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2.
Trials ; 22(1): 732, 2021 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-34688283

RESUMO

BACKGROUND: Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and health services. This study will evaluate the effectiveness of a team-based motivational engagement intervention, the Early Youth Engagement (EYE-2) intervention. METHODS AND DESIGN: The EYE-2 trial is a cluster randomised controlled trial comparing the EYE-2 intervention plus standardised EIP service to standardised EIP service alone, with randomisation at the clinical team (cluster) level. The study aimed to enrol 950 young people (aged 14-35 years) with first episode psychosis in 10 teams per arm. RESULTS: The primary outcome is time to disengagement: days from the date of allocation to care coordinator to date of the last contact following either refusal to engage with an EIP team or lack of response to EIP contact for 3 consecutive months which will be analysed using a shared frailty model. Secondary outcomes are Health of the Nation Outcome Scale (HoNOS), Process of Recovery Questionnaire (QPR), DIALOG (a service user-reported measure of quality of life and treatment satisfaction) and service use outcomes which will be analysed using mixed effects regression models. DISCUSSION: This paper is the detailed statistical analysis plan for the EYE-2 trial. Any changes to, or deviations from, this plan will be described and justified in the final trial report. TRIAL REGISTRATION: ISRCTN 51629746 . Prospectively registered on 7 May 2019. Date assigned 10 May 2019.


Assuntos
Transtornos Psicóticos , Qualidade de Vida , Adolescente , Análise Custo-Benefício , Humanos , Saúde Mental , Motivação , Transtornos Psicóticos/diagnóstico , Transtornos Psicóticos/terapia
3.
Int Health ; 2021 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-34634104

RESUMO

BACKGROUND: Podoconiosis, lymphatic filariasis and leprosy are highly stigmatised neglected tropical diseases that cause lymphoedema. Their enormous impacts on health-related quality of life, mental health and economic productivity can be significantly reduced by morbidity management and disability prevention (MMDP) services, but to deliver such services requires appropriate training of healthcare professionals. The aim of this study was to assess the knowledge, attitudes and practices (KAP) of rural Ethiopian healthcare professionals towards people with lymphoedema as a way to assess training needs. METHODS: This study used questionnaires to quantitatively assess KAP towards people with lymphoedema among rural healthcare professionals in northwest Ethiopia before and 12 months after a short training intervention. RESULTS: Questionnaires were administered to 14 health professionals at baseline and 21 at follow-up. At baseline, 71% (10/14) were found to hold at least one stigmatising attitude towards lymphoedema patients, compared with 66% (14/21) at follow-up. Large gaps in knowledge were noted, with many unable to identify ways of treating/preventing the diseases. CONCLUSIONS: This study showed high proportions of healthcare workers holding stigmatising views and lacking essential knowledge about lymphoedema. To maximise the impact of MMDP interventions, further research is urgently needed to understand how to address these issues.

4.
Trials ; 22(1): 645, 2021 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-34548065

RESUMO

BACKGROUND: Hypermobility is a poorly recognised and understood musculoskeletal disorder thought to affect around 20% of the population. Hypermobility is associated with reduced physiological and psychological functioning and quality of life and is a known risk factor for the development of an anxiety disorder. To date, no evidence-based, targeted treatment for anxiety in the context of hypermobility exists. The present intervention (ADAPT-Altering Dynamics of Autonomic Processing Therapy) is a novel therapy combining bio-behavioural training with cognitive approaches from clinical health psychology targeting the catastrophisation of internal sensations, with aim to improve autonomic trait prediction error. METHOD: Eighty individuals with diagnosed hypermobility will be recruited and the efficacy of ADAPT to treat anxiety will be compared to an Emotion-Focused Supportive Therapy (EFST) comparator therapy in a randomised controlled trial. The primary treatment target will be post therapy score on the Beck Anxiety Inventory, and secondary outcomes will also be considered in relation to interoception, depression, alexithymia, social and work adjustment, panic symptoms and dissociation. Due to COVID restrictions, the intervention will be moved to online delivery and qualitative assessment of treatment tolerance to online therapy will also be assessed. DISCUSSION: Online delivery of an intervention targeting anxiety would improve the quality of life for those experiencing anxiety disorder and help to reduce the £11.7 billion that anxiety disorders cost the UK economy annually. TRIAL REGISTRATION: World Health Organization ISRCTN17018615 . Registered on 20th February 2019; trial protocol version 2.


