6,138 research outputs found
Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial
BACKGROUND: The CORONIS trial reported differences in short-term maternal morbidity when comparing five pairs of alternative surgical techniques for caesarean section. Here we report outcomes at 3 years follow-up. METHODS: The CORONIS trial was a pragmatic international 2 × 2 × 2 × 2× 2 non-regular fractional, factorial, unmasked, randomised controlled trial done at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. In this follow-up study, we compared outcomes at 3 years following blunt versus sharp abdominal entry, exteriorisation of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus non-closure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Outcomes included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies. Outcomes were assessed masked to the original trial allocation. This trial is registered with the Current Controlled Trials registry, number ISRCTN31089967. FINDINGS: Between Sept 1, 2011, and Sept 30, 2014, 13,153 (84%) women were followed-up for a mean duration of 3·8 years (SD 0·86). For blunt versus sharp abdominal entry there was no evidence of a difference in risk of abdominal hernias (adjusted RR 0·66; 95% CI 0·39-1·11). We also recorded no evidence of a difference in risk of death or serious morbidity of the children born at the time of trial entry (0·99, 0·83-1·17). For exteriorisation of the uterus versus intra-abdominal repair there was no evidence of a difference in risk of infertility (0·91, 0·71-1·18) or of ectopic pregnancy (0·50, 0·15-1·66). For single versus double layer closure of the uterus there was no evidence of a difference in maternal death (0·78, 0·46-1·32) or a composite of pregnancy complications (1·20, 0·75-1·90). For closure versus non-closure of the peritoneum there was no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility (0·80, 0·61-1·06). For chromic catgut versus polyglactin-910 sutures there was no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (3·05, 0·32-29·29). Overall, severe adverse outcomes were uncommon in these settings. INTERPRETATION: Although our study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one technique over another. Other considerations will probably affect clinical practice, such as the time and cost saving of different approaches
Design, recruitment, and baseline characteristics of the LENS trial
Background: Findings from cardiovascular outcome trials suggest that treatment with fenofibrate may reduce the progression of diabetic retinopathy. However, no dedicated large-scale randomised trials have yet investigated this hypothesis.
Methods: LENS is a streamlined randomised double-masked placebo-controlled trial, based in Scotland, assessing whether treatment with fenofibrate (145 mg tablet daily or, in the context of impaired renal function, on alternate days) in people with early retinopathy reduces progression to referable diabetic retinopathy (defined in NHS Scotland's Diabetic Eye Screening grading scheme as referable background or proliferative retinopathy, or referable maculopathy in either eye) or treatment with retinal laser, intravitreal injections or vitrectomy. Adults with diabetes mellitus and non-referable retinopathy (mild background retinopathy in both eyes or observable background retinopathy in one/both eyes at the most recent NHS retinal screening assessment; or observable maculopathy in one/both eyes in the previous 3 years) were eligible. Potential participants were identified from routinely collected healthcare data and followed up using regular contact from the research team and linkage to national electronic morbidity, mortality, biochemistry and retinal screening records. Study treatment was mailed to participants.
Results: Between 18 September 2018 and 27 July 2021, 1151 participants were randomised. Their mean age was 61 (SD 12) years, 312 (27%) were female and 305 (26%) had type 1 diabetes. 96% had bilateral mild background retinopathy and 10% had observable maculopathy.
Conclusions: LENS will provide a robust evaluation of the efficacy of treating people at risk of progression of diabetic retinopathy with fenofibrate. Results are anticipated in mid-2024.
