Search Results for: Long COVID: principali risultati, meccanismi e raccomandazioni

Objectives
The Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

Design
Systematic review and thematic synthesis of studies reporting surgical innovation.

Data sources
Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers).

Eligibility criteria
Primary research studies of any design that involved invasive innovative devices or procedures.

Data extraction and synthesis
Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

Results
Of 1071 records screened, 104 studies published between 2011–2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

Conclusion
Reporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.

PROSPERO registration number
CRD42023427704.

Circulation, Ahead of Print. The postacute sequelae of SARS-CoV-2, also known as Long COVID, may affect 10% to 25% of individuals diagnosed with SARS-CoV-2. More than 100 symptoms have been reported among patients with Long COVID, but almost all patients report severe fatigue, orthostatic intolerance, shortness of breath, and reductions in exercise tolerance. Emerging data suggest that cardiovascular deconditioning plays a major role in the development of this syndrome and that reductions in functional capacity among patients with Long COVID are comparable to reductions seen among individuals with cardiovascular deconditioning resulting from bed rest. Concern has been raised about the use of exercise training as part of the management strategy for patients with Long COVID. However, exercise training appropriately tailored to the patient with cardiovascular deconditioning may be an effective strategy to facilitate improvement in symptoms. This American Heart Association scientific statement provides a concise yet comprehensive overview of mechanisms contributing to development of Long COVID and methods by which exercise training may be applied to this unique patient population to alleviate symptoms and improve quality of life. In addition, methods of reintroducing exercise and return to play among athletes affected by COVID-19 are discussed.

Al forum Fiaso i risultati del progetto pilota avviato in Puglia

Objectives
To develop a teaching exemplar for optimising the safe and accessible delivery of chair-based yoga to multimorbid older adult populations.

Design
A qualitative process evaluation embedded within the multi-site, randomised controlled Gentle Years Yoga trial for older adults (65+ years) with two or more long-term health conditions (trial status: completed).

Setting
Online and face-to-face interviews were conducted with participants and yoga teachers involved in the 12-week chair-based yoga intervention. Interview data were supplemented with observations of in-person and online yoga class delivery.

Participants
All yoga teachers delivering the yoga intervention were invited to take part in the interviews, together with a subsample of participants receiving the yoga intervention. Participants were purposively selected to represent the trial cohort demographics of gender, age, ethnicity, index of multiple deprivation, and number and intensity of chronic health conditions.

Results
25 yoga participants and 11 yoga teachers took part in one (N=19) or two (N=17) interviews. Participants were aged 66–91 years (mean age 74 years), with 2–8 long-term health conditions, most commonly osteoarthritis (N=15, 60%), cardiovascular disease (N=14, 56%), sensory conditions (N=9, 36%) and depression or anxiety (N=8, 32%). Yoga teachers were predominantly female (N=10, 91%), with 4–35 years yoga teaching experience across multiple yoga styles. Feedback from yoga teachers and participants was classified into six categories, generating a 21-item teaching exemplar. These covered aspects of delivery including class size and delivery formats, choosing appropriate physical content, enhancing inclusivity of personal beliefs through non-physical content, proactive teaching styles, communication tips and ways to boost visibility.

Conclusions
This 21-item list adds to the current educational base of yoga for older adults. Addressing both face-to-face and online class formats, this exemplar offers pragmatic guidance for yoga teachers to enhance the safe and accessible delivery of chair-based yoga to older adults and multimorbid populations.

Trial registration number
ISRCTN13567538.

Background
High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs (‘triple pill’) compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.

Methods
Guided by the UK Medical Research Council’s framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.

Results
Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of ‘better than usual’ care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill’s large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.

Conclusions
Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.

Trial registration number
ACTRN12612001120864, SLCTR/2015/020.

Objectives
Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context.

Design
Retrospective cohort study.

Setting
Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023.

Participants
Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis.

Primary and secondary outcome measures
The primary outcome was all-cause death and the secondary outcome was the composite disease progression.

Results
Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events.

Conclusions
Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events.

Trial registration number
NCT06349655.

