Extra Physiotherapy in Critical Care (EPICC) Trial Protocol: a randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill.

INTRODUCTION: Patients discharged from Critical Care suffer from excessive longer term morbidity and mortality. Physical and mental health measures of quality of life show a marked and immediate fall after admission to Critical Care with some recovery over time. However, physical function is still significantly reduced at 6 months. The National Institute for Health and Care Excellence clinical guideline on rehabilitation after critical illness, identified the need for high-quality randomised controlled trials to determine the most effective rehabilitation strategy for critically ill patients at risk of critical illness-associated physical morbidity. In response to this, we will conduct a randomised controlled trial, comparing physiotherapy aimed at early and intensive patient mobilisation with routine care. We hypothesise that this intervention will improve physical outcomes and the mental health and functional well-being of survivors of critical illness. METHODS AND ANALYSIS: 308 adult patients who have received more than 48 h of non-invasive or invasive ventilation in Critical Care will be recruited to a patient-randomised, parallel group, controlled trial, comparing two intensities of physiotherapy. Participants will be randomised to receive either standard or intensive physiotherapy for the duration of their Critical Care admission. Outcomes will be recorded on Critical Care discharge, at 3 and 6 months following initial recruitment to the study. The primary outcome measure is physical health at 6 months, as measured by the SF-36 Physical Component Summary. Secondary outcomes include assessment of mental health, activities of daily living, delirium and ventilator-free days. We will also include a health economic analysis. ETHICS AND DISSEMINATION: The trial has ethical approval from Newcastle and North Tyneside 2 Research Ethics Committee (11/NE/0206). There is a Trial Oversight Committee including an independent chair. The results of the study will be submitted for publication in peer-reviewed journals and presented at national and international scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN20436833.

Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals.

BACKGROUND: New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes, likely requiring them to change multiple different clinical behaviours. The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing, advising, and examining consistent with high-quality diabetes care. AIM: To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes. DESIGN/METHODS: We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention. We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes: prescribing for hypertension; prescribing for glycaemic control; providing physical activity advice; providing nutrition advice; providing on-going education; and ensuring that feet have been examined. The primary outcome will be the proportion of patients appropriately prescribed and examined (using anonymised computer records), and advised (using anonymous patient surveys) at 12 months. We will use behaviour change techniques targeting motivational, volitional, and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care. We will also investigate whether the intervention was delivered as designed (fidelity) by coding audiotaped workshops and interventionist delivery reports, and operated as hypothesised (process evaluation) by analysing responses to theory-based postal questionnaires. In addition, we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation, and a post-trial economic analysis to estimate the costs of the intervention and cost of service use. DISCUSSION: Consistent with UK Medical Research Council guidance and building on previous development research, this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care. TRIAL REGISTRATION: ISRCTN66498413.

Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services.

BACKGROUND: Young people with complex health needs have impairments that can limit their ability to carry out day-to-day activities. As well as coping with other developmental transitions, these young people must negotiate the transfer of their clinical care from child to adult services. The process of transition may not be smooth and both health and social outcomes may suffer.Increasingly, policy-makers have recognised the need to ensure a smoother transition between children's and adult services, with processes that are holistic, individualised, and person-centred; however, there is little outcome data to support proposed models of care. This study aims to identify the features of transitional care that are potentially effective and efficient for young people with complex health needs making their transition. METHODS/DESIGN: Longitudinal cohort study. 450 young people aged 14 years to 18 years 11 months (with autism spectrum disorder and an additional mental health problem, cerebral palsy or diabetes) will be followed through their transition from child to adult services and will contribute data at baseline, 12, 24 and 36 months. We will collect data on: health and wellbeing outcomes (participation, quality of life, satisfaction with services, generic health status (EQ-5D-Y) and condition specific measure of disease control or management); exposure to proposed beneficial features of services (such as having a key worker, appropriate involvement of parents); socio-economic characteristics of the sample; use of condition-related health and personal social services; preferences for the characteristics of transitional care.We will us regression techniques to explore how outcomes vary by exposure to service features and by characteristics of the young people. These data will populate a decision-analytic model comparing the costs and benefits of potential alternative ways of organising transition services.In order to better understand mechanisms and aid interpretation, we will undertake qualitative work with 15 young people, including interviews, non-participant observation and diary collection. DISCUSSION: This study will evaluate the effect of service components of transitional care, rather than evaluation of specific models that may be unsustainable or not generalisable. It has been developed in response to numerous national and international calls for such evaluation.

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial.

BACKGROUND: Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. METHODS: The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants' views on instruments and procedures will be sought to confirm their acceptability. DISCUSSION: The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN43218782.

Brief intervention to prevent hazardous drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized controlled trial.

