Accounts from developers of generic health state utility instruments explain why they produce different QALYs: A qualitative study.

PURPOSE AND SETTING: Despite the label "generic" health state utility instruments (HSUIs), empirical evidence shows that different HSUIs generate different estimates of Health-Related Quality of Life (HRQoL) in the same person. Once a HSUI is used to generate a QALY, the difference between HSUIs is often ignored, and decision-makers act as if 'a QALY is a QALY is a QALY'. Complementing evidence that different generic HSUIs produce different empirical values, this study addresses an important gap by exploring how HSUIs differ, and processes that produced this difference. 15 developers of six generic HSUIs used for estimating the QOL component of QALYs: Quality of Well-Being (QWB) scale; 15 Dimension instrument (15D); Health Utilities Index (HUI); EuroQol EQ-5D; Short Form-6 Dimension (SF-6D), and the Assessment of Quality of Life (AQoL) were interviewed in 2012-2013. PRINCIPAL FINDINGS: We identified key factors involved in shaping each instrument, and the rationale for similarities and differences across measures. While HSUIs have a common purpose, they are distinctly discrete constructs. Developers recalled complex developmental processes, grounded in unique histories, and these backgrounds help to explain different pathways taken at key decision points during the HSUI development. The basis for the HSUIs was commonly not equivalent conceptually: differently valued concepts and goals drove instrument design and development, according to each HSUI's defined purpose. Developers drew from different sources of knowledge to develop their measure depending on their conceptualisation of HRQoL. MAJOR CONCLUSIONS/CONTRIBUTION TO KNOWLEDGE: We generated and analysed first-hand accounts of the development of the HSUIs to provide insight, beyond face value, about how and why such instruments differ. Findings enhance our understanding of why the six instruments developed the way they did, from the perspective of key developers of those instruments. Importantly, we provide additional, original explanation for why a QALY is not a QALY is not a QALY.

Feasibility and acceptability of nurse-led youth clinics in Australian general practice.

Internationally, youth access to primary health care is problematic due to documented barriers such as cost, concerns about confidentiality, and knowledge about when to attend and available services. The treatment of health problems earlier in life together with engagement in prevention and health education can optimise youth health and maximise the potential of future wellbeing. This study investigated the feasibility, acceptability and cost of establishing nurse-led youth clinics in Victoria, Australia. Three general practices in rural and regional areas of Victoria implemented the nurse-led youth health clinics. The clinics were poorly attended by young people. Practice nurses identified several barriers to the clinic attendance including the short timeframe of the study, set times of the clinics and a lack of support for the clinics by some GPs and external youth health clinics, resulting in few referrals. The clinics cost from $5912 to $8557 to establish, which included training the practice nurses. Benefits of the clinics included increased staff knowledge about youth health issues and improved relationships within the general practice staff teams. The implementation of youth health clinics is not feasible in a short timeframe and to maximise use of the clinics, all members of the general practice team need to find the clinics acceptable.

The prevention access and risk taking in young people (PARTY) project protocol: a cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice.

BACKGROUND: There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. MAIN OUTCOMES: clinicians' detection of risk-taking and emotional distress, young people's intention to change and reduction of risk taking. SECONDARY OUTCOMES: pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. METHODS: PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff's self-perceived competency in young people's care and clinicians' detection and response to risk taking behaviours and emotional distress in 14-24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking behaviour and emotional distress three and 12 months post consultation. DISCUSSION: The PARTY trial is the first to examine the effectiveness and efficiency of a psychosocial risk screening and counselling intervention for young people attending primary care. It will provide important data on health risk profiles of young people attending general practice and on the effects of the intervention on engagement with primary care and health outcomes over 12 months. TRIAL REGISTRATION: ISRCTN16059206.

Shedding new light onto the ceiling and floor? A quantile regression approach to compare EQ-5D and SF-6D responses.

An important issue in the measurement of health status concerns the extent to which an instrument displays lack of sensitivity to changes in health status at the extremes of the distribution, known as floor and ceiling effects. Previous studies use relatively simple methods that focus on the mean of the distribution to examine these effects. The aim of this paper is to determine whether quantile regression using longitudinal data improves our understanding of the relationship between quality of life instruments. The study uses EQ-5D and SF-36 (converted to SF-6D values) instruments with both baseline and follow-up data. Relative to ordinary least least-squares (OLS), a first difference model shows much lower association between the measures, suggesting that OLS methods may lead to biased estimates of the association, due to unobservable patient characteristics. The novel finding, revealed by quantile regression, is that the strength of association between the instruments is different across different parts of the health distribution, and is dependent on whether health improves or deteriorates. The results suggest that choosing one instrument at the expense of another is difficult without good prior information surrounding the expected magnitude and direction of health improvement related to a health-care intervention.

