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1.  Prevalence of alcohol related attendance at an inner city emergency department and its impact: a dual prospective and retrospective cohort study 
Emergency Medicine Journal : EMJ  2015;33(3):187-193.
Background
Alcohol related hospital attendances are a potentially avoidable burden on emergency departments (EDs). Understanding the number and type of patients attending EDs with alcohol intoxication is important in estimating the workload and cost implications. We used best practice from previous studies to establish the prevalence of adult alcohol related ED attendances and estimate the costs of clinical management and subsequent health service use.
Methods
The setting was a large inner city ED in northeast England, UK. Data were collected via (i) retrospective review of hospital records for all ED attendances for four pre-specified weeks in 2010/2011 to identify alcohol related cases along with 12 months of follow-up of the care episode and (ii) prospective 24/7 assessment via breath alcohol concentration testing of patients presenting to the ED in the corresponding weeks in 2012/2013.
Results
The prevalence rates of alcohol related attendances were 12% and 15% for the retrospective and prospective cohorts, respectively. Prospectively, the rates ranged widely from 4% to 60% across week days, rising to over 70% at weekends. Younger males attending in the early morning hours at weekends made up the largest proportion of alcohol related attendances. The mean cost per attendance was £249 (SD £1064); the mean total cost for those admitted was £851 (SD £2549). The most common reasons for attending were trauma related injuries followed by psychiatric problems.
Conclusions
Alcohol related attendances are a major and avoidable burden on emergency care. However, targeted interventions at weekends and early morning hours could capture the majority of cases and help prevent future re-attendance.
doi:10.1136/emermed-2014-204581
PMCID: PMC4789717  PMID: 26698364
alcohol abuse; emergency departments
2.  Open urethroplasty versus endoscopic urethrotomy - clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial 
Trials  2015;16:600.
Background
Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms such as reduced urine flow. Initial treatment is typically by endoscopic urethrotomy but recurrence occurs in about 60 % of men within 2 years. The best treatment for men with recurrent bulbar stricture is uncertain. Repeat endoscopic urethrotomy opens the narrowing but it usually scars up again within 2 years requiring repeated procedures. The alternative of open urethroplasty involves surgically reconstructing the urethra, which may need an oral mucosal graft. It is a specialist procedure with a longer recovery period but may give lower risk of recurrence. In the absence of firm evidence as to which is best, individual men have to trade off the invasiveness and possible benefit of each option. Their preference will be influenced by individual social circumstances, availability of local expertise and clinician guidance. The open urethroplasty versus endoscopic urethrotomy (OPEN) trial aims to better guide the choice of treatment for men with recurrent urethral strictures by comparing benefit over 2 years in terms of symptom control and need for further treatment.
Methods/Design
OPEN is a pragmatic, UK multicentre, randomised trial. Men with recurrent bulbar urethral strictures (at least one previous treatment) will be randomised to undergo endoscopic urethrotomy or open urethroplasty. Participants will be followed for 24 months after randomisation, measuring symptoms, flow rate, the need for re-intervention, health-related quality of life, and costs. The primary clinical outcome is the difference in symptom control over 24 months measured by the area under the curve (AUC) of a validated score. The trial has been powered at 90 % with a type I error rate of 5 % to detect a 0.1 difference in AUC measured on a 0–1 scale. The analysis will be based on all participants as randomised (intention-to-treat). The primary economic outcome is the incremental cost per quality-adjusted life year. A qualitative study will assess willingness to be randomised and hence ability to recruit to the trial.
Discussion
The OPEN Trial seeks to clarify relative benefit of the current options for surgical treatment of recurrent bulbar urethral stricture which differ in their invasiveness and resources required. Our feasibility study identified that participation would be limited by patient preference and differing recruitment styles of general and specialist urologists. We formulated and implemented effective strategies to address these issues in particular by inviting participation as close as possible to diagnosis. In addition re-calculation of sample size as recruitment progressed allowed more efficient design given the limited target population and funding constraints. Recruitment is now to target.
Trial registration
ISRCTN98009168 Date of registration: 29 November 2012.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-1120-4) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-015-1120-4
PMCID: PMC4697334  PMID: 26718754
Bulbar urethra; Urethral stricture; Randomised trial urethroplasty; Endoscopic urethrotomy; Cost-effectiveness analysis
3.  The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: study protocol for a randomised controlled trial 
Trials  2015;16:421.
Background
Effective weight loss interventions are widely available but, after weight loss, most individuals regain weight. This article describes the protocol for the NULevel trial evaluating the effectiveness and cost-effectiveness of a systematically developed, inexpensive, scalable, technology-assisted, behavioural intervention for weight loss maintenance (WLM) in obese adults after initial weight loss.