Conducting clinical research in response to infectious disease outbreaks presents unique challenges. In a previous review, we identified a range of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges and proposed solutions to effective implementation of outbreak research responses. Following the COVID-19 pandemic, we conducted an update to explore if solutions recommended had been implemented, or new challenges identified. We searched seven databases (Ovid MEDLINE, Global Health, Embase, and PsycINFO, Scopus, Epistemonikos, Google Scholar) and grey literature from 01/06/2018 to 28/09/2023 for studies presenting PEARLES challenges/solutions to epi/pandemic research responses.

Risultati incoraggianti da studio fase 3 su sotatercept

Importance
Background rates are critical for contextualising safety signals arising from COVID-19-related interventions in investigational or real-world settings.

Objective
To estimate background rates of medical events of interest (MEI) for which COVID-19 infection and/or COVID-19 interventions may be risk factors in two US claims databases.

Design, setting and participants
This retrospective cohort study spans the pre-COVID-19 (2018–2019) and COVID-19 (2020–2021) periods. We constructed three cohorts, in each of Inovalon/HealthVerity (Inovalon/HV) and Optum databases: a COVID-19-positive adult cohort (2020–2021), a paediatric cohort (2018–2021) and a high-risk cohort (2018–2021) comprising patients at increased risk for severe COVID-19. Participants were indexed on the day they first qualified to enter each cohort during the study period. Background rates of 17 MEI were estimated per 1000 person-years (PY) with 95% CIs.

Main outcomes and measures
Annual incidence rates (IRs) of 17 MEI.

Results
Overall, 758 414 (COVID-19-positive adults; 57.8% women), 12 513 664 (high-risk adults; 56.8% women) and 8 510 627 (paediatric patients; 49.1% women) patients were identified in the HV database. IRs of MEI varied substantially by year, data source, study cohort and duration of follow-up. The IRs of MEI were highest among COVID-19-positive adults and lowest among paediatric patients. For example, IR of myocarditis/pericarditis per 1000 PY was 3.0 (95% CI: 2.6 to 3.4) in the COVID-19-positive adult cohort vs 0.36 (95% CI: 0.34 to 0.37) among high-risk adults and 0.05 (95% CI: 0.05 to 0.06) among paediatric patients. In the COVID-19-positive adult cohort, we observed higher IRs during 90-day follow-up (eg, IR of acute myocardial infarction (AMI) 26.5 (95% CI: 25.3 to 27.7)) vs 365-day follow-up (eg, IR of AMI 20.0 (95% CI: 9.2 to 20.8)) and during 2020 compared with 2021. IRs were higher in the high-risk adult and paediatric populations during the pre-COVID-19 period than during the COVID-19 pandemic.

Conclusions
Substantial variability was observed in IRs of MEI by study cohort, year, data source and follow-up duration. When generating background rates for contextualising safety signals from COVID-19 interventions, careful consideration must be given to the indicated subpopulation of interest, COVID-19-related temporal variations and data sources.

Introduction
interRAI is a global collaboration of clinicians, researchers and policy-makers who have developed a suite of assessment tools to assess the health status and care needs of older adults in various settings (ie, home, long-term care, etc). We aim to determine how interRAI tools have been used as an intervention and to evaluate intervention efficacy in older adults (65+) across diverse healthcare settings. Importantly, given the deployment of interRAI primarily in high-income countries, we anticipate that the findings may have minimal relevance to low- and middle-income nations, where there is an immediate and urgent need for equity in geriatric assessment.

Methods and analysis
To be included, all studies must satisfy our inclusion criteria, outlined by the population (ie, older adults and/or individuals providing some element of care to older adults), intervention (ie, randomised or non-randomised), comparator (ie, with or without one) and outcome (ie, how the interRAI formed the basis of a study intervention). Our search strategy is based on previous reviews of interRAI tools, our research and clinical experience, and the expertise of a specialised librarian. In addition to PubMed, we will conduct our search without date or language restrictions in Scopus, Embase,Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier and PsycInfo. Study screening will employ a team-based approach, with Kappa statistics >0.8 indicating ‘substantial’ agreement and an acceptable threshold. Data extraction will capture the study ID and design, as well as sample characteristics and outcomes. Reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews, with findings presented graphically and narratively.

