acute care: a scoping review on the effectiveness, safety and implementation challenges of Hospital-at-Home models

Por: Sultani · K. · Smeulers · M. · de Vries · R. · Zonderhuis · B. M. · Nanayakkara · P. W. B.
Objectives

The hospital-at-home (HaH) model has gained traction as a viable alternative to traditional inpatient care, allowing patients to receive care in their own homes. Despite its growing popularity, there is a lack of comprehensive research addressing effectiveness, safety and factors critical to the successful implementation of HaH programmes. We conducted a scoping review to comprehensively map and summarise the evidence on both admission avoidance and early-supported discharge up until now.

Design

A scoping review of randomised controlled trials (RCTs), conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews (PRISMA-ScR) guidelines.

Data sources

Ovid MEDLINE, Embase, CINAHL and Web of Science were systematically searched up to July 2024

Eligibility criteria for selecting studies

We included English-language RCTs published from 2005 onwards, involving adults (≥18 years) receiving acute care at home who would otherwise require hospital admission. Eligible studies evaluated admission avoidance or early supported discharge within HaH settings for acutely ill patients. Studies focusing on outpatient care, non-acute conditions or interventions not aligning with the widely accepted HaH definition were excluded. COVID-19-related studies were also excluded to avoid context-specific bias.

Data extraction and synthesis

Two reviewers independently extracted data on study characteristics, interventions and outcomes including mortality, length of stay, escalation rates, costs and patient and caregiver satisfaction. Implementation facilitators and barriers were also collected. Discrepancies were resolved by a third reviewer. Results were synthesised descriptively in accordance with PRISMA-ScR guidelines.

Results

Nine RCTs were identified. The review shows that the HaH model is at least as safe as usual care, with lower or comparable mortality rates. Length of stay varied, with some studies reporting longer stays in the HaH group due to cautious clinical practices. Cost analyses often indicate lower healthcare costs with staffing as the largest expense. Patient and caregiver satisfaction was high, but essential implementation factors were not clearly addressed.

Conclusion

The HaH model represents a promising alternative to acute inpatient care for suitable patients. Future research should focus on conducting larger RCTs, expanding the range of conditions suitable for HaH. Despite favourable clinical outcomes, substantial implementation barriers remain underexplored in current RCTs. This underscores the need to identify strategies for successful implementation, including the integration of technological advancements and qualitative insights into patient and caregiver experiences.

Patient experiences with group consultations when treated with semaglutide for obesity: a qualitative case study in a Danish general practice

Por: Dahl-Larsen · R. · Jakobsen · P. · Sondergaard · J. · Henriksen · J. E. · Assing Hvidt · E.
Objective

In this case study conducted in a Danish general practice, we aimed to explore how patients with obesity experience a novel treatment approach: group consultations (GCs) for weight loss, lifestyle changes and semaglutide treatment. To receive semaglutide treatment, patients were required to participate in GCs focused on lifestyle changes.

Design

A qualitative study design comprising individual, semistructured interviews was used. Patients were asked to reflect on and describe their past experiences with participating in GCs. Thematic analysis was used as an analytical strategy.

Setting

A general practice located in a larger city in the Region of Southern Denmark.

Participants

12 patients (eight women and four men) with obesity, aged between 27 years and 69 years, who met the Danish obesity treatment criteria for semaglutide (body mass index over 30 kg/m2 or over 27 kg/m2 with comorbidities), were included. Data were collected from 1 November 2023 to 31 January 2024.

Results

Before attending GCs, patients were worried about sharing personal information with other patients and losing their confidentiality. They also feared being judged by the others in the group, possibly due to previous experiences of stigmatisation. However, after participating in GCs, patients reported positive experiences with peer sharing, had no issues with confidentiality and found the consultations beneficial. Most patients indicated a preference for GCs over one-on-one consultations in the future.

Conclusions

Despite initial concerns about confidentiality and stigmatisation, patients ultimately had positive experiences and gained valuable peer support during group GCs in general practice. Various aspects of the group design, such as the hybrid consultation format and the role of the facilitator, may impact the effectiveness of peer support and influence patients’ overall experience of GCs.

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