Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates.
Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%.
This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications.
The protocol is registered in the clinical trial register number ISRCTN08132825.
To examine whether cervical favourability (measured by cervical length and the Bishop score) should inform obstetricians’ decision regarding labour induction for women with gestational hypertension or mild pre-eclampsia at term.
A post hoc analysis of the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT).
Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands.
A total of 756 women diagnosed with gestational hypertension or pre-eclampsia between 36 + 0 and 41 + 0 weeks of gestation randomly allocated to induction of labour or expectant management.
Data were analysed using logistic regression modelling.
Main outcome measures
The occurrence of a high-risk maternal situation defined as either maternal complications or progression to severe disease. Secondary outcomes were caesarean delivery and adverse neonatal outcomes.
The superiority of labour induction in preventing high-risk situations in women with gestational hypertension or mild pre-eclampsia at term varied significantly according to cervical favourability. In women who were managed expectantly, the longer the cervix the higher the risk of developing maternal high-risk situations, whereas in women in whom labour was induced, cervical length was not associated with a higher probability of maternal high-risk situations (test of interaction P = 0.03). Similarly, the beneficial effect of labour induction on reducing the caesarean section rate was stronger in women with an unfavourable cervix.
Against widely held opinion, our exploratory analysis showed that women with gestational hypertension or mild pre-eclampsia at term who have an unfavourable cervix benefited more from labour induction than other women.
The trial has been registered in the clinical trial register as ISRCTN08132825.
Bishop score; cervical length; expectant management; gestational hypertension; induction of labour; pre-eclampsia
Decision-making can be based on treatment preferences of the patient, the doctor, or by guidelines based on lay people's preferences. We compared valuations assigned by three groups: patients, obstetrical care professionals, and laypersons, for health states involving both mother and (unborn) child. Our aim was to compare the valuations of different groups using different valuation methods and complex obstetric health outcome vignettes that involve both maternal and neonatal outcomes.
Patients (n = 24), professionals (n = 30), and laypersons (n = 27) valued the vignettes using three valuation methods: visual analogue scale (VAS), time trade-off (TTO), and discrete choice experimentation (DCE). Each vignette covered five health attributes: maternal health ante partum, time between diagnosis and delivery, process of delivery, maternal outcome, and neonatal outcome. We used feasibility questionnaires, Generalization theory, test-retest reliability and within-group reliability to compare the valuation patterns between groups and methods. We assessed relative weights from each valuation method to test for consistency across groups.
Test-retest reliability was equal across groups, but different across methods: highest for VAS (ICC = 0.61-0.73), intermediate for TTO (ICC = 0.24-0.74) and lowest for DCE (kappa = 0.15-0.37). Within-group reliability was highest in all groups with VAS (ICC = 0.70-0.73), intermediate with DCE (kappa = 0.56-0.76) and lowest with TTO (ICC = 0.20-0.66). Effects of groups were smaller than effects of methods. Differences between groups were largest for severe health states.
Based on our results, decision making among laypersons should use TTO or DCE; patients should use VAS or TTO.
health outcome valuation; preference; vignettes; psychometrics; pregnancy; obstetrics
Gestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as the caesarean section rate. In view of this knowledge, one can raise the question whether women with severe hypertension, pre-eclampsia or deterioration chronic hypertension between 34 and 37 weeks of gestation should be delivered or monitored expectantly. Induction of labour might prevent maternal complications. However, induction of labour in late pre-term pregnancy might increase neonatal morbidity and mortality compared with delivery at term.
Pregnant women with severe gestational hypertension, mild pre-eclampsia or deteriorating chronic hypertension at a gestational age between 34+0 and 36+6 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant monitoring. In the expectant monitoring arm, women will be induced only when the maternal or fetal condition detoriates or at 37+0 weeks of gestation. The primary outcome measure is a composite endpoint of maternal mortality, severe maternal complications (eclampsia, HELLP syndrome, pulmonary oedema and thromboembolic disease) and progression to severe pre-eclampsia. Secondary outcomes measures are respiratory distress syndrome (RDS), neonatal morbidity and mortality, caesarean section and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be intention to treat. The power calculation is based on an expectant reduction of the maternal composite endpoint from 5% to 1% for an expected increase in neonatal RDS from 1% at 37 weeks to 10% at 34 weeks. This implies that 680 women have to be randomised.
