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INTRODUCTION: There is a recognised association between white coat hypertension (WCH) and adverse cardiovascular outcomes in older adults. However, there is no consensus on the management of WCH in this group. The objective of the Hypertension in the Very Elderly Trial (HYVET-2) study was to assess the feasibility of randomising 100 patients > 75years with WCH from General Practice in the UK to treatment or usual care. The study did not randomise any patients. In this follow-up study, we sought to explore the reasons for not recruiting. METHODS: Furthermore, using a mixed-methods study design, staff from 29 General Practice (GP) sites and the Clinical Research Network (CRN) in Kent, Surrey, and Sussex (KSS), UK, were sent an online questionnaire about local research facilities and infrastructure, and HYVET-2 study methodology and target population demographics. RESULTS: Nineteen (19) individuals responded to the online questionnaires (15 primary care staff, 4 CRN staff). Moreover, using a framework approach, we identified six themes summarising challenges to HYVET-2 recruitment. These themes are established approaches of primary care towards managing WCH in older people, target patient demographics, study design complexity, patient- facing study documents, limited research resources in primary care, and identification of eligible patients using existing coding. CONCLUSION: Our experience showed that recruiting older people from primary care to a WCH study was not feasible. A national scoping survey amongst primary care physicians in the UK, as well as robust patient and public involvement (PPI) targeting older people with WCH, might improve recruitment in future studies addressing the management of WCH in older people.
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INTRODUCTION: Scabies undermines quality of life through its highly disturbing disease symptoms, by distorting self-perception, and secondary to social stigma. Knowledge of its effect on quality of life in general and on specific aspects of day-to-day life is key to addressing the health needs of individual patients and to evaluating gains from community-based disease control interventions. OBJECTIVES: To measure the effect of scabies on the quality of life of people with the infestation. METHODS: A community-based cross-sectional study was conducted in a scabies outbreak-affected district in north-western Ethiopia. The study involved 381 households and 86 adults with scabies. We used the ten-item Cardiff Dermatology Life Quality Index (DLQI) tool to collect data. Cronbach's alpha value was used to determine the internal consistency of the Amharic version of the scale. Overall and Dermatology Life Quality (DLQ) domain specific mean scores were calculated. The association between sociodemographic characteristics and scabies-related life quality impairment was tested using Kruskal-Wallis test. RESULTS: Scabies moderately affected the quality of life of adults with scabies. The overall mean DLQI (mDLQI) score was 9.2 (SD = 7.6). 'Symptoms and feelings' and 'daily activity' DLQ domains had the highest mDLQI scores (3.5, SD = 1.9 and 2.2, SD = 2.5, respectively). 'Leisure activities' was the least affected domain 0.8 (SD = 1.1). In terms of severity, scabies had moderate or severe effect on DLQ of 54.7% of the participants and extremely severe effect was reported among 27% of the participants. However, no association was observed between sociodemographic characteristics and quality of life impairment. CONCLUSION: Quality of life was moderately impaired among people affected by scabies. Refocusing attention on management of disease symptoms, using standard scabies treatment, and providing psychosocial support to improve self-perception of people affected with scabies may help reduce quality of life impairment.
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OBJECTIVE: Household damp exposure is an important public health issue. We aimed to assess the impact of the location of household damp on respiratory outcomes during early life. METHODS: Household damp exposure was ascertained in children recruited to the GO-CHILD multicentre birth cohort study. The frequency of respiratory symptoms, infections, healthcare utilisation and medication prescription for wheezing were collected by postal questionnaires at 12 and 24 months. Log binomial and ordered logistic regression models were fitted to the data. RESULTS: Follow-up was obtained in 1344 children between August 2010 and January 2016. Visible damp was present in a quarter of households (25.3%) with 1 in 12 children's bedrooms affected (8.3%). Damp in the bathroom, kitchen or living room was not associated with any respiratory or infection-related outcomes. Damp in the child's bedroom was associated with an increased risk of dry cough (8.7% vs 5.7%) (adjusted relative risk 1.56, 95% CI 1.07 to 2.27; p=0.021) and odds of primary care attendance for cough and wheeze (7.6% vs 4.4%) (adjusted OR 1.37, 95% CI 1.07 to 1.76; p=0.009). There were also increased risk of inhaled corticosteroid (13.3% vs 5.9%) (adjusted RR 2.22, 95% CI 1.04 to 4.74; p=0.038) and reliever inhaler (8.3% vs 5.8%) (adjusted RR 2.01, 95% CI 1.21 to 2.79; p=0.018) prescription. CONCLUSION: Damp in the child's bedroom was associated with increased respiratory morbidity. In children presenting with recurrent respiratory symptoms, clinicians should enquire about both the existence and location of damp, the presence of which can help prioritise those families requiring urgent household damp assessment and remediation works.
