Risultati per: Studio REDUCE-IT e appropriatezza prescrittiva degli acidi grassi omega-3

Objectives
To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.

Design
Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.

Setting
Emergency departments in 23 UK hospitals.

Participants
1409 children aged 4–16 years attending with a torus (buckle) fracture, and their parents/guardian. Children’s mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language.

Interventions
Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728).

Outcome measures
Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three ‘free text’ questions (deriving subjective evaluations) and trial retention.

Results
MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI –1.23 to 1.32, p=0.94). The MMI group was more likely to report the information ‘very easy’ to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks’ timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%).

Conclusions
MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively.

Trial registration number
ISRCTN73136092 and ISRCTN13955395.

Objective
There are numerous studies reporting a disproportionally high prevalence of thrombophilia in women with a history of recurrent miscarriage (RM), which has led to overdiagnosis and treatment without an improvement in clinical outcomes. The objective of our study was to assess the prevalence of inherited and acquired thrombophilia in a large cohort of women with a history of early RM using internationally agreed diagnostic criteria and inclusion parameters and compare it to the meta-analysis results of existing literature.

Methods

Design
Retrospective cohort study and systematic review of literature.

Setting
This is a retrospective cohort study set-up in two dedicated tertiary centres for women with RM in Southwest London and Surrey. We reviewed all the available literature related to causes of RMs. We ascertained the prevalence of thrombophilia in the study population and compared it with historical and published prevalence in the general population.

Participants
1155 women between 2012 and 2017. All patients had three or more first trimester miscarriages and a full thrombophilia screen.

Results
The overall prevalence of thrombophilia in our study population is 9.2% (106/1155) with 8.1% (94/1155) of cases positive for inherited thrombophilia, which is similar to the general population; Factor V Leiden (4.9%; 57/1155) and prothrombin gene mutation (2.9%; 34/1155) were the most common inherited thrombophilias, while only 1% (12/1155) tested positive for acquired thrombophilia. Persistent positive lupus anticoagulant (LA) was found in 0.5% (6/1155) and persistent positive anticardiolipin (ACL) antibodies with a value ≥40 U/mL was found in 0.5% (6/1155) of patients. Tests for LA/ACL were performed a minimum of 12 weeks apart thus meeting the revised Sapporo criteria for a diagnosis of antiphospholipid syndrome.

Conclusion
The findings of our study demonstrate that the prevalence of inherited thrombophilia is similar in women with RM to that in the general population. Similarly, the prevalence of acquired thrombophilia, using the revised Sapporo criteria, in the cohort of RMs is similar to that in the general population. Therefore, we do not recommend investigation or treatment of inherited or acquired thrombophilia in women with RM.

PROSPERO registration number
CRD42020223554.

Introduction
Hyperlipidaemia contributes a significant proportion of modifiable cardiovascular disease (CVD) risk, which is a condition that disproportionally affects disadvantaged socioeconomic communities, with death rates in the most deprived areas being four times higher than those in the least deprived. With the national CVD Prevention programme being delivered to minimise risk factors, no evidence is available on what has been implemented in primary care for deprived populations. This study describes the protocol for the development of a tailored intervention aiming to optimise lipid management in primary care settings to help reduce inequalities in CVD risks and improve outcomes in deprived communities.

Methods and analysis
A mixed-methods approach will be employed consisting of four work packages: (1) rapid review and logic model; (2) assessment and comparison of CVD risk management for deprived with non-deprived populations in Northern England to England overall; (3) interviews with health professionals; and (4) intervention development. A systematic search and narrative synthesis will be undertaken to identify evidence-based interventions and targeted outcomes in deprived areas. General practice-level data will be assessed to establish the profile of lipid management, compared with the regional and national levels. Health professionals involved in the organisation and delivery of routine lipid management to deprived populations will be interviewed to understand the implementation and delivery of current lipid management and associated challenges. The prototype intervention will be informed by the evidence generated from workpackages 1–3, which will be reviewed and assessed using the nominal group technique to reach consensus. Training and skills development materials will also be developed as needed.