Methods/Design
A 12-month single-centre, two-armed parallel group, participant randomised controlled superiority trial is underway, recruiting a total of 288 previously obese adults after weight loss of ≥5 % within the previous 12 months. Participants are randomly assigned to intervention or control arms, with a 1:1 allocation, stratified by sex and percentage of body weight lost (<10 % vs ≥10 %). Change in weight (kg) from baseline to 12 months is the primary outcome. Weight, other anthropometric variables and 7-day physical activity (assessed via accelerometer) measures are taken at 0 and 12 months. Questionnaires at 0, 6 and 12 months assess psychological process variables, health service use and participant costs. Participants in the intervention arm initially attend an individual face-to-face WLM consultation with an intervention facilitator and then use a mobile internet platform to self-monitor and report their diet, daily activity (via pedometer) and weight through daily weighing on wirelessly connected scales. Automated feedback via mobile phone, tailored to participants’ weight regain and goal progress is provided. Participants in the control arm receive quarterly newsletters (via links embedded in text messages) and wirelessly connected scales. Qualitative process evaluation interviews are conducted with a subsample of up to 40 randomly chosen participants. Acceptability and feasibility of procedures, cost-effectiveness, and relationships among socioeconomic variables and WLM will also be assessed.
Discussion
It is hypothesised that participants allocated to the intervention arm will show significantly lower levels of weight regain from baseline than those in the control arm. To date, this is the first WLM trial using remote real-time weight monitoring and mobile internet platforms to deliver a flexible, efficient and scalable intervention, tailored to the individual. This trial addresses a key research need and has the potential to make a vital contribution to the evidence base to inform future WLM policy and provision.
Trial registration
http://www.isrctn.com/ISRCTN14657176 (registration date 20 March 2014).
doi:10.1186/s13063-015-0931-7
PMCID: PMC4580361  PMID: 26395774
Behaviour; Randomised controlled trial; Clinical protocol; Obesity; Overweight; Weight loss; Weight loss maintenance
4.  A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study 
Trials  2015;16:400.
Background
The position of invasive urodynamic testing (IUT) in diagnostic pathways for urinary incontinence is unclear, and systematic reviews have called for further trials evaluating clinical utility. The objective of this study was to inform the decision whether to proceed to a definitive randomised trial of IUT compared to clinical assessment with non-invasive tests, prior to surgery in women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI).
Methods
A mixed methods study comprising a pragmatic multicentre randomised pilot trial, a qualitative face-to face interview study with patients eligible for the trial, an exploratory economic evaluation including value of information study, a survey of clinicians’ views about IUT, and qualitative telephone interviews with purposively sampled survey respondents. Only the first and second of these elements are reported here.
Trial participants were randomised to either clinical assessment with non-invasive tests (control arm) or clinical assessment with non-invasive tests plus IUT (intervention arm).
The main outcome measures of these feasibility studies were confirmation that units can identify and recruit eligible women, acceptability of investigation strategies and data collection tools, and acquisition of outcome data to determine the sample size for a definitive trial. The primary outcome proposed for a definitive trial was ICIQ-FLUTS (total score) 6 months after surgery or the start of nonsurgical treatment.
Results
Of 284 eligible women, 222 (78 %) were recruited, 165/219 (75 %) returned questionnaires at baseline, and 125/200 returned them (63 %) at follow-up. Most women underwent surgery; management plans were changed in 19 (19 %) participants following IUT.
Participants interviewed were positive about the trial and the associated documentation.
Conclusions
All elements of a definitive trial were rehearsed. Such a trial would require between 232 and 922 participants, depending on the target difference in the primary outcome. We identified possible modifications to our protocol for application in a definitive trial including clarity over inclusion/exclusions, screening processes, reduction in secondary outcomes, and modification to patient questionnaire booklets and bladder diaries. A definitive trial of IUT versus clinical assessment prior to surgery for SUI or stress predominant MUI is feasible and remains relevant.
Trial registration
Current Controlled Trials: ISRCTN 71327395, registered 7 June 2010.
doi:10.1186/s13063-015-0928-2
PMCID: PMC4563900  PMID: 26350343
feasibility studies; pilot studies; interview studies; randomised controlled trial; stress urinary incontinence; urodynamics
5.  Is it worthwhile to conduct a randomized controlled trial of glaucoma screening in the United Kingdom? 
Objectives
To assess the value of conducting a glaucoma screening randomized controlled trial in the UK.
Methods
Decision model based economic evaluation and value of information analysis. Model derived from a previous health technology assessment. Model updated in terms of structure and parameter estimates with data from surveys, interviews with members of the public and health care providers and routine sources.
Results
On average, across a range of ages of initiating screening (40–60 years), glaucoma prevalence (1–5%), screening uptake (30–100%), and the performance of current case finding, screening was not cost-effective at a £30,000 threshold per quality adjusted life year (QALY) from the perspective of the National Health Service (NHS). The societal value of removing all uncertainty around glaucoma screening is £107 million at a threshold of £20,000 per QALY. For informing policy decisions on glaucoma screening, reducing uncertainty surrounding the NHS and personal social care cost of sight impairment (£74 million) was of most value, followed by reducing uncertainty in test performance (£14 million) and uptake of either screening or current eye care (£8 million each).