Ethics and dissemination
Ethics approval is not required. Our knowledge dissemination strategies include traditional research avenues (ie, manuscript publications). We will also create an infographic to disperse widely and leverage existing partnerships to provide community presentations.

Registration details
https://doi.org/10.17605/OSF.IO/BGJKP

Objectives and design
A qualitative study was undertaken to explore the nature of staffing strategies from the perspectives of nursing, medicine and health disciplines employed in a hospital setting.

Setting
Interviews were conducted in six hospitals in Canada between November 2022 and September 2023.

Results
118 healthcare professionals and leaders who experienced changes in staffing strategies participated in this study. Three themes emerged to describe new or adaptive staffing strategies: (1) valuing new roles and teams; (2) being redeployed; and (3) enhancing coverage.

Conclusions
Our study elucidates the staffing strategies that were employed during the COVID-19 pandemic that included creating new and adapting existing roles and teams; redeploying healthcare professionals; and enhancing coverage. Study findings can be used to guide leaders to use a proactive systematic approach to staffing models that includes adaptable and flexible staffing models within local contexts.

Introduction
Adolescent idiopathic scoliosis (AIS) is an acquired deformity that develops in 2–4% of otherwise healthy children during adolescent growth, substantially reducing their quality of life and creating a life-long burden of disease. Despite many years of dedicated research, the cause and mechanism of AIS are still unknown and no effective curative treatments are available for children suffering from this spinal and chest deformity. To date, all etiological studies focused on children with an already established scoliosis. EARLYBIRD aims to uncover the earliest pathoanatomical changes in AIS, by studying longitudinal spinal growth in children at increased risk for scoliosis development with MRI, starting before adolescence.

Methods and analysis
This prospective observational cohort study will follow two groups: 60 adolescent girls (8–10 years old) who have an older sibling or parent diagnosed with AIS (cohort 1) and 60 adolescents with 22q11.2 deletion syndrome, a genetic microdeletion associated with 50% scoliosis prevalence (cohort 2). Data collection will be completely radiation-free and occur at baseline and yearly during adolescence up to 15 years of age in girls and up to 16 in boys. A comprehensive physical examination, a dedicated spine and chest MRI as well as a standing three-dimensional (3-D) spinal ultrasound will be obtained at each time point. The main parameter will be the longitudinal changes in segmental axial rotation during growth in subjects that do and do not develop AIS. Secondary endpoints are longitudinal changes in 3-D morphology of the bone and intervertebral discs (IVDs) during normal spinal development and during scoliosis development, determining biomarkers for bone growth, implementing radiation-free imaging methods for spinal monitoring in adolescent patients at risk for scoliosis development and use these for spinal skeletal maturity and patient-specific spinal biomechanical analyses.

Ethics and dissemination
This protocol has been approved by the Medical Ethics Committee NedMed and is registered on clinicaltrials.gov (NCT05924347). Written informed consent will be obtained from all parents/legal representatives. Key findings will be disseminated via peer-reviewed journals and presentation at conferences. This study is funded by the European Research Council.

Introduction
Type 1 diabetes (T1D) is associated with changes in brain structure, cognition, mental health, and functional outcomes. While these changes have been linked to dysregulated glycaemic control, findings are inconsistent, and their long-term impact remains unclear. Most evidence comes from cross-sectional or short-term longitudinal studies, limiting insights into causal associations. To address this, we aim to study individuals with T1D approximately 30 years after onset to assess how early dysglycaemic insults during neurodevelopment influence cognitive and functional outcomes in mid-adulthood.

