Notes

Is actually sound bias resulting in transposon sequencing (TnSeq) assays? A case study with a Staphylococcus aureus TnSeq collection exposed to PCR-based as well as amplification-free enrichment techniques.
d of life for people with COPD, heart failure or cancer, indicating comparable illness trajectories.This supports the need to reconsider efforts in achieving equal access to palliative care interventions, which is still mainly offered to patients with cancer.
Pre-eclampsia, a multisystem disorder in pregnancy, is one of the most common causes of maternal morbidity and mortality worldwide. However, we lack methods for objective assessment of organ function in pre-eclampsia and predictors of organ impairment during and after pre-eclampsia. The women's and their partners' experiences of pre-eclampsia have not been studied in detail. To phenotype different subtypes of the disorder is of importance for prediction, prevention, surveillance, treatment and follow-up of pre-eclampsia.The aim of this study is to set up a multicentre database and biobank for pre-eclampsia in order to contribute to a safer and more individualised treatment and care.

This is a multicentre cohort study. Prospectively recruited pregnant women ≥18 years, diagnosed with pre-eclampsia presenting at Sahlgrenska University Hospital, Uppsala University Hospital and at Södra Älvsborgs Hospital, Sweden, as well as normotensive controls are eligible for participation. At inclusion and at 1-year folloed by the regional ethical review board in Gothenburg on 28 December 2018 (approval number 955-18) and by the Swedish Ethical Review Authority on 27 February 2019 (approval number 2019-00309).Results from the study will be published in international peer-reviewed journals.

ISRCTN13060768.
ISRCTN13060768.
Cancer-related fatigue (CRF) is a prevalent symptom in cancer survivors. Transcutaneous electrical acupoint stimulation (TEAS) has been reported as a promising therapy for CRF. This protocol is proposed for a systematic review that aims to assess the efficacy and safety of TEAS for CRF.

Cochrane Central Register of Controlled Trials, PubMed, Medline, Embase, Chinese National Knowledge Infrastructure, VIP, Wanfang database, Chinese Biomedical Literature Database, Chinese Clinical Trial Registry System, ClinicalTrials.gov and WHO International Clinical Trial Registry Platform will be searched from inception to 31 January 2021 without language limitations. The eligible randomised controlled trials will be included. The primary outcomes include changes in the revised Piper fatigue scale, the Brief fatigue inventory, the Multidimensional fatigue inventory and the Functional assessment of chronic illness therapy fatigue. The secondary outcomes are the quality-of-life measurement index, the Hamilton anxiety scale, the Hamilton depression scale and adverse events. The selection of studies, data extraction and assessment of risk of bias will be conducted independently by two reviewers. Data synthesis will be performed using RevMan V.5.4.1. The quality of evidence will be evaluated with the Grading of Recommendations, Assessment, Development and Evaluation system. This study will strictly adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines.

Ethical approval is not required as this is a systematic review and meta-analysis based on previously published studies involving no private information of patients. The results of this study will be disseminated in a peer-reviewed journal.

CRD42020220282.
CRD42020220282.
To examine experiences of participation in a mandatory system of continuing professional development (CPD) among doctors in Ireland, in order to identify areas for improvement.

A qualitative cross-sectional design was used.

1408 participants (701 male, 707 female) were recruited via email from a population of 4350 doctors enrolled on a Royal College of Physicians of Ireland Professional Competence Scheme (PCS) for the 2017/2018 year, and completed an online survey as part of a larger study examining experiences and attitudes towards participation in PCS. A subset of the sample (434 participants) responded to an optional open-ended question about PCS participation. Responses to the open-ended question were analysed using thematic analysis.

Thematic analysis resulted in five main themes relating to perceived barriers to PCS participation across a wide range of areas 'Evidence of participation', 'The structure of PCS', 'Questioning the benefits of formal CPD', 'Workplace challenges' and 'Access issues'.
more fully and develop appropriate solutions.
The Children and Young People's Health Partnership (CYPHP) Evelina London Model of Care is a new approach to integrated care delivery for children and young people (CYP) with common health complaints and chronic conditions. CYPHP includes population health management (services shaped by data-driven understanding of population and individual needs, applied in this case to enable proactive case finding and tailored biopsychosocial care), specialist clinics with multidisciplinary health teams and training resources for professionals working with CYP. selleck chemicals llc This complex health system strengthening programme has been implemented in South London since April 2018 and will be evaluated using a cluster randomised controlled trial with an embedded process evaluation. This protocol describes the within-trial and beyond-trial economic evaluation of CYPHP.