Conclusions
A glaucoma screening trial in the UK is unlikely to be the best use of research resources. Further research to quantify the costs of sight impairment falling on the NHS and personal social services is a priority. Further development of glaucoma tests and research into strategies to promote the uptake of screening or current eye care such as through the use of a behavioural intervention would be worthwhile.
doi:10.1177/1355819613499748
PMCID: PMC4509868  PMID: 24088295
decision analysis; health policy; public health; ophthalmology
6.  The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial 
Trials  2015;16:263.
Background
The role of tonsillectomy in the management of adult tonsillitis remains uncertain and UK regional variation in tonsillectomy rates persists. Patients, doctors and health policy makers wish to know the costs and benefits of tonsillectomy against conservative management and whether therapy can be better targeted to maximise benefits and minimise risks of surgery, hence maximising cost-effective use of resources. NATTINA incorporates the first attempt to map current NHS referral criteria against other metrics of tonsil disease severity.
Methods/design
A UK multi-centre, randomised, controlled trial for adults with recurrent tonsillitis to compare the clinical and cost-effectiveness of tonsillectomy versus conservative management.
An initial feasibility study comprises qualitative interviews to investigate the practicality of the protocol, including willingness to randomise and be randomised. Approximately 20 otolaryngology staff, 10 GPs and 15 ENT patients will be recruited over 5 months in all 9 proposed main trial participating sites.
A 6-month internal pilot will then recruit 72 patients across 6 of the 9 sites. Participants will be adults with recurrent acute tonsillitis referred by a GP to secondary care. Randomisation between tonsillectomy and conservative management will be according to a blocked allocation method in a 1:1 ratio stratified by centre and baseline disease severity.
If the pilot is successful, the main trial will recruit a further 528 patients over 18 months in all 9 participating sites. All participants will be followed up for a total of 24 months, throughout which both primary and secondary outcome data will be collected. The primary outcome is the number of sore throat days experienced over the 24-month follow-up. The pilot and main trials include an embedded qualitative process evaluation.
Discussion
NATTINA is designed to evaluate the relative effectiveness and efficiency of tonsillectomy versus conservative management in patients with recurrent sore throat who are eligible for surgery. Most adult tonsil disease and surgery has an impact on economically active age groups, with individual and societal costs through loss of earnings and productivity. Avoidance of unnecessary operations and prioritisation of those individuals likely to gain most from tonsillectomy would reduce costs to the NHS and society.
Trial registration
ISRCTN55284102, Date of Registration: 4 August 2014
doi:10.1186/s13063-015-0768-0
PMCID: PMC4467045  PMID: 26047934
Tonsillitis; Sore throat; Tonsillectomy; Surgery; Randomised controlled trial
7.  The ETTAA study protocol: a UK-wide observational study of ‘Effective Treatments for Thoracic Aortic Aneurysm’ 
BMJ Open  2015;5(6):e008147.
Introduction
Chronic thoracic aortic aneurysm (CTAA) affecting the arch or descending aorta is an indolent but life-threatening condition with a rising prevalence as the UK population ages. Treatment may be in the form of open surgical repair (OSR) surgery, endovascular stent grafting (ESG) or best medical therapy (BMT). Currently, there is no consensus on the best management strategy, and no UK-specific economic studies that assess outcomes beyond the chosen procedure, but this is required in the context of greater demand for treatment and limited National Health Service (NHS) resources.
Methods and analysis
This is a prospective, multicentre observational study with statistical and economic modelling of patients with CTAA affecting the arch or descending aorta. We aim to gain an understanding of how treatments are currently chosen, and to determine the clinical effectiveness and cost-effectiveness of the three available treatment strategies (BMT, ESG and OSR). This will be achieved by: (1) following consecutive patients who are referred to the teams collaborating in this proposal and collecting data regarding quality of life (QoL), medical events and hospital stays over a maximum of 5 years; (2) statistical analysis of the comparative effectiveness of the three treatments; and (3) economic modelling of the comparative cost-effectiveness of the three treatments. Primary study outcomes are: aneurysm growth, QoL, freedom from reintervention, freedom from death or permanent neurological injury, incremental cost per quality-adjusted life year gained.
Ethics and dissemination
The study will generate an evidence base to guide patients and clinicians to determine the indications and timing of treatment, as well as informing healthcare decision-makers about which treatments the NHS should provide. The study has achieved ethical approval and will be disseminated primarily in the form of a Health Technology Assessment monograph at its completion.
Trial registration number
ISRCTN04044627.
doi:10.1136/bmjopen-2015-008147
PMCID: PMC4458682  PMID: 26038360
VASCULAR MEDICINE
8.  Does quality of life improve in octogenarians following cardiac surgery? A systematic review 
BMJ Open  2015;5(4):e006904.
Objectives
Current outcome measures in cardiac surgery are largely described in terms of mortality. Given the changing demographic profiles and increasingly aged populations referred for cardiac surgery this may not be the most appropriate measure. Postoperative quality of life is an outcome of importance to all ages, but perhaps particularly so for those whose absolute life expectancy is limited by virtue of age. We undertook a systematic review of the literature to clarify and summarise the existing evidence regarding postoperative quality of life of older people following cardiac surgery. For the purpose of this review we defined our population as people aged 80 years of age or over.
