Colonoscopic cancer detection rate: a new performance measure - is it FIT for purpose?

Introduction: Gastrointestinal symptoms correlate poorly with cancer diagnosis. A faecal immunochemical test (FIT) result of ≥10 µg has high sensitivity and negative predictive value for colorectal cancer (CRC) detection. An FIT-based diagnostic pathway may lead to more effective resource utilisation. We aimed to use National Endoscopy Database (NED) data to create a new colonoscopy performance measure, cancer detection rate (CDR) to assess the appropriate identification of target populations for colonoscopy; then to use CDR to assess the impact of implementing an FIT-based referral pathway locally. Methods: NED data were analysed to compare local diagnostic colonoscopic CDR in 2019 (prepathway revision) and 2021 (postpathway revision), benchmarked against overall national CDR for the same time frames. Results: 1, 123, 624 NED diagnostic colonoscopies were analysed. Locally, there was a significant increase in CDR between 2019 and 2021, from 3.01% (2.45%-3.47%) to 4.32% (3.69%-4.95%), p=0.003. The CDR increase was due to both a 10% increase in the number of CRCs detected and a 25% reduction in the number of diagnostic colonoscopies performed. Nationally, there was a smaller, but significant, increase in CDR from 2.02% (1.99%-2.07%) to 2.33% (2.29%-2.37%), p<0.001. The rate of increase in CDR% between 2019 and 2021 was significantly different locally compared with nationally. Conclusion: Our study indicates that the introduction of a robustly vetted FIT-based algorithm to determine whether diagnostic colonoscopy is required, is effective in increasing the colonoscopic CDR. Moreover, CDR appears to be a meaningful performance metric that can be automatically calculated through NED, enabling monitoring of the quality of referral and vetting pathways.

Correction: Kujawski et al. Autonomic and Cognitive Function Response to Normobaric Hyperoxia Exposure in Healthy Subjects. Preliminary Study. Medicina 2020, 56, 172.

There was an error in the original publication [...].

Prospective association of occupational and leisure-time physical activity with orthostatic blood pressure changes in older adults.

Orthostatic hypotension (OH) is common in older people. We examined the influence of self-reported occupational-related physical activity (PA) and leisure-time physical exercise (PE) on orthostatic response in a sample of older people over a 2 year period. Supine and orthostatic systolic blood pressure (sBP), diastolic blood pressure (dBP), and mean blood pressure (mBP) were assessed in response to Active Stand (AS) test in 205 older subjects (> 60 years old) at baseline and 2-year follow-up. OH was found in 24 subjects (11.71%) at baseline and 20 subjects (9.76%) after 2 years, with a significant degree of variability in the occurrence of OH after 2 years. Twenty-two subjects who had OH at baseline were free of it after 2 years, two subjects had persistent OH at baseline and after 2 years. After 2 years, adults with occupational PA showed no significant decrease of blood pressure in response to AS test, while lack of undertaking an occupation-related PA was significantly related with a greater decrease in sBP and mBP in response to AS testing in the 1st min. Occupation-related PA and leisure-time-related PE were related to an increase in the response of BP on AS in change between baseline and after 2 years. High between-subjects variance in OH over 2 years was noted. Occupations that involved continuous physical activity and leisure-time physical exercise in middle age were both protective for BP decline on orthostatic stress test within 2 years.

Identifying, synthesising and appraising existing evidence relating to myalgic encephalomyelitis/chronic fatigue syndrome and pregnancy: a mixed-methods systematic review.