This trial will provide insight as to whether in women with hypertensive disorders late pre-term, induction of labour is an effective treatment to prevent severe maternal complications without compromising the neonatal morbidity.
NTR1792 Clinical trial registration: http://www.trialregister.nl
An increased awareness of patients’ and parents’ care preferences regarding foot care is desirable from a clinical perspective as such information may be utilised to optimise care delivery. The aim of this study was to examine parents’ preferences for, and valuations of foot care and foot-related outcomes in juvenile idiopathic arthritis (JIA).
A discrete choice experiment (DCE) incorporating willingness-to-pay (WTP) questions was conducted by surveying 42 parents of children with JIA who were enrolled in a randomised-controlled trial of multidisciplinary foot care at a single UK paediatric rheumatology outpatients department. Attributes explored were: levels of pain; mobility; ability to perform activities of daily living (ADL); waiting time; referral route; and footwear. The DCE was administered at trial baseline. DCE data were analysed using a multinomial-logit-regression model to estimate preferences and relative importance of attributes of foot care. A stated-preference WTP question was presented to estimate parents’ monetary valuation of health and service improvements.
Every attribute in the DCE was statistically significant (p < 0.01) except that of cost (p = 0.118), suggesting that all attributes, except cost, have an impact on parents’ preferences for foot care for their child. The magnitudes of the coefficients indicate that the strength of preference for each attribute was (in descending order): improved ability to perform ADL, reductions in foot pain, improved mobility, improved ability to wear desired footwear, multidisciplinary foot care route, and reduced waiting time. Parents’ estimated mean annual WTP for a multidisciplinary foot care service was £1,119.05.
In terms of foot care service provision for children with JIA, parents appear to prefer improvements in health outcomes over non-health outcomes and service process attributes. Cost was relatively less important than other attributes suggesting that it does not appear to impact on parents’ preferences.
Juvenile idiopathic arthritis; Foot; Discrete choice experiment; Health economics; Podiatry
To present an episodic random utility model that unifies time trade-off and discrete choice approaches in health state valuation.
First, we introduce two alternative random utility models (RUMs) for health preferences: the episodic RUM and the more common instant RUM. For the interpretation of time trade-off (TTO) responses, we show that the episodic model implies a coefficient estimator, and the instant model implies a mean slope estimator. Secondly, we demonstrate these estimators and the differences between the estimates for 42 health states using TTO responses from the seminal Measurement and Valuation in Health (MVH) study conducted in the United Kingdom. Mean slopes are estimates with and without Dolan's transformation of worse-than-death (WTD) responses. Finally, we demonstrate an exploded probit estimator, an extension of the coefficient estimator for discrete choice data that accommodates both TTO and rank responses.
By construction, mean slopes are less than or equal to coefficients, because slopes are fractions and, therefore, magnify downward errors in WTD responses. The Dolan transformation of WTD responses causes mean slopes to increase in similarity to coefficient estimates, yet they are not equivalent (i.e., absolute mean difference = 0.179). Unlike mean slopes, coefficient estimates demonstrate strong concordance with rank-based predictions (Lin's rho = 0.91). Combining TTO and rank responses under the exploded probit model improves the identification of health state values, decreasing the average width of confidence intervals from 0.057 to 0.041 compared to TTO only results.
The episodic RUM expands upon the theoretical framework underlying health state valuation and contributes to health econometrics by motivating the selection of coefficient and exploded probit estimators for the analysis of TTO and rank responses. In future MVH surveys, sample size requirements may be reduced through the incorporation of multiple responses under a single estimator.
The identification of the attribution of economic value that users of a health system assign to a health service could be useful in planning these services. The method of contingent valuation can provide information about the user's perception of value in monetary terms, and therefore comparable between services of a very different nature. This study attempts to extract the economic value that the subject, user of primary care nursing services in a public health system, attributes to this service by the method of contingent valuation, based on the perspectives of Willingness to Pay (WTP) and Willingness to Accept [Compensation] (WTA).
