PP24 Time: take-home naloxone in multicentre emergency settings: protocol for a feasibility study

2019 ◽  
Vol 36 (1) ◽  
pp. e10.1-e10
Author(s):  
Matthew Jones ◽  
Helen Snooks ◽  
Jenna Bulger ◽  
Alan Watkins ◽  
Chris Moore ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Linked Data ◽  
Cost Effective ◽  
Feasibility Trial ◽  
Adverse Event Rate ◽  
Opioid Overdose ◽  
Opioid Agonist ◽  
Data Matching ◽  
The Uk

BackgroundOpioids such as heroin kill more people worldwide than any other drug. Death rates associated with opioid poisoning in the UK are at record levels. Naloxone is an opioid agonist which can be distributed in take home ‘kits’. This intervention is known as Take Home Naloxone (THN).MethodsWe propose to carry out a randomised controlled feasibility trial (RCT) of THN distributed in emergency settings clustered by Emergency Department (ED) catchment area, and local ambulance service; with anonymised linked data outcomes. This will include distribution of THN by paramedics and ED staff to patients at risk of opioid overdose. Existing linked data will be used to develop a discriminant function to retrospectively identify people at high risk of overdose death based on observable predictors of overdose to include in outcome follow up.ResultsWe will gather outcomes up to one year including; deaths (and drug related); emergency admissions; intensive care admissions; ED attendances (and overdose related); 999 attendances (and for overdose); THN kits issued; and NHS resource usage. We will agree progression criteria following consultation with research team members related to sign up of sites; successful identification and provision of THN to eligible participants; successful follow up of eligible participants and opioid decedents; adverse event rate; successful data matching and data linkage; and retrieval of outcomes within three months of projected timeline.ConclusionsTHN programmes are currently run by some drug services in the UK. However, saturation is low. There has been a lack of experimental research in to THN, and so questions remain: Does THN reduce deaths? Are there unforeseen harms associated with THN? Is THN cost effective? This feasibility study will establish whether a fully powered cluster RCT can be used to answer these questions.

scholarly journals Protocol for Take home naloxone In Multicentre Emergency setting (TIME): Feasibility Study

2020 ◽  
Author(s):  
Matthew Jones ◽  
Fiona Bell ◽  
Jonathan Benger ◽  
Sarah Black ◽  
Penny Buykx ◽  
...  
Keyword(s):  
At Risk ◽  
Feasibility Study ◽  
Adverse Event Rate ◽  
Opioid Overdose ◽  
Emergency Setting ◽  
Risk Of Death ◽  
Emergency Ambulance ◽  
Patients At Risk ◽  
One Year

Abstract Background Opioids, such as heroin, kill more people worldwide by overdose than any other type of drug, and death rates associated with opioid poisoning in the UK are at record levels (1, 2). Naloxone is an opioid antagonist which can be distributed in ‘kits’ for administration by witnesses in an overdose emergency. This intervention is known as Take Home Naloxone (THN). We know that THN can save lives on an individual level, but there is currently limited evidence about the effectiveness of THN distribution on an aggregate level, in specialist drug service settings or in emergency service settings. Notably, we do not know whether THN kits reduce deaths from opioid overdose in at-risk populations, if there are unforeseen harms associated with THN distribution or if THN is cost-effective. In order to address this research gap, we aim to determine the feasibility of a fully-powered cluster Randomised Controlled Trial (RCT) of THN distribution in emergency settings. Methods We will carry out a feasibility study for a RCT of THN distributed in emergency settings at four sites, clustered by Emergency Department (ED) and catchment area within its associated ambulance service. THN is a peer-administered intervention. At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose. At two control sites, practice will carry on as usual. We will develop a method of identifying a population to include in an evaluation, comprising people at risk of fatal opioid overdose, who may potentially receive naloxone included in a THN kit. We will gather anonymised outcomes up to one year following a 12 month ‘live’ trial period for patients at risk of death from opioid poisoning. We expect approximately 100 patients at risk of opioid overdose to be in contact with each service during the one year recruitment period. Our outcomes will include: deaths; emergency admissions; intensive care admissions; and ED attendances. We will collect numbers of eligible patients attended by participating emergency ambulance paramedics and attending ED; THN kits issued; and NHS resource usage. We will determine whether to progress to a fully-powered trial based on pre-specified progression criteria: sign-up of sites (n = 4); staff trained (>= 50%); eligible participants identified (>= 50%); THN provided to eligible participants (>= 50%); people at risk of death from opioid overdose identified for inclusion in follow up (>= 75% of overdose deaths); outcomes retrieved for high risk individuals (>= 75%); and adverse event rate (<10% difference between study arms).Discussion This feasibility study is the first randomised, methodologically robust investigation of THN distribution in emergency settings. The study addresses an evidence gap related to the effectiveness of THN distribution in emergency settings. As this study is being carried out in emergency settings, obtaining informed consent on behalf of participants is not feasible. We therefore employ novel methods for identifying participants and capturing follow up data, with effectiveness dependent on the quality of the available routine data.Trial registration ISRCTN13232859 (Registered 16/02/2018)