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BACKGROUND: Blood pressure is a vital hemodynamic marker during the neonatal period. However, normative values are often derived from small observational studies. Understanding the normative range would help to identify ideal thresholds for intervention to treat hypotension or hypertension. Therefore, the aim of this study was to assess observed blood pressure values in neonates who have not received any blood-pressure modifying treatments from birth to three months postnatal age and whether these vary according to birth weight, gestational age and postnatal age. METHODS: This was a systematic review. A literature search was conducted in MEDLINE, PubMed, Embase, Cochrane Library, and CINAHL from 1946 to 2017 on blood pressure in neonates from birth to 3 months of age (PROSPERO ID CRD42018092886). Unpublished data were included where appropriate. RESULTS: Of 3,587 non-duplicate publications identified, 30 were included (one unpublished study). Twelve studies contained data grouped by birth weight, while 23 contained data grouped by gestational age. Study and clinical heterogeneity precluded meta-analyses thus results are presented by subgroup. A consistent blood pressure rise was associated with increasing birth weight, gestational age, and postnatal age. In addition, blood pressure seemed to rise more rapidly in the most preterm and low birth weight neonates. CONCLUSION: Despite blood pressure increasing with birth weight, gestational age, and postnatal age, there was marked blood pressure variability observed throughout. To better define hypotension and hypertension, future studies should develop consistent approaches for factors related to blood pressure variability, including the method and timing of measurement as well as statistical control of relevant patient characteristics.
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BACKGROUND: Stigma related to lower-limb lymphoedema poses a major psychosocial burden to affected persons and acts as a barrier to them accessing morbidity management and disability prevention (MMDP) services. Community Conversation (CC), which actively engages community members and disseminates health information amongst them, is believed to break the vicious cycle of stigma by enhancing disease-related health literacy at the community level. METHODS: A quasi-experimental study was conducted in Northern Ethiopia to assess the role of the CC intervention in reducing stigma. In two control districts, a comprehensive and holistic MMDP care package was implemented that included physical health, mental health and psychosocial interventions, whilst in the intervention district the CC intervention was added to the MMDP care package. A total of 289 persons affected by lymphoedema and 1659 community members without lymphoedema were included in the study. RESULTS: Over the course of the intervention, in all sites, community members' knowledge about the causes of lymphoedema increased, and perceived social distance and stigmatizing attitudes towards people with lymphoedema decreased in the community, whilst experienced and internalized stigma decreased amongst affected persons. There were no significant changes for perceived social support. However, the changes were greater in the control sites overall, i.e. those districts in which the holistic care package was implemented without CC. CONCLUSION: The findings suggest that the CC intervention provides no additional stigma reduction when used alongside a holistic MMDP care package. Provision of comprehensive and holistic MMDP services may be adequate and appropriate to tackle stigma related to lower-limb lymphoedema in a resource-constrained setting like Ethiopia.
