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1.
Ecol Appl ; 2020 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-32338804

RESUMO

Indigenous rights, knowledge, and value systems are linked inextricably to the lands, waters, and non-human beings that form the environments of Indigenous Peoples. Across the globe, the rights of Indigenous peoples are being formally recognized and as a result, efforts are being made to include Indigenous Knowledge and value systems in environmental policy and decision making. Scientists and decision makers must not only recognize this reality, but also operationalize these efforts through meaningful changes to create space for the inclusion of Indigenous Knowledge, Indigenous values, and sovereignty within the current methods for scientific enquiry and the development of environmental policies. Professionals in the environmental field have a responsibility to ensure that their work has a positive impact on Indigenous Peoples and their environments. In this study, we explore the concept of consultation and informed consent through the lens of the development of environmental policy and decision making. We will discuss these concepts in the context of ecological risk assessment related to a case study focused on contaminated sediment in a harbor within the Great Lakes. We will demonstrate a process that deconstructs the current protocols for risk assessments at sites with localized pollutants in sediment and rebuilds them with elements that recognize both Western and Indigenous knowledge systems. This process includes collaborative fieldwork, relationship building, and informal and formal interviews with participants and community members. By utilizing such approaches, we were able to develop a risk assessment framework that recognizes the sovereignty of Indigenous peoples and promotes effective Nation-to-Nation decision making.

3.
BMJ ; 368: m322, 2020 02 26.
Artigo em Inglês | MEDLINE | ID: mdl-32102782

RESUMO

OBJECTIVE: To evaluate the effectiveness and cost effectiveness of a complex intervention in primary care that aims to increase uptake of hepatitis C virus (HCV) case finding and treatment. DESIGN: Pragmatic, two armed, practice level, cluster randomised controlled trial and economic evaluation. SETTING AND PARTICIPANTS: 45 general practices in South West England (22 randomised to intervention and 23 to control arm). Outcome data were collected from all intervention practices and 21/23 control practices. Total number of flagged patients was 24 473 (about 5% of practice list). INTERVENTION: Electronic algorithm and flag on practice systems identifying patients with HCV risk markers (such as history of opioid dependence or HCV tests with no evidence of referral to hepatology), staff educational training in HCV, and practice posters/leaflets to increase patients' awareness. Flagged patients were invited by letter for an HCV test (with one follow-up) and had on-screen pop-ups to encourage opportunistic testing. The intervention lasted one year, with practices recruited April to December 2016. MAIN OUTCOME MEASURES: Primary outcome: uptake of HCV testing. SECONDARY OUTCOMES: number of positive HCV tests and yield (proportion HCV positive); HCV treatment assessment at hepatology; cost effectiveness. RESULTS: Baseline HCV testing of flagged patients (six months before study start) was 608/13 097 (4.6%) in intervention practices and 380/11 376 (3.3%) in control practices. During the study 2071 (16%) of flagged patients in the intervention practices and 1163 (10%) in control practices were tested for HCV: overall intervention effect as an adjusted rate ratio of 1.59 (95% confidence interval 1.21 to 2.08; P<0.001). HCV antibodies were detected in 129 patients from intervention practices and 51 patients from control practices (adjusted rate ratio 2.24, 1.47 to 3.42) with weak evidence of an increase in yield (6.2% v 4.4%; adjusted risk ratio 1.40, 0.99 to 1.95). Referral and assessment increased in intervention practices compared with control practices (adjusted rate ratio 5.78, 1.6 to 21.6) with a risk difference of 1.3 per 1000 and a "number needed to help" of one extra HCV diagnosis, referral, and assessment per 792 (95% confidence interval 558 to 1883) patients flagged. The average cost of HCV case finding was £4.03 (95% confidence interval £2.27 to £5.80) per at risk patient and £3165 per additional patient assessed at hepatology. The incremental cost effectiveness ratio was £6212 per quality adjusted life year (QALY), with 92.5% probability of being below £20 000 per QALY. CONCLUSION: HepCATT had a modest impact but is a low cost intervention that merits optimisation and implementation as part of an NHS strategy to increase HCV testing and treatment. TRIAL REGISTRATION: ISRCTN61788850.