Incorporation of process preferences within the QALY framework: a study of alternative methods.

OBJECTIVE: This article explores the implications of incorporating process preferences using time tradeoff and standard gamble methods to assess the benefits of health care. METHODS: Data were derived from 2 sources: a randomized controlled trial of alternative palliative care treatments (plastic stents, thermal ablation, or brachytherapy) for esophageal cancer, and a valuation survey conducted among individuals who had previously undergone curative treatment for such cancer. Costs and quality-adjusted life years (QALYs) associated with different palliative treatments in terms of health outcome values were compared to costs and QALYs based on process values derived from 3 different treatment allocation methods: 1) receipt of most preferred treatment; 2) receipt of least preferred treatment; and 3) mean process values. RESULTS: Process values produced a different number of QALYs and QALY gains compared to those derived from health outcome values. However, treatment recommendations based on process values corresponded with those based on health outcome values: brachytherapy was identified as the more cost-effective treatment in terms of the incremental cost-per-QALY ratio by both the standard health outcome values approach and methods based on process values. These findings were supported by probabilistic analysis using the net monetary benefit framework. CONCLUSIONS: Estimation of process preferences provides additional information to policy makers in judgments over the cost-effectiveness of health care programs. These methods offer a promising alternative to standard cost-per-QALY estimation using health outcomes. However, further research examining the role of process preferences in decision making in other clinical applications appears warranted.

Prospective epidemiologic study of the outcome and cost-effectiveness of antenatal screening to detect neonatal alloimmune thrombocytopenia due to anti-HPA-1a.

BACKGROUND: To assess the value of antenatal screening to detect neonatal alloimmune thrombocytopenia (NAIT) due to anti-HPA-1a, a prospective study was carried out to quantify the potential clinical benefits and determine whether screening would be cost-effective. STUDY DESIGN AND METHODS: An observational prospective controlled study was carried out on 26,506 pregnant women over 2 years. HPA-1a phenotyping was performed in the first trimester and women confirmed HPA-1a-negative were tested for anti-HPA-1a during pregnancy, at delivery, and 10 to 14 days after birth. Babies of HPA-1a-negative women were tested at delivery for thrombocytopenia and examined for signs of bleeding. Economic evaluation was undertaken on the basis of the data collected during the study. RESULTS: Twenty-five of 318 women (7.9%) had anti-HPA-1a detected for the first time. Eight women (43 per 100,000) gave birth to babies with NAIT, and 5 (27 per 100,000) had severe thrombocytopenia. Three babies had mild signs of bleeding, and no cases of intracranial hemorrhage (ICH) or fetal loss were detected. It is estimated that it would cost 60,596 pounds (98,771 US dollars) to detect a case of severe NAIT, where anti-HPA-1a has been identified for the first time, and 1,151,323 pounds (1,876,656 US dollars) to prevent a case of ICH, assuming that detection allowed successful intervention. CONCLUSIONS: Our data suggest that severe HPA-1a NAIT is underdiagnosed in the absence of routine antenatal screening. Serious bleeding complications and ICH, however, occur less frequently in first cases of NAIT than suspected from the literature, and the costs of screening and possible intervention must be balanced against the procedural risks.

A randomised controlled trial of microwave endometrial ablation without endometrial preparation in the outpatient setting: patient acceptability, treatment outcome and costs.

OBJECTIVE: To compare outpatient microwave endometrial ablation (MEA) in the postmenstrual phase to standard MEA treatment after drug preparation in a day case theatre environment. DESIGN: A randomised controlled trial. SETTING: A large United Kingdom teaching hospital. POPULATION: Two hundred and ten women complaining of excessive menstrual loss. METHODS: Two hundred and ten women with excessive menstrual loss were randomised. Ninety-seven women were treated as outpatients in the immediate post-menstrual phase and 100 were treated in an operating theatre after hormonal preparation. All procedures were commenced under local anaesthesia with or without conscious sedation. Analysis was by modified intention to treat. MAIN OUTCOME MEASURES: Primary outcome measures were satisfaction with treatment (measured at one year) and acceptability of treatment (measured at two weeks). Secondary outcome measures were menstrual outcome and financial cost. RESULTS: Significantly more women found treatment post-menses acceptable; 86 (89.5%) versus 76 (76.0%) [difference in proportions 13.6%, 95% CI (3.0%, 23.9%)]. Similar numbers in each arm were totally or generally satisfied with the treatment, 86 (92.5%) versus 84 (88.4%) [difference in proportions 4.1%, 95% CI (-4.7%, 12.9%)] while amenorrhoea rates at one year were comparable, 52 (55.9%) versus 60 (61.9%). [difference in proportions -5.9%, 95% CI (-19.8%, 7.6%)]. The mean health service costs were 124 pounds (95% CI 86-194 pounds) lower for the patients in the post-menses group. CONCLUSION: MEA performed under local anaesthesia (with or without conscious sedation) in the post-menstrual phase achieves high levels of satisfaction is very acceptable to patients and results in significantly reduced health service costs. Importantly menstrual outcomes are not affected by omission of drug preparation. There is now good evidence to support the use of MEA, without drug endometrial preparation, in the outpatient setting.