Assuntos
COVID-19 , Instabilidade Articular , Ansiedade/diagnóstico , Ansiedade/prevenção & controle , Humanos , Instabilidade Articular/diagnóstico , Instabilidade Articular/terapia , Qualidade de Vida , SARS-CoV-2 , Resultado do Tratamento
5.
J Perinatol ; 41(9): 2317-2329, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34365475

RESUMO

OBJECTIVE: A comprehensive understanding of the factors contributing to perinatal blood pressure is vital to ensure optimal postnatal hemodynamic support. The objective of this study was to review existing literature on maternal and perinatal factors influencing blood pressure in neonates up to 3 months corrected age. METHODS: A systematic search of published literature in OVID Medline, OVID Embase and the COCHRANE library identified publications relating to maternal factors affecting blood pressure of neonates up to corrected age of 3 months. Summary data were extracted and compared (PROSPERO CRD42018092886). RESULTS: Of the 3683 non-duplicate publications identified, 44 were eligible for inclusion in this review. Topics elicited were sociodemographic factors, maternal health status, medications, smoking during pregnancy, and cord management at birth. Limited data were available for each factor. Results regarding the impact of these factors on neonatal blood pressure were inconsistent across studies. CONCLUSIONS: There is insufficient evidence to draw definitive conclusions regarding the impact of various maternal and perinatal factors on neonatal blood pressure. Future investigations of neonatal cardiovascular therapies should account for these factors in their study design. Similarly, studies on maternal diseases and perinatal interventions should include neonatal blood pressure as part of their primary or secondary analyses.


Assuntos
Pressão Sanguínea , Feminino , Humanos , Lactente , Recém-Nascido , Gravidez
7.
Trials ; 22(1): 272, 2021 Apr 12.
Artigo em Inglês | MEDLINE | ID: mdl-33845856

RESUMO

BACKGROUND: Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. METHOD: The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14-35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. DISCUSSION: The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. TRIAL REGISTRATION: ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.


Assuntos
Transtornos Psicóticos , Adolescente , Análise Custo-Benefício , Humanos , Londres , Saúde Mental , Motivação , Transtornos Psicóticos/diagnóstico , Transtornos Psicóticos/terapia
8.
Int J Geriatr Psychiatry ; 36(7): 1011-1019, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33686788

RESUMO

BACKGROUND: Traditional healthcare education typically focuses on short block clinical placements based on acute care, investigations and technical aspects of diagnosis and treatment. It may therefore fail to build the understanding, compassion and person-centred empathy needed to help those with long-term conditions, like dementia. Time for Dementia was developed to address this. METHOD: Parallel group comparison of two cohorts of UK medical students from universities, one participating in Time for Dementia (intervention group) and one not (control group). In Time for Dementia students visit a person with dementia and their family in pairs for 2 hours three times a year for 2 years, the control group received their normal curriculum. RESULTS: In an adjusted multilevel model (intervention group n = 274, control n = 112), there was strong evidence supporting improvements for Time for Dementia participants in: total Approaches to Dementia Questionnaire score (coefficient: 2.19, p = 0.003) and its person-centredness subscale (1.32, p = 0.006) and weaker evidence in its hopefulness subscale (0.78, p = 0.070). There was also strong evidence of improvement in the Dementia Knowledge Questionnaire (1.63, p < 0.001) and Dementia Attitudes Scale (total score: 6.55, p < 0.001; social comfort subscale: 4.15, p < 0.001; dementia knowledge subscale: 3.38, p = 0.001) scores. No differences were observed on the Alzheimer's Disease Knowledge Scale, the Medical Condition Regard Scale or the Jefferson Scale of Empathy. DISCUSSION: Time for Dementia may help improve the attitudes of medical students towards dementia promoting a person-centred approach and increasing social comfort. Such patient-focused programmes may be a useful complement to traditional medical education.