OBJECTIVES: To identify, synthesise and appraise evidence relating to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and pregnancy. DESIGN: Mixed-methods systematic review, using convergent segregated design. DATA SOURCES: MEDLINE, EMBASE, Scopus, PsycINFO, CINAHL, MedRxiv, PROSPERO and grey literature sources through 6 August 2023. ELIGIBILITY CRITERIA: We included original research studies, expert opinion and grey literature reporting on ME/CFS and pregnancy/post partum (up to 2 years), risk of pregnancy outcomes with ME/CFS or experiences during pregnancy for mother, partner or health and social care professionals following ME/CFS during pregnancy, all where the evidence was relevant to a confirmed ME/CFS diagnosis prior to pregnancy. DATA EXTRACTION AND SYNTHESIS: Three independent reviewers completed all screening, data extraction and quality assessment. Risk of bias was assessed using the mixed-methods appraisal tool V.2018. Qualitative and quantitative literature was analysed separately using thematic and descriptive syntheses. Findings were integrated through configuration. RESULTS: Searches identified 3675 articles, 16 met the inclusion criteria: 4 quantitative (1 grey), 11 qualitative (9 grey) and 1 grey mixed-methods study. Of the four quantitative studies that reported on ME/CFS severity during pregnancy, two suggested pregnancy negatively impacted on ME/CFS, one found most women had no change in ME/CFS symptoms and one found ME/CFS improved; this difference in symptom severity across studies was supported by the qualitative evidence. The qualitative literature also highlighted the importance of individualised care throughout pregnancy and birth, and the need for additional support during family planning, pregnancy and with childcare. Only one quantitative study reported on pregnancy outcomes, finding decreased vaginal births and higher rates of spontaneous abortions and developmental and learning delays associated with pregnancies in those with ME/CFS. CONCLUSIONS: Current evidence on ME/CFS in pregnancy is limited and findings inconclusive. More high-quality research is urgently needed to support the development of evidence-based guidelines on ME/CFS and pregnancy.

Patient Self-Testing of Kidney Function at Home, a Prospective Clinical Feasibility Study in Kidney Transplant Recipients.

Introduction: People with long-term health conditions often attend clinics for kidney function tests. The Self-Testing Own Kidneys (STOK) study assessed feasibility of kidney transplant recipients using hand-held devices to self-test kidney function at home and investigated agreement between home self-test and standard clinic test results. Methods: A prospective, observational, single-center, clinical feasibility study (TRN: ISRCTN68116915), with N = 15 stable kidney transplant recipients, investigated blood potassium and creatinine results agreement between index self-tests at home (patient self-testing of capillary blood, using Abbott i-STAT Alinity analyzers [i-STAT]) and reference tests in clinic (staff sampled venous blood, analyzed with laboratory Siemens Advia Chemistry XPT analyzer) using Bland-Altman and error grid analysis. Results: The mean within-patient difference between index and reference test in creatinine was 2.25 µmol/l (95% confidence interval [CI]: -12.13, 16.81 µmol/l) and in potassium was 0.66 mmol/l (95% CI: -1.47, 2.79 mmol/l). All creatinine pairs and 27 of 40 (67.5%) potassium pairs were judged clinically equivalent. Planned follow-up analysis suggests that biochemical variables associated with potassium measurement in capillary blood were predominant sources of paired test result differences. Paired patient and nurse i-STAT capillary blood test potassium results were not statistically significantly different. Conclusions: This small feasibility study observed that training selected patients to competently use hand-held devices to self-test kidney function at home is possible. Self-test creatinine results showed good analytical and clinical agreement with standard clinic test results. Self-test potassium results showed poorer agreement with standard clinic test results; however, patient self-use of i-STATs at home was not a statistically significant source of difference between paired potassium test results.

Optimizing lipid management-impact of the COVID 19 pandemic upon cardiovascular risk in England.

