OP7  Did west midlands ambulance service paramedics’ usage of adrenaline change after the publication of the paramedic2 results, but prior to any guideline change? A service evaluation

2020 ◽  
Vol 37 (10) ◽  
pp. e4.3-e5
Author(s):  
Imogen M Gunson

BackgroundThis project evaluated whether practice change occurred amongst Paramedics directly after the publication of the PARAMEDIC2 trial, regarding adrenaline administration during out-of-hospital cardiac arrest (OHCA) without a change in guidelines. When Paramedics are exposed to a seminal publication there is anecdotal concern their autonomous practice changes, based on comprehension of findings ahead of potential guideline changes, however little evidence appraises whether this really occurs.MethodsA service evaluation to determine any variation in adrenaline administration during OHCA, before and after publication of the PARAMEDIC2 trial.WMAS electronic patient record data that has been collected for use within OHCA ambulance quality indicators was used to evaluate practice variation.Proportion of adult patients receiving adrenaline, number of administrations and time to first administration from EMS arrival (or arrest if EMS witnessed) are reported.This evaluation assesses from the day after recruitment ended on 18th October 2017 until the trial results publication on 19th July 2018, and the same timeframe (273 days) post-publication.ResultsProportion receiving adrenalinePre-publication: 88.7% of 3026 casesPost-publication: 88.0% of 2682 casesMean number of adrenaline administrationsPre-publication: 4Post-publication: 4Mean time to adrenalinePre-publication: 30:02 minutesPost-publication: 30:11 minutesConclusionsIn both datasets, average time to first adrenaline administration and number of administrations were found to be similar. This suggests Paramedic practice adheres to current guidelines when a highly anticipated article is published, however this may vary by intervention so further work is recommended. Limitations of retrospective observational evaluations include uncontrolled treatment variables; however randomised controlled trials cannot assess standard practice. Individuals need continued awareness for implications of changing practice following a trial publication, as patient safety could be breached whilst the wider medical community are scrutinising the trial results. This demonstrates how routine data can be used to evaluate practice and changes within it.

2020 ◽  
Vol 37 (10) ◽  
pp. e13.1-e13
Author(s):  
Helen Snooks ◽  
Matthew Jones ◽  
Ashra Khanom ◽  
Ronan Lyons ◽  
Alan Watkins

BackgroundThe use of anonymised routine linked data in designing and conducting randomised controlled trials (RCTs) has great potential. Sample sizes can be large, inclusion rates high and follow up periods prolonged, while the disruption to participants’ usual routines may be minimised. However, challenges and limitations in using routine linked data in RCTs remain. We sought to describe challenges and opportunities associated with designing and conducting RCTs using anonymised linked routine data in primary and emergency settings.MethodsSynthesis of trial designs used, regulatory processes followed and findings from three trials: PRISMATIC; SAFER 2; TIMEResultsIn each of these trials we have used routine linked data as a key part of the research study design:PRISMATIC (a stepped wedge trial of predictive risk stratification in primary care) utilised linked data outcomes related to emergency admissions to hospital, GP activity and outpatient appointments. Outcomes were included for 230,000 people registered to participating GP practices in the Swansea areaSAFER 2: a cluster randomised trial of referral to falls services by ambulance paramedics included linked data outcomes related to subsequent emergency episodes for 4,655 patients across three UK regionsTIME: feasibility trial of Take Home Naloxone randomised by city; routine linked data used to identify population for inclusion in follow up and outcomesEthics, research and information governance permissions have caused delay in each trial; inclusion rates have been much higher than is usual in RCTs (outcomes for >80% of eligible patients); large trials have been achievable at reasonable cost (each trial <£2,000,000). Questions remain about differences between self-reported and routinely available outcomes; and between routine data outcomes collected prospectively and through the anonymised linked route.ConclusionsThere are clear benefits in using anonymised linked data outcomes in trials but further research is required to understand costs and limitations


2020 ◽  
Vol 105 (8) ◽  
pp. 724-729 ◽  
Author(s):  
Bruna Rubbo ◽  
Sunayna Best ◽  
Robert Anthony Hirst ◽  
Amelia Shoemark ◽  
Patricia Goggin ◽  
...  