Assuntos
Demência , Estudantes de Medicina , Currículo , Atenção à Saúde , Demência/terapia , Humanos , Inquéritos e Questionários
9.
BMJ Sex Reprod Health ; 47(2): 117-128, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32499381

RESUMO

INTRODUCTION: A clinical prediction rule (CPR) using psychosocial questions was previously derived to target sexual healthcare in general practice by identifying women at risk of unintended pregnancy (UIP) and sexually transmitted infections (STIs). This psychosocial CPR may help target resources within contraception and sexual health (CASH) services. This study investigated how well it predicted recent self-reported risk of UIP and STI acquisition among women attending a CASH clinic. METHODS: Female patients aged 16-44 years attending a CASH clinic in South-East England were offered a questionnaire on arrival. This comprised psychosocial questions, and others addressing three sexual risks: (1) two or more male sexual partners in the last year (2+P), (2) risk of STI acquisition through most recent partner and (3) risk of UIP in the last 6 months. A CPR score was calculated for each participant and cross-tabulated against self-report of each sexual risk to estimate CPR sensitivity and specificity. RESULTS: The psychosocial questions predicting 2+P had sensitivity 83.2% (95% CI 79.3% to 86.5%) and specificity 56.1% (95% CI 51.3%-60.6%). Those predicting combined 2+P and/or risk of STI acquisition through most recent partner had a sensitivity of 89.1% (95% CI 85.7%-91.8%) and specificity of 43.7% (95% CI 39.0%-48.5%). Questions predicting risk of UIP in the last 6 months had a sensitivity of 82.5% (95% CI 78.6%-86.0%) and specificity of 48.3% (95% CI 43.4%-53.1%). CONCLUSIONS: The CPR demonstrated good sensitivity but low specificity, so may be suited to triaging or stratifying which interventions to offer CASH patients and by which mode (eg, online vs face-to-face). Further investigation of causal links between psychosocial factors and sexual risk is warranted to support development of psychosocial interventions for this patient group.


Assuntos
Medição de Risco/métodos , Comportamento Sexual/psicologia , Adolescente , Adulto , Instituições de Assistência Ambulatorial/organização & administração , Instituições de Assistência Ambulatorial/estatística & dados numéricos , Estudos Transversais , Inglaterra , Feminino , Humanos , Gravidez , Serviços de Saúde Reprodutiva/organização & administração , Serviços de Saúde Reprodutiva/estatística & dados numéricos , Medição de Risco/estatística & dados numéricos , Autorrelato , Inquéritos e Questionários
10.
Disabil Rehabil ; 43(1): 85-97, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31131641

RESUMO

PURPOSE: Evidence is increasing for effective virtual reality therapy for motor rehabilitation for children with Cerebral Palsy. We assessed the feasibility of a virtual reality therapy mode of intervention, appropriateness of measures, and potential cost-effectiveness. METHODS: A 12-week, 2-group, parallel-feasibility trial (ISRCT 17624388) using Nintendo Wii FitTM at home. Children aged 5-16, with ambulatory Cerebral Palsy, who were able to follow simple instructions were randomised to two groups; one supported by physiotherapists (individualised activity programme), the other unsupported with children having free choice (control). Children were assessed in clinic at baseline, week 6, and week 12 by blinded assessors. Feasibility of the intervention was assessed via recruitment, adherence, and usefulness of measurement tools. RESULTS: Forty-four children were eligible (out of 48 approached): 31 consented, 30 were randomised, 21 completed the study; 10 in the supported group and 11 in the unsupported group. Nine children discontinued from tiredness, after-school activities, homework, surgery, technical difficulties or negative system feedback. The supported group completed 19 of 36 (IQR 5-35) possible sessions; the unsupported group 24 of 36 sessions (IQR 8-36). Gross Motor Function Measure scores varied by Cerebral Palsy severity after the intervention. There were no adverse events. CONCLUSION: Virtual reality therapy offers potential as a therapeutic adjunct for children with Cerebral Palsy, warranting substantive confirmatory study. Gross Motor Function Measure, with modifications to improve sensitivity, appeared appropriate as a primary measure, with Timed up and Go test secondary. The intervention was inexpensive costing £20 per child. An explanatory trial to evaluate the clinical/cost-effectiveness of commercial system virtual reality therapy is feasible with minor methodological adaptation. Implications for rehabilitation Home-based interactive computer gaming was feasible, safe and cost effective as a therapy adjunct. Discontinue if additional pressures are present: imminent surgery, family resilience to technical difficulties, negative system feedback, after-school activities. Change in Gross Motor Function Measurement scores varied by severity of Cerebral Palsy.