BACKGROUND: We sought to understand the impact of the COVID-19 pandemic on lipid-lowering therapy prescribing as a potential cause of the excess cardiovascular mortality seen post-pandemic in England. We examined temporal changes over 3 years in the prescribing of high-intensity and non-high-intensity statin therapy and ezetimibe. SOURCES OF DATA: We utilized data available via the National Health Service (NHS) Business Services Authority (NHSBSA) Information Services Data Warehouse, extracting 3 monthly data from October 2018 to December 2021 on high- and low-intensity statin and ezetimibe prescribing, (commencement, cessation or continuation) through each time period of study and those before, and after, the period of interest. AREAS OF AGREEMENT: Optimizing lipid management is a key component of the NHS Long Term Plan ambition to reduce deaths from cardiovascular disease, stroke and dementia. AREAS OF CONTROVERSY: The COVID-19 pandemic and associated lockdown have seen a significant reduction in prescribing of lipid-lowering therapies. If cardiovascular risk is not to worsen in the forthcoming years, urgent action is needed to ensure that the impact of the pandemic upon optimization of cholesterol and the historical undertreatment of cholesterol is reversed and improved. AREAS TIMELY FOR DEVELOPING RESEARCH: Prescription data available via NHSBSA can support our understanding of the implications of policy and behaviour and highlight the impact of guidelines in practise. GROWING POINTS: Understanding the impact of the COVID-19 pandemic upon cholesterol management and the opportunities for newer lipid-lowering therapies delivered using a population health approach have the potential to enhance lipid-lowering and improve cardiovascular mortality and morbidity and reduce health inequalities.

Effects of whole-body cryotherapy and static stretching are maintained 4 weeks after treatment in most patients with chronic fatigue syndrome.

In the previous study, whole-body cryotherapy (WBC)+static stretching (SS) has been shown to reduce the severity of some symptoms in Chronic Fatigue Syndrome (CFS) noted just after the therapy. Here we consider the effects of treatment and explore the sustainability of symptom improvements at four weeks (one-month) follow-up. Twenty-two CFS patients were assessed one month after WBC + SS programme. Parameters related to fatigue (Chalder Fatigue Questionnaire (CFQ), Fatigue Impact Scale (FIS), Fatigue Severity Scale (FSS)), cognitive function (Trial Making test part A and B (TMT A and TMT B and its difference (TMT B-A)), Coding) hemodynamic, aortic stiffness (aortic systolic blood pressure (sBP aortic)) and autonomic nervous system functioning were measured. TMT A, TMT B, TMT B-A and Coding improved at one month after the WBC + SS programme. WBC + SS had a significant effect on the increase in sympathetic nervous system activity in rest. WBC + SS had a significant, positive chronotropic effect on the cardiac muscle. Peripheral and aortic systolic blood pressure decreased one month after WBC + SS in comparison to before. Effects of WBC + SS on reduction of fatigue, indicators of aortic stiffness and symptoms severity related to autonomic nervous system disturbance and improvement in cognitive function were maintained at one month. However, improvement in all three fatigue scales (CFQ, FIS and FSS) was noted in 17 of 22 patients. In addition, ten patients were treated initially but they were not assessed at 4 weeks, and are thus not included in the 22 patients who were examined on follow-up. The overall effects of WBC + SS noted at one month post-treatment should be interpreted with caution.

The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue in Participants With Primary Sjögren's Syndrome.

OBJECTIVES: Fatigue is one of the most important symptoms needing improvement in Primary Sjögren's syndrome (PSS). Previous data from our group suggest that noninvasive stimulation of the vagus nerve (nVNS) may improve symptoms of fatigue. This experimental medicine study uses the gammaCore device (electroCore) and a sham device to investigate the relationship between nVNS and fatigue in PSS, and to explore potential mechanisms involved. MATERIALS AND METHODS: Forty participants with PSS were randomly assigned to use active (n = 20) or sham (n = 20) nVNS devices twice daily for 54 days in a double-blind manner. Patient-reported measures of fatigue were collected at baseline and day 56: Profile of Fatigue (PRO-F)-Physical, PRO-F-Mental and Visual Analogue Scale of abnormal fatigue (fVAS). Neurocognitive tests, immunologic responses, electroencephalography alpha reactivity, muscle acidosis, and heart rate variability were compared between devices from baseline to day 56 using analysis of covariance. RESULTS: PRO-F-Physical, PRO-F-Mental, and fVAS scores were significantly reduced at day 56 in the active group only (p = 0.02, 0.02, and 0.04, respectively). Muscle bioenergetics and heart rate variability showed no change between arms. There were significant improvements in digit span and a neurocognitive test (p = 0.03), and upon acute nVNS stimulation, frontal region alpha reactivity showed a significant negative relationship with fatigue scores in the active group (p < 0.01). CONCLUSIONS: We observed significant improvements in three measures of fatigue at day 56 with the active device but not the sham device. Directly after device use, fatigue levels correlate with measures of alpha reactivity, suggesting modulation of cholinergic system integrity as a mechanism of action for nVNS.