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Linfedema , Humanos , Etiópia , Linfedema/terapia , Estigma Social , Morbidade , Extremidade InferiorRESUMO
BACKGROUND: Acute severe asthma (ASA) is a leading cause of hospital attendance in children. Standard first-line therapy consists of high-dose inhaled bronchodilators plus oral corticosteroids. Treatment for children who fail to respond to first-line therapy is problematic: the use of intravenous agents is inconsistent, and side effects are frequent. High-flow humidified oxygen (HiFlo) is widely used in respiratory conditions and is increasingly being used in ASA, but with little evidence for its effectiveness. A well-designed, adequately powered randomized controlled trial (RCT) of HiFlo therapy in ASA is urgently needed, and feasibility data are required to plan such an RCT. In this study, we describe the protocol for a feasibility study designed to fill this knowledge gap. OBJECTIVE: This study aims to establish whether a full RCT of early HiFlo therapy in children with ASA can be conducted successfully and safely, to establish whether recruitment using deferred consent is practicable, and to define appropriate outcome measures and sample sizes for a definitive RCT. The underlying hypothesis is that early HiFlo therapy in ASA will reduce the need for more invasive treatments, allow faster recovery and discharge from hospital, and in both these ways reduce distress to children and their families. METHODS: We conducted a feasibility RCT with deferred consent to assess the use of early HiFlo therapy in children aged 2 to 11 years with acute severe wheeze not responding to burst therapy (ie, high-dose inhaled salbutamol with or without ipratropium). Children with a Preschool Respiratory Assessment Measure score ≥5 after burst therapy were randomized to commence HiFlo therapy or follow standard care. The candidate primary outcomes assessed were treatment failure requiring escalation and time to meet hospital discharge criteria. Patient and parent experiences were also assessed using questionnaires and telephone interviews. RESULTS: The trial was opened to recruitment in February 2020 but was paused for 15 months owing to the COVID-19 pandemic. The trial was reopened at the lead site in July 2021 and opened at the other 3 sites from August to December 2022. Recruitment was completed in June 2023. CONCLUSIONS: This feasibility RCT of early HiFlo therapy in children with ASA recruited to the target despite major disturbances owing to the COVID-19 pandemic. The data are currently being analyzed and will be published separately. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Registry ISRCTN78297040; https://www.isrctn.com/ISRCTN78297040. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54081.
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Background: The use of a second informant (co-respondent) is a common method of identifying potential bias in outcome data (e.g., parent-report child outcomes). There is, however, limited evidence regarding methods of increasing response rates from co-respondents. The use of financial incentives is associated with higher levels of engagement and follow-up data collection in online surveys. This study investigated whether financial incentives paid to index participants in an online trial of a parenting-focused intervention, would lead to higher levels of co-respondent data collection. Methods: A study within a trial (SWAT) using a parallel group RCT design. Participants in the host study (an RCT of an online intervention) were randomised into one of two SWAT arms: received/did not receive a £15 voucher when referred co-respondent completed baseline measures. Primary outcome was completion (No/Yes) of Spence Children's Anxiety Scale (SCAS or SCAS-Pre) at baseline. Additional analysis explored impact of incentives on data quality. Results: Intention to treat analysis of 899 parents (183 co-respondents) in the no-incentive arm, and 911 parents (199 co-respondents) in incentive arm. Nomination of co-respondents was similar between incentive arms. The RR for the incentive arm compared to the no incentive arm was 1.13 (95% CI: 0.91 to 1.41, p = 0.264) indicating that incentives did not impact completion of outcomes by consented co-respondents. There were no indications of different data quality between arms. Discussion: The finding that payment of financial incentives to index participant does not lead to greater levels of co-respondent outcome completion suggests that careful consideration should be made before allocating resources in this way in future trials. Trial registration: The host study was registered at Study Record | ClinicalTrials.gov and the SWAT study was registered in the SWAT Store | The Northern Ireland Network for Trials Methodology Research (qub.ac.uk): SWAT number 143: Filetoupload,1099612,en.pdf (qub.ac.uk).