11.
J Pain Symptom Manage ; 62(2): 312-325.e2, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33348031

RESUMO

CONTEXT: Palliative care remains suboptimal in end-stage liver disease (ESLD). OBJECTIVES: We report qualitative outcomes from the REDUCe study. We aimed to explore and contrast experiences/perceptions/care pathways of patients with refractory ascites due to ESLD randomized to either palliative long-term abdominal drains (LTADs) (allow home drainage) vs. large volume paracentesis (LVP) (hospital drainage). METHODS: Concurrent embedded qualitative study in a 12-week feasibility randomized controlled trial. Telephone interviews were conducted, data being recorded, transcribed verbatim, and analyzed using applied thematic analysis, considered in terms of a pathway approach toward accessing health care. Quantitative outcomes were collected (integrated palliative outcome scale, short-form liver disease quality of life, EQ-5D-5 L, Zarit Burden Interview-12). RESULTS: Fourteen patients (six allocated LTAD and eight LVP) and eight nurses participated in the qualitative study. The patient journey in the LVP group could be hindered by challenges along the entire care pathway, from recognizing the need for drainage to a lengthy wait in hospital for drainage and/or to be discharged. These issues also impacted upon caregivers. In contrast, LTADs appeared to transform this care pathway at all levels across the patient's journey by removing the need for hospital drainage. Additional benefits included personalized care, improved symptom control of ascites, being at home, and regular support from community nurses. Nurses also viewed the LTAD favorably, though expressed the need for additional support should this become standard of care. CONCLUSION: Patients and nurses expressed acceptability of palliative LTAD in ESLD and preference for this approach in enabling care at home. Proceeding to a definitive trial is feasible. TRIAL REGISTRATION: ISRCTN30697116, date assigned: 07/10/2015.


Assuntos
Ascite , Paracentese , Ascite/etiologia , Ascite/terapia , Humanos , Cirrose Hepática/complicações , Cirrose Hepática/terapia , Cuidados Paliativos , Qualidade de Vida
12.
Trans R Soc Trop Med Hyg ; 114(12): 1021-1034, 2020 12 16.
Artigo em Inglês | MEDLINE | ID: mdl-33169165

RESUMO

We conducted an implementation research study to integrate a holistic package of physical health, mental health and psychosocial care for podoconiosis, lymphatic filariasis and leprosy into routine healthcare in Gusha cluster, Guagusa Shikudad district, northwest Ethiopia. The healthcare package included training patients in lower limb hygiene and skin care and provision of shoes, hygiene supplies and medication. The implementation activities included training events, workshops, awareness raising, self-help groups, supportive supervision, staff secondments and advisory board meetings. The cost of implementing the care package in Gusha cluster, with a population of 30 558 people, was 802 655 Ethiopian birr (ETB) (£48 159) and the cost of delivering care to 235 participants was 204 388 ETB (£12 263), or 870 ETB (£52) per person. There was a 35% decrease in the mean disability scores (measured using the World Health Organization Disability Assessment Schedule 2.0) and a 45% improvement in the dermatology-specific quality of life (measured using the Dermatology Life Quality Index) at the 3-month follow-up compared with baseline. There were reductions in the number of days with symptoms, days off usual activities/work and days with reduced activity due to illness, all of which were statistically significant. Our pilot suggests that integration of the care package into routine healthcare in Ethiopia may be effective in improving health-related quality of life and disability and reducing time out of economic activity due to illness.