Methods
A systematic review of MEDLINE, EMBASE, Cochrane Library, trial registers and conference abstracts was undertaken to identify studies addressing quality of life following cardiac surgery in patients 80 or over.
Results
Forty-four studies were identified that addressed this topic, of these nine were prospective therefore overall conclusions are drawn from largely retrospective observational studies. No randomised controlled data were identified.
Conclusions
Overall there appears to be an improvement in quality of life in the majority of elderly patients following cardiac surgery, however there was a minority in whom quality of life declined (8–19%). There is an urgent need to validate these data and if correct to develop a robust prediction tool to identify these patients before surgery. Such a tool could guide informed consent, policy development and resource allocation.
doi:10.1136/bmjopen-2014-006904
PMCID: PMC4420984  PMID: 25922099
GERIATRIC MEDICINE
9.  Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers 
Trials  2015;16:12.
Background
Central to the design of a randomised controlled trial is the calculation of the number of participants needed. This is typically achieved by specifying a target difference and calculating the corresponding sample size, which provides reassurance that the trial will have the required statistical power (at the planned statistical significance level) to identify whether a difference of a particular magnitude exists. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of participants should be recruited. Despite the critical role of the target difference for the primary outcome in the design of randomised controlled trials, its determination has received surprisingly little attention. This article provides guidance on the specification of the target difference for the primary outcome in a sample size calculation for a two parallel group randomised controlled trial with a superiority question.
Methods
This work was part of the DELTA (Difference ELicitation in TriAls) project. Draft guidance was developed by the project steering and advisory groups utilising the results of the systematic review and surveys. Findings were circulated and presented to members of the combined group at a face-to-face meeting, along with a proposed outline of the guidance document structure, containing recommendations and reporting items for a trial protocol and report. The guidance and was subsequently drafted and circulated for further comment before finalisation.
Results
Guidance on specification of a target difference in the primary outcome for a two group parallel randomised controlled trial was produced. Additionally, a list of reporting items for protocols and trial reports was generated.
Conclusions
Specification of the target difference for the primary outcome is a key component of a randomized controlled trial sample size calculation. There is a need for better justification of the target difference and reporting of its specification.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-014-0526-8) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-014-0526-8
PMCID: PMC4302137  PMID: 25928502
Target difference; clinically important difference; sample size; randomised controlled trial; guidance
10.  Methods for Specifying the Target Difference in a Randomised Controlled Trial: The Difference ELicitation in TriAls (DELTA) Systematic Review 
PLoS Medicine  2014;11(5):e1001645.
Jonathan Cook and colleagues systematically reviewed the literature for methods of determining the target difference for use in calculating the necessary sample size for clinical trials, and discuss which methods are best for various types of trials.
Please see later in the article for the Editors' Summary
Background
Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation.
Methods and Findings
A comprehensive systematic review of medical and non-medical literature was carried out for methods that could be used to specify the target difference for an RCT sample size calculation. The databases searched were MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, PsycINFO, Science Citation Index, EconLit, the Education Resources Information Center (ERIC), and Scopus (for in-press publications); the search period was from 1966 or the earliest date covered, to between November 2010 and January 2011. Additionally, textbooks addressing the methodology of clinical trials and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) tripartite guidelines for clinical trials were also consulted. A narrative synthesis of methods was produced. Studies that described a method that could be used for specifying an important and/or realistic difference were included. The search identified 11,485 potentially relevant articles from the databases searched. Of these, 1,434 were selected for full-text assessment, and a further nine were identified from other sources. Fifteen clinical trial textbooks and the ICH tripartite guidelines were also reviewed. In total, 777 studies were included, and within them, seven methods were identified—anchor, distribution, health economic, opinion-seeking, pilot study, review of the evidence base, and standardised effect size.
Conclusions
A variety of methods are available that researchers can use for specifying the target difference in an RCT sample size calculation. Appropriate methods may vary depending on the aim (e.g., specifying an important difference versus a realistic difference), context (e.g., research question and availability of data), and underlying framework adopted (e.g., Bayesian versus conventional statistical approach). Guidance on the use of each method is given. No single method provides a perfect solution for all contexts.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
A clinical trial is a research study in which human volunteers are randomized to receive a given intervention or not, and outcomes are measured in both groups to determine the effect of the intervention. Randomized controlled trials (RCTs) are widely accepted as the preferred study design because by randomly assigning participants to groups, any differences between the two groups, other than the intervention under study, are due to chance. To conduct a RCT, investigators calculate how many patients they need to enroll to determine whether the intervention is effective. The number of patients they need to enroll depends on how effective the intervention is expected to be, or would need to be in order to be clinically important. The assumed difference between the two groups is the target difference. A larger target difference generally means that fewer patients need to be enrolled, relative to a smaller target difference. The target difference and number of patients enrolled contribute to the study's statistical precision, and the ability of the study to determine whether the intervention is effective. Selecting an appropriate target difference is important from both a scientific and ethical standpoint.
