Psychometric properties of the EQ-5D-5L in patients with major depression: factor analysis and Rasch analysis.

BACKGROUND: The EQ-5D is one of the most recommended questionnaires for cost-effectiveness studies. AIMS: To study the psychometric properties of the EQ-5D-5L in patients with major depression. METHODS: This prospective observational study included 433 patients with major depression who completed the EQ-5D-5L and Patient Health Questionnaire-9 (PHQ-9) questionnaires at baseline, of whom 310 also did six months later. The structural validity was assessed by confirmatory factor analysis, the item functioning by item response analysis, and reliability by Cronbach's alpha. Convergent validity and known-groups validity was studied using the PHQ-9 and a general health question. To assess responsiveness effect sizes were calculated. RESULTS: The results supported the unidimensionality and showed adequate item functioning, with somewhat age-related item differential functioning for the mobility dimension. Cronbach's alpha was 0.77. The EQ-5D-5L showed a high correlation with the PHQ-9 and general health. The more severe the depression level and the poorer the general health, the lower the EQ-5D-5L scores (p < 0.001). Responsiveness parameters showed moderate changes among "improved" patients. CONCLUSIONS: These findings support the adequate psychometric properties of the EQ-5D-5L in patients with major depression. It could be very useful for clinicians and researchers as an outcome measure and for use in economic evaluation.

Health Related Quality of Life in Major Depressive Disorder: evolution in time and factors associated.

Major Depressive Disorder (MDD) is the most prevalent mental disorder. We aimed to analyze which factors were associated to their Health-Related Quality of Life (HRQoL) perception in patients diagnosed of MDD and how they evolved over six months.

Response Mapping Methods to Estimate the EQ-5D-5L From the Western Ontario McMaster Universities Osteoarthritis in Patients With Hip or Knee Osteoarthritis.

OBJECTIVES: The mapping technique can estimate generic preference-based measure scores through a specific measure that cannot be used in economic evaluations. This study compared 2 response mapping methods to estimate EQ-5D-5L scores using the Western Ontario McMaster Universities Osteoarthritis (WOMAC). METHODS: The sample consisted of 758 patients with the hip or knee osteoarthritis recruited in baseline. Bayesian networks (BN) and multinomial logistic regression (ML) were used as response mapping models. Predictions were obtained using the 6-month follow-up as a validation sample. The mean absolute error, mean squared error, deviation from the root mean squared error and intraclass correlation coefficient were calculated as precision measures. RESULTS: There was 5.5% of missing data, which was removed. The mean age was 69.6 years (standard deviation = 10.5), with 61.6% of women. The BN model presented lower mean absolute error, mean squared error, root mean squared error and higher intraclass correlation coefficient than the ML model. Only the WOMAC items pain and physical function items were related with the EQ-5D-5L dimensions. CONCLUSION: BN response mapping models are more robust methods, with better prediction results, than ML models. The BN model also provided a graphic representation of the dependency relationships between the EQ-5D-5L dimensions and the different WOMAC items that could be useful in the clinical investigation of patients with hip or knee osteoarthritis.

Mapping WOMAC Onto the EQ-5D-5L Utility Index in Patients With Hip or Knee Osteoarthritis.

OBJECTIVES: To map the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) onto the EQ-5D-5L in patients with hip or knee osteoarthritis (OA). METHODS: A prospective observational study was conducted on 758 patients with hip or knee OA who completed the EQ-5D-5L and WOMAC questionnaires, of whom 644 completed them both again 6 months later. Baseline data were used to derive mapping functions. Generalized additive models were used to identify to which powers the WOMAC subscales should be raised to achieve a linear relationship with the response. For the modeling, general linear models (GLM), Tobit models, and beta regression models were used. Age, sex, and affected joints were also considered. Preferred models were selected based on Akaike and Bayesian information criteria, adjusted R2, mean absolute error (MAE), and root mean squared error (RMSE). The functions were validated with the follow-up data using MAE, RMSE, and the intraclass correlation coefficient. RESULTS: The preferred models were a GLM with Pain2+Pain3+Function+Pain·Function as covariates and a beta model with Pain3+Function+Function2+Function3 as covariates. The adjusted R2 were similar (0.6190 and 0.6136, respectively). The predictive performance of these models in the validation sample was similar and both models showed an overprediction for health states worse than death. CONCLUSION: To our knowledge, these are the first functions mapping the WOMAC onto the EQ-5D-5L in patients with hip or knee OA. They showed an acceptable fit and precision and could be very useful for clinicians and researchers when cost-effectiveness studies are needed and generic preference-based health-related quality of life instruments to derive utilities are not available.

Mapping analysis to predict EQ-5D-5 L utility values based on the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires in the Spanish population suffering from lower limb osteoarthritis.