Assuntos
Filariose Linfática , Elefantíase , Hanseníase , Atenção à Saúde , Elefantíase/terapia , Filariose Linfática/epidemiologia , Filariose Linfática/terapia , Etiópia/epidemiologia , Humanos , Hanseníase/terapia , Extremidade Inferior , Qualidade de Vida
13.
Trans R Soc Trop Med Hyg ; 114(12): 1035-1037, 2020 12 16.
Artigo em Inglês | MEDLINE | ID: mdl-33236119

RESUMO

BACKGROUND: While morbidity attributable to podoconiosis is relatively well studied, its pattern of mortality has not been established. METHODS: We compared the age-standardised mortality ratios (SMRs) of two datasets from northern Ethiopia: podoconiosis patients enrolled in a 1-y trial and a Health and Demographic Surveillance System cohort. RESULTS: The annual crude mortality rate per 1000 population for podoconiosis patients was 28.7 (95% confidence interval [CI] 17.3 to 44.8; n=663) while that of the general population was 2.8 (95% CI 2.3 to 3.4; n=44 095). The overall SMR for the study period was 6.0 (95% CI 3.6 to 9.4). CONCLUSIONS: Podoconiosis patients experience elevated mortality compared with the general population and further research is required to understand the reasons.


Assuntos
Elefantíase , Elefantíase/epidemiologia , Etiópia/epidemiologia , Humanos
14.
Trans R Soc Trop Med Hyg ; 114(12): 983-994, 2020 12 16.
Artigo em Inglês | MEDLINE | ID: mdl-33190154

RESUMO

BACKGROUND: Podoconiosis, lymphatic filariasis (LF) and leprosy are neglected tropical diseases (NTDs) that cause lymphoedema. When left untreated, they lead to substantial disability. This study determined the quality of life (QOL) and depression associated with lymphoedema in patients with podoconiosis, LF and leprosy. The study was conducted in northwestern Ethiopia. METHODS: This baseline cross-sectional study, nested within an interventional, non-comparative, longitudinal study, included patients with lymphoedema. Depression and QOL were assessed using versions of the 9-item Patient Health Questionnaire and Dermatologic Life Quality Index (DLQI), respectively, that had been translated into Amharic and validated. Factors associated with depression and QOL were assessed using multivariate linear regression analysis. RESULTS: Of the 251 patients with lymphoedema included in the study, 119 (47.4%) had moderate to severe depression and overall QOL was poor (mean±standard deviation [SD] DLQI score: 11.4±4.2). Disability was significantly associated with depression (ß=0.26 [95% confidence interval {CI} 0.19 to 0.33]). Currently receiving treatment (ß=-3.05 [95% CI -5.25 to -0.85), disability (ß=-0.08 [95% CI -0.15 to -0.01]) and social support (moderate support: ß=-2.27 [95% CI -3.66 to -0.89] and strong support: ß=-2.87 [95% CI -5.35 to -0.38]) were significantly associated with better QOL. CONCLUSION: High levels of depression and low QOL were found among patients with lymphoedema due the three NTDs in Ethiopia.