Ethics and dissemination
Ethics approval has been obtained from the Faculty of Medical Sciences Research Ethics Committee at Newcastle University, UK. Findings will be disseminated to the participating sites, participants, commissioners, and in peer-reviewed journals and academic conferences.

Objectives
To estimate the cost and cost effectiveness of reactive case detection (RACD), reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) to reduce malaria in a low endemic setting.

Setting
The study was part of a 2×2 factorial design cluster randomised controlled trial within the catchment area of 11 primary health facilities in Zambezi, Namibia.

Participants
Cost and outcome data were collected from the trial, which included 8948 community members that received interventions due to their residence within 500 m of malaria index cases.

Outcome measures
The primary outcome was incremental cost effectiveness ratio (ICER) per in incident case averted. ICER per prevalent case and per disability-adjusted life years (DALY) averted were secondary outcomes, as were per unit interventions costs and personnel time. Outcomes were compared as: (1) rfMDA versus RACD, (2) RAVC versus no RAVC and (3) rfMDA+RAVC versus RACD only.

Results
rfMDA cost 1.1x more than RACD, and RAVC cost 1.7x more than no RAVC. Relative to RACD only, the cost of rfMDA+RAVC was double ($3082 vs $1553 per event). The ICERs for rfMDA versus RACD, RAVC versus no RAVC and rfMDA+RAVC versus RACD only were $114, $1472 and $842, per incident case averted, respectively. Using prevalent infections and DALYs as outcomes, trends were similar. The median personnel time to implement rfMDA was 20% lower than for RACD (30 vs 38 min per person). The median personnel time for RAVC was 34 min per structure sprayed.

Conclusion
Implemented alone or in combination, rfMDA and RAVC were cost effective in reducing malaria incidence and prevalence despite higher implementation costs in the intervention compared with control arms. Compared with RACD, rfMDA was time saving. Cost and time requirements for the combined intervention could be decreased by implementing rfMDA and RAVC simultaneously by a single team.

Trial registration number
NCT02610400; Post-results.

Introduction
Improving oral health and reducing oral health inequalities is an important global health priority. ‘Upstream interventions’ are a vital part of the collective effort to reduce oral disease burdens, however it is a rather nebulous term. Furthermore, there is little evidence on the effectiveness, impact and sustainability of upstream interventions that have focused on oral health and wider public health measures that impact on oral health. The aim of this scoping review is to systematically map and synthesise evidence on the effectiveness, impact and sustainability of upstream interventions on population oral health and reducing socioeconomic oral health inequalities.

Methods and analysis
This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist. A detailed search strategy will be used to conduct a comprehensive search of electronic databases: Scopus, Embase and MEDLINE, PsycINFO and CINAHL, ASSIA and Cochrane Database of Systematic Reviews. A search of grey literature will also be completed to identify relevant dissertations, governmental reports and evaluations of implemented policies. Identification and extraction of data will be performed by two pairs of reviewers. Oversight and feedback will be provided by an independent expert advisory group.

Ethics and dissemination
This study will review published and available grey literature and does not require an ethics review. The scoping review protocol has been registered with the Open Science Framework. The final report will be circulated and disseminated through publication and feed into the work of the ongoing Lancet Commission on Oral Health. Due to the policy relevance of this work, discussions will take place with key stakeholders regarding the implications of the findings for future policy development.

Objective
To evaluate the impact of the ‘Getting it Right First Time’ (GIRFT) national improvement programme in orthopaedics, which started in 2012.

Design
Mixed-methods study comprising statistical analysis of linked national datasets (National Joint Registry; Hospital Episode Statistics; Patient-Reported Outcomes); economic analysis and qualitative case studies in six National Health Service (NHS) Trusts.

Setting
NHS elective orthopaedic surgery in England.

Participants
736 088 patients who underwent primary hip or knee replacement at 126 NHS Trusts between 1 April 2009 and 31 March 2018, plus 50 NHS staff.