Assuntos
Hepacivirus/isolamento & purificação , Hepatite C/diagnóstico , Avaliação de Processos e Resultados em Cuidados de Saúde , Atenção Primária à Saúde/economia , Antivirais/uso terapêutico , Análise Custo-Benefício , Inglaterra , Hepatite C/tratamento farmacológico , Hepatite C/economia , Hepatite C/virologia , Humanos , Kit de Reagentes para Diagnóstico/economia , Kit de Reagentes para Diagnóstico/provisão & distribução , Medicina Estatal
4.
BJU Int ; 125(4): 506-514, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31900963

RESUMO

OBJECTIVE: To test the hypothesis that the baseline clinico-pathological features of the men with localized prostate cancer (PCa) included in the ProtecT (Prostate Testing for Cancer and Treatment) trial who progressed (n = 198) at a 10-year median follow-up were different from those of men with stable disease (n = 1409). PATIENTS AND METHODS: We stratified the study participants at baseline according to risk of progression using clinical disease stage, pathological grade and PSA level, using Cox proportional hazard models. RESULTS: The findings showed that 34% of participants (n = 505) had intermediate- or high-risk PCa, and 66% (n = 973) had low-risk PCa. Of 198 participants who progressed, 101 (51%) had baseline International Society of Urological Pathology Grade Group 1, 59 (30%) Grade Group 2, and 38 (19%) Grade Group 3 PCa, compared with 79%, 17% and 5%, respectively, for 1409 participants without progression (P < 0.001). In participants with progression, 38% and 62% had baseline low- and intermediate-/high-risk disease, compared with 69% and 31% of participants with stable disease (P < 0.001). Treatment received, age (65-69 vs 50-64 years), PSA level, Grade Group, clinical stage, risk group, number of positive cores, tumour length and perineural invasion were associated with time to progression (P ≤ 0.005). Men progressing after surgery (n = 19) were more likely to have a higher Grade Group and pathological stage at surgery, larger tumours, lymph node involvement and positive margins. CONCLUSIONS: We demonstrate that one-third of the ProtecT cohort consists of people with intermediate-/high-risk disease, and the outcomes data at an average of 10 years' follow-up are generalizable beyond men with low-risk PCa.

5.
BMJ Open ; 10(1): e035505, 2020 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-31964677

RESUMO

INTRODUCTION: Outcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction. METHODS AND ANALYSIS: The CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) a modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; (4) strategies to promote dissemination and adoption of the CMS. ETHICS AND DISSEMINATION: Ethical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS.

6.
Bull Environ Contam Toxicol ; 104(1): 21-26, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31811320

RESUMO

Polar Organic Chemical Integrative Samplers (POCIS) were deployed in two watersheds in Córdoba province and one watershed in Buenos Aires province in Argentina. The fungicides, tebuconazole, carbendazim and azoxystrobin, and the herbicides, atrazine, dicamba and 2,4-D were detected in POCIS deployed in each of the three watersheds. Estimated time weighted average concentrations of atrazine were greater than 2 µg/L at the outflow of Brava Lake in Buenos Aires province, and this concentration exceeds the Canadian water quality guideline for protection of aquatic life. The concentrations of all other pesticides were less than 400 ng/L. The distribution of pesticides detected in surface waters indicated that the sources were runoff from agricultural and urban lands and discharges from wastewater treatment plants.

7.
Eur Urol ; 77(3): 320-330, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31771797

RESUMO

BACKGROUND: The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer (PCa) randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy. OBJECTIVE: To determine report outcomes according to treatment received in men in randomised and treatment choice cohorts. DESIGN, SETTING, AND PARTICIPANTS: This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy. INTERVENTION: Two cohorts included 1643 men who agreed to be randomised; 997 declined randomisation and chose treatment. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Health-related quality of life impacts on urinary, bowel, and sexual function were assessed using patient-reported outcome measures. Analysis was carried out based on treatment received for each cohort and on pooled estimates using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores. RESULTS AND LIMITATIONS: According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6mo) and urinary incontinence (55% at 6mo) after surgery, and of sexual dysfunction (88% at 6mo) and bowel dysfunction (5% at 6mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and outdating of the interventions being evaluated during the lengthy follow-up required in trials of screen-detected PCa. CONCLUSIONS: Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group. PATIENT SUMMARY: More than 90 out of every 100 men with localised prostate cancer do not die of prostate cancer within 10yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are much better after active monitoring, but the risks of spreading of prostate cancer are more common.