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OBJECTIVES: To evaluate the implementation of frailty screening in people living with HIV (PLWH) in a large urban cohort of patients in Brighton, UK. METHODS: Focus group discussions with HIV professionals and PLWH interviews helped inform the design and implementation of the frailty screening pathway in the clinic. Data were collected from PLWH aged over 60 years attending their HIV annual health check from July 2021 to January 2023 (n = 590), who were screened for frailty by nurses using the FRAIL scale. We assessed the proportions of PLWH who screened as frail, prefrail or robust and compared patient characteristics across groups. All PLWH identified as frail were offered a comprehensive geriatric assessment delivered by a combined HIV geriatric clinic, and uptake was recorded. RESULTS: A total of 456/590 (77.3%) PLWH aged over 60 years were screened for frailty. Median age and time since HIV diagnosis (range) for those screened were 66 (60-99) years and 21 (0-32) years, respectively. In total, 56 (12.1%) of those screened were identified as frail, 118 (25.9%) as prefrail and 282 (61.8%) as robust. A total of 10/56 (18%) people identified as frail declined an appointment in the geriatric clinic. Compared with non-frail individuals, frail PLWH had been living with HIV for longer and had a greater number of comorbidities and comedications but were not chronologically older. CONCLUSIONS: Implementing frailty screening in PLWH over 60 years old is feasible in a large cohort of PLWH, as recommended by the European AIDS Clinical Society. More research is needed to determine if frailty screening can improve clinical outcomes of older PLWH and the use of the comprehensive geriatric assessment within HIV services.
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Fragilidade , Infecções por HIV , Idoso , Humanos , Pessoa de Meia-Idade , Fragilidade/diagnóstico , Fragilidade/epidemiologia , Idoso Fragilizado , Infecções por HIV/complicações , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Avaliação Geriátrica , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Mass drug administration (MDA) is among the five major strategies that are currently in use to control, eliminate or eradicate Neglected Tropical Diseases (NTDs). Optimising MDA to control multiple NTDs maximises impact. The objective of this study is to estimate the secondary impact of ivermectin MDA for onchocerciasis on the prevalence of scabies. METHODS: This quasi-experimental study was conducted in Ayu Guagusa district, northwestern Ethiopia. Scabies prevalence was estimated in surveys before the MDA, at 6 and 12 months afterwards. The sample size was 1437 people from a panel of 381 randomly selected study households. Multistage sampling was employed in randomly selecting six kebeles (the lowest administrative unit) with respective gotes (small villages) and households. All members of the selected households were invited to participate in the study and participants who were available in all three surveys formed a cohort. RESULTS: Scabies prevalence was similar prior to the MDA (13.4%, 95% CI 11.7 to 15.2%) and 6 months after (11.7%, 95% CI 10.1 to 13.2%) but was substantially greater at 12 months (22.1%, 95% CI 20.1 to 24.1%). The 6-month incidence and disappearance rates were 10.8% (95% CI 8.8 to 13.2%) and 82.6% (95% CI 75.0 to 88.6%), respectively. CONCLUSIONS: Ivermectin MDA for onchocerciasis was not observed to have a secondary impact on the prevalence of scabies over the follow-up period of 12 months.
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Oncocercose , Escabiose , Humanos , Ivermectina/uso terapêutico , Escabiose/tratamento farmacológico , Escabiose/epidemiologia , Escabiose/prevenção & controle , Oncocercose/tratamento farmacológico , Oncocercose/epidemiologia , Oncocercose/prevenção & controle , Administração Massiva de Medicamentos , Prevalência , Etiópia/epidemiologiaRESUMO