Intervention
Improvement bundle including ‘deep dive’ visits by senior clinician to NHS Trusts, informed by bespoke set of routine performance data, to discuss how improvements could be made locally.

Main outcome measures
Number of procedures conducted by low volume surgeons; use of uncemented hip implants in patients >65; arthroscopy in year prior to knee replacement; hospital length of stay; emergency readmissions within 30 days; revision surgery within 1 year; health-related quality of life and functional status.

Results
National trends demonstrated substantial improvements beginning prior to GIRFT. Between 2012 and 2018, there were reductions in procedures by low volume surgeons (ORs (95% CI) hips 0.58 (0.53 to 0.63), knees 0.77 (0.72 to 0.83)); uncemented hip prostheses in >65 s (OR 0.56 (0.51 to 0.61)); knee arthroscopies before surgery (OR 0.48 (0.41 to 0.56)) and mean length of stay (hips –0.90 (–1.00 to -0.81), knees –0.74 days (–0.82 to –0.66)). The additional impact of visits was mixed and comprised an overall economic saving of £431 848 between 2012 and 2018, but this was offset by the costs of the visits. Staff reported that GIRFT’s influence ranged from procurement changes to improved regional collaboration.

Conclusion
Nationally, we found substantial improvements in care, but the specific contribution of GIRFT cannot be reliably estimated due to other concurrent initiatives. Our approach enabled additional analysis of the discrete impact of GIRFT visits.

Objectives
Current soil-transmitted helminth (STH) morbidity control guidelines primarily target deworming of preschool and school-age children. Emerging evidence suggests that community-wide mass drug administration (cMDA) may interrupt STH transmission. However, the success of such programmes depends on achieving high treatment coverage and uptake. This formative analysis was conducted to evaluate the implementation climate for cMDA and to determine barriers and facilitators to launch.

Settings
Prior to the launch of a cMDA trial in Benin, India and Malawi.

Participants
Community members (adult women and men, children, and local leaders), community drug distributors (CDDs) and health facility workers.

Design
We conducted 48 focus group discussions (FGDs) with community members, 13 FGDs with CDDs and 5 FGDs with health facility workers in twelve randomly selected clusters across the three study countries. We used the Consolidated Framework for Implementation Research to guide the design of the interview guide and thematic analysis.

Results
Across all three sites, aspects of the implementation climate that were facilitators to cMDA launch included: high community member demand for cMDA, integration of cMDA into existing vaccination campaigns and/or health services, and engagement with familiar health workers. Barriers to launching cMDA included mistrust towards medical interventions, fear of side effects and limited perceived need for interrupting STH transmission. We include specific recommendations from community members regarding cMDA distribution sites, personnel requirements, delivery timing and incentives, leaders to engage and methods for mobilising participants.

Conclusions
Prior to launching the cMDA programme as an alternative to school-based MDA, cMDA was found to be generally acceptable across diverse geographical and demographic settings. Community members, CDDs and health workers felt that engaging communities and tailoring programmes to the local context are critical for success. Potential barriers may be mitigated by identifying local concerns and addressing them via targeted community sensitisation prior to implementation.

Trial registration number
NCT03014167; Pre-results.

Waste in research has been well documented, but initiatives to reduce it are scarce. Here, we share our initial experiences of implementing Lean thinking and visual management into hospital research units in the Region of Southern Denmark. A Transformation Guiding Team (TGT) anchored in the top management was established with participation from leaders, researchers and patient representatives. The role of the TGT was to implement Lean methods, considering patients as primary end-users of the research results. This is in line with an explicit decision on setting patient values first in clinical settings at participating hospitals. The leaders of the research units were instructed in Lean thinking and Lean methods during a five-module course focusing on increasing value and reducing waste in research production. Initial experiences were that Lean tools could create a patient-centred vision that through visual management could identify waste in work processes. Concerns were lack of evidence for using Lean methods in research leadership and that the model itself could be a time consumer. Some lessons learnt were that adding Lean tools in research leadership should not just provide increased research productivity, but also improve other important key performance indicators such as quality of research and patient-relevant results. We intend to evaluate the value of the initiative by follow-up research and publish the outcome of key behavioural and key performance indicators.