This is an economic study with a transversal design. The contingent valuation method will be used to estimate the user's willingness to pay (WTP) for the care received from the primary care nurse and the willingness to accept [compensation] (WTA), were this service eliminated. A survey that meets the requisites of the contingent valuation method will be constructed and pilot-tested. Subsequently, 600 interviews will be performed with subjects chosen by systematic randomized sampling from among those who visit nursing at twenty health centers with different socioeconomic characteristics in the Community of Madrid. The characteristics of the subject and of the care received that can explain the variations in WTP, WTA and in the WTP/WTA ratio expressed will be studied. A theoretical validation of contingent valuation will be performed constructing two explanatory multivariate mixed models in which the dependent variable will be WTP, and the WTP/WTA relationship, respectively.
The identification of the attribution of economic value to a health service that does not have a direct price at the time of use, such as a visit to primary care nursing, and the definition of a profile of "loss aversion" in reference to the service evaluated, can be relevant elements in planning, enabling incorporating patient preferences to health policy decision-making.
The incidence of reported adolescent and adult pertussis continues to rise in the United States. Acellular pertussis vaccines for adolescents and adults have been developed and may be available soon for use in the U.S. Our objectives were: (1) to describe patient valuations of pertussis disease and vaccination; and (2) to compare valuations for short-term and long-term health states associated with pertussis.
We conducted telephone surveys with 515 adult patients and parents of adolescent patients with pertussis in Massachusetts to determine valuations of pertussis-related health states for disease and vaccination using time trade-off (TTO) and contingent valuation (CV) techniques. Respondents were randomized to complete either a short-term or long-term TTO exercise. Discrimination between health states for each valuation technique was assessed using Tukey's method, and valuations for short-term vs. long-term health states were compared using the Wilcoxon rank-sum test.
Three hundred three (59%) and 309 (60%) respondents completed and understood the TTO and CV exercises, respectively. Overall, respondents gave lower valuations (lower TTO and higher CV values) to avoid a given state for adolescent/adult disease compared to vaccine adverse events. Infant complications due to pertussis were considered worse than adolescent/adult disease, regardless of the method of valuation. The short-term TTO resulted in lower mean valuations and larger mean differences between health states than the long-term TTO exercise.
Pertussis was considered worse than adverse events due to vaccination. Short-term health-state valuation is better able to discriminate among health states, which is useful for cost-utility analysis.
pertussis; time trade-off; willingness-to-pay; short-term health-state
The effect of lead time in time trade-off (TTO) valuation is not well understood. The purpose of this study was to investigate the effects on health-state valuation of the length of lead time and the way the lead-time TTO task is displayed visually.
Using two general population samples, we compared three lead-time TTO variants: 10 years of lead time in full health preceding 5 years of unhealthy time (standard); 5 years of lead time preceding 5 years of unhealthy time (experimental); and 10 years of lead time and 5 years of unhealthy time, presented with a visual aid to highlight the point where the lead time ends (experimental). Participants were randomized to receive one of the lead-time variants, as administered by a computer software program.
Health-state values generated by TTO valuation tasks using a longer lead time were slightly lower than those generated by tasks using a shorter lead time. When lead time and unhealthy time were presented with visual aids highlighting the difference between the lead time and unhealthy time, respondents spent more time considering health states with a value close to 0.
Different lead-time time trade-off variants should be carefully studied in order to achieve the best measurement of health-state values using this new method.
EQ-5D-5L; EQ-VT; Time trade-off; I100
The time tradeoff (TTO) method is often used to derive Quality-Adjusted Life Year health state valuations. An important problem with this method is that results have been found to be responsive to the procedure used to elicit preferences. In particular, fixing the duration in the health state to be valued and inferring the duration in full health that renders an individual indifferent, causes valuations to be higher than when the duration in full health is fixed and the duration in the health state to be valued is elicited. This paper presents a new test of procedural invariance for a broad range of time horizons, while using a choice-based design and adjusting for discounting. As one of the known problems with the conventional procedure is the violation of constant proportional tradeoffs (CPTO), we also investigate CPTO for the alternative TTO procedure. Our findings concerning procedural invariance are rather supportive for the TTO procedure. We find no violations of procedural invariance except for the shortest gauge duration. The results for CPTO are more troublesome: TTO scores depend on gauge duration, reinforcing the evidence reported when using the conventional procedure.