INTRODUCTION: Respiratory infections and wheeze have a considerable impact on the health of young children and consume significant healthcare resources. We aimed to evaluate the effect of environmental factors on respiratory infections and symptoms in early childhood. METHODS: Environmental risk factors including: daycare attendance; breastfeeding; siblings; damp within the home; environmental tobacco smoke (ETS); child's bedroom flooring; animal exposure; road traffic density around child's home; and solid fuel pollution within home were assessed in children recruited to the GO-CHILD multicentre prospective birth cohort study. Follow-up information on respiratory infections (bronchiolitis, pneumonia, otitis media and cold or flu), wheeze and cough symptoms, healthcare utilisation and medication prescription was collected by postal questionnaires at 12 and 24 months. Log binomial and ordered logistic regression models were fitted to the data. RESULTS: Follow-up was obtained on 1344 children. Daycare was associated with increased odds of pneumonia (odds ratio [OR] = 2.39, 95% confidence interval [CI]: 1.04-5.49), bronchiolitis (OR = 1.40, 1.02-1.90), otitis media (OR = 1.68, 1.32-2.14) and emergency department attendance for wheeze (RR = 1.81, 1.17-2.80). Breastfeeding beyond 6 months was associated with a reduced odds of bronchiolitis (OR = 0.55, 0.39-0.77) and otitis media (OR = 0.75, 0.59-0.99). Siblings at home was associated with an increased odds of bronchiolitis (OR = 1.65, 1.18-2.32) and risk of reliever inhaler prescription (RR = 1.37, 1.02-1.85). Visible damp was associated with an increased odds of wheeze (OR = 1.85, 1.11-3.19), and risk of reliever inhaler (RR = 1.73, 1.04-2.89) and inhaled corticosteroid prescription (RR = 2.61, 1.03-6.59). ETS exposure was associated with an increased odds of primary care attendance for cough or wheeze (OR = 1.52, 1.11-2.08). Dense traffic around the child's home was associated with an increased odds of bronchiolitis (OR = 1.32, 1.08-2.29). CONCLUSION: Environmental factors likely influence the wide variation in infection frequency and symptoms observed in early childhood. Larger population studies are necessary to further inform and guide public health policy to decrease the burden of respiratory infections and wheeze in young children.
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Bronquiolite , Otite Média , Pneumonia , Infecções Respiratórias , Poluição por Fumaça de Tabaco , Animais , Humanos , Pré-Escolar , Estudos de Coortes , Estudos Prospectivos , Fatores de Risco , Infecções Respiratórias/epidemiologia , Infecções Respiratórias/etiologia , Poluição por Fumaça de Tabaco/efeitos adversos , Bronquiolite/complicações , Pneumonia/complicações , Otite Média/epidemiologia , Otite Média/etiologia , Tosse/complicações , Sons Respiratórios/etiologiaRESUMO
OBJECTIVES: People with HIV are an ageing population with an increased risk of cognitive impairment. Although cognitive impairment is dependent upon assessment, the acceptability of screening for cognitive impairment is unclear. This study aimed to explore the views of people with HIV and healthcare workers regarding routine screening for cognitive impairment. METHODS: In-depth individual qualitative interviews were conducted with purposively sampled people with HIV and focus groups of healthcare workers from a UK HIV service. Verbatim pseudonymized transcripts were analysed using reflexive thematic analysis supported by NVivo. RESULTS: Twenty people with HIV were interviewed and 12 healthcare workers participated in three focus groups. People with HIV were concerned about developing cognitive issues and were receptive to routine screening. Screening was seen as relevant and an important part of managing health in older age. Healthcare workers expressed concerns regarding the capacity of HIV services to implement routine screening and questioned the validity of screening measures used. People with HIV felt that screening and subsequent detection of cognitive impairment, if present, may help them to prepare for future issues and promote active management strategies and care pathways that would support cognitive health. People with HIV felt that screening should be brief and delivered by the HIV service and that they should be given a choice of administration method. Indications of cognitive impairment detected by a brief screening assessment should be discussed face to face and followed up with a comprehensive assessment. CONCLUSIONS: People with HIV are concerned about cognitive impairment and would welcome regular screening for this as part of the holistic care provided by the HIV team. Both people with HIV and healthcare workers would like more information on cognitive impairment, its screening and ways to support cognitive health.