BACKGROUND: Whilst the overall proportion of young people drinking alcohol in the United Kingdom has decreased in recent years, those who do drink appear to drink a larger amount, and more frequently. Early and heavy drinking by younger adolescents is a significant public health problem linked to intellectual impairment, increased risk of injuries, mental health issues, unprotected or regretted sexual experience, violence, and sometimes accidental death, which leads to high social and economic costs. This feasibility pilot trial aims to explore the feasibility of delivering brief alcohol intervention in a school setting with adolescents aged 14 and 15 and to examine the acceptability of study measures to school staff, young people and parents. METHODS AND DESIGN: Seven schools across one geographical area in the North East of England will be recruited. Schools will be randomly allocated to one of three conditions: provision of an advice leaflet (control condition, n = 2 schools); a 30-minute brief interactive session, which combines structured advice and motivational interviewing techniques delivered by the school learning mentor (level 1 condition, n = 2 schools); and a 60-minute session involving family members delivered by the school learning mentor (level 2 condition, n = 3 schools). Participants will be year 10 school pupils (aged 14 and 15) who screen positively on a single alcohol screening question and who consent to take part in the trial. Year 10 pupils in all seven schools will be followed up at 6 and 12 months. Secondary outcome measures include the ten-question Alcohol-Use Disorders Identification Test. The EQ-5D-Y and a modified short service use questionnaire will inform the health and social resource costs for any future economic evaluation.Young people recruited into the trial will also complete a 28-day timeline follow back questionnaire at 12-month follow-up. A qualitative evaluation (with young people, school staff, learning mentors, and parents) will examine facilitators and barriers to the use of screening and brief intervention approaches in the school setting in this age group. TRIAL REGISTRATION: Trial reference number ISRCTN07073105.

The Do-Well study: protocol for a randomised controlled trial, economic and qualitative process evaluations of domiciliary welfare rights advice for socio-economically disadvantaged older people recruited via primary health care.

BACKGROUND: Older people in poor health are more likely to need extra money, aids and adaptations to allow them to remain independent and cope with ill health, yet in the UK many do not claim the welfare benefits to which they are entitled. Welfare rights advice interventions lead to greater welfare income, but have not been rigorously evaluated for health benefits. This study will evaluate the effects on health and well-being of a domiciliary welfare rights advice service provided by local government or voluntary organisations in North East England for independent living, socio-economically disadvantaged older people (aged ≥60 yrs), recruited from general (primary care) practices. METHODS/DESIGN: The study is a pragmatic, individually randomised, single blinded, wait-list controlled trial of welfare rights advice versus usual care, with embedded economic and qualitative process evaluations. The qualitative study will examine whether the intervention is delivered as intended; explore responses to the intervention and examine reasons for the trial findings; and explore the potential for translation of the intervention into routine policy and practice. The primary outcome is the effect on health-related quality of life, measured using the CASP 19 questionnaire. Volunteer men and women aged ≥60 years (1/household) will be identified from general practice patient registers. Patients in nursing homes or hospitals at the time of recruitment will be excluded. General practice populations will be recruited from disadvantaged areas of North East England, including urban, rural and semi-rural areas, with no previous access to targeted welfare rights advice services delivered to primary care patients. A minimum of 750 participants will be randomised to intervention and control arms in a 1:1 ratio. DISCUSSION: Achieving a trial design that is both ethical and acceptable to potential participants, required methodological compromises. The choice of follow-up length required a trade-off between sufficient time to demonstrate health impact and the need to allow the control group access to the intervention as early as possible. The study will have implications for fundamental understanding of social inequalities and how to tackle them, and provides a model for similar evaluations of health-orientated social interventions. If the health benefits of this intervention are proven, targeted welfare rights advice services should be extended to ensure widespread provision for older people and other vulnerable groups. CURRENT CONTROLLED TRIALS ISRCTN NUMBER: ISRCTN37380518.

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing.

BACKGROUND: Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness.The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness. METHODS/DESIGN: This is a mixed methods pragmatic multicentre feasibility pilot study with four components:-(a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial.(b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience.(c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial.(d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions. DISCUSSION: The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN71327395 assigned 7th June 2010.

Surgical treatments for men with benign prostatic enlargement: cost effectiveness study.