Procedural invariance; Constant proportional tradeoffs; Discounting; Time tradeoff method; D90; I10
Economic valuations of health care programs often require using patients as subjects, implying that research methodology should conform to the surrounding social, cultural and ethical context. The significance of patients' opinions in health care decisions has been well defined but in Greece, and perhaps elsewhere, clinicians remain skeptical. The purpose of this study was to investigate, for the first time in Greece, the feasibility of measuring preference-based health-state utilities and willingness to pay and to determine the context-based adaptations required to overcome inherent elicitation problems.
A survey including a time trade-off (TTO), a standard gamble (SG), and two willingness-to-pay (WTP) questions was self-administered to a homogenous group of 606 end stage renal disease patients in 24 dialysis facilities throughout Greece and the overall response rate was 78.5%. Typical elicitation methods were adapted to overcome methodological problems such as subjective life expectancy and question framing. Spearman's correlation coefficients were calculated between utilities and WTP and parametric tests (independent samples t-test and ANOVA) examined score differences as a result of demographic and clinical factors.
Mean health-state utilities were 72.56 (TTO) and 91.06 (SG) and these were statistically significantly different (P < 0.0005). Significant correlations, in the expected directions, were observed between TTO – SG, TTO – WTP and SG – WTP (P < 0.01). High ceiling effects were observed in the TTO and SG methods indicating patients' adversity to risk and unwillingness to trade-off life years. Higher WTP was observed from younger patients (P < 0.0005), males (P < 0.05), higher education levels (P < 0.01), single (P < 0.0005) and employed (P < 0.005).
This study demonstrated, to a fair extent, that adapting research methods to context-based particularities does not necessarily compromise results and should be considered in situations where standard methods cannot be applied. On the other hand, it is emphasized that the results from this study are preliminary and should be interpreted cautiously until further research demonstrates the practicality, reliability and validity of alternative measurement approaches.
This article examines the effect that different specifications of the time trade-off (TTO) valuation task may have on values for EQ-5D-5L health states. The new variants of the TTO, namely lead-time TTO and lag-time TTO, along with the classic approach to TTO were compared using two durations for the health states (15 and 20 years). The study tested whether these methods yield comparable health-state values. TTO tasks were administered online. It was found that lag-time TTO produced lower values than lead-time TTO and that the difference was larger in the longer time frame. Classic TTO values most resembled those of the lag-time TTO in a 20-year time frame in terms of mean absolute difference. The relative importance of different domains of health was systematically affected by the duration of the health state. In the tasks with a 10-year health-state duration, anxiety/depression had the largest negative impact on health-state values; in the tasks with a 5-year duration, the pain/discomfort domain had the largest negative impact.
Time trade-off; Lead-time TTO; Lag-time TTO; Utility; Health-state preferences; I10
The effects of socio-demographic characteristics of the respondent, including age, on valuation scores of hypothetical health states remain inconclusive. Therefore, we analyzed data from a study designed to discriminate between the effects of respondents' age and time preference on valuations of health states to gain insight in the contribution of individual response patterns to the variance in valuation scores.
A total of 212 respondents from three age groups valued the same six hypothetical health states using three different methods: a Visual Analogue Scale (VAS) and two variants of the Time trade-off (TTO). Analyses included a generalizability study, principal components analysis, and cluster analysis.
Valuation scores differed significantly, but not systematically, between valuation methods. A total of 36.8% of variance was explained by health states, 1.6% by the elicitation method, and 0.2% by age group. Individual differences in the use of the response scales (e.g. a tendency to give either high or low TTO scores, or a high or low scoring tendency on the VAS) were the main source of remaining variance. These response patterns were not related to age or other identifiable respondent characteristics.