ObjectiveIn England, the National Health Service commissioned a National Management Service for children with primary ciliary dyskinesia (PCD). The aims of this study were to describe the health of children seen in this Service and compare lung function to children with cystic fibrosis (CF).DesignMulti-centre service evaluation of the English National Management PCD Service.SettingFour nationally commissioned PCD centres in England.Patients333 children with PCD reviewed in the Service in 2015; lung function data were also compared with 2970 children with CF.ResultsMedian age at diagnosis for PCD was 2.6 years, significantly lower in children with situs inversus (1.0 vs 6.0 years, p<0.001). Compared with national data from the CF Registry, mean (SD) %predicted forced expiratory volume in one second (FEV1) was 76.8% in PCD (n=240) and 85.0% in CF, and FEV1 was lower in children with PCD up to the age of 15 years. Approximately half of children had some hearing impairment, with 26% requiring hearing aids. Children with a lower body mass index (BMI) had lower FEV1 (p<0.001). One-third of children had positive respiratory cultures at review, 54% of these grew Haemophilus influenzae.ConclusionsWe provide evidence that children with PCD in England have worse lung function than those with CF. Nutritional status should be considered in PCD management, as those with a lower BMI have significantly lower FEV1. Hearing impairment is common but seems to improve with age. Well-designed and powered randomised controlled trials on management of PCD are needed to inform best clinical practice.


2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Elizabeth Wager ◽  
◽  
Sabine Kleinert

Abstract Background Inaccurate, false or incomplete research publications may mislead readers including researchers and decision-makers. It is therefore important that such problems are identified and rectified promptly. This usually involves collaboration between the research institutions and academic journals involved, but these interactions can be problematic. Methods These recommendations were developed following discussions at World Conferences on Research Integrity in 2013 and 2017, and at a specially convened 3-day workshop in 2016 involving participants from 7 countries with expertise in publication ethics and research integrity. The recommendations aim to address issues surrounding cooperation and liaison between institutions (e.g. universities) and journals about possible and actual problems with the integrity of reported research arising before and after publication. Results The main recommendations are that research institutions should: develop mechanisms for assessing the integrity of reported research (if concerns are raised) that are distinct from processes to determine whether individual researchers have committed misconduct; release relevant sections of reports of research integrity or misconduct investigations to all journals that have published research that was investigated; take responsibility for research performed under their auspices regardless of whether the researcher still works at that institution or how long ago the work was done; work with funders to ensure essential research data is retained for at least 10 years. Journals should: respond to institutions about research integrity cases in a timely manner; have criteria for determining whether, and what type of, information and evidence relating to the integrity of research reports should be passed on to institutions; pass on research integrity concerns to institutions, regardless of whether they intend to accept the work for publication; retain peer review records for at least 10 years to enable the investigation of peer review manipulation or other inappropriate behaviour by authors or reviewers. Conclusions Various difficulties can prevent effective cooperation between academic journals and research institutions about research integrity concerns and hinder the correction of the research record if problems are discovered. While the issues and their solutions may vary across different settings, we encourage research institutions, journals and funders to consider how they might improve future collaboration and cooperation on research integrity cases.


2016 ◽  
Vol 34 (2) ◽  
pp. 90-94 ◽  
Author(s):  
Catharina Klausenitz ◽  
Thomas Hesse ◽  
Henriette Hacker ◽  
Klaus Hahnenkamp ◽  
Taras Usichenko

Objective Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. Methods Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students’ recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. Results Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. Conclusions AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.


2021 ◽  
pp. 8-10
Author(s):  
Nandita Chaturvedi ◽  
Nidhi Nidhi ◽  
Malobika Bhattacharya

Introduction:Vernal keratoconjunctivitis(VKC) is a chronic, recurrent, inammatory disease of ocular surface showing seasonal exacerbation, affecting young children. Topical steroids are the mainstay in the treatment of ocular allergy, but their use should be judicious since they carry serious side effects . Loteprednol and uorometholone carry better safety prole. Present study was conducted with the aim of comparing the efcacy of these two widely used steroids.Objectives:To compare total subjective symptom score (TSSS), total objective sign score (TOSS) and side effects of medications before and after treatment at each visit.Materials & Methods:A prospective randomised controlled study was performed on 92 patients of VKC over four weeks. Patients were allotted to either of the two arms of treatment (i.e. LP 0.5% or FML 0.1%). Subjective and objective assessments of the signs and symptoms of VKC were done using standard scoring methodologies at 7, 14, 21 and 28 days post treatment. The main outcome measure was measured in terms of TSSS and TOSS before and after treatment at each visit. Secondary outcomes included side effects. Statistical analysis of the data collected was carried out.Results: Loteprednol showed greater reduction in symptoms initially but by the end of study there was no statistically signicant difference in effect between the two drugs.Conclusions: Final improvement in clinical features and safety prole, at the end of 4 weeks was similar in eyes treated with either of the two drugs. Hence, both the drugs can be safely used in the treatment of VKC.