Introduction
Multimorbidity, defined as the co-occurrence of two or more long-term medical conditions, is an increasing public health concern worldwide causing enormous burden to individuals, healthcare systems and societies. The most effective way of decreasing the burden caused by multimorbidity is to find tools for its successful prevention but gaps in research evidence limit capacities to develop prevention strategies. The aim of the MOLTO study (Multimorbidity – identifying the most burdensome patterns, risk factors and potentials to reduce future burden) is to provide novel evidence required for cost-effective prevention of multimorbidity by defining the multimorbidity patterns causing the greatest burden at the population level, by examining their risk and protective factors and by estimating the potentials to reduce the future burden.

Methods and analysis
The MOLTO study is based on the data from the Finnish population-based cross-sectional (FINRISK 2002–2012, FinHealth 2017 the Migrant Health and Well-being Study 2010–2012) and longitudinal (Health 2000/2011) health examination surveys with individual-level link to administrative health registers, allowing register-based follow-up for the study participants. Both cross-sectional and longitudinal study designs will be used. Multimorbidity patterns will be defined using latent class analysis. The burden caused by multimorbidity as well as risk and protective factors for multimorbidity will be analysed by survival analysis methods such as Cox proportional hazards and Poisson regression models.

Ethics and dissemination
The survey data have been collected following the legislation at the time of the survey. The ethics committee of the Hospital District of Helsinki and Uusimaa has approved the data collection and register linkages for each survey. The results will be published as peer-reviewed scientific publications.

Question: A previously healthy 43-year-old woman presented with epigastric pain and intermittent postprandial vomiting for 1 year. The patient denied any fever, night sweats, extraintestinal symptoms, and perianal disease. Physical examination was unremarkable. Initial laboratory values were within normal limits except for increased erythrocyte sedimentation rate (46 mm/h) and positive fecal calprotectin. Ileocolonoscopy revealed erosions in the terminal ileum. Biopsy specimens showed unspecific alterations with acute and chronic inflammation.

BackgroundThe COVID-19 Ambulance Response Assessment (CARA) study was a prospective, longitudinal survey of UK ambulance staff during the first wave of the COVID-19 pandemic. CARA aimed to evaluate perceptions of preparedness and wellbeing, and to collect staff suggestions to benefit working practices and conditions.MethodThree online questionnaires were presented, coinciding with the acceleration, peak and deceleration phases of the first COVID-19 wave in 2020. Inductive thematic analysis was employed to represent 14,237 free text responses from 3,717 participants to 18 free-text questions overall. This report focuses on experiences of IPC practices.ResultsMany participants lacked confidence in using PPE because of low familiarity, an inadequate evidence-base and changing policy. Some experienced insufficient supply, items of poor quality and suboptimal fit-testing procedure. PPE use was further influenced by discomfort, urgency, and perceptions of risk. Various suggestions were made to improve IPC practices, including decontamination personnel, staff ‘bubbles’ and limiting exposure through public education and remote triage improvements.ConclusionRepeated poor experiences of implementing IPC practices1 2 demand that lessons are learnt from this pandemic. PPE developed with specific regard for ambulance staff’s unique working environment and for them to receive regular familiarization training in its use would likely benefit performance and confidence. Overall, ambulance staff emphasised the need for IPC policies to be pragmatic, evidence-based and communicated with clarity.ReferencesBillings J, Ching B C F, Gkofa V, Greene T, & Bloomfield M. (2020). Healthcare workers experiences of working on the frontline and views about support during COVID-19 and comparable pandemics: A rapid review and meta-synthesis. MedRxiv. https://www.medrxiv.org/content/10.1101/2020.06.21.20136705v1.full-textHoughton C, Meskell P, Delaney H, Smalle M, Glenton C, Booth A, Chan XHS, Devane D. & Biesty L M. (2020). Barriers and facilitators to healthcare workers’ adherence with infection prevention and control (IPC) guidelines for respiratory infectious diseases: a rapid qualitative evidence synthesis. Cochrane Database of Systematic Reviews, (4).Conflict of interestNone.FundingCollege of Paramedics.