Why Was This Study Done?
There are several ways to determine an appropriate target difference. The authors wanted to determine what methods for specifying the target difference are available and when they can be used.
What Did the Researchers Do and Find?
To identify studies that used a method for determining an important and/or realistic difference, the investigators systematically surveyed the research literature. Two reviewers screened each of the abstracts chosen, and a third reviewer was consulted if necessary. The authors identified seven methods to determine target differences. They evaluated the studies to establish similarities and differences of each application. Points about the strengths and limitations of the method and how frequently the method was chosen were also noted.
What Do these Findings Mean?
The study draws attention to an understudied but important part of designing a clinical trial. Enrolling the right number of patients is very important—too few patients and the study may not be able to answer the study question; too many and the study will be more expensive and more difficult to conduct, and will unnecessarily expose more patients to any study risks. The target difference may also be helpful in interpreting the results of the trial. The authors discuss the pros and cons of different ways to calculate target differences and which methods are best for which types of studies, to help inform researchers designing such studies.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001645.
Wikipedia has an entry on sample size determination that discusses the factors that influence sample size calculation, including the target difference and the statistical power of a study (statistical power is the ability of a study to find a difference between treatments when a true difference exists). (Note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages.)
The University of Ottawa has an article that explains how different factors influence the power of a study
doi:10.1371/journal.pmed.1001645
PMCID: PMC4019477  PMID: 24824338
12.  Developing Effective and Efficient care pathways in chronic Pain: DEEP study protocol 
BMC Oral Health  2014;14:6.
Background
Pain affecting the face or mouth and lasting longer than three months (“chronic orofacial pain”, COFP) is relatively common in the UK. This study aims to describe and model current care pathways for COFP patients, identify areas where current pathways could be modified, and model whether these changes would improve outcomes for patients and use resources more efficiently.
Methods/Design
The study takes a prospective operations research approach. A cohort of primary and secondary care COFP patients (n = 240) will be recruited at differing stages of their care in order to follow and analyse their journey through care. The cohort will be followed for two years with data collected at baseline 6, 12, 18, and 24 months on: 1) experiences of the care pathway and its impacts; 2) quality of life; 3) pain; 4) use of health services and costs incurred; 5) illness perceptions. Qualitative in-depth interviews will be used to collect data on patient experiences from a purposive sub-sample of the total cohort (n = 30) at baseline, 12 and 24 months. Four separate appraisal groups (public, patient, clincian, service manager/commissioning) will then be given data from the pathway analysis and asked to determine their priority areas for change. The proposals from appraisal groups will inform an economic modelling exercise. Findings from the economic modelling will be presented as incremental costs, Quality Adjusted Life Years (QALYs), and the incremental cost per QALY gained. At the end of the modelling a series of recommendations for service change will be available for implementation or further trial if necessary.
Discussion
The recent white paper on health and the report from the NHS Forum identified chronic conditions as priority areas and whilst technology can improve outcomes, so can simple, appropriate and well-defined clinical care pathways. Understanding the opportunity cost related to care pathways benefits the wider NHS. This research develops a method to help design efficient systems built around one condition (COFP), but the principles should be applicable to a wide range of other chronic and long-term conditions.
doi:10.1186/1472-6831-14-6
PMCID: PMC3909482  PMID: 24447722
Orofacial pain; Health economics; Quality of life; Qualitative methods; Chronic pain; Care pathways
14.  Issues in the incorporation of economic perspectives and evidence into Cochrane reviews 
Systematic Reviews  2013;2:83.
Background
Methods for systematic reviews of the effects of health interventions have focused mainly on addressing the question of 'What works?’ or 'Is this intervention effective in achieving one or more specific outcomes?’ Addressing the question 'Is it worth it given the resources available?’ has received less attention. This latter question can be addressed by applying an economic lens to the systematic review process.
This paper reflects on the value and desire for the consideration by end users for coverage of an economic perspective in a Cochrane review and outlines two potential approaches and future directions.
Methods
Two frameworks to guide review authors who are seeking to include an economic perspective are outlined. The first involves conducting a full systematic review of economic evaluations that is integrated into a review of intervention effects. The second involves developing a brief economic commentary. The two approaches share a set of common stages but allow the tailoring of the economic component of the Cochrane review to the skills and resources available to the review team.
Results
The number of studies using the methods outlined in the paper is limited, and further examples are needed both to explore the value of these approaches and to further develop them. The rate of progress will hinge on the organisational leadership, capacity and resources available to the CCEMG, author teams and other Cochrane entities. Particular methodological challenges to overcome relate to understanding the key economic trade-offs and casual relationships for a given decision problem and informing the development of evaluations designed to support local decision-makers.