8.
Trials ; 20(1): 750, 2019 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-31856886

RESUMO

The FITNET-NHS Trial is a UK, national, trial investigating whether an online cognitive behavioural therapy program (FITNET-NHS) for treating chronic fatigue syndrome/ME in adolescents is clinically effective and cost-effective in the NHS. At the time of writing (September 2019), the trial was recruiting participants. This article presents an update to the planned sample size and data collection duration previously published within the trial protocol. TRIAL REGISTRATION: ISRCTN, ID: 18020851. Registered 8 April 2016.

9.
Health Technol Assess ; 23(68): 1-94, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31856942

RESUMO

BACKGROUND: Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive-behavioural therapy for depression. To the authors' knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive-behavioural therapy for depression in autism. OBJECTIVES: The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial. DESIGN: The study comprised a randomised controlled trial (n = 70) with a nested qualitative evaluation (n = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual. SETTING: Adult autism services in two NHS regions. PARTICIPANTS: Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded. INTERVENTIONS: The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression. MAIN OUTCOME MEASURES: Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori. RESULTS: The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses. CONCLUSIONS: The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted. FUTURE WORK: Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN54650760. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.

10.
Autism ; : 1362361319889272, 2019 Nov 29.
Artigo em Inglês | MEDLINE | ID: mdl-31782656

RESUMO

Low-intensity cognitive behaviour therapy including behavioural activation is an evidence-based treatment for depression, a condition frequently co-occurring with autism. The feasibility of adapting low-intensity cognitive behaviour therapy for depression to meet the needs of autistic adults via a randomised controlled trial was investigated. The adapted intervention (guided self-help) comprised materials for nine individual sessions with a low-intensity psychological therapist. Autistic adults (n = 70) with depression (Patient Health Questionnaire-9 score ⩾10) recruited from National Health Service adult autism services and research cohorts were randomly allocated to guided self-help or treatment as usual. Outcomes at 10-, 16- and 24-weeks post-randomisation were blind to treatment group. Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual. The adapted intervention was well-received, 86% (n = 30/35) of participants attended the pre-defined 'dose' of five sessions of treatment and 71% (25/35) attended all treatment sessions. The findings of this pilot randomised controlled trial indicate that low-intensity cognitive behaviour therapy informed by behavioural activation can be successfully adapted to meet the needs of autistic people. Evaluation of the effectiveness of this intervention in a full scale randomised controlled trial is now warranted.

11.
BMJ Open ; 9(11): e030907, 2019 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-31748296

RESUMO

INTRODUCTION: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. METHODS AND ANALYSIS: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery. ETHICS AND DISSEMINATION: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10386621.

12.
Aquat Toxicol ; 217: 105335, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31706209

RESUMO

One of the categories of environmental contaminants possibly contributing to declining sockeye salmon (Oncorhynchus nerka) in the Fraser River, British Columbia, Canada is pesticides. In this 4-month study, the effects of environmentally relevant concentrations of a waterborne neonicotinoid, clothianidin (0.15, 1.5, 15 and 150 µg/L), on embryonic, alevin and early swim-up fry sockeye salmon derived from four unique genetic crosses of the Pitt River, BC stock were investigated. There were no significant effects of clothianidin on survival, hatching, growth or deformities, although genetic variation significantly affected these endpoints. Clothianidin caused a significant 4.7-fold increase in whole body 17ß-estradiol levels in swim-up fry after exposure to 0.15 µg/L, but no effects were observed on testosterone levels. In addition, hepatic expression of the gene encoding glucocorticoid receptor 2 was also impacted at the highest concentration of clothianidin tested, and was found to be ∼4-fold lower compared to the sockeye reared in control water. These results indicate additional examination of clothianidin and its effects on salmonid gonad development and the reproductive and stress endocrine axes in general, is warranted.