Trial Registrations: NCT03439345; ISRCTN15073006; EuDRACT 2016–002656-24
Progress in prevention of mother-to-child transmission of HIV infection in Ukraine: results from a birth cohort study
Background: Ukraine was the epicentre of the HIV epidemic in Eastern Europe, which has the most rapidly accelerating HIV epidemic world-wide today; national HIV prevalence is currently estimated at 1.6%. Our objective was to evaluate the uptake and effectiveness of interventions for prevention of mother-to-child transmission (PMTCT) over an eight year period within operational settings in Ukraine, within the context of an ongoing birth cohort study.Methods: The European Collaborative Study (ECS) is an ongoing birth cohort study in which HIV-infected pregnant women identified before or during pregnancy or at delivery were enrolled and their infants prospectively followed. Three centres in Ukraine started enrolling in 2000, with a further three joining in September 2006.Results: Of the 3356 women enrolled, 21% (689) reported current or past injecting drug use (IDU). Most women were diagnosed antenatally and of those, the proportion diagnosed in the first/second trimester increased from 47% in 2000/01 (83/178) to 73% (776/1060) in 2006/07 (p < 0.001); intrapartum diagnosis was associated with IDU (Adjusted odds ratio 4.38; 95% CI 3.19-6.02). The percentage of women not receiving any antiretroviral prophylaxis declined from 18% (36/205) in 2001 to 7% in 2007 (61/843) p < 0.001). Use of sdNVP alone substantially declined after 2003, with a concomitant increase in zidovudine prophylaxis. Median antenatal zidovudine prophylaxis duration increased from 24 to 72 days between 2000 and 2007. Elective caesarean section (CS) rates were relatively stable over time and 34% overall. Mother-to-child transmission (MTCT) rates decreased from 15.2% in 2001 (95% CI 10.2-21.4) to 7.0% in 2006 (95% CI 2.6-14.6). In adjusted analysis, MTCT risk was reduced by 43% with elective CS versus vaginal delivery and by 75% with zidovudine versus no prophylaxis.Conclusion: There have been substantial improvements in use of PMTCT interventions in Ukraine, including earlier diagnosis of HIV-infected pregnant women and increasing coverage with antiretroviral prophylaxis and the initial MTCT rate has more than halved. Future research should focus on hard-to-reach populations such as IDU and on missed opportunities for further reducing the MTCT rate
The arabin pessary to prevent preterm birth in women with a twin pregnancy and a short cervix : The STOPPIT 2 RCT
Funding Information: The research reported in this issue of the journal was funded by the HTA programme as project number 13/04/22. The contractual start date was in November 2014. The draft report began editorial review in September 2020 and was accepted for publication in February 2021. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. Declared competing interests of authors: Jane E Norman has received grants from government and charitable bodies for research into understanding the mechanism of term and preterm labour and understanding treatments. Within the last 3 years, Jane E Norman has acted on a Data Safety and Monitoring Board for a study involving a preterm birth therapeutic agent for GlaxoSmithKline plc (GlaxoSmithKline plc, Brentford, UK) and has provided consultancy for a small pharmaceutical company (Dilafor AB, Solna, Sweden) on drugs to alter labour progress. She was on the Health Technology Assessment (HTA) Maternal Neonatal and Child Health Panel (2013–18) and she was a member of the National Institute for Health Research (NIHR) HTA and Efficacy and Mechanism Evaluation (EME) Editorial Board (2012–14). John Norrie reports grants from the University of Edinburgh (Edinburgh, UK) during the conduct of the study, and declares that he is or has been a member of the following: HTA Commissioning Sub-Board (EOI) (2012–16), NIHR CTU Standing Advisory Committee (2017–present), NIHR HTA and EME Editorial Board (2014–19), Pre-Exposure Prophylaxis Impact Review Panel (2017–present), EME Strategy Advisory Committee (2019–present), EME – Funding Committee Members (2019–present), EME Funding Committee Sub-Group Remit & Comp Check (2019–present), HTA General Committee (2016–19), HTA Funding Committee Policy Group (formerly Clinical Studies Group) (2016–19), HTA Commissioning Committee (2010–16) and was a member of the HTA and EME Editorial Board between 2014 and 2019. Sarah Cunningham-Burley reports personal fees and other from the Wellcome Trust (London, UK), other from the University of Copenhagen (Copenhagen, Denmark), other funding from NIHR Global Health Research, personal fees from the French National Cancer Institute (Paris, France) and personal fees from the Health Research Board (Dublin, Ireland), outside the submitted work. Andrew Shennan is