Meta-Analysis of Exploring the Effect of Curcumin Supplementation with or without Other Advice on Biochemical and Anthropometric Parameters in Patients with Metabolic-Associated Fatty Liver Disease (MAFLD).

Metabolic (dysfunction)-associated fatty liver disease (MAFLD), previously known as non-alcoholic fatty liver disease (NAFLD), is the most common chronic liver disease. MAFLD is characterized by the excessive presence of lipids in liver cells and metabolic diseases/dysfunctions, e.g., obesity, diabetes, pre-diabetes, or hypertension. Due to the current lack of effective drug therapy, the potential for non-pharmacological treatments such as diet, supplementation, physical activity, or lifestyle changes is being explored. For the mentioned reason, we reviewed databases to identify studies that used curcumin supplementation or curcumin supplementation together with the use of the aforementioned non-pharmacological therapies. Fourteen papers were included in this meta-analysis. The results indicate that the use of curcumin supplementation or curcumin supplementation together with changes in diet, lifestyle, and/or physical activity led to statistically significant positive changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), fasting blood insulin (FBI), homeostasis model assessment of insulin resistance (HOMA-IR), total triglycerides (TG), total cholesterol (TC), and waist circumference (WC). It appears that these therapeutic approaches may be effective in alleviating MAFLD, but more thorough, better designed studies are needed to confirm this.

Digitally deployed, GP remote consultation video intervention that aims to reduce opioid prescribing in primary care: protocol for a mixed-methods evaluation.

INTRODUCTION: Opioid prescribing rates are disproportionately high in the North of England. In addition to patients' complex health needs, clinician prescribing behaviour is also a key driver. Although strategies have been initiated to reduce opioid prescribing nationally, the COVID-19 pandemic has interrupted service provision and created challenges for the system and health professionals to tackle this complex issue. A pilot intervention using smartphone video messaging has been developed to remotely explain the rationale for opioid reduction and facilitate self-initiation of support. The aim of this study is to evaluate the potential benefits, risks and economic consequences of 'at scale' implementation. METHODS AND ANALYSIS: This will be a mixed-methods study comprising a quasi-experimental non-randomised before-and-after study and qualitative interviews. The intervention arm will comprise 50 General Practitioner (GP) Practices using System 1 (a clinical computer system hosting the intervention) who will deliver the video to their patients via text message. The control arm will comprise 50 practices using EMIS (a different computer system) who will continue usual care. Monthly practice level prescribing and consultation data will be observed for 6 months postintervention. A general linear model will be used to estimate the association between the exposure and the main outcome (opioid prescribing; average daily quantity (ADQ)/1000 specific therapeutic group age-sex related prescribing unit). Semi-structured interviews will be undertaken remotely with purposively selected participants including patients who received the video, and health professionals involved in sending out the videos and providing additional support. Interviews will be audio recorded, transcribed and analysed thematically. ETHICS AND DISSEMINATION: Ethics approval has been granted by the NHS Health Research Authority Research Ethics Committee (22/PR/0296). Findings will be disseminated to the participating sites, participants, and commissioners, and in peer-reviewed journals and academic conferences. TRIAL REGISTRATION NUMBER: NCT05276089.