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Disfunção Cognitiva , Infecções por HIV , Humanos , Infecções por HIV/complicações , Pessoal de Saúde , Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/etiologia , Pesquisa QualitativaRESUMO
BACKGROUND: The WHO aims to prevent, eliminate or control neglected tropical diseases, including scabies, by 2030. However, limited epidemiological data presented a challenge to control efforts, especially in high burden countries. There was a major scabies outbreak in northern Ethiopia starting in 2015 and prevalence has since increased across much of the country. OBJECTIVE: To estimate scabies prevalence, identify its predictors, and assess community perception of, and knowledge about, the infestation. DESIGN: Population-based cross-sectional study. STUDY SETTING: Ayu Guagusa district, Amhara region, northern Ethiopia. PARTICIPANTS: 1437 people who were members of 381 randomly selected households participated in the study. Five trained mid-level health workers clinically diagnosed people with scabies. OUTCOME MEASURES: Clinically diagnosed scabies infestation. DATA ANALYSIS: Multi-level logistic regression models were fitted to adjust for individual and household-level confounding variables, and identify predictors of scabies infestation. RESULTS: Scabies prevalence was 13.4% (95% CI 11.8 to 15.5). Households of more than five people (adjusted OR (aOR)=3.5, 95% CI 1.2 to 10.2) were associated with increased odds of developing scabies, however, females had lower odds (aOR=0.5 95% CI 0.3 to 0.8). Scabietic lesions most frequently involved the trunk (62.0%), and vesicles were the most common types of lesions (67.7%). Two-thirds of adult study participants had heard about scabies and most obtained scabies related information from informal sources. Only 32% of cases sought care for scabies from any source. CONCLUSION: Scabies prevalence was high, signifying the need for community-based control interventions. Host density and sex were important predictors of scabies. Despite the favourable attitude toward the effectiveness of scabies treatment, healthcare seeking was low.
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Escabiose , Adulto , Feminino , Humanos , Estudos Transversais , Etiópia/epidemiologia , Características da Família , Prevalência , Escabiose/epidemiologia , MasculinoRESUMO
BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. METHODS: This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. DISCUSSION: If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK's National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.
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Terapia Cognitivo-Comportamental , Transtornos Psicóticos , Humanos , Transtornos Psicóticos/diagnóstico , Transtornos Psicóticos/terapia , Pessoal Técnico de Saúde , Inglaterra , Comportamentos Relacionados com a Saúde , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Increasing levels of photovoltaic (PV) penetration to the electricity grid brings challenges to both design and operation of the grid due to its vulnerability to climate change. A crucial aspect of PV operation is power ramps leading to variability and instability in the grid. With notable large-scale PV deployment planned, including the world's largest planned solar energy infrastructure in Powell Creek Australia, characterising future ramps is crucial for ensuring stable power generation to support large-scale economic development. Using CORDEX-Australasia projections under RCP8.5 and RCP4.5 emission scenarios, future solar ramps across Australia have been characterised up to 2100. Results predict a reduction in ramp magnitude across Australia, with changes in frequency and period length varying with the location. This work highlights the importance of considering future changes in climate when designing large-scale solar farms to ensure the incorporation of frequency control devices and storage plans for a reliable power supply.
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OBJECTIVES: Maraviroc may reduce hepatic inflammation in people with HIV and non-alcoholic fatty liver disease (HIV-NAFLD) through CCR5-receptor antagonism, which warrants further exploration. METHODS: We performed an open-label 96-week randomised-controlled feasibility trial of maraviroc plus optimised background therapy (OBT) versus OBT alone, in a 1:1 ratio, for people with virologically-suppressed HIV-1 and NAFLD without cirrhosis. Dosing followed recommendations for HIV therapy in the Summary of Product Characteristics for maraviroc. The primary outcomes were safety, recruitment and retention rates, adherence and data completeness. Secondary outcomes included the change in Fibroscan-assessed liver stiffness measurements (LSM), controlled attenuation parameter (CAP) and Enhanced Liver Fibrosis (ELF) scores. RESULTS: Fifty-three participants (53/60, 88% of target) were recruited; 23 received maraviroc plus OBT; 89% were male; 19% had type 2 diabetes mellitus. The median baseline LSM, CAP & ELF scores were 6.2 (IQR 4.6-7.8) kPa, 325 (IQR 279-351) dB/m and 9.1 (IQR 8.6-9.6) respectively. Primary outcomes: all individuals eligible after screening were randomised; there was 92% (SD 6.6%) adherence to maraviroc [target >90%]; 83% (95%CI 70%-92%) participant retention [target >65%]; 5.5% of data were missing [target <20%]. There were noo Serious Adverse Reactions; mild-moderate intensity Adverse Reactions were reported by five participants (5/23, 22% (95%CI 5%-49%)) [target <10%]. All Adverse Reactions resolved. Secondary outcomes: no important differences were seen by treatment group for the change from baseline in LSM, CAP or ELF scores. CONCLUSIONS: This feasibility study provides preliminary evidence of maraviroc safety amongst people with HIV-NAFLD, and acceptable recruitment, retention, and adherence rates. These data support a definitive randomised-controlled trial assessing maraviroc impact on hepatic steatosis and fibrosis. TRIAL REGISTRATION: Clinical trial registry: ISCRTN, registration number 31461655.