Individual response patterns in this study were more important determinants of TTO or VAS valuations of health states than age or other respondent characteristics measured. Further valuation research should focus on explaining individual response patterns as a possible key to understanding the determinants of health state valuations.
The ability to compare incremental changes in Quality Adjusted Life Years (QALYs) generated by different condition-specific preference-based measures (CSPBMs), or indeed between generic measures, is often criticised even where the valuation methods and source of values are the same. A key concern is the impact of excluding key dimensions from a descriptive system. This study examines the impact of adding a generic pain/discomfort dimension to a CSPBM, the AQL-5D (an asthma-specific CSPBM), by valuing samples of states from the AQL-5D with and without the new dimension using an interviewer administered time trade-off with a sample of the UK general public. 180 respondents provided 720 valuations for states with and without pain/discomfort. As expected the additional pain/discomfort dimension was found to have a significant and relatively large coefficient. More importantly for comparing changes in QALYs across populations the addition of pain/discomfort significantly impacts on the coefficients of the other dimensions and the degree of impact differs by dimension and severity level. The net effect on the utility value depends on the severity of their state: the addition of pain/discomfort at level 1 (no pain/discomfort) or 2 (moderate pain/discomfort) significantly increased the mean health state values in an asthma patient population; whereas level 3 pain/discomfort (extreme) reduced values. Comparability between measures requires that the impact of different dimensions on preferences is additive, whether or not they are included in the classification system. Our results cast doubt on this assumption, implying that the chosen measure must contain all important and relevant dimensions in its classification system.
► As expected the additional pain or discomfort dimension was associated with significant coefficients for levels 2 and 3 in the model of the health state valuation data. ► The additional dimension had a significant impact on the coefficients of other dimensions, but this differed by dimension and level. ► The net impact on the health state value depended on the level of the pain or discomfort dimension, with level 1 or 2 being associated with higher values and level 3 with lower values. ► This has important implications for the strategy of adding dimensions to existing instruments and for the achievement cross instrument comparability.
Preference-based measures of health; Cross programme comparability; Condition-specific measures; UK
Patient-centered health care and shared decision making are of increasing importance in the management of AIDS/HIV patients and require an intensive consideration of patient preferences. The present study assesses expectations and needs of patients from the physician point of view. The aim of this study was to compare patient and physician perspectives of relevant aspects of treatment quality such as effectiveness, quality of life and further treatment options.
The study was performed as an anonymous survey including German physicians. Physicians treating large numbers of AIDS/HIV patients were preferably contacted. The physicians were asked to assess their view of patient preferences of therapy characteristics using direct measurement, as well as by means of a Discrete Choice Experiment (DCE). The questionnaire was adopted from a previous study in which AIDS/HIV patients were asked to assess their treatment preferences.
131 physicians completed the questionnaire, 88% of these on paper and 12% online. 70% of the physicians were male. The mean duration since licensure was 17 years. The most frequent specialist areas were internal medicine (N = 55), infectiology (N = 31) and general medicine (N = 27). In the direct measurement the most relevant therapy characteristics were “drug does not affect or not affect appearance much”, “self-application of the drug is possible” and “rarely occurring longer periods of nausea and diarrhea”. Six treatment characteristics were selected and used to generate eight virtual pairs of therapies. To evaluate the assessments a random effect logit model was employed. In view of the physicians avoidance of an obvious perceptibility of the disease the emotional quality of life had by far the strongest impact on the patients’ treatment preferences as rated by physicians. With some distance the physical quality of life with less diarrhea or nausea, as well as the possibility to participate in social life followed on the same level.
Discrete Choice Experiment proved to be a valid survey technique in the evaluation of AIDS/HIV treatment preferences as assessed by patients and by physicians assessing the view of their patients. Covering a broad range of treatment characteristics, the physician assessments of preferences were very close to those of AIDS/HIV patients emphasizing the high impact of quality of life, in particular the emotional quality of life on patient preferences in the selection of treatments. Thus, the selection of particular treatment options should be accompanied by a deliberate consideration of treatment features, which need to be considered in order to maximize patient adherence and compliance.