Relative Energy Deficiency in Sport (RED-S) in Adolescents - A Practical Review.

There are many immediate and longer-term physical, psychological and metabolic benefits of being active during adolescence. These benefits exist when exercise and physical activity are undertaken in a state of energy balance. When exercise occurs in an environment of low energy availability, this is currently termed relative energy deficiency in sport and there are potential significant negative effects on mental well-being, bone, endocrine and metabolic health. Therefore, relative energy deficiency in sport may present to many different specialists or allied health professionals depending upon the symptoms or reasons for seeking help, which include injury, such as bone stress or soft tissue problems, irregular or absent menstruation, stress, anxiety or low mood, or sporting underperformance as examples. The promotion of physical activity in adolescence is a critical part of public health strategy. In parallel with this positive public health message, there needs to be an increase in the awareness of, and education about, relative energy deficiency in sport for those working with and looking after adolescents.This review provides an up to date, practical evidenced based guide on the recognition, investigation and management of relative energy deficiency in sport in the adolescent, both male and female.

Effects of Sitting Callisthenic Balance and Resistance Exercise Programs on Cognitive Function in Older Participants.

BACKGROUND: Exercise training programs have the potential to improve cognitive function in older subjects. However, the majority of training programs are based on aerobic modality. In the current study, the influence of 3 months programs of sitting callisthenic balance (SCB) and resistance training (RT) on cognitive functioning and the mediating role that a change in the level of neurotrophic factors and strength in older, healthy participants plays were examined. MATERIAL AND METHODS: Global cognitive function was examined using MoCA, short-term memory using Digit Span and Delayed Matching to Sample, set shifting using Trial Making Test Part B, speed of processing simple visual stimuli using Simple Reaction Time, decision making using Choice Reaction Time, visual attention with Visual Attention Test (VAT), tests. Strength of lower and upper limbs, neurotrophin level (irisin, brain-derived neurotrophic factor (BDNF), neurotrophin 3 (NT-3), neurotrophin 4/5 (NT 4/5) were examined. RESULTS: Improved scores in RT vs. SCB were noted in MoCA (p = 0.02), reaction time in SRT (p = 0.02), TMT B (p = 0.03), errors committed in CRT (p = 0.04) and VAT (p = 0.02) were observed. No significant changes in the level of neurotrophic factors were observed. Changes in upper limb strength were related to changes in the number of errors committed in the SRT (p = 0.03). Lower limb strength changes explained the dynamics of the number of correct answers (p = 0.002) and errors committed (p = 0.006) in VAT. CONCLUSIONS: Both SCB and RT influenced multiple cognitive domains. The RT program improved global cognitive functioning, while no improvement was noticed in the SCB group. Decision making, visual attention and global cognitive function were improved after the RT program. Set-shifting, short-term visual memory processing speed of simple visual stimuli were improved after the SCB program, while a decrease in the processing speed of simple visual stimuli was noted in the RT group. Changes in irisin were related to set-shifting and short-term memory, while in BDNF to an improvement in the processing speed of simple visual stimuli. Resistance exercise training programs could be applied to prevent age related declines of cognitive function in healthy older subjects.

Cardiovascular-related conditions and risk factors in primary care for deprived communities before and during the COVID-19 pandemic: an observational study in Northern England.