Conclusions
Methods for incorporating economic perspectives and evidence into Cochrane intervention reviews are established. Their role is not to provide a precise estimate of 'cost-effectiveness’ but rather to help end-users of Cochrane reviews to determine the implications of the economic components of reviews for their own specific decisions.
doi:10.1186/2046-4053-2-83
PMCID: PMC3849717  PMID: 24050504
Cost-utility analysis; Cost-effectiveness analysis; Systematic review; Meta-analysis; Cochrane collaboration
15.  Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services 
BMC Public Health  2013;13:675.
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.
doi:10.1186/1471-2458-13-675
PMCID: PMC3724698  PMID: 23875722
Transition; Adolescence; Chronic illness; Disability; Evaluation; Protocol
16.  Surgery versus Active Monitoring in Intermittent Exotropia (SamExo): study protocol for a pilot randomised controlled trial 
Trials  2012;13:192.
Background
Childhood intermittent exotropia [X(T)] is a type of strabismus (squint) in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision). Treatment options for X(T) include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T) are limited, and there is no randomised controlled trial (RCT) evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia) pilot study has been designed to test the feasibility of such a trial in the UK.
Methods
Design: an external pilot patient randomised controlled trial.
Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust.
Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T). Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit.
Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T).
Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring); 3-, 6- and 9-month (primary outcome) clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire); qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial.
Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or loss to follow-up; reasons for agreeing/declining participation; variability of cure rates (to inform power calculations for a definitive RCT); completion rates of outcome measures.
Discussion
The SamExo pilot trial will provide important pointers regarding the feasibility of a full RCT of immediate surgery versus deferred surgery/active monitoring. The results of this pilot, including differences in cure rates, will inform the design of a definitive RCT.
Trial registration
ISRCTN44114892
doi:10.1186/1745-6215-13-192
PMCID: PMC3521171  PMID: 23072556
Intermittent exotropia; Divergent strabismus; Surgery; Feasibility studies; Pilot study; Randomised controlled trial; Children; Parents; Qualitative research
17.  Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e001039.
Objective
To assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.
Design
Participatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women initiating breast feeding and living in disadvantaged areas.
Methods
Quantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.
Main outcome measures
Quantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.
Results
A median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff–team–woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.
Conclusions
Implementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.
Trial registration
ISRCTN27207603. The study protocol and final report is available on request.
Article summary
Article focus
To use a participatory approach to design, deliver and implement a feeding support team intervention integrated into routine postnatal ward care and to deliver a pilot randomised controlled trial (RCT) of proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To use a mixed qualitative and quantitative methods process evaluation to assess the study acceptability, feasibility and intervention fidelity from the perspectives of women and National Health Service staff.
To inform the design of a future definitive RCT.
Key messages
Women living in disadvantaged areas are unlikely to initiate calls for help with breast feeding and proactive telephone calls may help to counteract the inverse care law.
Women undervalue both breast feeding and their own needs compared with the needs of others as a reason to ask for help in the context of overstretched maternity services.
A caring, reassuring woman-centred communication style with continuity of care from hospital to home was valued and increased women's confidence.
Strengths and limitations of this study
The participatory approach embedding a rigorous RCT within a before-and-after cohort study with mixed-methods data to evaluate implementation processes and costs are strengths that will enable us to design a feasible and acceptable definitive trial.
The contribution of the personal characteristics and skills of the feeding team to the intervention was important and may be challenging to replicate.
The low number of women who reported having an entire breast feed observed is a limitation and warrants further investigation.
More research is required before feeding teams and proactive calls are widely implemented as there are likely to be unintended consequences to such an organisational change in postnatal care.
doi:10.1136/bmjopen-2012-001039
PMCID: PMC3341595  PMID: 22535794
18.  The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e000652.
Objective
To assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.
Design
Randomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women living in disadvantaged areas initiating breast feeding.
Methods
Eligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.
Main outcome measures
Primary outcome: any breast feeding at 6–8 weeks assessed by a telephone call from a researcher blind to group allocation. Secondary outcomes: exclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.
Results
There was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6–8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6–8 weeks; costs were sensitive to service organisation.
Conclusions
Proactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.
Trial registration number
ISRCTN27207603. The study protocol and final report are available on request.
Article summary
Article focus
To pilot the potential effectiveness and cost-effectiveness of continuing proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To assess the feasibility of implementing a dedicated feeding team on a postnatal ward.
To design an effective health service intervention for infant feeding by re-organising how routine care is provided to inform a larger programme of research.
Key messages
Proactive telephone care delivered by a dedicated feeding team shows promise for increasing breastfeeding rates 6–8 weeks after birth.
Only having a dedicated feeding team on a postnatal ward did not appear to make any difference to feeding outcomes at 6–8 weeks after birth.
We have demonstrated the feasibility of (1) implementing the FEeding Support Team intervention as part of routine postnatal care and (2) the recruitment and data collection processes for a proposed definitive trial.
Strengths and limitations of this study
Using a participatory approach and embedding a rigorous randomised control trial within a before-and-after cohort study with mixed methods data to evaluate costs are strengths that will enable us to design a definitive trial.
It is likely that the effect sizes are overestimated as the sample size was small and no sample size calculation was performed prior to the study.