BACKGROUND: The EQ-5D-5 L is a quality-of-life questionnaire based on individuals' preferences that is widely employed for cost-effectiveness analysis. Given the current demand for mapping algorithms to directly assign "utilities", this study aimed to generate different mapping models for predicting EQ-5D-5 L utility values based on scores of the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires provided by patients suffering from hip and knee osteoarthritis (OA), respectively, and to assess the predictive capability of these functions. METHODS: This was a prospective, observational study. Following the criteria of the American Rheumatism Association, 361 patients with hip OA and 397 with knee OA from three regions in Spain were included. Health-related quality of life (HRQoL) was assessed through the EQ-5D-5 L general questionnaire and the OHS and OKS specifically for lower limb OA. Based on the scores on the OHS and OKS questionnaires, EQ-5D-5 L utilities were estimated using 4 models: ordinary least squares (OLS), Tobit, generalized linear model (GLM), and beta regression (Breg). The models were validated on the same patients after 6 months: the mean absolute error (MAE) and mean squared error (MSE) with their 95% confidence intervals (CI), mean values of standard errors (SE), intraclass correlation coefficients (ICC), and Bland-Altman plots were obtained. RESULTS: The lowest MAEs were obtained using GLM and Breg models, with values of 0.1103 (0.0993-0.1214) and 0.1229 (0.1102-0.1335) for hip OA, and values of 0.1127 (0.1014-0.1239) and 0.1141 (0.1031-0.1251) for knee OA. MSE values were also lower using GLM and Breg. ICCs between predicted and observed values were around or over the 0.8 cut-off point. Bland-Altman plots showed an acceptable correlation, but precision was lower for subjects with worse HRQoL, which was also evident when comparing MAEs of the bottom and top halves of the utilities scale. Predictive equations for utilities based on OHS/OKS scores were proposed. CONCLUSIONS: The OHS and OKS scores allow for estimating EQ-5D-5 L utility indexes for patients with hip and knee OA, respectively, with adequate validity and precision. GLM and Breg produce the best predictions. The predictive power of proposed equations is more consistent for subjects in better health condition.

Interventions to improve medication adherence in mental health: the update of a systematic review of cost-effectiveness.

OBJECTIVE: Medication non-adherence in mental health problems has social and economic costs. The objective of the study was to review the cost-effectiveness of interventions to enhance medication adherence in patients with mental health problems. METHODS: The update of a previous systematic review was performed. Databases were searched in June 2019: MEDLINE, PSYCINFO, EMBASE, CINAHL, CRD, WOS. Cost-effectiveness studies comparing an intervention to improve the medication adherence with other interventions/usual care in adults with mental health problems were included. Data were extracted, methodological quality of the studies was assessed and a narrative synthesis was performed. RESULTS: Nine studies were included in the review. The interventions that showed medication adherence increase were: a financial incentive when depot injection was taken by patients with psychotic disorders, a value-based benefit design policy including copayment and counselling in a company setting, and a medication treatment decision supported by a pharmacogenetic test. The other studies (coaching by pharmacists; a psychological and educational intervention at health care centres) did not find differences between groups. No study found cost differences between alternatives. CONCLUSIONS: Interventions to improve medication adherence in adults with mental health problems could be cost-effective, especially those based on financial incentives, although more research is needed. KEYPOINTS There are several types of interventions designed to enhance medication adherence in patients with mental health problems. Few of them have demonstrated cost-effectiveness. Two studies found that a financial incentive per depot injection in patients with psychotic disorders improved the medication adherence. Two other studies found improvement in adherence due to two specific interventions: a value-based benefit design policy in a company setting and a pharmacogenetic test supporting the medication treatment decision. No study found differences in costs between the intervention and the comparator. More research is needed to implement cost-effective interventions.

EQ-5D-5L utilities per health states in Spanish population with knee or hip osteoarthritis.