OBJECTIVE: To determine which surgical treatment for lower urinary tract symptoms suggestive of benign prostate enlargement is cost effective. DESIGN: Care pathways describing credible treatment strategies were decided by consensus. Cost-utility analysis used Markov modelling and Monte Carlo simulation. DATA SOURCES: Clinical effectiveness data came from a systematic review and an individual level dataset. Utility values came from previous economic evaluations. Costs were calculated from National Health Service (NHS) and commercial sources. METHODS: The Markov model included parameters with associated measures of uncertainty describing health states between which individuals might move at three monthly intervals over 10 years. Successive annual cohorts of 25,000 men were entered into the model and the probability that treatment strategies were cost effective was assessed with Monte Carlo simulation with 10,000 iterations. RESULTS: A treatment strategy of initial diathermy vaporisation of the prostate followed by endoscopic holmium laser enucleation of the prostate in case of failure to benefit or subsequent relapse had an 85% probability of being cost effective at a willingness to pay value of pound20,000 (euro21,595, $28,686)/quality adjusted life year (QALY) gained. Other strategies with diathermy vaporisation as the initial treatment were generally cheaper and more effective than the current standard of transurethral resection repeated once if necessary. The use of potassium titanyl phosphate laser vaporisation incurred higher costs and was less effective than transurethral resection, and strategies involving initial minimally invasive treatment with microwave thermotherapy were not cost effective. Findings were unchanged by wide ranging sensitivity analyses. CONCLUSION: The outcome of this economic model should be interpreted cautiously because of the limitations of the data used. The finding that initial vaporisation followed by holmium laser enucleation for failure or relapse might be advantageous both to men with lower urinary tract symptoms and to healthcare providers requires confirmation in a good quality prospective clinical trial before any change in current practice. Potassium titanyl phosphate laser vaporisation was unlikely to be cost effective in our model, which argues against its unrestricted use until further evidence of effectiveness and cost reduction is obtained.

Women's preferences in screening for Down syndrome.

OBJECTIVES: In this article, we seek to establish women's preferences (expressed as utility values) for a number of scenarios relating to the process and associated outcomes of first- and second-trimester screening for Down syndrome. METHODS: We used the standard gamble (SG) approach with a sample of 100 pregnant women. Standard gamble is a choice-based preference elicitation technique that values scenarios on a 0-1 scale. RESULTS: A true negative screening test, whether obtained in the first or second trimester, had the highest utility scores (both 0.98), which were not significantly different from the scores for the false-positive scenarios leading to first- or second-trimester invasive testing but the birth of a healthy infant (0.95 and 0.94, respectively). The mean utility score for the false-negative scenario resulting in the birth of a Down syndrome infant (0.77) was lower than both the true negative scenarios and the false-positive healthy baby scenarios (p < 0.000). CONCLUSION: We did not find any differences in the values of the key scenarios regarding either the timing of reassurance of a healthy fetus or the ability to access early surgical termination, rather than later medical termination for a Down syndrome fetus.

Randomised controlled trial of welfare rights advice accessed via primary health care: pilot study [ISRCTN61522618].

BACKGROUND: Little research has directly evaluated the impact of increasing financial or material resources on health. One way of assessing this lies with assisting people to obtain full welfare benefit entitlements. In 2000-1, 2.3 million pensioners were living in poverty in the UK and estimates suggest that around one million do not claim the financial support to which they are entitled. The effectiveness of welfare rights advice services delivered via primary health care to promote health and reduce health inequalities is unknown. METHODS: The main objectives of this study were to assess the feasibility and acceptability of a randomised controlled trial of welfare rights advice in a community setting and identify appropriate health and social outcome measures in order to plan a definitive trial. This was a single blind, community-based, pilot randomised controlled trial. 126 men and women aged 60 years and over, recruited from 4 general practices in Newcastle upon Tyne, UK, participated. The intervention comprised a structured welfare rights assessment followed by active assistance with welfare benefit claims over the following 24 months. The control group received the intervention after a six month delay. A range of socio-economic, health, behavioural and psycho-social outcomes were measured. RESULTS: 126 out of 400 people invited agreed to participate and 109 were followed up at 24 months. Both the intervention and research procedures were feasible and acceptable to participants and professionals involved. 68 (58%) of all participants received a welfare benefit award (31 financial, 16 non-financial and 21 both). Median time to receipt of benefits from initial assessment was 14 (range 1 to 78) weeks and median financial award was pounds 55 (Euro 81, dollar 98) per household per week. There was little evidence of health-related differences between groups or over time, which could be due to limitations of the study design. CONCLUSION: Modification of the study design, including selection of study participants, timing of interventions and length of follow up are recommended for a definitive trial. More appropriate health and psycho-social outcome measures relevant to the elderly population should be sought, particularly focussing on those issues highlighted in the accompanying qualitative study.

The estimation of a preference-based measure of health from the SF-36.

This paper reports on the findings of a study to derive a preference-based measure of health from the SF-36 for use in economic evaluation. The SF-36 was revised into a six-dimensional health state classification called the SF-6D. A sample of 249 states defined by the SF-6D have been valued by a representative sample of 611 members of the UK general population, using standard gamble. Models are estimated for predicting health state valuations for all 18,000 states defined by the SF-6D. The econometric modelling had to cope with the hierarchical nature of the data and its skewed distribution. The recommended models have produced significant coefficients for levels of the SF-6D, which are robust across model specification. However, there are concerns with some inconsistent estimates and over prediction of the value of the poorest health states. These problems must be weighed against the rich descriptive ability of the SF-6D, and the potential application of these models to existing and future SF-36 data set.