Assuntos
Embrião não Mamífero/efeitos dos fármacos , Desenvolvimento Embrionário/efeitos dos fármacos , Guanidinas/toxicidade , Neonicotinoides/toxicidade , Rios/química , Salmão/crescimento & desenvolvimento , Tiazóis/toxicidade , Poluentes Químicos da Água/toxicidade , Migração Animal/efeitos dos fármacos , Animais , Colúmbia Britânica , Sistema Endócrino/efeitos dos fármacos , Sistema Endócrino/crescimento & desenvolvimento , Estradiol/metabolismo , Regulação da Expressão Gênica no Desenvolvimento/efeitos dos fármacos , Fígado/metabolismo , Receptores de Glucocorticoides/genética , Reprodução/efeitos dos fármacos , Salmão/metabolismo , Natação
13.
BMJ Open ; 9(9): e029538, 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31551376

RESUMO

INTRODUCTION: Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV 'Treatment as Prevention' (TasP) in PWID. METHODS AND ANALYSIS: We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome - chronic HCV prevalence in PWID - is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a 'virtual cohort' of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. ETHICS AND DISSEMINATION: Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials.gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.

14.
BMC Fam Pract ; 20(1): 121, 2019 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-31481017

RESUMO

BACKGROUND: BATHE is a brief psychosocial intervention designed for physician use in patient consultations. The technique has gained some international recognition, but there is currently limited research evidence to demonstrate its acceptability and benefits to patient care. We conducted a pilot cluster randomised controlled trial and feasibility study to explore the use of BATHE as a key component of a person-focused intervention to improve the care of frequent attending patients in UK primary care. METHODS: A nested qualitative interview study conducted within a pilot trial. The trial took place in six general practices in the South West of England. Eligible patients had been identified as being in the top 3% of attenders in the previous 12 months. General practitioners (GPs) were trained to use BATHE during a one-hour initial training session, and two top-up trainings which included feedback on implementation fidelity. GPs were asked to use BATHE with their study patients for a period of 12 months. 34 GPs were trained and documented using BATHE in a total of 577 consultations with eligible patients during the intervention period. At the end of the intervention period, GPs and study patients from the intervention practices were invited to take part in an interview. Interviews were semi-structured, audio-recorded and transcribed. Thematic analysis was used. RESULTS: Eleven GPs and 16 patients took part in post-intervention interviews. Benefits of using BATHE included making consultations more person-centred, challenging assumptions that the GP knew what was going on for the patient and their main concerns, and supporting self-management. Difficulties reported included changing existing consultation habits, identifying appropriate consultations in which to use BATHE, and organisational constraints. CONCLUSIONS: The study suggests that using BATHE is both acceptable and beneficial but also highlighted some of the difficulties GPs had incorporating BATHE into routine practice. Strategies to reduce these difficulties are needed before the extent of the potential benefits of BATHE can be fully assessed. TRIAL REGISTRATION: ISRCTN62939408 Prospectively registered on 24/06/2015.

15.
BMC Public Health ; 19(1): 1111, 2019 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-31412818

RESUMO

BACKGROUND: Numerous interventions to increase children's physical activity levels are published, yet, few studies report indicators of external validity. Process evaluations are critical for assessing intervention implementation, sustainability and effectiveness. A mixed-methods process evaluation, using the RE-AIM framework, was conducted to evaluate the internal and external validity of Action 3:30R, a revised teaching assistant-led after-school intervention which aimed to increase physical activity in children aged 8-10 years and was underpinned by Self-determination Theory (SDT). METHODS: Data were collected and reported in line with the five components of RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance). Quantitative measures included logbooks, registers and self-reported teaching-efficacy, autonomy support, child enjoyment and perceived exertion questionnaires. Questionnaire data were collected at three points throughout the 15-week intervention. Observations by trained researchers were also conducted to assess fidelity to the intervention manual and its underpinning theory. Post-intervention focus groups with pupils and interviews with teaching assistants (TAs), school staff and external stakeholders explored the implementation and potential sustainability of Action 3:30R from stakeholders' perspectives. RESULTS: Action 3:30R appealed to a broad range of pupils, including girls and less-active pupils. The Action 3:30R TA training was implemented as intended and was perceived as valuable professional development. Releasing staff for training was a barrier in two of the six intervention schools, which were unable to deliver the intervention as a result. Pupils enjoyed the intervention, and the Action 3:30R core principles underpinned by SDT were implemented with high fidelity, as was the intervention itself. Scheduling conflicts with other clubs and lack of parental support were perceived as the main barriers to recruitment and attendance. Lack of space and season were cited as the main barriers affecting the quality of delivery. The study shows evidence of maintenance, as one intervention school decided to continue Action 3:30R beyond the study. Funding and continued TA training were suggested as factors which may affect the maintenance of Action 3:30R. CONCLUSIONS: Action 3:30R is an enjoyable, autonomy-supportive after-school programme, which engages a range of pupils and offers TAs valuable training. RE-AIM provided helpful structure and is recommended for intervention evaluations. TRIAL REGISTRATION: ISRCTN34001941 . Prospectively registered 01/12/2016.