2018 ◽  
Vol 35 (4) ◽  
pp. 706-712 ◽  
Author(s):  
Anjana Srinivasan ◽  
Alex Al Khoury ◽  
Svetlana Puzhko ◽  
Carole Dobrich ◽  
Meira Stern ◽  
...  

Background: Infant tongue-tie can cause breastfeeding problems, which may be improved by frenotomy. However, controversy exists among the medical community. Research aim: To examine the influence of frenotomy on infants with posterior ankyloglossia, by quantifying the changes in breastfeeding and maternal nipple pain using standardized tools. Methods: Newborns ( N = 30) below 12 weeks of age were recruited from the Herzl–Goldfarb Breastfeeding Clinic between April 2014 and April 2015. Diagnosis of posterior ankyloglossia was made clinically. Frenotomy was performed. Mothers received breastfeeding counseling before and after the procedure. Pain and breastfeeding were assessed before the procedure, immediately after the procedure, and after 2 days, 7 days and 14 days. Breastfeeding was assessed using the LATCH Tool and by subjective questioning. Maternal nipple pain was assessed using the Numeric Rating System. Results: No complications were reported with frenotomy. There was a significant improvement in LATCH score immediately post-frenotomy, with an increase in median scores from 7.5 to 8.5 ( p < .0001, Wilcoxon signed rank test). There was a significant decrease in median pain score immediately post-frenotomy, from 3.0 on the left nipple and 3.25 on the right nipple, to 0 bilaterally ( p < .0001, Wilcoxon signed rank test). Subjective improvement in breastfeeding was reported by 90% of mothers immediately after frenotomy and 83% of mothers at Day 14. Conclusion: Frenotomy for posterior ankyloglossia may improve breastfeeding and nipple pain.


PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262197
Author(s):  
Christiane Riedinger ◽  
Jackie Campbell ◽  
William M. P. Klein ◽  
Rebecca A. Ferrer ◽  
Juliet A. Usher-Smith

Risk perception refers to how individuals interpret their susceptibility to threats, and has been hypothesised as an important predictor of intentions and behaviour in many theories of health behaviour change. However, its components, optimal measurement, and effects are not yet fully understood. The TRIRISK model, developed in the US, conceptualises risk perception as deliberative, affective and experiential components. In this study, we aimed to assess the replicability of the TRIRISK model in a UK sample by confirmatory factor analysis (CFA), explore the inherent factor structure of risk perception in the UK sample by exploratory factor analysis (EFA), and assess the associations of EFA-based factors with intentions to change behaviour and subsequent behaviour change. Data were derived from an online randomised controlled trial assessing cancer risk perception using the TRIRISK instrument and intention and lifestyle measures before and after communication of cancer risk. In the CFA analysis, the TRIRISK model of risk perception did not provide a good fit for the UK data. A revised model developed using EFA consisted of two separate “numerical” and “self-reflective” factors of deliberative risk perception, and a third factor combining affective with a subset of experiential items. This model provided a better fit to the data when cross-validated. Using multivariable regression analysis, we found that the self-reflective and affective-experiential factors of the model identified in this study were reliable predictors of intentions to prevent cancer. There were no associations of any of the risk perception factors with behaviour change. This study confirms that risk perception is clearly a multidimensional construct, having identified self-reflective risk perception as a new distinct component with predictive validity for intention. Furthermore, we highlight the practical implications of our findings for the design of interventions incorporating risk perception aimed at behaviour change in the context of cancer prevention.


2021 ◽  
Author(s):  
Fatihiyya Wangara ◽  
Janne Estill ◽  
Hillary Kipruto ◽  
Kara Wools-Kaloustian ◽  
Wendy Chege ◽  
...  