a member of the NIHR HTA Commissioning Committee (2018–22). Stephen C Robson was a member of the NIHR EME Funding Committee (2012–15). Steven Thornton is a trustee of a number of charities, including those that fund related research. He reports personal fees from GlaxoSmithKline plc, during the conduct of the study and outside the submitted work, and personal fees from Johnson & Johnson (Johnson & Johnson, Brunswick, NJ, USA) for consulting services. He holds positions in the Royal College of Obstetricians and Gynaecologists (London, UK) and other organisations. He was a member of the NIHR EME Strategy Advisory Committee (2018–19), EME – Funding Committee Members (2015–19), EME Funding Committee Sub-Group Remit & Comp Check (2018–19) and the Medical Research Council Multimorbidity Board (2020). Neil Marlow reports personal fees from Shire-Takeda (London, UK), Novartis Pharmaceuticals UK Ltd (London, UK) and GlaxoSmithKlein plc, outside the submitted work. Sarah J Stock declares that she is a member of the NIHR HTA General Committee (2016–22). In addition, Sarah J Stock received other research funding from the NIHR (14/32/01 QUIDS), Wellcome Trust (209560/Z/17/Z) and Chief Scientist Office (Edinburgh, UK), during the course of the study. Philip R Bennett reports personal fees and membership of a scientific panel from ObsEva (Plan-les-Ouates, Switzerland), outside the submitted work. In addition, Philip R Bennett has a patent PCT/GB1997/000529 WO1997031631 A1 ‘COX-2 selective inhibitors for managing labour and uterine contractions’ issued, a patent PCT/GB2004/001380 WO2005053705 A1 ‘Use of a cyclopentenone prostaglandin for delaying the onset and/or preventing the continuation of labour’ (priority date 2 December 2003) issued, a patent PCT/GB2016/050618 ‘Circulating miRNAs predictive of cervical shortening and preterm birth’ (pending UK filing 6 March 2015/full international filing completed 7 March 2016) issued, a patent PCT/GB2016/ 050621 ‘Rapid evaporative ionisation mass spectroscopy (REIMS) and desorbtion electrospray ionisation mass spectroscopy (DESI-MS) analysis of swabs and biopsy samples’ (pending UK filing 6 March 2015/full international filing completed 7 March 2016) pending, a patent PCT/GB2019 ‘Desorbtion electrospray ionisation mass spectroscopy (DESI-MS) analysis of swabs to predict vaginal microbiota’ (pending UK filing March 2019) pending, and a patent PCT/GB2019/ ‘Circulating miRNAs predictive of IUGR’ (pending UK filing March 2019) pending.Publisher PD
San Diego Regional Climate Collaborative Annual Report 2021
The San Diego Regional Climate Collaborative is a network for public agencies that serves the San Diego region to share expertise, leverage resources and advance comprehensive solutions to facilitate climate change planning. By partnering with academia, nonprofits, and businesses, the SDRCC also works to leverage the profile of regional leadership. This is the 2021 San Diego Regional Climate Collaborative Annual Report.https://digital.sandiego.edu/npi-sdclimate/1017/thumbnail.jp
Documenting the Recovery of Vascular Services in European Centres Following the Initial COVID-19 Pandemic Peak: Results from a Multicentre Collaborative Study.
OBJECTIVE
To document the recovery of vascular services in Europe following the first COVID-19 pandemic peak.
METHODS
An online structured vascular service survey with repeated data entry between 23 March and 9 August 2020 was carried out. Unit level data were collected using repeated questionnaires addressing modifications to vascular services during the first peak (March - May 2020, "period 1"), and then again between May and June ("period 2") and June and July 2020 ("period 3"). The duration of each period was similar. From 2 June, as reductions in cases began to be reported, centres were first asked if they were in a region still affected by rising cases, or if they had passed the peak of the first wave. These centres were asked additional questions about adaptations made to their standard pathways to permit elective surgery to resume.
RESULTS
The impact of the pandemic continued to be felt well after countries' first peak was thought to have passed in 2020. Aneurysm screening had not returned to normal in 21.7% of centres. Carotid surgery was still offered on a case by case basis in 33.8% of centres, and only 52.9% of centres had returned to their normal aneurysm threshold for surgery. Half of centres (49.4%) believed their management of lower limb ischaemia continued to be negatively affected by the pandemic. Reduced operating theatre capacity continued in 45.5% of centres. Twenty per cent of responding centres documented a backlog of at least 20 aortic repairs. At least one negative swab and 14 days of isolation were the most common strategies used for permitting safe elective surgery to recommence.