Methods and analysis
This protocol paper outlines an observational, case/control, cross-sectional/longitudinal and descriptive study that follows up the original Royal Children’s Hospital (RCH) Diabetes Cohort Study. The initial study recruited children in Australia diagnosed with T1D between 1990 and 1992, conducting five waves of data collection. We now introduce the Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications Study to assess brain, cognition and functional outcomes in mid-adulthood, approximately 30 years post-T1D onset. Both T1D participants from the original cohort and healthy controls will participate in semistructured interviews, neuroimaging and cognitive testing. T1D participants will also undergo complications screening. Data from this study and previous waves will be used to (Aim 1) explore cross-sectional and longitudinal impacts of T1D on brain health over 30 years. Linear regression will analyse cross-sectional outcomes, and multivariate analysis will assess cognitive variables jointly. Longitudinal outcomes will be examined using linear mixed-effects regression for IQ patterns, with secondary outcomes analysed via generalised linear models. Additionally, linear mixed-effects regression (Aim 2) will identify T1D-related metabolic factors affecting brain outcomes, with covariate selection informed by the construction of directed acyclic graphs (DAGs).

Ethics and dissemination
The study was approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC 35 240F and 2019.065). The research findings will be disseminated through peer-reviewed publications, conference presentations, and print and social media. Participants will receive a summary of the study findings on its completion.

Objective
For every 100 women having a vaginal birth, approximately four will experience a severe (third-degree or fourth-degree) perineal tear. Severe perineal tears are associated with significant short-term and long-term consequences if not recognised and repaired. There are global efforts to reduce incidence of severe perineal tears including initiatives to strengthen education and training of clinicians in perineal anatomy and perineal tear assessment and classification. This systematic review aimed to describe and evaluate the effectiveness of these initiatives.

Design
Systematic review, reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Data sources
Medline (Ovid), CINAHL Complete (EBSCO), MIDIRS and EMBASE (Ovid) were searched through 15 February 2024.

Eligibility criteria
Studies reporting simple or complex interventions aimed at improving the skills and knowledge of clinicians in perineal anatomy and/or the clinical assessment and classification of perineal tears were eligible.

Data extraction and synthesis
Two reviewers independently screened studies for eligibility and appraised the quality of individual studies using the Cochrane Risk of Bias (RoB) 2.0 tool or Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool.

Results
In total, 7645 citations were screened and 39 studies included. We identified nine unique interventions including training programmes, short workshops and senior obstetrician supervision. Many studies were from high-income countries, in primary care settings and at high risk of bias.

Conclusions
Effective education included practical components, such as hands-on skills and training in perineal anatomy, assessment and classification, rather than senior supervision alone. Ongoing review of practice appears to be crucial for maintaining knowledge and skills. Future research should focus on interventions tailored to limited-resource settings, and the optimal length and intensity of training programmes to assess and classify perineal tears.

PROSPERO registration number
CRD42020185431.

Objectives
To evaluate factors associated with clinic follow-up after traumatic spinal injury (TSI) in Tanzania, focusing on demographic, injury-related and hospital variables. We hypothesised that socioeconomic and injury-specific factors would predict follow-up adherence.

Design
Retrospective observational cohort study.

Setting
Tertiary government referral centre for neurosurgery and orthopaedics in Dar es Salaam, Tanzania.

Participants
443 adults with TSI admitted between September 2016 and October 2021. Inclusion criteria included survival to discharge and availability of the discharge date. Patients with missing data were excluded.

Primary and secondary outcome measures
Primary outcomes were any clinic follow-up and 1-year follow-up post-discharge. Secondary outcome was time to loss of follow-up. Logistic regression was used to identify factors associated with follow-up, and Kaplan-Meier survival analysis assessed follow-up duration.

Results
Of 443 patients (85.8% male, median age 34 years), 52.4% returned for follow-up. Independent factors associated with return included private insurance (adjusted OR (aOR) 2.69, 95% CI 1.38 to 5.45, p=0.005), involvement in a road traffic accident (aOR 2.15, 95% CI 1.22 to 3.83, p=0.009), lumbar injuries (aOR 2.26, 95% CI 1.30 to 4.00, p=0.004), neurological improvement at discharge (aOR 3.52, 95% CI 1.72 to 7.64, p=0.001) and hospital stays shorter than 24 days (aOR 1.63, 95% CI 1.07 to 2.47, p=0.022). Among those who returned, only 25.4% completed 1 year of follow-up. Predictors of 1-year follow-up included being female (aOR 4.87, 95% CI 2.31 to 10.56, p