Comparing generic preference-based health-related quality-of-life measures: advancing the research agenda.

Interest in generic preference-based health-related quality-of-life measures has grown considerably in recent years. Given the availability of several different measures, there is a question over the extent to which different measures produce different results. To determine the interchangeability between measures, a number of head-to-head comparisons have been undertaken to assess levels of agreement or association. However, the assessment of interchangeability may be addressed using a number of different methods. This paper reviews the methods that have been employed to examine the degree of interchangeability between the Assessment of Quality of Life, EuroQol-5D, Health Utilities Index Mark III, Short-Form-6D, Quality of Wellbeing and 15-dimension measures. It suggests a need to develop alternative econometric strategies and to explore, more fully, economic concepts of validity.

Immediate computed tomography scanning of acute stroke is cost-effective and improves quality of life.

BACKGROUND AND PURPOSE: Stroke is very common, but computed tomography (CT) scanning, an expensive and finite resource, is required to differentiate cerebral infarction, hemorrhage, and stroke mimics. We determined whether, and in what circumstances, CT is cost-effective in acute stroke. METHODS: We developed a decision tree representing acute stroke care pathways populated with data from multiple sources. We determined the effect of diagnostic information from CT scanning on functional outcome, length of stay, costs, and quality of life during 5 years for 13 alternative CT strategies (varying proportions and types of patients and rapidity of scanning). RESULTS: For 1000 patients aged 70 to 74 years, the policy "scan all strokes within 48 hours" cost 10,279,728 pounds sterling and achieved 1982.3 quality-adjusted life years (QALYs). The most cost-effective strategy was "scan all immediately" (9,993,676 pounds sterling and 1982.4 QALYs). The least cost-effective was "scan patients on anticoagulants and those in a life-threatening condition immediately and the rest within 14 days" (12,592,666 pounds sterling and 1931.8 QALYs). "Scan no patients" reduced QALYs (1904.2) and increased cost (10,544,000 pounds sterling). CONCLUSIONS: Immediate CT scanning is the most cost-effective strategy. For the majority of acute stroke patients, increasing independent survival by correct early diagnosis, ensuring appropriate subsequent treatment and management decisions, reduced costs of stroke and increased QALYs.

The cost of microwave endometrial ablation under different anaesthetic and clinical settings.

OBJECTIVE: To compare the costs of microwave endometrial ablation under local anaesthetic and general anaesthetic in an operating theatre and to estimate the cost of performing treatment under local anaesthetic in a dedicated clinic setting. DESIGN: The costing study was undertaken alongside a randomised controlled trial comparing the acceptability of microwave endometrial ablation using local versus general anaesthetic in a theatre setting. SETTING: Department of Gynaecology, Aberdeen Royal Infirmary, Scotland. SAMPLES: One hundred and twenty-seven women undergoing microwave endometrial ablation who had been randomly allocated to general or local anaesthetic. METHODS: Health and non-health service resource use was recorded prospectively. Data on resource use were combined with unit costs estimated using standardised methods to determine the cost per patient for microwave endometrial ablation under local or general anaesthetic in theatre. A model was developed to estimate the health service cost of microwave endometrial ablation under local anaesthetic in a clinic setting. MAIN OUTCOME MEASURES: Health and non-health service costs. RESULTS: There was little difference in cost when treatments were performed under local or general anaesthetic in theatre. The median health and non-health cost of microwave endometrial ablation was 440 pounds and 120 pounds, respectively, under general anaesthetic and 428 pounds and 125 pounds per women under local anaesthetic. The health service cost of microwave endometrial ablation using local anaesthetic in a clinic setting was estimated to be 432 pounds per treatment; however, this varied from 389 pounds to 491 pounds in the sensitivity analysis. CONCLUSION: There are minimal cost savings to the patient or health service from using local rather than general anaesthetic for microwave endometrial ablation in a theatre setting. Cost modelling suggests that in a clinic setting microwave endometrial ablation has a similar cost to theatre based treatment once re-admissions for treatment under general anaesthetic are considered. Sensitivity analysis indicated that these findings were sensitive to assumptions in the model.