AIDS/HIV; Physician judgment; Patient preferences; Stated preferences; Discrete-choice-experiment (DCE); Direct assessment
The most common method of evaluating beneficial impacts of environmental policies is cost-benefit analysis (CBA). In the present review, CBA methods for air pollution impacts are reviewed. Three types of air pollution effects are identified, including health, productivity, and amenity. Market valuation, stated preference methods, and revealed preference methods are identified for valuing benefits. Three types of costs are deseribed, including private sector costs, societal costs, and governmental regulatory costs. A benefits valuation approach based on Freeman's principals is described. A costs valuation approach based on U.S. Environmental Protection Agency and Dixon et al. principals is deseribed. Limitations associated with estimates of benefits and costs are summarized. Input assumptions and results are compared for several existing air pollution control analyses. The importance of CBA in environmental policy studies is discussed. Our conceptual approaches should be useful in analyses of urban air pollution impacts and air pollution prevention policies.
cost-benefit analysis; urban air pollution; environmental policy; benefit valuation; cost estimation
BACKGROUND: Meta-analyses of randomized controlled trials suggest that elective induction of labour at 41 weeks' gestation, compared with expectant management with selective labour induction, is associated with fewer perinatal deaths and no increase in the cesarean section rate. The authors studied the changes over time in the rates of labour induction in post-term pregnancies in Canada and examined the effects on the rates of stillbirth and cesarean section. METHODS: Changes in the proportion of total births at 41 weeks' and at 42 or more weeks' gestation, and in the rate of stillbirths at 41 or more weeks' (versus 40 weeks') gestation in Canada between 1980 and 1995 were determined using data from Statistics Canada. Changes in the rates of labour induction and cesarean section were determined using data from hospital and provincial sources. RESULTS: There was a marked increase in the proportion of births at 41 weeks' gestation (from 11.9% in 1980 to 16.3% in 1995) and a marked decrease in the proportion at 42 or more weeks (from 7.1% in 1980 to 2.9% in 1995). The rate of stillbirths among deliveries at 41 or more weeks' gestation decreased significantly, from 2.8 per 1000 total births in 1980 to 0.9 per 1000 total births in 1995 (p < 0.001). The stillbirth rate also decreased significantly among births at 40 weeks' gestation, from 1.8 per 1000 total births in 1980 to 1.1 per 1000 total births in 1995 (p < 0.001). The magnitude of the decrease in the stillbirth rate at 41 or more weeks' gestation was greater than that at 40 weeks' gestation (p < 0.001). All hospital and provincial sources of data indicated that the rate of labour induction increased significantly between 1980 and 1995 among women delivering at 41 or more weeks' gestation. The associated changes in rates of cesarean section were variable. INTERPRETATION: Between 1980 and 1995 clinical practice for the management of post-term pregnancy changed in Canada. The increased rate of labour induction at 41 or more weeks' gestation may have contributed to the decreased stillbirth rate but it had no convincing influence either way on the cesarean section rate.
Objective To determine neonatal outcomes (perinatal mortality and special care unit admission) and maternal outcomes (mode of delivery, delivery complications) of elective induction of labour compared with expectant management.
Design Retrospective cohort study using an unselected population database.
Setting Consultant and midwife led obstetric units in Scotland 1981-2007.
Participants 1 271 549 women with singleton pregnancies of 37 weeks or more gestation.
Interventions Outcomes of elective induction of labour (induction of labour with no recognised medical indication) at 37, 38, 39, 40, and 41 weeks’ gestation compared with those of expectant management (continuation of pregnancy to either spontaneous labour, induction of labour or caesarean section at a later gestation).
Main outcome measures Extended perinatal mortality, mode of delivery, postpartum haemorrhage, obstetric anal sphincter injury, and admission to a neonatal or special care baby unit. Outcomes were adjusted for age at delivery, parity, year of birth, birth weight, deprivation category, and, where appropriate, mode of delivery.