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Diabetes Mellitus Tipo 2 , Técnicas de Imagem por Elasticidade , Infecções por HIV , HIV-1 , Hepatopatia Gordurosa não Alcoólica , Humanos , Masculino , Feminino , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Maraviroc/uso terapêutico , Diabetes Mellitus Tipo 2/complicações , Estudos de Viabilidade , Cirrose Hepática/patologia , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Infecções por HIV/patologia , Fígado/patologiaRESUMO
Persistent inequalities in relation to health outcomes continue to exist among patients identifying as lesbian, gay, and bisexual (LGB), and very little is known about outcomes specific to bisexual populations. This study's aim was to compare the health of individuals identifying as LGB with heterosexual counterparts within primary care in England. Cross-sectional survey data from the year 10 (2015/2016) English General Practice Patient Survey (GPPS) dataset, which consisted of 836,312 responses (38.9% response rate), including 23,834 people who identified as gay, lesbian, bisexual or "other" was analyzed. Health outcomes were assessed through self-reported quality of life, physical and mental health, and confidence in managing own health. Multifactorial logistic regression (adjusting for age, ethnic group, working status, and socioeconomic status) were conducted. Long-term physical and mental health problems were more than twice as likely to be reported for people within LGB groups compared to the heterosexual group for both genders, except bisexual women where the odds were more than four times greater (OR = 4.275, 95% CI, 3.896, 4.691; p < .001). Bisexual women were half as likely to report the absence of a long-term health problem (OR = 0.452, 95% CI 0.419, 0.488; p < .001). LGB groups across both genders, reported a higher proportion of individuals that did not feel confident in managing their health and experienced significantly worse quality of life compared to heterosexuals. LGB patients consistently report poorer health outcomes than heterosexual patients. Bisexual people of both genders consistently experienced worse physical and mental health outcomes compared with the other recorded sexual orientations.
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Patients with advanced chronic liver disease have a complex symptom burden and many are not candidates for curative therapy. Despite this, provision of palliative interventions remains woefully inadequate, with an insufficient evidence base being a contributory factor. Designing and conducting palliative interventional trials in advanced chronic liver disease remains challenging for a multitude of reasons. In this manuscript we review past and ongoing palliative interventional trials. We identify barriers and facilitators and offer guidance on addressing these challenges. We hope that this will reduce the inequity in palliative care provision in advanced chronic liver disease.
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Background: Demand for diagnostic assessment in children with possible autism has recently increased significantly. Services are under pressure to deliver timely and high-quality diagnosis, following National Institute and Care Excellence multidisciplinary assessment guidelines. This UK National Health Service study aimed to answer: how many hours of health professional time are required to deliver autism diagnostic assessment, and how much does this cost?. Method: Case notes of 20 children (1-16 yrs.) from 27 NHS trusts, assessed through an autism diagnostic pathway in the previous year, were examined retrospectively. Data included: hours of professional time, diagnostic outcome. Assessment costs calculated using standardised NHS tariffs. Results: 488 children (aged 21-195 months, mean 82.9 months, SD 39.36) from 22 Child Development Services (CDS), four Child and Adolescent Mental Health Services (CAMHS) and one tertiary centre; 87% were either under 5 (36%) or 5 to 11 years (51%). Children seen by CDS were younger than CAMHS (mean (SD) 6.10 (2.72) vs. 10.39 (2.97) years, p < 0.001). Mean days to diagnosis were 375 (SD 235), with large variation (range 41-1553 days). Mean hours of professional time per child was 11.50 (SD 7.03) and varied substantially between services and individuals. Mean cost of assessment was £846.00 (SD 536.31). 339 (70.0%) children received autism diagnosis with or without comorbidity; 54 (11%) received no neurodevelopmental diagnosis; 91 (19%) received alternative neurodevelopmental diagnoses. Children with one or more coexisting conditions took longer to diagnose, and assessment was more costly, on average 117 days longer, costing £180 more than a child with no neurodevelopmental diagnosis. Age did not predict days to diagnosis or assessment costs. Conclusion: Typical assessment took 11â h of professional time and over 12-months to complete, costing GB£850 per child. Variation between centres and children reflect differences in practice and complexity of diagnostic presentation. These results give information to those delivering/planning autism assessments using multi-disciplinary team approach, in publicly funded health systems. Planning of future diagnostic services needs to consider growing demand, the need for streamlining, enabling context appropriate services, and child/family complexity.