Assuntos
Exercício Físico , Serviços de Saúde Escolar/organização & administração , Criança , Estudos de Viabilidade , Feminino , Grupos Focais , Humanos , Masculino , Autonomia Pessoal , Prazer , Avaliação de Programas e Projetos de Saúde , Inquéritos e Questionários
16.
BMJ Open Respir Res ; 6(1): e000425, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31258918

RESUMO

Background: Chronic obstructive pulmonary disease (COPD) accounts for 10% of emergency hospital admissions in the UK annually. Nearly 33% of patients are readmitted within 28 days of discharge. We evaluated the effectiveness of implementing standardised packages of care called 'care bundles' on COPD readmission, emergency department (ED) attendance, mortality, costs and process of care. Methods: This is a mixed-methods, controlled before-and-after study with nested case studies. 31 acute hospitals in England and Wales which introduced COPD care bundles (implementation sites) or provided usual care (comparator sites) were recruited and provided monthly aggregate data. 14 sites provided additional individual patient data. Participants were adults admitted with an acute exacerbation of COPD. Results: There was no evidence that care bundles reduced 28-day COPD readmission rates: OR=1.02 (95% CI 0.83 to 1.26). However, the rate of ED attendance was reduced in implementation sites over and above that in comparator sites (implementation: IRR=0.63 (95% CI 0.56 to 0.71); comparator: IRR=1.12 (95% CI 1.02 to 1.24); group-time interaction p<0.001). At implementation sites, delivery of all bundle elements was higher but was only achieved in 2.2% (admissions bundle) and 7.6% (discharge bundle) of cases. There was no evidence of cost-effectiveness. Staff viewed bundles positively, believing they help standardise practice and facilitate communication between clinicians. However, they lacked skills in change management, leading to inconsistent implementation. Discussion: COPD care bundles were not effectively implemented in this study. They were associated with a reduced number of subsequent ED attendances, but not with change in readmissions, mortality or reduced costs. This is unsurprising given the low level of bundle uptake in implementation sites, and it remains to be determined if COPD care bundles affect patient care and outcomes when they are effectively implemented. Trial registration number: ISRCTN13022442.

