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

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 £55 (€81, $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

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

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods/design</p> <p>This is a mixed methods pragmatic multicentre feasibility pilot study with four components:-</p> <p>(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.</p> <p>(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.</p> <p>(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.</p> <p>(d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration number</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN71327395">ISRCTN71327395</a> assigned 7^thJune 2010.</p

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN43218782</p

Economic issues in the provision of antenatal screening for Down's syndrome

This thesis exammes the economiC issues related to the prOVISIon of antenatal screening for the genetic disorder commonly referred as Down's syndrome (DS). DS is associated with a number of serious medical consequences and an increased mortality rate. The offer of screening for DS to pregnant women has been a feature of antenatal care for over 30 years. In recent years an increasing number of screening techniques have been developed based on biochemical testing and ultrasound scanning. This thesis pays particular attention to three of these tests, nuchal translucency screening (NT), the combined test (CT), and the integrated test (IT). These three tests differ in terms of their efficacy in detecting cases of DS and differ by the time point (trimester) in the pregnancy that they can provide results to women. The empirical studies presented here examine issues of cost-effectiveness (for NT) and women's preferences (based on the characteristics of NT, CT, and IT) using the methods of standard gamble, a discrete choice experiment (DCE), and contingent valuation (based on willingness to pay). A conceptual model (Figure 2.1) is provided to underpin the empirical research that resulted from the review of key methodological issues discussed and presented in Chapter2. The cost-effectiveness analysis showed that once the issue of the spontaneous abortion of fetuses with DS has been accounted for, NT screening carried out in the first trimester of pregnancy may not detect significantly more cases of DS than a second trimester screening test based on biochemical testing alone. However, NT by definition does provide the screening result earlier in the pregnancy; but using NT does bring about a net increase in screening costs and produces a positive incremental costeffectiveness ratio. It should be noted that cost estimates produced here do not attempt to take into account any cost savings that may accrue to the health care sector or to other sectors as result of preventing the live birth of a child with DS. Probabilistic sensitivity analysis (with results taking into account spontaneous abortion of DS fetuses) showed that at a societal willingness to pay of £30 000 per DS case prevented there was only a 46% probability ofNT screening being cost-effective. The cost-effectiveness analysis of NT screening was complemented by a standard gamble survey in which women were asked to value DS screening scenarios based on various screening outcomes. The aim was to see if women placed more value on screening results presented earlier in the pregnancy (i.e. in the first trimester of pregnancy as opposed to the second trimester). The results found that women did not value earlier screening results more highly than later ones. This result held both for scenarios that featured negative screening results, i.e. a result showing that a pregnancy was not affected by DS, or positive screening results i.e. a result showing that a pregnancy was affected by DS followed by a termination of pregnancy. In very recent times in the UK the use of the CT or the IT has been strongly championed by various advocates. In essence they differ in that the CT offers first trimester results and the IT offers second trimester results. Empirical evidence also suggests they differ by efficacy in terms of the DS detection rates they achieve and by the number of false-positive screening results that occur. To gain more understanding of women's preferences with regard to the different attributes of these screening tests a DCE was undertaken. The results of this showed that women were more likely to choose a screening option that had high detection and low false-positive rates, that women preferred (when necessary) that the termination of an affected pregnancy was done using a medical termination, but that the timing of the test (as defined by week of pregnancy) was not statistically significant in the regression model. The sample of women that completed the DCE was given full descriptions of the CT and the IT and was asked to state a straight preference of one of the tests over the other. In addition they were also asked to state their maximum willingness to pay in order to guarantee their choice of screening test. The binary choice question (of CT or IT) showed an almost exact salsa split in choosing the CT or the IT. This result is not consistent with the findings described above that suggested that the timing of the test was not important but that test performance was important. In the description given to women the IT was shown to have a better detection rate than the CT and was no worse in terms of false-positive results. If women's preferences were driven by test performance and not by timing then the logical choice would be the IT. The empirical results presented shed new light on the key trade-offs that are involved when choosing amongst screening methods and it was demonstrated that the results from the various evaluative approaches used here do not always lead to the same conclusions. What the results did show is that the sole provision of anyone screening programme would not necessarily match the choices that women would make and that different groups of women (for example by age) may make different screening choices. This conclusion challenges the recently issued NICE clinical guidance on antenatal care that instructs providers of screening for DS in England and Wales to routinely use the CT in the first trimester of pregnancy. This highlights the gap between aspirations to use a wider evaluative approach by ascertaining and acting on the preferences of individual pregnant women and the imperative to use health care resources efficiently.EThOS - Electronic Theses Online ServiceGBUnited Kingdo

Valuing Health-Related Quality of Life: A Review of Health State Valuation Techniques

Given the growing need to value health-related quality of life, a review of the literature relating to health state valuation techniques was undertaken to appraise the current theoretical and empirical evidence available to inform on the techniques, to identify consensus, identify disagreement and identify important areas for future research. A systematic search of the literature was conducted, covering standard gamble (SG), time trade-off (TTO), visual analogue scale (VAS), magnitude estimation (ME) and person trade-off (PTO) techniques. The basic concepts of practicality, reliability, theoretical validity and empirical validity formed the criteria for reviewing the performance of valuation techniques. In terms of practicality and reliability, we found little evidence relating to ME and PTO. SG, TTO and VAS have been shown to be practical on a range of populations. There is little difference between the reliability of SG, TTO and VAS, and present evidence does not offer a basis to differentiate between them. When considering the theoretical basis of techniques, we conclude that choice-based methods (i.e. SG, TTO and PTO) are best placed to reflect the strength of preference for health, with the choice between these techniques depending on the study characteristics and the perspective employed. Empirical evidence relating to the theoretical perspective of the techniques has shown that there are problems with all techniques in terms of descriptive validity.Pharmacoeconomics, Quality of life

Antenatal care for first time mothers: a discrete choice experiment of women's views on alternative packages of care

Objective: To investigate the views of women in relation to the provision of antenatal care. Methods: A discrete choice experiment using a sample of 100 women who were nulliparous (pregnant for the first time) and attending for routine ultrasound scan in the 20th week of their pregnancy. Results: Women preferred antenatal care visits to be provided by a community midwife at a local clinic and to have 10 visits rather than 7. In addition they favoured the provision of education/preparation for birth, the use of uterine artery Doppler screening, and the provision of a telephone advice line. The results show that women were prepared to trade-off fewer antenatal care visits to ensure access to their packages of antenatal care that reflected their preferences. Conclusions: Whilst the number of antenatal care visits is important to women they may accept fewer visits if antenatal care is provided by midwives and they receive enhanced service provision such as a telephone advice line and uterine artery Doppler screening