BACKGROUND: The objective of this study was to obtain utilities by means of EQ-5D-5L for different health states in patients with knee osteoarthritis (KOA) or hip osteoarthritis (HOA) in Spain, and to compare these values with those used in foreign studies with the aim of discussing their transferability for their use in economic evaluations conducted in Spain. METHODS: Primary study: Observational prospective study of KOA or HOA patients in Spain. Sociodemographic and clinical characteristics were collected to characterize the sample. Utilities were elicited using the EQ-5D-5L questionnaire. ANOVA and bivariable analyses were conducted to identify differences between health states. LITERATURE REVIEW: Using the bibliographic databases NSH EED and CEA Registry, we conducted searches of model-based cost utilities analyses of technologies in KOA or HOA patients. Health states and utilities were extracted and compared with values obtained from the Spanish sample. RESULTS: Three hundred ninety-seven subjects with KOA and 361 subjects with HOA were included, with average utilities of 0.544 and 0.520, respectively. In both samples, differences were found in utilities according to level of pain, stiffness and physical function (WOMAC) and severity of symptoms (Oxford scales), so that the worst the symptoms, the lower the utilities. The utilities after surgery were higher than before surgery. Due to limitations from our study related to sample size and observational design, it was not possible to estimate utilities for approximately half the health states included in the published models because they were directly related to specific technologies. For almost 100% of health states of the selected studies we obtained very different utilities from those reported in the literature. CONCLUSIONS: To our knowledge this is the first article with detailed utilities estimated using the EQ-5D-5L in Spain for KOA and HOA patients. In both populations, utilities are lower for worse health states in terms of level of pain, stiffness and physical function according to WOMAC, and according to the Oxford scales. Most utilities obtained from the Spanish sample are lower than those reported in the international literature. Further studies estimating utilities from local populations are required to avoid the use of foreign sources in economic evaluations.

Efficacy, Effectiveness, Safety, and Cost-effectiveness of Epidural Adhesiolysis for Treating Failed Back Surgery Syndrome. A Systematic Review.

BACKGROUND: Failed back surgery syndrome (FBSS) has a profound impact on patients' quality of life and represents a major clinical challenge and a significant economic burden for society. Adhesiolysis is used as a treatment to eliminate perineural/epidural adhesions in patients with chronic pain attributed to FBSS. OBJECTIVE: To evaluate the efficacy, effectiveness, safety, and cost-effectiveness of epidural adhesiolysis compared with other procedures for treating FBSS. METHOD: A systematic review was conducted. The electronic databases Medline/PreMedline, EMBASE, Cochrane Library Plus, Centre for Reviews and Dissemination databases, SCOPUS, Science Citation Index, and PEDRO were consulted through April 2017. Predefined criteria were used to determine inclusion of the studies and to assess their methodological quality. RESULTS: Ten reports were included. No randomized controlled trials (RCTs) on efficacy or cost-effectiveness were found. Three reports (corresponding to two RCTs, N = 212) suggested that adhesiolysis was effective, especially for pain and disability. However, both studies presented serious methodological flaws. In addition to RCTs, seven observational studies with high risk of bias reported data on effectiveness and safety. Fifty-eight adverse events were reported among 130 patients undergoing endoscopic adhesiolysis, and 19 among the 110 undergoing percutaneous adhesiolysis. CONCLUSIONS: The evidence on the efficacy and cost-effectiveness of adhesiolysis for treating FBSS is nonexistent, whereas evidence on its effectiveness and safety is insufficient. Incorporating data from observational studies did not improve the quality of the evidence on effectiveness.

Psychometric properties of the EQ-5D-5L in patients with hip or knee osteoarthritis: reliability, validity and responsiveness.

PURPOSE: To study the psychometric properties, including reliability, validity and responsiveness, of the Spanish EQ-5D-5L questionnaire for patients with hip or knee osteoarthritis (OA). METHODS: We included 758 patients with hip or knee OA who completed the EQ-5D-5L and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, of whom 644 also did 6 months later. The EQ-5D-5L contains five questions from which a utility index is derived. The WOMAC covers three dimensions: pain, stiffness and physical function. Floor and ceiling effects were calculated. Reliability was assessed using Cronbach's alpha. Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L and WOMAC. We examined known-groups validity by comparing the EQ-5D-5L between subgroups defined by WOMAC scores using ANOVA or the Kruskal-Wallis test. Effect sizes were calculated to assess responsiveness, and minimal clinically important difference (MCID) was estimated. RESULTS: The EQ-5D-5L showed minimal floor and ceiling effects (< 3%). Cronbach's alpha was 0.86. The EQ-5D-5L index was strongly correlated with WOMAC pain and function scores (- 0.688 and - 0.782). Patients with higher WOMAC scores had significantly (p < 0.0001) lower EQ-5D-5L index. The 20.19% had hip or knee replacement during the follow-up. Effect sizes were small among non-surgical patients, but > 0.80 among "improved" surgical patients, being the MCID for improvement 0.32 points. CONCLUSIONS: The results support the reliability, validity and responsiveness of the EQ-5D-5L, overcoming the limitations of the EQ-5D-3L in these patients. Therefore, the EQ-5D-5L could be very useful as an outcome measure, at least in patients with hip or knee OA.

Validation of the Spanish version of the Oxford knee score and assessment of its utility to characterize quality of life of patients suffering from knee osteoarthritis: a multicentric study.