Assuntos
Filariose Linfática , Elefantíase , Hanseníase , Linfedema , Estudos Transversais , Depressão/epidemiologia , Depressão/etiologia , Elefantíase/epidemiologia , Filariose Linfática/complicações , Filariose Linfática/epidemiologia , Etiópia/epidemiologia , Humanos , Hanseníase/complicações , Estudos Longitudinais , Linfedema/epidemiologia , Linfedema/etiologia , Qualidade de Vida
16.
BMJ Open ; 10(10): e037675, 2020 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-33060082

RESUMO

INTRODUCTION: Neglected tropical diseases (NTDs) causing lower limb lymphoedema such as podoconiosis, lymphatic filariasis (LF) and leprosy are common in Ethiopia. Routine health services for morbidity management and disability prevention (MMDP) of lymphoedema caused by these conditions are still lacking, even though it imposes a huge burden on affected individuals and their communities in terms of physical and mental health, and psychosocial and economic outcomes. This calls for an integrated, holistic approach to MMDP across these three diseases. METHODS AND ANALYSIS: The 'Excellence in Disability Prevention Integrated across NTDs' (EnDPoINT) implementation research study aims to assess the integration and scale-up of a holistic package of care-including physical health, mental health and psychosocial care-into routine health services for people with lymphoedema caused by podoconiosis, LF and leprosy in selected districts in Awi zone in the North-West of Ethiopia. The study is being carried out over three phases using a wide range of mixed methodologies. Phase 1 involves the development of a comprehensive holistic care package and strategies for its integration into the routine health services across the three diseases, and to examine the factors that influence integration and the roles of key health system actors. Phase 2 involves a pilot study conducted in one subdistrict in Awi zone, to establish the care package's adoption, feasibility, acceptability, fidelity, potential effectiveness, its readiness for scale-up, costs of the interventions and the suitability of the training and training materials. Phase 3 involves scale-up of the care package in three whole districts, as well as its evaluation in regard to coverage, implementation, clinical (physical health, mental health and psychosocial) and economic outcomes. ETHICS AND DISSEMINATION: Ethics approval for the study has been obtained in the UK and Ethiopia. The results will be disseminated through publications in scientific journals, conference presentations, policy briefs and workshops.


Assuntos
Filariose Linfática , Elefantíase , Hanseníase , Reabilitação Psiquiátrica , Elefantíase/prevenção & controle , Filariose Linfática/prevenção & controle , Etiópia , Serviços de Saúde , Humanos , Hanseníase/prevenção & controle , Saúde Mental , Projetos Piloto
18.
BMJ Open ; 10(7): e035596, 2020 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-32636281

RESUMO

INTRODUCTION: At least 30% of people living with HIV (PLWH) infection have non-alcoholic fatty liver disease (NAFLD), which has now become a leading cause of hepatic fibrosis and cirrhosis. Management is based largely on lifestyle modifications, which are difficult to achieve, and therapeutic options are urgently needed. Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD. However, dosing is usually two times per day, unlike most currently recommended antiretroviral therapies. This study will investigate the feasibility and acceptability of addition of MVC to combination antiretroviral therapy in PLWH and NAFLD as a treatment for NAFLD. METHODS AND ANALYSIS: This is a phase IV, randomised, open-label, non-invasive feasibility study. Sixty individuals with well-controlled HIV-1 and NAFLD will be recruited from UK HIV clinics and randomised 1:1 to receive either optimised background therapy (OBT) plus MVC or OBT alone. Follow-up will be every 24 weeks for 96 weeks. The primary outcome measures will include recruitment and retention rates, adverse events and adherence. Secondary outcomes will include changes in markers of hepatic fibrosis, including the Enhanced Liver Fibrosis score, median liver stiffness measurement and controlled attenuation parameter scores on Fibroscan, and quality of life assessments. Analyses will be performed according to intention-to-treat principles. For secondary outcomes, estimated differences and 95% CIs between the groups using a t-method will be presented for continuous variables and as exact 95% binomial CIs for categorical variables. ETHICS AND DISSEMINATION: Ethical approval was obtained through the London Dulwich UK Research Ethics Committee (reference 17/LO/2093). Results will be disseminated both through community groups and peer-reviewed scientific literature.Trial registration number SRCTN31461655. EudraCT number 2017-004141-24; Pre-results.