OBJECTIVES: The North East of England, ranked as having the highest poverty levels and the lowest health outcomes, has the highest cardiovascular disease (CVD) premature mortality. This study aimed to compare CVD-related conditions and risk factors for deprived practice populations with other general practice (GP) populations in Northern England to England overall, before and during COVID-19 to identify changes in recorded CVD-related risk factors and conditions and evidence-based lipid prescribing behaviour. DESIGN: A population-based observational study of aggregated practice-level data obtained from publicly accessible data sets. SETTING: 34 practices that fall into the 15% most deprived practice populations in England were identified as the most deprived communities in the North East and North Cumbria (Deep End). PARTICIPANTS: Patients aged ≥16 registered with GP and diagnosed with any form of CVD. PRIMARY AND SECONDARY OUTCOME MEASURES: CVD-related conditions and risk factors, statin prescribing. RESULTS: Deep End (n=263 830) had a smaller, younger and more deprived population with lower levels of employment and full-time education and higher smoking prevalence. They had some higher recorded CVD-related conditions than England but lower than the non-Deep End. Atrial fibrillation (-0.9, -0.5), hypertension (-3.7, -1.3) and stroke and transient ischaemic attack rates (-0.5, -0.1) appeared to be lower in the Deep End than in the non-Deep End but the optimal statin prescribing rate was higher (3.1, 8.2) than in England. CONCLUSION: Recorded CVD-related risk factors and conditions remained comparable before and during COVID-19. These are higher in the Deep End than in England and similar or lower than the non-Deep End, with a higher optimal statin prescribing rate. However, it was not possible to control for age and sex. More work is needed to estimate the consequences of the pandemic on disadvantaged communities and to compare whether the findings are replicated in other areas of deprivation.

Assessing a 12-month course of oral alendronate for adults with avascular necrosis of the hip: MANTIS RCT with internal pilot.

BACKGROUND: People with avascular necrosis of the hip have very limited treatment options currently available to stop the progression of this disease; this often results in the need for a hip replacement. There is some weak evidence that a class of drugs called bisphosphonates may delay the course of the disease, and this trial was commissioned and set up to provide robust evidence regarding the use of bisphosphonates in adults aged ≥ 18 years with this condition. OBJECTIVES: The aim of the Managing Avascular Necrosis Treatments: an Interventional Study ( MANTIS ) trial was to evaluate the clinical effectiveness and cost-effectiveness of a 12-month course of alendronate in the treatment of avascular necrosis. DESIGN: This was a 66-month, definitive, multisite, two-arm, parallel-group, placebo-controlled, double-blind, randomised controlled trial, with an internal pilot phase. SETTING: Eight secondary care NHS hospitals across the UK. PARTICIPANTS: Planned trial size - 280 adult patients with avascular necrosis. INTERVENTION: Participants in the intervention group received 70 mg of alendronate (an oral bisphosphonate) weekly for 12 months. MAIN OUTCOMES: The main outcomes were Oxford Hip Score at 12 months (short-term outcome) and the time to decision that a hip replacement is required at 36 months (long-term outcome). RESULTS: Twenty-one patients were recruited and randomised to receive either the intervention drug, alendronate, or a placebo-matched tablet. LIMITATIONS: This trial was principally limited by low disease prevalence. Other limitations included the late disease stage at which participants were identified and the rapid progression of the disease. FUTURE WORK: This trial was limited by a low recruitment rate. Avascular necrosis of the hip should be treated as a rare disease. Future trials would need to recruit many more sites and recruit over a longer time period, and, for this reason, a registry may provide a more effective means of collecting data pertaining to this disease. CONCLUSIONS: The MANTIS trial was terminated at the end of the pilot phase, because it did not meet its go/no-go criteria. The main issue was a poor recruitment rate, owing to a lower than expected disease prevalence and difficulties in identifying the condition at a sufficiently early stage. Those patients who were identified and screened either were too advanced in their disease progression or were already taking medication. We would not recommend that a short-term interventional study is conducted on this condition until its prevalence, geographic foci and natural history and better understood. The difficulty of acquiring this understanding is likely to be a barrier in most health-care markets. One means of developing this understanding would be the introduction of a database/registry for patients suffering from avascular necrosis of the hip. TRIAL REGISTRATION: The trial is registered as ISRCTN14015902. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 43. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: The Managing Avascular Necrosis Treatments: an Interventional Study ( MANTIS ) trial was designed to compare ways of treating patients with avascular necrosis who are seeking to slow down the deterioration of their condition. Alendronate is a drug routinely available across the NHS in both tablet and injection form, and doctors and scientists believe that it might prevent ongoing hip deterioration and result in fewer patients requiring a total hip replacement. WHAT DID WE DO?: This trial attempted to compare alendronate taken as a tablet with an identical-looking tablet that did not contain any of the drug (a placebo) to find out if alendronate reduced the number of patients requiring a hip replacement and having pain (compared with patients who did not get alendronate). WHAT DID WE FIND?: Patients were willing to participate in the trial but we were able to recruit only a small number to the study. The main reason for this was difficulty in identifying potentially suitable patients and approaching them at the right point in their medical care. This was more challenging than anticipated, particularly because the NHS sites and professionals that patients with this condition seek out are extremely variable in the UK. It was also difficult to locate and identify patients with the condition at an early enough stage, and before they had already started taking the drug. WHAT DOES THIS MEAN?: More information on patients with this rare condition, such as NHS referral pathways, and an understanding of how the condition progresses may help to improve our understanding of this patient group. This information could also help us determine whether or not there is scope to carry out the study in a different way that might enable these patients to be more easily identified.