Our sample included women requiring longer hospital stays due to birth complications.
The reactive call service was only free to those who had the same mobile phone network provider.
The incremental cost-effectiveness ratios presented represent the most favourable set of assumptions for proactive telephone support and are sensitive to how the service is organised.
doi:10.1136/bmjopen-2011-000652
PMCID: PMC3341594  PMID: 22535790
19.  Systematic Review of Escalated Imatinib Doses Compared with Sunitinib or Best Supportive Care, for the Treatment of People with Unresectable/Metastatic Gastrointestinal Stromal Tumours Whose Disease has Progressed on the Standard Imatinib Dose 
Introduction
We conducted a systematic review of evidence on the effectiveness of imatinib at escalated doses of 600 mg/day or 800 mg/day for treatment of adults with unresectable or metastatic gastrointestinal stromal tumours (GIST), following progression on imatinib at the 400 mg/day dose, compared with sunitinib and/or ‘best supportive care’.
Methods
Electronic searches were undertaken to identify relevant randomised controlled trials (RCTs), non-randomised studies, and case series reporting outcome data on survival, quality of life or adverse events. Titles and abstracts were screened by two reviewers and full text reports of potentially relevant studies assessed for inclusion. Included studies were quality assessed by two reviewers and data were extracted. Five studies reported data on the relevant population and were included.
Results and Discussion
Median overall survival for imatinib (800 mg/day) and sunitinib both were less than 2 years. Around 25% of patients required either an imatinib dose delay or reduction. Approximately one-third of patients receiving dose escalated imatinib (either dose) showed either response or stable disease. Amongst those responding to the escalated 800 mg/day dose, median progression-free survival was over 25 months. The statistical likelihood of response may depend on exon mutational status. There were few data and those that were available were potentially biased, due to their non-randomised nature. Further data are needed to justify international guideline recommendations on imatinib dose escalation.
Conclusion
A prospective audit of management and outcomes for unresectable GIST patients treated with dose escalation upon progression at 400 mg/day may be appropriate as an RCT may be unfeasible.
doi:10.1007/s12029-011-9325-6
PMCID: PMC3348468  PMID: 21971958
GIST; Gastrointestinal stromal tumours; Unresectable; Metastatic; Cancer; Imatinib; Sunitinib
20.  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 
Trials  2011;12:169.
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.
doi:10.1186/1745-6215-12-169
PMCID: PMC3152523  PMID: 21733166
21.  The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE): study protocol for a randomized controlled trial 
Trials  2011;12:133.
Background
Glaucoma is the leading cause of irreversible blindness. Although primary open-angle glaucoma is more common, primary angle-closure glaucoma (PACG) is more likely to result in irreversible blindness. By 2020, 5·3 million people worldwide will be blind because of PACG. The current standard care for PACG is a stepped approach of a combination of laser iridotomy surgery (to open the drainage angle) and medical treatment (to reduce intraocular pressure). If these treatments fail, glaucoma surgery (eg, trabeculectomy) is indicated. It has been proposed that, because the lens of the eye plays a major role in the mechanisms leading to PACG, early clear lens extraction will improve glaucoma control by opening the drainage angle. This procedure might reduce the need for drugs and glaucoma surgery, maintain good visual acuity, and improve quality of life compared with standard care.
EAGLE aims to evaluate whether early lens extraction improves patient-reported, clinical outcomes, and cost-effectiveness, compared with standard care.
Methods/Design
EAGLE is a multicentre pragmatic randomized trial. All people presenting to the recruitment centres in the UK and east Asia with newly diagnosed PACG and who are at least 50 years old are eligible.
The primary outcomes are EQ-5D, intraocular pressure, and incremental cost per quality adjusted life year (QALY) gained. Other outcomes are: vision and glaucoma-specific patient-reported outcomes, visual acuity, visual field, angle closure, number of medications, additional surgery (e.g., trabeculectomy), costs to the health services and patients, and adverse events.
A single main analysis will be done at the end of the trial, after three years of follow-up. The analysis will be based on all participants as randomized (intention to treat). 400 participants (200 in each group) will be recruited, to have 90% power at 5% significance level to detect a difference in EQ-5D score between the two groups of 0·05, and a mean difference in intraocular pressure of 1·75 mm Hg. The study will have 80% power to detect a difference of 15% in the glaucoma surgery rate. Trial Registration: ISRCTN44464607.
doi:10.1186/1745-6215-12-133
PMCID: PMC3121608  PMID: 21605352
22.  Urological cancer care pathways: development and use in the context of systematic reviews and clinical practice guidelines 
World Journal of Urology  2011;29(3):291-301.
Background
Making healthcare treatment decisions is a complex process involving a broad stakeholder base including patients, their families, health professionals, clinical practice guideline developers and funders of healthcare.
Methods
This paper presents a review of a methodology for the development of urological cancer care pathways (UCAN care pathways), which reflects an appreciation of this broad stakeholder base. The methods section includes an overview of the steps in the development of the UCAN care pathways and engagement with clinical content experts and patient groups.