scholarly journals Protocol for Take home naloxone In Multicentre Emergency setting (TIME): Feasibility Study

2020 ◽  
Author(s):  
Matthew Jones ◽  
Fiona Bell ◽  
Jonathan Benger ◽  
Sarah Black ◽  
Penny Buykx ◽  
...  
Keyword(s):  
At Risk ◽  
Feasibility Study ◽  
Adverse Event Rate ◽  
Opioid Overdose ◽  
Emergency Setting ◽  
Risk Of Death ◽  
Emergency Ambulance ◽  
Patients At Risk ◽  
One Year

Abstract Background Opioids, such as heroin, kill more people worldwide by overdose than any other type of drug, and death rates associated with opioid poisoning in the UK are at record levels. Naloxone is an opioid antagonist which can be distributed in ‘kits’ for administration by witnesses in an overdose emergency. This intervention is known as Take Home Naloxone (THN). There is a lack of rigorous experimental research into the effectiveness of THN distribution, with fundamental questions remaining unanswered: do THN kits reduce deaths? are there unforeseen harms associated with THN distribution? and is THN distribution cost-effective? We seek to establish the feasibility of a fully-powered cluster Randomised Controlled Trial (RCT) of THN distribution in emergency settings to answer these questions.Methods We will carry out a feasibility study for a RCT of THN distributed in emergency settings at four sites, clustered by Emergency Department (ED) and catchment area within its associated ambulance service. At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose. At two control sites practice will carry on as usual. THN is a peer-administered intervention. We will develop a method of identifying a population to include in an evaluation, comprising people at risk of opioid overdose, who may potentially receive THN. We will gather anonymised outcomes up to one year following a 12 month ‘live’ trial period for patients at risk of death from opioid poisoning. We expect approximately 100 patients at risk of opioid overdose to be in contact with each service during the one year recruitment period. Our outcomes will include: deaths; emergency admissions; intensive care admissions; and ED attendances. We will collect numbers of eligible patients attended by participating emergency ambulance paramedics and attending ED; THN kits issued; and NHS resource usage. We will determine whether to progress to a fully powered trial based on pre-specified progression criteria: sign-up of sites (n = 4); staff trained (>= 50%); eligible participants identified (>= 50%); THN provided to eligible participants (>= 50%); people at risk of death from opioid overdose identified for inclusion in follow up (>= 75% of overdose deaths); outcomes retrieved for high risk individuals (>= 75%); and adverse event rate (<10% difference between trial arms).Discussion This feasibility study is the first randomised, methodologically robust investigation of THN distribution in emergency settings. The study addresses an evidence gap related to the effectiveness of THN distribution in emergency settings. As this study is being carried out in emergency settings, obtaining informed consent on behalf of participants is not feasible. We therefore employ novel methods for identifying participants and capturing follow up data, the effectiveness of which are dependent on the quality of the available routine data.