One-Year Neurodevelopmental Outcomes After Neonatal Opioid Withdrawal Syndrome: A Prospective Cohort Study.

Purpose: The aims of this study were, in a cohort of children with neonatal opioid withdrawal syndrome (NOWS), (a) to report 1-year neurodevelopmental outcomes and specifically characterize speech, language, and hearing outcomes and (b) to report the prevalence of cleft lip and/or cleft palate. Method: This prospective observational cohort study includes newborns with confirmed in utero opioid exposure who received pharmacological treatment for NOWS. During 1-year-old developmental visits, we administered standardized assessments (Bayley Scales of Infant and Toddler Development-Third Edition [Bayley-III] or Developmental Assessment of Young Children-Second Edition [DAYC-2]-due to COVID-19 restrictions). We compared Bayley-III scores to standardized population means using one-sample z tests. We report estimates, 95% confidence intervals, and two-sided p values. Results: We enrolled 202 infants (October 2018 to March 2020). Follow-up at 1-year was 80%. Infants with NOWS had lower Bayley-III scores at 1 year compared to published norms for cognitive, language, and motor domains. One infant with NOWS was diagnosed with isolated cleft palate and Pierre Robin sequence. All infants passed the newborn hearing screen, and 7.5% had a formal hearing evaluation after neonatal intensive care unit discharge, with 40% having abnormal or inconclusive results; middle ear effusion was the leading cause of abnormal hearing (66.7%). Ten percent of children received a speech-language pathology referral prior to 2 years of age. Infants born to mothers with mental health conditions were more likely to have Bayley-III or DAYC-2 scores below 95 in language or motor domains. Conclusions: Infants with pharmacologically treated NOWS have significantly lower cognitive, language, and motor scores on standardized developmental testing compared to population means at 1 year of age. Early speech-language pathology referral is frequently necessary to promote optimal development in this population. Supplemental Material: https://doi.org/10.23641/asha.20044403.

Tailoring lipid management interventions to reduce inequalities in cardiovascular disease risk management in primary care for deprived communities in Northern England: a mixed-methods intervention development protocol.

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.

Effect of moderate to high intensity aerobic exercise on blood pressure in young adults: The TEPHRA open, two-arm, parallel superiority randomized clinical trial.