CONCLUSION
Centres reported a broad return of services approaching pre-pandemic "normal" by July 2020. Many introduced protocols to manage peri-operative COVID-19 risk. Backlogs in cases were reported for all major vascular surgeries
Clinical Outcomes of Soft Tissue Preservation Surgery With Hydroxyapatite-Coated Abutments Compared to Traditional Percutaneous Bone Conduction Hearing Implant Surgery—A Pragmatic Multi-Center Randomized Controlled Trial
Background: Soft tissue preservation using a hydroxyapatite-coated abutment in bone conduction hearing implant surgery may lead to improved clinical outcomes over the short (1 year) and long term (3 years). Methods: In this open multi-center, randomized (1:1), controlled clinical trial, subjects with conductive, mixed hearing loss or single-sided sensorineural deafness were randomly assigned to receive the conventional intervention, a titanium abutment with soft tissue reduction surgery (control), or a new intervention, a hydroxyapatite-coated abutment with soft tissue preservation surgery (test). The primary efficacy outcome was the combined endpoint of numbness, pain, peri-abutment dermatitis, and soft tissue thickening/overgrowth after 1 and 3 years. Results: The Intention-to-treat (ITT) population consisted of 52 control subjects and 51 test subjects. The difference between the groups after 1 year of follow-up as measured by the primary efficacy outcome was not statistically significant (p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance
COACH Faculty Job Satisfaction Survey: Provost Report: University of Washington Tacoma
Climate survey of faculty, conducted by the Collaborative on Academic Careers in Higher Education at the Harvard Graduate School of Educatio
Interprofessional Collaboration Among Complementary And Integrative Health Providers In Private Practice And Community Health Centers
Background: The current healthcare environment is placing increasing emphasis on interprofessional collaboration (IPC). IPC may be of particular importance to complementary and integrative health (CIH) providers who have historically practiced in silos. The extent to which these providers are collaborating with each other and with other providers is not known. Purpose: Investigate aspects of IPC occurring in a sample of CIH providers. Method: A qualitative health services study using semi-structured interviews. Discussion: CIH providers were found to be collaborating with each other and other providers. Subjects indicated IPC had a positive impact on practice and on patient care. Educating students and practitioners about other health disciplines was seen as being key to collaboration between professions, as was being able to communicate using terms others could understand. Conclusions: Results of this study can contribute to broadening the scope of IPC, improve clinical outcomes, improve efficiency for healthcare systems, and may be useful to institutions engaged in training CIH providers in development of curricular content.https://doi.org/10.1016/j.xjep.2019.02.00
Clinical characteristics with inflammation profiling of long COVID and association with 1-year recovery following hospitalisation in the UK: a prospective observational study
Background
No effective pharmacological or non-pharmacological interventions exist for patients with long COVID. We aimed to describe recovery 1 year after hospital discharge for COVID-19, identify factors associated with patient-perceived recovery, and identify potential therapeutic targets by describing the underlying inflammatory profiles of the previously described recovery clusters at 5 months after hospital discharge.
Methods
The Post-hospitalisation COVID-19 study (PHOSP-COVID) is a prospective, longitudinal cohort study recruiting adults (aged ≥18 years) discharged from hospital with COVID-19 across the UK. Recovery was assessed using patient-reported outcome measures, physical performance, and organ function at 5 months and 1 year after hospital discharge, and stratified by both patient-perceived recovery and recovery cluster. Hierarchical logistic regression modelling was performed for patient-perceived recovery at 1 year. Cluster analysis was done using the clustering large applications k-medoids approach using clinical outcomes at 5 months. Inflammatory protein profiling was analysed from plasma at the 5-month visit. This study is registered on the ISRCTN Registry, ISRCTN10980107, and recruitment is ongoing.
Findings
2320 participants discharged from hospital between March 7, 2020, and April 18, 2021, were assessed at 5 months after discharge and 807 (32·7%) participants completed both the 5-month and 1-year visits. 279 (35·6%) of these 807 patients were women and 505 (64·4%) were men, with a mean age of 58·7 (SD 12·5) years, and 224 (27·8%) had received invasive mechanical ventilation (WHO class 7–9). The proportion of patients reporting full recovery was unchanged between 5 months (501 [25·5%] of 1965) and 1 year (232 [28·9%] of 804). Factors associated with being less likely to report full recovery at 1 year were female sex (odds ratio 0·68 [95% CI 0·46–0·99]), obesity (0·50 [0·34–0·74]) and invasive mechanical ventilation (0·42 [0·23–0·76]). Cluster analysis (n=1636) corroborated the previously reported four clusters: very severe, severe, moderate with cognitive impairment, and mild, relating to the severity of physical health, mental health, and cognitive impairment at 5 months. We found increased inflammatory mediators of tissue damage and repair in both the very severe and the moderate with cognitive impairment clusters compared with the mild cluster, including IL-6 concentration, which was increased in both comparisons (n=626 participants). We found a substantial deficit in median EQ-5D-5L utility index from before COVID-19 (retrospective assessment; 0·88 [IQR 0·74–1·00]), at 5 months (0·74 [0·64–0·88]) to 1 year (0·75 [0·62–0·88]), with minimal improvements across all outcome measures at 1 year after discharge in the whole cohort and within each of the four clusters.
Interpretation
The sequelae of a hospital admission with COVID-19 were substantial 1 year after discharge across a range of health domains, with the minority in our cohort feeling fully recovered. Patient-perceived health-related quality of life was reduced at 1 year compared with before hospital admission. Systematic inflammation and obesity are potential treatable traits that warrant further investigation in clinical trials.
Funding
UK Research and Innovation and National Institute for Health Research
- …