Results At each gestation between 37 and 41 completed weeks, elective induction of labour was associated with a decreased odds of perinatal mortality compared with expectant management (at 40 weeks’ gestation 0.08% (37/44 764) in the induction of labour group versus 0.18% (627/350 643) in the expectant management group; adjusted odds ratio 0.39, 99% confidence interval 0.24 to 0.63), without a reduction in the odds of spontaneous vertex delivery (at 40 weeks’ gestation 79.9% (35 775/44 778) in the induction of labour group versus 73.7% (258 665/350 791) in the expectant management group; adjusted odds ratio 1.26, 1.22 to 1.31). Admission to a neonatal unit was, however, increased in association with elective induction of labour at all gestations before 41 weeks (at 40 weeks’ gestation 8.0% (3605/44 778) in the induction of labour group compared with 7.3% (25 572/350 791) in the expectant management group; adjusted odds ratio 1.14, 1.09 to 1.20).
Conclusion Although residual confounding may remain, our findings indicate that elective induction of labour at term gestation can reduce perinatal mortality in developed countries without increasing the risk of operative delivery.
The completeness of preferences is assumed as one of the axioms of expected utility theory but has been subject to little empirical study.
Fifteen non-health professionals was recruited and familiarised with the standard gamble technique. The group then met five times over six months and preferences were elicited independently on 41 scenarios. After individual valuation, the group discussed the scenarios, following which preferences could be changed. Changes made were described and summary measures (mean and median) before and after discussion compared using paired t test and Wilcoxon Signed Rank Test. Semi-structured telephone interviews were carried out to explore attitudes to discussing preferences. These were transcribed, read by two investigators and emergent themes described.
Sixteen changes (3.6%) were made to preferences by seven (47%) of the fifteen members. The difference between individual preference values before and after discussion ranged from -0.025 to 0.45. The average effect on the group mean was 0.0053. No differences before and after discussion were statistically significant. The group valued discussion highly and suggested it brought four main benefits: reassurance; improved procedural performance; increased group cohesion; satisfying curiosity.
The hypothesis that preferences are incomplete cannot be rejected for a proportion of respondents. However, brief discussion did not result in substantial number of changes to preferences and these did not have significant impact on summary values for the group, suggesting that incompleteness, if present, may not have an important effect on cost-utility analyses.
By polling individual responses to hypothetical scenarios, valuation studies estimate population preferences toward health on a quality-adjusted life year (QALY) scale. The scenarios typically involve trade-offs in time (time trade-off [TTO]), risk (standard gamble [SG]), or number of persons affected (person trade-off [PTO]). This paper revisits the QALY assumptions and provides a coherent health econometric approach that unites TTO, SG, and PTO techniques under a common estimator. The proposed approach avoids the use of ratio statistics in QALY estimation and the common convention of arbitrarily changing trade-off responses. As an example, 34% of the TTO responses from the seminal Measurement and Valuation of Health (MVH) study were changed in the original UK analysis, which led to substantially lower QALY estimates. As a general rule, if the original estimate is less than 0.5 QALYs, add 0.25 QALYs to get the new estimates.
QALY; Time Trade-off; Health-related Quality of Life
It is necessary to develop a proper payment system for more health care facilities to provide hospice and palliative cares. In deciding the proper level of payment for hospice per diem fee, willingness to pay (WTP) may provide one of the critical information. This study was conducted to determine WTP for hospice care and to analyze those factors affecting WTP.
Materials and Methods
A contingent valuation method with a double-bounded dichotomous-choice model was used. Interview survey was organized and conducted by a survey company from April 4 to 18, 2008. The mean WTP was calculated through an infinite integration of survival functions.
The average willingness to pay was found to be 42,240 Korean won (KRW) (USD 35), with the amount becoming higher as hospice services were deemed more necessary or where average monthly household income was higher. The amount was also higher among male respondents than females.
To compare this WTP with actual cost (32,500 KRW) (USD 27) for hospice care. To facilitate hospice service, hospice specific payment system should be developed. This study provides information regarding the general public's preference of hospice service and their WTP for hospice care, and it may be useful in the decision-making process.
Hospice; willingness to pay; Per diem payment
This study aims to elicit the value of the willingness to pay (WTP) for a quality-adjusted life year (QALY) and to examine the factors associated with the WTP for a QALY (WTP/QALY) value under the Thai health care setting.