Background: Exercise is advised for young adults with elevated blood pressure, but no trials have investigated efficacy at this age. We aimed to determine whether aerobic exercise, self-monitoring and motivational coaching lowers blood pressure in this group. Methods: The study was a single-centre, open, two-arm, parallel superiority randomized clinical trial with open community-based recruitment of physically-inactive 18-35 year old adults with awake 24 h blood pressure 115/75mmHg-159/99 mmHg and BMI<35 kg/m2. The study took place in the Cardiovascular Clinical Research Facility, John Radcliffe Hospital, Oxford, UK. Participants were randomized (1:1) with minimisation factors sex, age (<24, 24-29, 30-35 years) and gestational age at birth (<32, 32-37, >37 weeks) to the intervention group, who received 16-weeks aerobic exercise training (three aerobic training sessions per week of 60 min per session at 60-80% peak heart rate, physical activity self-monitoring with encouragement to do 10,000 steps per day and motivational coaching to maintain physical activity upon completion of the intervention. The control group were sign-posted to educational materials on hypertension and recommended lifestyle behaviours. Investigators performing statistical analyses were blinded to group allocation. The primary outcome was 24 h awake ambulatory blood pressure (systolic and diastolic) change from baseline to 16-weeks on an intention-to-treat basis. Clinicaltrials.gov registered on March 30, 2016 (NCT02723552). Findings: Enrolment occurred between 30/06/2016-26/10/2018. Amongst the 203 randomized young adults (n = 102 in the intervention group; n = 101 in the control group), 178 (88%; n = 76 intervention group, n = 84 control group) completed 16-week follow-up and 160 (79%; n = 68 intervention group, n = 69 control group) completed 52-weeks follow-up. There were no group differences in awake systolic (0·0 mmHg [95%CI, -2·9 to 2·8]; P = 0·98) or awake diastolic ambulatory blood pressure (0·6 mmHg [95%CI, -1·4. to 2·6]; P = 0·58). Aerobic training increased peak oxygen uptake (2·8 ml/kg/min [95%CI, 1·6 to 4·0]) and peak wattage (14·2watts [95%CI, 7·6 to 20·9]) at 16-weeks. There were no intervention effects at 52-weeks follow-up. Intepretation: These results do not support the exclusive use of moderate to high intensity aerobic exercise training for blood pressure control in young adults. Funding: Wellcome Trust, British Heart Foundation, National Institute for Health Research, Oxford Biomedical Research Centre.

Adipokines Level and Cognitive Function-Disturbance in Homeostasis in Older People with Poorly Managed Hypertension: A Pilot Study.

AIM: To explore the network relationship between cognitive function, depressive symptom intensity, body composition, proxies of cognitive reserve, trophic factor, adipokines and myokines, physical performance and blood pressure in a group of older people with poorly managed hypertension (PMHTN) compared to a normotensive (NTN) group. MATERIALS AND METHODS: History of hypertension and blood pressure level were examined in older participants. Thirty-one subjects diagnosed with PMHTN (history of hypertension diagnosis and values of sBP or dBP over 140/90 mmHg) and eighteen NTN (lack of history of hypertension and sBP and dBP lower than 140/90 mmHg) participated. Participants completed physical and cognitive function assessments: including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and its two subtests Delayed Recall (DR) and Verbal Fluency (VF) and Trail Making Test Part B (TMT B). Factors associated with cognitive functioning: age, years of education, cognitive and travel activity were assessed using a questionnaire. Visceral fat was determined by bioimpedance testing and gait velocity and agility assessed using an Up and Go test. To summarize the strength and direction (negative or positive) of a relationship between two variables, Spearman's rank correlation coefficient was used. Then, network graphs were created to illustrate the relationship between variables. Node strength (number of edges per node), neighbourhood connectivity (the average connectivity of all the neighbours of a node), stress (the number of shortest paths passing through each node) were compared in network from PMHTN group to network from NTN group. RESULTS: Neighbourhood connectivity and stress were significantly higher in of the PMHTN network compared to NTN (6.03 ± 1.5 vs. 4.23 ± 2.5, p = 0.005 and 118.21 ± 137.6 vs. 56.87 ± 101.5, p = 0.02, accordingly). CONCLUSION: In older subjects with poorly managed hypertension, dyshomeostasis was observed, compared to normotensive subjects.