“Take home” naloxone: what does the evidence base tell us?

2015 ◽  
Vol 15 (2) ◽  
pp. 67-75 ◽  
Author(s):  
Josefien J. F. Breedvelt ◽  
Derek K. Tracy ◽  
Emily C. Dickenson ◽  
Lucy V. Dean
Keyword(s):  
Evidence Base ◽  
Future Research ◽  
Opioid Overdose ◽  
Pilot Studies ◽  
Content Type ◽  
Practical Concern ◽  
Drug Overdoses ◽  
Associated Risk Factors ◽  
The Uk

Purpose – Opiod users are at high risk of suffering from drug overdoses. Naloxone has been used for decades in emergency treatment settings to reverse the symptoms of opioid overdose. Pilot studies and regional programmes have been rolled out to make naloxone more widely available. This review of user/carer administration of naloxone – so-called “take home naloxone” – aims to provide health professionals and interested readers with an up-to-date evidence base, clinical implications and practical concern considerations for such community management. The paper aims to discuss these issues. Design/methodology/approach – A review and analysis of the recent literature on naloxone. Findings – The evidence base suggests training and education is effective in preparing users for wider naloxone distribution. Furthermore, studies of varying quality indicate that naloxone may prove useful in reducing overdose-related deaths. However, even after implementation ineffective response techniques continued to be used at times and there remained a heistance to call medical services post overdose. Intranasal naloxone may reduce some of the risks associated with intramuscular naloxone. Ethical considerations, including provision of a needle and syringe kit to the community, should be considered. Studies suffered from a lack of follow-up data and methodological difficulties are associated with establishing opioid-related deaths post implementation. Two running trials in the UK might mitigate these concerns. Research limitations/implications – Future research is needed to address wider context of an overdose and targeting associated risk factors. Originality/value – Clinicians and other professionals will be informed on the most up-to-date evidence base and which areas are improtant to consider when take-home naloxone is introduced in their services.

scholarly journals Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 infection: An Open Label Feasibility Study

2020 ◽  
Author(s):  
Abhimanyu Kumar ◽  
Govind Prasad ◽  
Sanjay Srivastav ◽  
Vinod Kumar Gautam ◽  
Neha Sharma
Keyword(s):  
Feasibility Study ◽  
Hospital Setting ◽  
Feasibility Trial ◽  
Tinospora Cordifolia ◽  
Control Group ◽  
Open Label ◽  
Asymptomatic Patients ◽  
In Silico Study ◽  
Herbal Plant

Background: Guduchi Ghan Vati (aqueous extract of Tinospora cordifolia) is an essential herbal plant in Indian traditional medicine (Ayurveda) that is well documented as an immunomodulator and antimicrobial agent. A recent in silico study found the therapeutic efficacy of Guduchi against SARS-CoV-2. Based on available evidence, we conducted a feasibility study of the safety and efficacy of Guduchi Ghan Vati in asymptomatic patients with covid-19. Patients and methods: An open label, feasibility trial was conducted on 46 patients in the hospital setting. A single-arm study with no control group and blinding was executed in Jodhpur, Rajasthan, India. All patients orally received 2 tablets (1000 mg) twice daily for 2 weeks. Clinical parameters were collected at baseline, day 3, day 7 and day 14. Patients were continuously monitored for side effects and adverse reactions during the study period. . Results: Out of 46 asymptomatic patients included in the study, 40 completed the 14-day follow-up period. None developed any Covid-19 symptoms after admission to the hospital. On day 3 post-treatment, viral clearance was reported in 16 (32.5%) patients. By the end of D-7, 38 (95%) patients had viral load disappearance. Follow-up at D-14 showed that all participants tested negative. Conclusion: In adult patients with asymptomatic Covid-19, Gudhuchi Ghan Vati could be effective. Randomized controlled trials with larger sample sizes in patients with Covid-19 are urgently needed to confirm the definite benefit with Ayurveda.