17.
Health Technol Assess ; 23(34): 1-48, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31304912

RESUMO

BACKGROUND: Acute otitis media (AOM) is a common reason for primary care consultations and antibiotic prescribing in children. Options for improved pain control may influence antibiotic prescribing and consumption. OBJECTIVE: The Children's Ear Pain Study (CEDAR) investigated whether or not providing anaesthetic-analgesic ear drops reduced antibiotic consumption in children with AOM. Secondary objectives included pain control and cost-effectiveness. DESIGN: A multicentre, randomised, parallel-group (two-group initially, then three-group) trial. SETTING: Primary care practices in England and Wales. PARTICIPANTS: 1- to 10-year-old children presenting within 1 week of suspected AOM onset with ear pain during the preceding 24 hours and not requiring immediate antibiotics. Participating children were logged into the study and allocated using a remote randomisation service. INTERVENTIONS: Two-group trial - unblinded comparison of anaesthetic-analgesic ear drops versus usual care. Three-group trial - blinded comparison of anaesthetic-analgesic ear drops versus placebo ear drops and unblinded comparison with usual care. MAIN OUTCOME MEASURES: The primary outcome measure was parent-reported antibiotic use by the child over 8 days following enrolment. Secondary measures included ear pain at day 2 and NHS and societal costs over 8 days. RESULTS: Owing to a delay in provision of the placebo drops, the recruitment period was shortened and most participants were randomly allocated to the two-group study (n = 74) rather than the three-group study (n = 32). Comparing active drops with usual care in the combined two-group and three-group studies, 1 out of 39 (3%) children allocated to the active drops group and 11 out of 38 (29%) children allocated to the usual-care group consumed antibiotics in the 8 days following enrolment [unadjusted odds ratio 0.09, 95% confidence interval (CI) 0.02 to 0.55; p = 0.009; adjusted for delayed prescribing odds ratio 0.15, 95% CI 0.03 to 0.87; p = 0.035]. A total of 43% (3/7) of patients in the placebo drops group consumed antibiotics by day 8, compared with 0% (0/10) of the three-group study active drops groups (p = 0.051). The economic analysis of NHS costs (£12.66 for active drops and £11.36 for usual care) leads to an estimated cost of £5.19 per antibiotic prescription avoided, but with a high degree of uncertainty. A reduction in ear pain at day 2 in the placebo group (n = 7) compared with the active drops group (n = 10) (adjusted difference in means 0.67, 95% CI -1.44 to 2.79; p = 0.51) is consistent with chance. No adverse events were reported in children receiving active drops. LIMITATIONS: Estimated treatment effects are imprecise because the sample size target was not met. It is not clear if delayed prescriptions of an antibiotic were written prior to randomisation. Few children received placebo drops, which hindered the investigation of ear pain. CONCLUSIONS: This study suggests that reduced antibiotic use can be achieved in children with AOM by combining a no or delayed antibiotic prescribing strategy with anaesthetic-analgesic ear drops. Whether or not the active drops relieved ear pain was not established. FUTURE WORK: The observed reduction in antibiotic consumption following the prescription of ear drops requires replication in a larger study. Future work should establish if the effect of ear drops is due to pain relief. TRIAL REGISTRATION: Current Controlled Trials ISRCTN09599764. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 34. See the NIHR Journals Library website for further project information. Alastair D Hay was funded by a NIHR Research Professorship (funding identifier NIHR-RP-02-12-012).

18.
BMC Public Health ; 19(1): 865, 2019 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-31269926

RESUMO

BACKGROUND: The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. A feasibility randomised controlled trial was conducted in England to adapt the intervention to the UK context. An embedded process evaluation focused on three key questions. 1. Was it feasible and acceptable to implement the intervention as planned? 2. How did the intervention affect staff and parent mediators? 3. Were the trial design and methods acceptable? METHODS: Twelve nurseries in south-west England were recruited and randomised to intervention or control. The intervention comprised: NAP SACC UK Partner (Health Visitor) support to nurseries to review practice and policies against best practice, and then set goals to improve physical activity, nutrition and oral health; two staff training workshops; and a web-based parent support element. The process evaluation comprised: observations of Partner training (n = 1), Partner/manager meetings (n = 5) and staff workshops (n = 10); semi-structured interviews with Partners (n = 4), managers (n = 12), staff (n = 4) and parents (n = 20); analysis of self-assessment forms, goal setting forms and Partner logbooks; and assessment of staff and parent knowledge, motivation and self-efficacy mediators. RESULTS: Overall, NAP SACC UK was feasible to implement and acceptable to nursery staff, managers, Partners and parents. The intervention was implemented as planned in five of the six intervention nurseries. Partners and managers appreciated the opportunity to review and improve nursery practices and valued the relationship forged between them. Staff rated the training workshops highly, despite attending outside of working hours. Most goals set by nurseries were achieved. However, Partners raised concerns about Health Visitors' capacity to deliver the intervention in any subsequent roll out. Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group. The web-based parent element was not well used and should be removed from any subsequent trial. The trial methods were acceptable to managers, staff, Partners and parents. CONCLUSIONS: Implementing and evaluating a physical activity and nutrition intervention in nursery settings is feasible and acceptable. A full RCT of NAP SACC UK (with appropriate modifications) is warranted. TRIAL REGISTRATION: ISRCTN16287377 (10 Apr 2015).