Stroke, Volume 53, Issue Suppl_1, Page AWP53-AWP53, February 1, 2022. Background and Purpose:Endovascular therapy for acute ischemic stroke has revolutionized clinical care for stroke patients with large vessel occlusion (LVO), but treatment remains time sensitive. At our stroke center, up to half of the door-to-groin time is accounted for after the patient arrives in the neuro-interventional radiology (NIR) suite. Here we apply the concept of a highly visible timer in the NIR suite to quantify the impact on endovascular treatment time in stroke patients with LVO.Methods:This was a single-center prospective pseudo-randomized study conducted over a 32-week period (September 14, 2020 through April 25, 2021). Pseudo-randomization was achieved by turning the timer on and off in 2-week intervals. The primary outcome and secondary outcomes were reduction in IR to groin time and 90-day mRS, respectively. We also performed a stratified analysis based on anesthesia status for the procedure along with a multivariate regression to evaluate the effect of the intervention on treatment time while accounting for endotracheal intubation.Results:During the 32-week study period, 97 mechanical thrombectomies were performed. The timer was ON and OFF for 38 and 59 cases, respectively. The timer resulted in a reduction in IR-to-groin time (27.7 mins vs 32.6 mins; p=0.02). Endotracheal intubation (80% of overall cohort) was associated with a longer NIR-to-groin time (33 mins vs 23 mins; p

Stroke, Volume 53, Issue Suppl_1, Page A144-A144, February 1, 2022. Background and Purpose:Glucagon-like peptide-1 receptor agonists (GLP1-RA) are antihyperglycemic medications which may have a pleotropic benefit in reducing the risk of stroke. However, with ischemic stroke being the most common stroke subtype in diabetic individuals, it is currently unknown if this benefit remains present when evaluating ischemic stroke in isolation. The aim of this study was to identify whether GLP1-RA medications lower the risk of ischemic stroke.Methods:A 1:1 propensity score matched analysis of a retrospective cohort of patients from the TriNetX platform was performed with the outcome of ischemic stroke, defined with ICD-10-CM codes, during 5 years of follow-up. The exposure was prescription of a GLP1-RA, after which follow-up began. Subgroup propensity matched analyses were performed on individual GLP1-RA medications.Results:256,938 diabetic individuals prescribed a GLP1-RA were matched with an equal cohort of unexposed diabetics. Demographic and diabetic parameters were equally matched (mean age 57.4 years, 52.5% using insulin concurrently, mean hemoglobin A1c 8.3%). Composite ischemic stroke was lower in the GLP1-RA cohort (3.5%; 8,961/256,938 versus 5.8%; 14,806/256,938) with a risk ratio of 0.61 (95% 0.59-0.62), odds ratio of 0.59 (95% CI 0.58-0.61), hazard ratio of 0.71 (95% CI 0.60-0.87), without violation of the PH assumption (p=0.4). Rate of first-time incident stroke followed a similar pattern: (1.9%; 4,746/246,735 versus 3.3%; 8,044/241,891), risk ratio of 0.58 (95% CI 0.56 – 0.60), odds ratio of 0.57 (0.57 – 0.59), hazard ratio of 0.76 (0.67 – 0.86) with preservation of the PH assumption (p= 0.25). All four GLP1-RA medications lowered the event rate of ischemic stroke.Conclusions:In our study of a large cohort of adults with diabetes, the use of a GLP1-RA reduced the risk of ischemic stroke, consistent with post-hoc analyses of randomized controlled trials.