scholarly journals InFORM: Improving care for people who Frequently call 999: co-production of guidance through an Observational study using Routine linked data and Mixed methods

2019 ◽  
Vol 4 (3) ◽  
Author(s):  
Ashrafunessa Khanom ◽  
Adrian Edwards ◽  
Bethan Edwards ◽  
Heather Hughes ◽  
Ann John ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Outcomes ◽  
Focus Groups ◽  
Linked Data ◽  
Third Sector ◽  
Care Providers ◽  
Complex Needs ◽  
Data Matching ◽  
Future Evaluation

BackgroundPeople who frequently call the 999 ambulance service present an operational challenge to providers and their needs are inadequately met by current service provision. Aim of researchTo understand patterns and health outcomes of frequent calling and to work with stakeholders to co-produce guidance for formal testing in a future evaluation. MethodsThis mixed methods study will include a scoping review of national and international literature followed by an epidemiological study of callers at the all Wales level exploring health outcomes through anonymised linked data. We will also explore the views of patients using qualitative Bio-photographic interview method with a follow up interview at six months and use focus groups with care providers from across primary and emergency care and the third sector. We will use generalised linear model to analyse quantitative data and qualitative data will be analysed thematically. ResultsFindings will include follow up of eligible patients; successful data matching and data linkage; retrieval of outcomes within 12 months. Outcomes will include: adverse events, deaths, emergency admissions; 999 attendances. Qualitative results will include Bio-photographic interviews with completed scrap books and interviews based on the books (n=34). Care provider focus groups (n= 22). Output Co-produced guidance developed with stakeholders. ConclusionHigh users of the 999-ambulance represent a significant policy challenge to emergency ambulance services and often present with complex needs. This study will inform on the characteristics of callers and how to address their care supported with a co-produced guidance for care providers.

scholarly journals Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): Protocol for a Single-Arm Feasibility Study.

2020 ◽  
Author(s):  
Julie Latchem-Hastings ◽  
Elizabeth Randell ◽  
Kate Button ◽  
Fiona Jones ◽  
Rachel Lowe ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Process Evaluation ◽  
Feasibility Study ◽  
Progressive Multiple Sclerosis ◽  
Feasibility Trial ◽  
Self Management ◽  
Physiotherapy Intervention ◽  
Home Based

Abstract Background. We have co-designed a tailored blended physiotherapy intervention for people with Progressive Multiple Sclerosis (MS) who often struggle to access support for physical activity. Underpinned by self-management principles, the Lifestyle, Exercise and Activity Package for people with MS intervention, which we call the LEAP-MS intervention, incorporates face-to-face or online physiotherapy coaching sessions with an accompanying online physical activity platform. The LEAP-MS platform is a multi-user system enabling user and physiotherapist to co-create activity plans. The LEAP-MS platform consists of an information and activity suite, interactive components enabling selection of exercises into an activity programme, goal setting, and activity logging. The platform also facilitates online remote support from a physiotherapist through an embedded online messaging function. We aim to evaluate the LEAP-MS platform in a feasibility trial. Methods. LEAP-MS will be evaluated within a single arm feasibility study with embedded process evaluation. After registration and initial eligible screening, 21 participants will be required to complete baseline self-completion measures. This will be followed by an initial home-based or online coaching session with a physiotherapist (who has received tailored self-management and digital resource training) and access to the online intervention for an initial three-month period. During this period participants are given the option to request up to five further home-based or online physiotherapy coaching sessions. Follow-up questionnaires and semi-structured interviews will be administered three months after baseline with participants and intervention physiotherapists. The LEAP-MS platform will be available to participants for a further three months. Usage of the LEAP-MS platform will be tracked during the full six-month period and final follow up will be conducted six months after baseline. Discussion. Feasibility outcomes (recruitment, retention, intervention uptake and safety) will be reported. The process evaluation will be undertaken to identify possible mechanisms for any observed effects. The data here will inform full scale evaluations of this co-produced, blended physiotherapy intervention. Trial registration: ClinicalTrials.gov NCT03951181. Registered 15th May 2019 https://clinicaltrials.gov/ct2/show/NCT03951181