A community-based survey was conducted among 1191 randomly selected respondents. Each respondent was interviewed face-to-face to elicit his/her health state preference in each of three pairs of health conditions: (1) unilateral and bilateral blindness, (2) paraplegia and quadriplegia, and (3) mild and moderate allergies. A visual analog scale (VAS) and time trade off (TTO) were used as the eliciting methods. Subsequently, the respondents were asked about their WTP for the treatment and prevention of each pair of health conditions by using a bidding-game technique.
With regards to treatment, the mean WTP for a QALY value (WTP/QALYtreatment) estimated by the TTO method ranged from 59,000 to 285,000 baht (16.49 baht = US$1 purchasing power parity [PPP]). In contrast, the mean WTP for a QALY value in terms of prevention (WTP/QALYprevention) was significantly lower, ranging from 26,000 to 137,000 baht. Gender, household income, and hypothetical scenarios were also significant factors associated with the WTP/QALY values.
The WTP/QALY values elicited in this study were approximately 0.4 to 2 times Thailand’s 2008 GDP per capita. These values were in line with previous studies conducted in several different settings. This study’s findings clearly support the opinion that a single ceiling threshold should not be used for the resource allocation of all types of interventions.
ceiling threshold; health resource allocation; time trade off; visual analog scale
Melasma is a common hyperpigmentation disorder that has a significant effect on an individual's quality of life. However, there is no preference-based measurement that reflects quality of life in patients with melasma. The objective of this study was to assess the impact of melasma on quality of life by using a health status measurement - the Dermatology Life Quality Index (DLQI) - and a preference-based measurement - Willingness to Pay (WTP) and Time Trade-Off (TTO).
A cross-sectional descriptive study was conducted. Seventy-eight patients with melasma who attended the melasma clinic at Siriraj Hospital from February to March 2009 were recruited in this study. The Thai version of the DLQI, questionnaires about WTP, standard TTO, and daily TTO were used to assess patients' quality of life.
Seventy-seven (98.7%) patients were female with a mean age of 47.8 ± 7.9 years. The mean health utility based on standard TTO was 0.96. The utility obtained by the daily TTO method was 0.92 and was significantly correlated with an economically inactive occupation (p < 0.05). The mean monthly WTP for the most effective treatment was 1,157 baht (7.2% of monthly income), ranging from 100 to 5,000 baht (1 USD ~ 35.1 baht). The WTP was significantly correlated with monthly personal income and the total DLQI score.
The WTP method could be a useful tool with which to measure the quality of life of patients with melasma.
Gestational Diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.
Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the Outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurement4s are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.
The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms.
The study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number NCT01058772.
To develop a set of EQ-5D health state values for the Argentine general population.
Consecutive subjects attending six primary care centers in Argentina were selected based on quota sampling and interviewed using the EuroQol Group protocol for measurement and valuation of health studies. Initially respondents were randomly assigned a unique card set; however, to improve efficiency, subjects were later randomly assigned to one of three fixed sets of EQ-5D states. Using the VAS and TTO responses for these states, we estimated a valuation model using ordinary least squares regression clustered by respondent. Predicted values for EQ-5D health states are compared to published values for the United States.
Six hundred eleven subjects were interviewed by 14 trained interviewers, rendering 6,887 TTO and 6,892 VAS responses. The model had an R2 of 0.897 and 0.928 for TTO and VAS respectively. The mean absolute difference between observed and predicted values was 0.039 for TTO and 0.020 for VAS, each showing a Lin’s concordance coefficient above 0.98. United States and Argentine TTO predicted values were highly correlated (Pearson’s rho=0.963), though the average absolute difference was clinically meaningful (0.06), rejecting the US values for nearly two thirds of the states (62.8%). The Argentine population placed lower values on mild states and higher values on severe states.
This study provides an Argentine value set that could be used locally or regionally, with meaningful and significant differences with that of the US. Health policy in Latin America must incorporate local values for sovereignty and validity.
utility measurement; HRQOL; patient preference; cost effectiveness analysis