The economic evaluation will identify, measure and value resources and health outcome impacts of CYPHP compared with enhanced usual care from a National Health Service/Pehical approval from South West-Cornwall and Plymouth Research Ethics Committee (REC Reference 17/SW/0275). Results will be submitted for publication in peer-reviewed journals, made available in briefing papers for local decision-makers, and provided to the local community through website and public events. Findings will be generalisable to community-based models of care, especially in urban settings.

NCT03461848.
NCT03461848.
Evidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP.

This is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18-64 years, and permanent residents of study sites. HbA1c test will nting diabetes.

NCT04074148, 2019/783.
NCT04074148, 2019/783.
To determine whether time elapsed since the second injection of the Pfizer-BioNTech BNT162b2 mRNA vaccine was significantly associated with the risk of covid-19 infection after vaccination in people who received two vaccine injections.

Test negative design study.

Electronic health records of a large state mandated healthcare organisation, Israel.

Adults aged ≥18 years who had received a reverse transcription polymerase chain reaction (RT-PCR) test between 15 May 2021 and 17 September 2021, at least three weeks after their second vaccine injection, had not received a third vaccine injection, and had no history of covid-19 infection.

Positive result for the RT-PCR test. Individuals who tested positive for SARS-CoV-2 and controls were matched for week of testing, age category, and demographic group (ultra-orthodox Jews, individuals of Arab ancestry, and the general population). Conditional logistic regression was adjusted for age, sex, socioeconomic status, and comorbid conditions.

83 057 adults rececine dose after at least 90 days.
To evaluate efficacy and safety of guselkumab, an anti-interleukin-23p19-subunit antibody, in patients with psoriatic arthritis (PsA) with prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFi).

Adults with active PsA (≥3 swollen and ≥3 tender joints) who discontinued ≤2 TNFi due to IR (lack of efficacy or intolerance) were randomised (21) to subcutaneous guselkumab 100 mg or placebo at week 0, week 4, then every 8 weeks (Q8W) through week 44. Patients receiving placebo crossed over to guselkumab at week 24. The primary (ACR20) and key secondary (change in HAQ-DI, ACR50, change in SF-36 PCS and PASI100) endpoints, at week 24, underwent fixed-sequence testing (two-sided α=0.05). Adverse events (AEs) were assessed through week 56.

Among 285 participants (female (52%), one (88%) or two (12%) prior TNFi), 88% of 189 guselkumab and 86% of 96 placebo→guselkumab patients completed study agent through week 44. A statistically significantly higher proportion of patients receiving guselkumab (44.4%) than placebo (19.8%) achieved ACR20 (%difference (95% CI) 24.6 (14.1 to 35.2); multiplicity-adjusted p<0.001) at week 24. Guselkumab was superior to placebo for each key secondary endpoint (multiplicity-adjusted p<0.01). ACR20 response (non-responder imputation) in the guselkumab group was 58% at week 48; >80% of week 24 responders maintained response at week 48. Through week 24, serious AEs/serious infections occurred in 3.7%/0.5% of 189 guselkumab-randomised and 3.1%/0% of 96 placebo-randomised patients; the guselkumab safety profile was similar through week 56, with no deaths or opportunistic infections.

Guselkumab significantly improved joint and skin manifestations and physical function in patients with TNFi-IR PsA. A favourable benefit-risk profile was demonstrated through 1 year.

NCT03796858.
NCT03796858.
To
whether patients with immune-mediated inflammatory disease (IMIDs), who did not respond to two doses of the SARS-CoV-2 vaccine, develop protective immunity, if a third vaccine dose is administered.

Patients with IMID who failed to seroconvert after two doses of SARS-CoV-2 vaccine were subjected to a third vaccination with either mRNA or vector-based vaccines. Anti-SARS-CoV-2 IgG, neutralising activity and T cell responses were assessed at baseline and 3 weeks after revaccination and also evaluated seprarately in rituximab (RTX) and non-RTX exposed patients.

66 non-responders were recruited, 33 treated with RTX, and 33 non-exposed to RTX. Overall, 49.2% patients seroconverted and 50.0% developed neutralising antibody activity. Seroconversion (78.8% vs 18.2%) and neutralising activity (80.0% vs 21.9%) was higher in non-RTX than RTX-treated patients with IMID, respectively. Humoral vaccination responses were not different among patients showing positive (59.3%) or negative (49.7%) T cell responses at baseline. Patients remaining on mRNA-based vaccines showed similar vaccination responses compared with those switching to vector-based vaccines.

Overall, these data strongly argue in favor of a third vaccination in patients with IMID lacking response to standard vaccination irrespective of their B cell status.
Overall, these data strongly argue in favor of a third vaccination in patients with IMID lacking response to standard vaccination irrespective of their B cell status.
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