scholarly journals Pros and cons of using anonymised linked routine data to improve efficiency of randomised controlled trials in healthcare: experience in primary and emergency care

2019 ◽  
Vol 4 (3) ◽  
Author(s):  
Helen Snooks ◽  
Alan Watkins ◽  
Matthew Jones ◽  
Ashrafunessa Khanom ◽  
Jenna Jones ◽  
...  
Keyword(s):  
Linked Data ◽  
Randomised Controlled Trials ◽  
Randomised Trial ◽  
Routine Data ◽  
Feasibility Trial ◽  
Cluster Randomised Trial ◽  
Controlled Trials ◽  
Ethics Research ◽  
Randomised Controlled

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

scholarly journals Study protocol for the antidepressant advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care: a feasibility study

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035905
Author(s):  
Phillippa Harrison ◽  
Ewan Carr ◽  
Kimberley Goldsmith ◽  
Allan H Young ◽  
Mark Ashworth ◽  
...  
Keyword(s):  
Primary Care ◽  
Decision Support ◽  
Health Service ◽  
Service Use ◽  
Antidepressant Treatment ◽  
Decision Support Tool ◽  
Feasibility Trial ◽  
Support Tool ◽  
The Uk

IntroductionThe Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary care service. The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.Methods and analysisThe study is a parallel group, cluster-randomised controlled feasibility trial where participants are blind to treatment allocation. GPs were assigned to two treatment arms: (1) treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices. The study will assess recruitment and lost to follow-up rates, GP satisfaction with the tool and impact on health service use. A meaningful long-term roll-out unit cost will be calculated for the tool, and service use data will be collected at baseline and follow-up to inform a full economic evaluation of a future trial.Ethics and disseminationThe study has received National Health Service ethical approval from the London—Camberwell St Giles Research Ethics Committee (ref: 17/LO/2074). The trial was pre-registered in the Clinical Trials.gov registry. The results of the study will be published in a pre-publication archive within 1 year of completion of the last follow-up assessment.Trial registration numberNCT03628027.

scholarly journals Early Supported Discharge for patients with febrile neutropenia – Experience at a large district hospital in the UK

2019 ◽  
Vol 18 (1) ◽  
pp. 10-15
Author(s):  
Clair I. W. Brunner ◽  
◽  
Joanne Botten ◽  
Nic Wennike ◽  
Lucy Ford ◽  
...  
Keyword(s):  
Cost Effective ◽  
Outpatient Setting ◽  
Septic Complications ◽  
Neutropenic Sepsis ◽  
Early Supported Discharge ◽  
Same Day Discharge ◽  
Before And After ◽  
Life Threatening ◽  
The Uk

Neutropenic sepsis can be life threatening, with mortality 2-21%. The heterogeneity of patients referred with “suspected neutropenic sepsis” has led to strategies being developed to risk-stratify patients and identify those with a low risk of septic complications that could be managed in the outpatient setting, such as The Multinational Association for Supportive Care in Cancer score (MASCC). Outcomes for patients referred with suspected neutropenic sepsis were assessed before and after use of MASCC guided early-supported discharge. 50/123 (41%) patients over 24 months were eligible for early-supported discharge. 26/50 patients had same-day discharge, 14 had overnight admission, 8 stayed 2 nights and 2 stayed 3 nights. Patients received on average 2 follow-up telephone consultations. There were 5 readmissions (10%) and no adverse events. In comparison group; 8 patients over 3-months would have been suitable, potentially saving 40 bed-days. This shows MASCC guided early-supported discharge is safe and cost-effective.