Results
The development process is outlined, the uses of the urological cancer care pathways discussed and the implications for clinical practice highlighted. The full set of UCAN care pathways is published in this paper. These include care pathways on localised prostate cancer, locally advanced prostate cancer, metastatic prostate cancer, hormone-resistant prostate cancer, localised renal cell cancer, advanced renal cell cancer, testicular cancer, penile cancer, muscle invasive and metastatic bladder cancer and non-muscle invasive bladder cancer.
Conclusion
The process provides a useful framework for improving urological cancer care through evidence synthesis, research prioritisation, stakeholder involvement and international collaboration. Although the focus of this work is urological cancers, the methodology can be applied to all aspects of urology and is transferable to other clinical specialties.
doi:10.1007/s00345-011-0660-9
PMCID: PMC3099176  PMID: 21350870
Urological cancer; Care pathways; Systematic review; Clinical practice guidelines
23.  The translation research in a dental setting (TRiaDS) programme protocol 
Background
It is well documented that the translation of knowledge into clinical practice is a slow and haphazard process. This is no less true for dental healthcare than other types of healthcare. One common policy strategy to help promote knowledge translation is the production of clinical guidance, but it has been demonstrated that the simple publication of guidance is unlikely to optimise practice. Additional knowledge translation interventions have been shown to be effective, but effectiveness varies and much of this variation is unexplained. The need for researchers to move beyond single studies to develop a generalisable, theory based, knowledge translation framework has been identified.
For dentistry in Scotland, the production of clinical guidance is the responsibility of the Scottish Dental Clinical Effectiveness Programme (SDCEP). TRiaDS (Translation Research in a Dental Setting) is a multidisciplinary research collaboration, embedded within the SDCEP guidance development process, which aims to establish a practical evaluative framework for the translation of guidance and to conduct and evaluate a programme of integrated, multi-disciplinary research to enhance the science of knowledge translation.
Methods
Set in General Dental Practice the TRiaDS programmatic evaluation employs a standardised process using optimal methods and theory. For each SDCEP guidance document a diagnostic analysis is undertaken alongside the guidance development process. Information is gathered about current dental care activities. Key recommendations and their required behaviours are identified and prioritised. Stakeholder questionnaires and interviews are used to identify and elicit salient beliefs regarding potential barriers and enablers towards the key recommendations and behaviours. Where possible routinely collected data are used to measure compliance with the guidance and to inform decisions about whether a knowledge translation intervention is required. Interventions are theory based and informed by evidence gathered during the diagnostic phase and by prior published evidence. They are evaluated using a range of experimental and quasi-experimental study designs, and data collection continues beyond the end of the intervention to investigate the sustainability of an intervention effect.
Discussion
The TRiaDS programmatic approach is a significant step forward towards the development of a practical, generalisable framework for knowledge translation research. The multidisciplinary composition of the TRiaDS team enables consideration of the individual, organisational and system determinants of professional behaviour change. In addition the embedding of TRiaDS within a national programme of guidance development offers a unique opportunity to inform and influence the guidance development process, and enables TRiaDS to inform dental services practitioners, policy makers and patients on how best to translate national recommendations into routine clinical activities.
doi:10.1186/1748-5908-5-57
PMCID: PMC2920875  PMID: 20646275
24.  A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol 
Trials  2010;11:41.
Background
Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery.
Methods/Design
A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery.
Discussion
We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice.
Trial Registration
Trial registration number - ISRCTN32188676
doi:10.1186/1745-6215-11-41
PMCID: PMC2873273  PMID: 20398378
25.  Quality of life in the five years after intensive care: a cohort study 
Critical Care  2010;14(1):R6.
Introduction
Data on quality of life beyond 2 years after intensive care discharge are limited and we aimed to explore this area further. Our objective was to quantify quality of life and health utilities in the 5 years after intensive care discharge.
Methods
A prospective longitudinal cohort study in a University Hospital in the UK. Quality of life was assessed from the period before ICU admission until 5 years and quality adjusted life years calculated.
Results
300 level 3 intensive care patients of median age 60.5 years and median length of stay 6.7 days, were recruited. Physical quality of life fell to 3 months (P = 0.003), rose back to pre-morbid levels at 12 months then fell again from 2.5 to 5 years after intensive care (P = 0.002). Mean physical scores were below the population norm at all time points but the mean mental scores after 6 months were similar to those population norms. The utility value measured using the EuroQOL-5D quality of life assessment tool (EQ-5D) at 5 years was 0.677. During the five years after intensive care unit, the cumulative quality adjusted life years were significantly lower than that expected for the general population (P < 0.001).
Conclusions
Intensive care unit admission is associated with a high mortality, a poor physical quality of life and a low quality adjusted life years gained compared to the general population for 5 years after discharge. In this group, critical illness associated with ICU admission should be treated as a life time diagnosis with associated excess mortality, morbidity and the requirement for ongoing health care support.
doi:10.1186/cc8848
PMCID: PMC2875518  PMID: 20089197

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