Assuntos
Protocolos Clínicos , Infecções por HIV/complicações , Maraviroc/uso terapêutico , Hepatopatia Gordurosa não Alcoólica/complicações , Biomarcadores/análise , Estudos de Viabilidade , Infecções por HIV/fisiopatologia , Humanos , Londres , Maraviroc/efeitos adversos , Hepatopatia Gordurosa não Alcoólica/fisiopatologia
19.
BMC Infect Dis ; 20(1): 524, 2020 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-32689975

RESUMO

BACKGROUND: Currently recommended boosted protease-inhibitor (bPI) regimens may be associated with increased risk of cardiovascular or chronic kidney diseases; in addition, boosted regimens are particularly associated with drug-drug interactions. Since both cardiovascular and renal disease, and polypharmacy, are common in ageing people with HIV, there is a need for alternative efficacious regimens. bPI-based regimens are often the treatment of choice for individuals with pre-treatment or treatment-acquired resistance but it is plausible that carefully selected HIV-positive individuals with drug resistance, who are virologically suppressed on their current bPI regimen, could maintain virological efficacy when switched to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) fixed dose combination (FDC). METHODS/DESIGN: A phase IV, investigator-initiated, multicentre, open label pilot, randomised two-arm study to assess the safety and efficacy of switching from bPI regimen to B/F/TAF single tablet regimen in integrase inhibitor-naïve, virologically suppressed adults with HIV-1 infection harbouring drug resistance mutations. Eligible individuals will either continue on their bPI regimen or switch to B/F/TAF FDC. After 24 weeks, all participants in the bPI arm will be switched to B/F/TAF and followed for a further 24 weeks and all participants will be followed for 48 weeks. The primary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at week 24 using pure virologic response whilst the secondary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48. Other secondary outcome measures include between arm comparisons of drug resistance at virological failure, safety and tolerability and patient-reported outcome measures. DISCUSSION: We aim to provide preliminary evidence of the efficacy of switching to B/F/TAF in patients with virological suppression on a bPI-based regimen who harbour select drug resistance mutations. TRIAL REGISTRATION: ISRCTN 44453201 , registered 19 June 2019 and EudraCT 2018-004732-30.


Assuntos
Adenina/análogos & derivados , Farmacorresistência Viral/genética , Emtricitabina/uso terapêutico , Infecções por HIV/tratamento farmacológico , Inibidores de Integrase de HIV/uso terapêutico , HIV-1/efeitos dos fármacos , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Inibidores de Proteases/uso terapêutico , Inibidores da Transcriptase Reversa/uso terapêutico , Adenina/uso terapêutico , Adulto , Combinação de Medicamentos , Emtricitabina/efeitos adversos , Feminino , Infecções por HIV/genética , Infecções por HIV/virologia , Inibidores de Integrase de HIV/efeitos adversos , Compostos Heterocíclicos de 4 ou mais Anéis/efeitos adversos , Humanos , Masculino , Mutação , Projetos Piloto , Estudos Prospectivos , Inibidores de Proteases/efeitos adversos , Inibidores da Transcriptase Reversa/efeitos adversos , Resultado do Tratamento
20.
Aliment Pharmacol Ther ; 52(1): 107-122, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32478917

RESUMO

BACKGROUND: Palliative care remains suboptimal in end-stage liver disease. AIM: To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison. METHODS: A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion. RESULTS: Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (µmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway. CONCLUSIONS: The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation. TRIAL REGISTRATION: ISRCTN30697116, date assigned: 07/10/2015.


Assuntos
Ascite/terapia , Drenagem , Doença Hepática Terminal/terapia , Cirrose Hepática/terapia , Idoso , Ascite/sangue , Ascite/etiologia , Creatinina/sangue , Doença Hepática Terminal/sangue , Doença Hepática Terminal/complicações , Feminino , Humanos , Cirrose Hepática/sangue , Cirrose Hepática/complicações , Masculino , Pessoa de Meia-Idade , Cuidados Paliativos , Albumina Sérica
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