AbstractIntroductionHIV prevalence estimates is a key indicator to inform the coverage and effectiveness of HIV prevention measures. Many countries including Kenya transitioned from sentinel surveillance to the use of routine antenatal care data to estimate the burden of HIV. Countries in Sub Saharan Africa reported several challenges of this transition, including low uptake of HIV testing and sub national / site-level differences in HIV prevalence estimates.MethodsWe examine routine data from Kwale County, Kenya, for the period January 2015 to December 2019 and predict HIV prevalence among women attending antenatal care (ANC) at 100% HIV status ascertainment. We estimate the bias in HIV prevalence estimates as a result of imperfect uptake of HIV testing and make recommendations to improve the utility of ANC routine data for HIV surveillance. We used a generalized estimating equation with binomial distribution to model the observed HIV prevalence as explained by HIV status ascertainment and region (Sub County). We then used marginal standardization to predict the HIV prevalence at 100% HIV status ascertainment.ResultsHIV testing at ANC was at 91.3%, slightly above the global target of 90%. If there was 100% HIV status ascertainment at ANC, the HIV prevalence would be 2.7% (95% CI 2.3-3.2). This was 0.3% lower than the observed prevalence. Similar trends were observed with yearly predictions except for 2018 where the HIV prevalence was underestimated with an absolute bias of -0.2%. This implies missed opportunities for identifying new HIV infections in the year 2018.ConclusionsImperfect HIV status ascertainment at ANC overestimates HIV prevalence among women attending ANC in Kwale County. However, the use of ANC routine data may underestimate the true population prevalence. There is need to address both community level and health facility level barriers to the uptake of ANC services.Key questionsWhat is already known?▪HIV surveillance estimates from antenatal clinics (ANC) can serve as a useful proxy for HIV prevalence trends in the general female population.▪Kenya has conducted multiple studies which have shown that national HIV prevalence estimates from sentinel surveillance and those from routine program data to be similar.▪However, these studies have also revealed ongoing challenges to the suitability of using routine data as compared to sentinel surveillance including sub optimal uptake of HIV testing and sub national/ site-level differences in HIV prevalence estimates.What are the new findings?▪HIV positive pregnant women are more likely to be tested at ANC as compared to HIV negative women, leading to higher HIV prevalence estimates among women attending ANC.▪Health facility level HIV prevalence estimates are lower than that of the general population.What do the new findings imply?▪HIV positive women are underrepresented in antenatal clinics.▪In Kwale County (and similar contexts), use of routine ANC data is still not a reliable method to estimate HIV prevalence, both at facility and community level.


2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.


2021 ◽  
Vol 28 (4) ◽  
pp. 72-84
Author(s):  
V. N. Antonov ◽  
M. V. Osikov ◽  
G. L. Ignatova ◽  
S. О. Zotov

Background. The coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has swept across countries worldwide. Despite an unprecedented volume of research, few drug therapies have been proved effective. The lack of evidence-based strategies entailed many practical treatments. Hypercoagulability observed in COVID-19 patients has sparked a debate in the medical community on therapeutic value of anticoagulants.Objectives. A review of up-to-date evidence supporting the therapeutic effect of unfractionated and low molecular-weight heparin as anticoagulant in treatment for COVID-19. Methods. Russian-language and foreign literature was mined in the RSCI, Scopus, PubMed, medRxiv and eLibrary databases for the years 2020–2021, with considering selected impactive publications within 1991–2019 as well. The query keywords were COVID-19, heparin [гепарин], hemostasis [гемостаз], thromboembolism [тромбоэмболия]. Peer-reviewed scientific journals received priority. Content and descriptive analytics were used as research tools.Results. The review surveyed 84 literature sources, with 51 articles selected for downstream analysis. We highlight usage of heparin and its fractions in treatment for COVID-19 and preclinical evidence verifying the antiviral and anti-inflammatory properties of heparin and synthetic heparin-like drugs in COVID-19. The known and plausible side effects demanding additional prospective randomised controlled trials on anticoagulant application in COVID-19 are reviewed, with an assessment of oral direct-acting anticoagulant drug efficiency.Conclusion. Drug-based therapies for haemostasis correction in COVID-19 are currently limited. The paucity of evidence warrants heparin usage as a safer therapy in acute COVID-19 compared to oral anticoagulants. However, the balance of its potential benefits vs. risks must be observed. The benefits and risk uncertainty in heparin treatment require randomised clinical trials and further studies to evaluate safety of direct-acting oral anticoagulants after the patient’s discharge in COVID-19.


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