Assuntos
Fenômenos Fisiológicos da Nutrição Infantil , Exercício Físico , Promoção da Saúde/organização & administração , Saúde Bucal , Pré-Escolar , Inglaterra , Estudos de Viabilidade , Humanos , Avaliação de Programas e Projetos de Saúde
19.
Lancet Psychiatry ; 6(8): 659-666, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31272912

RESUMO

BACKGROUND: Evidence from high income countries (HICs) suggests that individuals who present to hospital after self-harm are an important target for suicide prevention, but evidence from low and middle-income countries (LMICs) is lacking. We aimed to investigate the risk of repeat self-harm and suicide, and factors associated with these outcomes, in a large cohort of patients presenting to hospital with self-harm in rural Sri Lanka. METHODS: In this cohort study, hospital presentations for self-harm at 13 hospitals in a rural area of North Central Province (population 224 000), Sri Lanka, were followed up with a self-harm surveillance system, established as part of a community randomised trial, and based on data from all hospitals, coroners, and police stations in the study area. We estimated the risk of repeat non-fatal and fatal self-harm and risk factors for repetition with Kaplan-Meier methods and Cox proportional hazard models. Sociodemographic (age, sex, and socioeconomic position) and clinical (past self-harm and method of self-harm) characteristics investigated were drawn from a household survey in the study area and data recorded at the time of index hospital presentation. We included all individuals who had complete data for all variables in the study in our primary analysis. OUTCOMES: Between July 29, 2011, and May 12, 2016, we detected 3073 episodes of self-harm (fatal and non-fatal) in our surveillance system, of which 2532 (82·3%) were linked back to an individual in the baseline survey. After exclusion of 145 ineligible episodes, we analysed 2259 index episodes of self-harm. By use of survival models, the estimated risk of repeat self-harm (12 months: 3· 1%, 95% CI 2·4-3·9; 24 months: 5·2%, 4·3-6·4) and suicide (12 months: 0·6%, 0·4-1·1; 24 months: 0·8%, 0·5-1·3) in our study was considerably lower than that in HICs. A higher risk of repeat self-harm was observed in men than in women (fatal and non-fatal; hazard ratio 2·0, 95% CI 1·3-3·2; p=0·0021), in individuals aged 56 years and older compared with those aged 10-25 years (fatal; 16·1, 4·3-59·9; p=0·0027), and those who used methods other than poisoning in their index presentation (fatal and non-fatal; 3·9, 2·0-7·6; p=0·00027). We found no evidence of increased risk of repeat self-harm or suicide in those with a history of self-harm before the index episode. INTERPRETATION: Although people who self-harm are an important high-risk group, focusing suicide prevention efforts on those who self-harm might be somewhat less important in LMICs compared with HICs given the low risk of repeat self-harm and subsequent suicide death. Strategies that focus on other risk factors for suicide might be more effective in reducing suicide deaths in LMICs in south Asia. A better understanding of the low incidence of repeat self-harm is also needed, as this could contribute to prevention strategies in nations with a higher incidence of repetition and subsequent suicide death. FUNDING: Wellcome Trust.


Assuntos
Comportamento Autodestrutivo/epidemiologia , Comportamento Autodestrutivo/psicologia , Suicídio/estatística & dados numéricos , Adolescente , Adulto , Distribuição por Idade , Criança , Estudos de Coortes , Feminino , Hospitais Rurais , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores Sexuais , Sri Lanka/epidemiologia , Adulto Jovem
20.
J Clin Epidemiol ; 115: 14-24, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31276780

RESUMO

OBJECTIVES: Core outcome set (COS) development often begins with a systematic review to identify outcomes. Reviews frequently show heterogeneity in numbers of outcomes reported across trials. Contributing to this is a lack of a uniform definition for an outcome. This study proposes a first working definition for a unique trial outcome to support reporting a quantitative assessment of outcome reporting heterogeneity (ORH). STUDY DESIGN AND SETTING: Eligible COS literature (development papers, protocols, and reviews) were identified using the COMET database, Ovid MEDLINE, and PubMed. Outcome numbers, definitions, timing, and grouping methodology were examined. RESULTS: One hundred and thirty two studies were included. 82 (88.1%) studies (excluding protocols) reported a total number of unique outcomes (median, 82; range, 12-5776; IQR, 261). Timing of assessment was reported in 32 (31.4%) studies. Methods to group similar outcomes were reported in 8 (7.8%) articles. No study defined how outcomes were agreed as different and how final numbers of unique outcomes were determined. It is proposed that a unique outcome requires original meaning and context. Thus ORH is suggested to be the reporting of multiple unique outcomes across trials related to one health care condition. CONCLUSION: This review identified inconsistencies in how authors define, extract, group, and count trial outcomes. Further work is needed to refine our proposed definitions to optimize COS development and allow a quantifiable measure of ORH.

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