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Background: Low dose naltrexone (LDN) is used off-label by many individuals with fibromyalgia to help manage their pain. There is no current systematic literature review summarising the evidence to support this use of LDN. The objectives of this study were to evaluate if patients with fibromyalgia prescribed LDN have reduced pain scores and greater quality of life compared with those allocated to placebo in randomized controlled trials. Secondly to determine if changes in inflammatory markers and brain structure and function are observed among patients with fibromyalgia taking LDN. Methods: Systematic literature searches were conducted in MEDLINE, Embase Classic + Embase, APA PsychInfo, and The Cochrane Library from inception to May 2022. Reference lists from the selected papers were cross-checked with database search results. Results: Three studies met our inclusion criteria for the assessment of efficacy, and two studies on potential LDN mechanisms. Results indicated some evidence to suggest LDN reduces pain and increases quality of life. One study reported baseline erythrocyte sedimentation rate (ESR) predicted LDN response (≥30% reduction in fibromyalgia symptoms) and a second study showed plasma concentrations of inflammatory biomarkers were lower after LDN treatment. To our knowledge, there are no brain imaging studies reporting the effect of LDN in patients with fibromyalgia. All studies were based on small sample sizes, were restricted to women and the risk of bias was assessed to be high. There is also some evidence of publication bias. Conclusion: The strength of evidence from randomized controlled trials to support the use of LDN among patients with fibromyalgia is low. Two small studies suggest ESR and cytokines may be involved in the mechanism by which LDN exerts its effects. Two trials (INNOVA and FINAL) are currently in progress, but further work is needed among men and different ethnic groups.
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INTRODUCTION: Many people ageing with HIV are also living with multiple comorbidities and geriatric syndromes including frailty and cognitive deterioration. These complex needs can be challenging to meet within existing HIV care services. This study investigates the acceptability and feasibility of screening for frailty and of using a comprehensive geriatric assessment approach, delivered via the Silver Clinic, to support people living with HIV affected by frailty. METHODS AND ANALYSIS: Mixed-methods, parallel-group, randomised, controlled feasibility trial aiming to recruit 84 people living with HIV≥50, identified as frail. Participants will be recruited from the HIV unit at the Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, UK. Participants will be randomised 1:1 to receive usual HIV care or the Silver Clinic intervention, which uses a comprehensive geriatric assessment approach. Psychosocial, physical and service use outcomes will be measured at baseline, 26 weeks and 52 weeks. Qualitative interviews will be conducted with a subset of participants from both arms. Primary outcome measures include recruitment and retention rates and completion of clinical outcome measures. These will be used in conjunction with a priori progression criteria and the qualitative data (acceptability of trial procedures and intervention) to determine the feasibility and design of a definitive trial. ETHICS AND DISSEMINATION: This study has been approved by East Midlands-Leicester Central Research Ethics Committee (reference 21/EM/0200). All participants will receive written information about the study and be required to provide informed consent. Results will be disseminated via peer-reviewed journals, conferences and community engagement. TRIAL REGISTRATION NUMBER: ISRCTN14646435.