scholarly journals A weight management programme for fathers of children aged 4–11 years: cultural adaptation and the Healthy Dads, Healthy Kids UK feasibility RCT

2020 ◽  
Vol 8 (2) ◽  
pp. 1-166 ◽  
Author(s):  
Kate Jolly ◽  
Tania Griffin ◽  
Manbinder Sidhu ◽  
Peymane Adab ◽  
Adrienne Burgess ◽  
...  
Keyword(s):  
Health Research ◽  
Ethnically Diverse ◽  
Public Health Research ◽  
Feasibility Trial ◽  
Phase 2 ◽  
Socioeconomically Disadvantaged ◽  
Weight Management Programme ◽  
Phase 1B ◽  
The Uk

Background More men than women in the UK are living with overweight or obesity, but men are less likely to engage with weight loss programmes. Healthy Dads, Healthy Kids is an effective Australian weight management programme that targets fathers, who participate with their primary school-aged children. Behavioural interventions do not always transfer between contexts, so an adaptation of the Healthy Dads, Healthy Kids programme to an ethnically diverse UK setting was trialled. Objectives To adapt and test the Australian Healthy Dads, Healthy Kids programme for delivery to men in an ethnically diverse, socioeconomically disadvantaged UK setting. Design Phase 1a studied the cultural adaptation of the Healthy Dads, Healthy Kids programme and was informed by qualitative data from fathers and other family members, and a theoretical framework. Phase 1b was an uncontrolled feasibility trial. Phase 2 was a randomised controlled feasibility trial. Setting Two ethnically diverse, socioeconomically disadvantaged UK cities. Participants In phase 1a, participants were parents and family members from black and minority ethnic groups and/or socioeconomically deprived localities. In phases 1b and 2, participants were fathers with overweight or obesity and their children aged 4–11 years. Interventions The adapted Healthy Dads, Healthy Kids intervention comprised nine sessions that targeted diet and physical activity and incorporated joint father–child physical activity. Healthy Dads, Healthy Kids was delivered in two programmes in phase 1b and four programmes in phase 2. Those in the comparator arm in phase 2 received a family voucher to attend a local sports centre. Main outcome measures The following outcomes were measured: recruitment to the trial, retention, intervention fidelity, attendance, feasibility of trial processes and collection of outcome data. Results Forty-three fathers participated (intervention group, n = 29) in phase 2 (48% of recruitment target), despite multiple recruitment locations. Fathers’ mean body mass index was 30.2 kg/m2 (standard deviation 5.1 kg/m2); 60.2% were from a minority ethnic group, with a high proportion from disadvantaged localities. Twenty-seven (63%) fathers completed follow-up at 3 months. Identifying sites for delivery at a time that was convenient for the families, with appropriately skilled programme facilitators, proved challenging. Four programmes were delivered in leisure centres and community venues. Of the participants who attended the intervention at least once (n = 20), 75% completed the programme (attended five or more sessions). Feedback from participants rated the sessions as ‘good’ or ‘very good’ and participants reported behavioural change. Researcher observations of intervention delivery showed that the sessions were delivered with high fidelity. Conclusions The intervention was well delivered and received, but there were significant challenges in recruiting overweight men, and follow-up rates at 3 and 6 months were low. We do not recommend progression to a definitive trial as it was not feasible to deliver the Healthy Dads, Healthy Kids programme to fathers living with overweight and obesity in ethnically diverse, socioeconomically deprived communities in the UK. More work is needed to explore the optimal ways to engage fathers from ethnically diverse socioeconomically deprived populations in research. Trial registration Current Controlled Trials ISRCTN16724454. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 2. See the NIHR Journals Library website for further project information.

Sign in / Sign up

Export Citation Format

Share Document