Stroke, Volume 53, Issue Suppl_1, Page AWMP33-AWMP33, February 1, 2022. Introduction:The faster IV Alteplase and mechanical thrombectomy is initiated in acute ischemic stroke, the better the outcome. Delays can significantly impact times to treatment. A mechanism to communicate time targets to code stroke teams can play an important role in providing knowledge about time sensitive metrics. The utilization of the ASA Stroke Time Tracker tool was created to improve communication in a timely manner to stroke teams providing acute treatment. The emphasis is on the education of time targets to improve door to treatment times.Hypothesis:To explore whether the use of the American Stroke Association Time Tracker tool as a communication instrument is associated with improved DTN and DTD times in both direct and transfer patients.Methods:In March 2020 the application of the ASA time tracker tool was introduced. A retrospective review revealed that DTN times improved from 58.7% to 71.6 % for those receiving t-PA within 45 minutes or less during the period the tool was in use. To explore whether timely feedback using the Time Tracker tool was associated with improved DTD times, mechanical thrombectomy data including DTD was collected and communicated to stroke care teams in April 2021. Compilation of time sensitive metrics in the evaluation of DTN times continued through Q2 2021. A retrospective analysis was conducted.Results:For those who received IV Alteplase, the percentage of patients treated within 30 minutes continued to improve, 21.1% (Q3 2020) vs. 35.7% (Q2 2021). The percentage of patients treated within 45 minutes also improved from 71.8% (Q3 2020) to 80.0% (Q2 2021). In patients who received endovascular therapy during Quarter 3 2020, 56.1% met the advanced therapy AHA Elite Plus criteria of DTD within 60 minutes (transfer patients) OR within 90 minutes (direct admit). This improved to 73.1% patients in Quarter 2 2021, during the use of the tool.Conclusions:There is an association between use of the ASA Time Tracker tool and improved DTN and DTD times. Further study should include continued use of the tool to confirm an association between direct communication with Code Stroke teams and improved treatment times.

Stroke, Volume 53, Issue Suppl_1, Page ATP253-ATP253, February 1, 2022. Intracerebral hemorrhage (ICH) causes rapid mechanical damage and initiates secondary injury mechanisms, such as from toxic by-products of blood degradation, that cause extended cell death. Experimentally, several rehabilitative treatments (rehab) can mitigate late cell death, and one recent study suggests it is by accelerating hematoma clearance, thereby minimizing neurotoxicity. Here, we assessed whether early, intense, enriched rehab (ER) enhances functional benefit and reduces ICH injury.Methods:In experiment 1, rats (n=56) were randomly assigned to groups following collagenase-induced striatal ICH: ER-Dark, ER-Light, CONTROL-Dark, or CONTROL-Light. ER rats completed four reach training sessions and six hours of environmental enrichment daily for 10d (d5-14 after ICH), in either the dark or light phase of their housing cycle. Rats were euthanized on d14 and hematoma volume was assessed. In experiment 2 (n=72), rats were randomized to: ER-10, ER-20, or CONTROL. Using the same ER protocol, rats in ER-10 and ER-20 completed 10d (d5-14) or 20d (d5-14 and 19-28) of ER during the dark phase of their housing cycle. Rats were euthanized on d60, and brains were fixed for histological processing. In both experiments, rats completed behavioural assessments prior to ICH, pre-treatment (d4 post-ICH) and post treatment (experiment 1, d13-14; experiment 2, d16-17 and d30-31).Results:In experiment 1 there was no significant difference in reaching intensity between ER completed in light vs. dark (p=0.3318), and both groups reached extensively (3912±947 reaches). ER resulted in slightly better reaching success between d4 and d14 (p=0.0272) but did not significantly alter residual hematoma volume (p=0.9653). In experiment 2, ER duration did not significantly impact reaching success between d4 and d31 (p=0.0587) or reduce lesion size (p=0.6401).Conclusion:While similar rehab methods have been beneficial in other work, these findings suggest that slight variations in protocols (rehab initiation, intensity, time in enrichment) have a large impact on treatment efficacy. Additionally, these results underscore the importance of studying rehabilitation after ICH, as the use of comparable treatments appear to be far more efficacious for ischemic injury.