BACKGROUND: Knee osteoarthritis (OA) represents a heavy burden for patients and the society as a whole. The Oxford Knee Score (OKS) is a well known tool to assess the quality of life in patients with Knee OA. The purpose of this study was to analyze the psychometric properties of the Spanish version of the OKS, including its reliability, validity, and responsiveness. METHODS: Prospective observational study that included 397 patients diagnosed with knee OA according to the criterion of the American Rheumatism Association, which were recruited in 3 different Spanish regions. Their self-perceived health-related quality of life (HRQL) was assessed through 3 questionnaires: a generic one (the EQ-5D-5 L) and two specific ones adapted to Spanish (the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Oxford Knee Score (OKS). The follow-up period was 6 months, and the acceptability of the OKS was evaluated, together with its psychometric properties, presence of ceiling and floor effects, validity, reliability, and sensitivity to change. RESULTS: The OKS was fully answered in 99.5% of cases, with no evidence of ceiling or floor effects. Its factor structure can be explained in a single dimension. Its discriminating capacity was very good compared to the groups generated by the WOMAC and the EQ-5D-5 L. The correlation of the OKS with the dimensions of the latter questionnaires was around 0.7. The test-retest reliability was excellent (ICC 0.993; CI 95%: 0.990-0.995) and so was its internal consistency (Cronbach's α = 0.920). The effect size was 0.7 for moderate improvements in the HQRL, which is similar to that of the dimensions of the WOMAC and greater than for the EQ-5D-5 L. The minimum clinically significant difference that was detected by the questionnaire was 6.1 points, and the minimum detectable change was 4.4 points. CONCLUSIONS: The Spanish-adapted version of the OKS is a useful, valid tool for assessing the perceived HRQL in patients suffering from knee OA, with psychometric properties similar to the WOMAC, and that allows for discriminating the patient's condition at a particular moment as well as for appraising changes over time.

Cost-of-Illness in Rare Diseases.

Cost-of-illness (COI) studies quantify the economic burden of a disease, including direct healthcare and non-healthcare costs and productivity losses. Different approaches can be adopted to evaluate the resources associated to a disease and to calculate the total costs. Prevalence-based studies estimate the total costs of a disease during a given period, while incidence-based studies measure lifetime costs from onset until death. Data can be collected from individuals, using a bottom-up approach, or from population statistics, using a top-down approach. Different perspectives are possible, but the broadest and also mostly used is the societal one. Appropriate discounting should be applied for future costs and a sensitivity analyses of main parameters should be performed. The main limitation of COI studies is that they don't account the outcomes or benefits of possible treatments.There is a lack of COI studies in the field of rare diseases. A multinational COI study (BURQOL-RD) evaluated recently the burden of 10 rare diseases in Europe, using a prevalence-based method with a bottom-up approach to quantify resources from a societal perspective, which is the mostly used methodology for COI studies in rare diseases; however, several other studies illustrate different approaches to conduct COI analysis in this field, such as incidence-based methods or narrower perspectives.COI studies are useful to inform policy-makers about the magnitude of a disease. To support correctly the decision-making process, it is necessary to identify the cost-drivers through COI studies with robust design and standardized methodology.

METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY.

OBJECTIVES: The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis. METHODS: Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale. RESULTS: All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account. CONCLUSIONS: Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.

Cross-cultural adaptation and validation of the Spanish version of the Oxford Hip Score in patients with hip osteoarthritis.

BACKGROUND: Osteoarthritis (OA) of the hip is a disease that entails a major burden for patients and the society as a whole. One way of measuring this burden for the patient is through impact on Health-related Quality of Life (HRQL). The Oxford Hip Score (OHS) is a well-known tool to measure HRQL in patients with OA of the hip. This study aims to assess the psychometric properties of the Spanish-adapted version of the OHS, including its reliability, validity, and sensitivity to change. METHODS: Prospective observational study that included 361 patients diagnosed with hip OA (according to the criterion of the American College of Rheumatology) from 3 different Spanish regions. Their HRQL was assessed using a generic questionnaire, the EQ-5D-5 L, and two specific ones (the Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC, and the OHS) adapted to Spanish. There was a follow-up period of 6 months, and the acceptability, psychometric properties, presence of ceiling and floor effects, validity, reliability, and sensitivity to changes of the OHS were measured. RESULTS: The OHS was fully answered in 99.4% of cases with no indication of ceiling or floor effects. Its factor structure can be explained in a single dimension. Its discriminative capacity was very good compared to the groups generated by the WOMAC and the EQ-5D-5 L. The correlation between the OHS and dimensions of the WOMAC or EQ-5D-5 L utilities was ≥0.7. Excellent test-retest reliability (ICC = 0.992; CI95%: 0.994-0.998) and internal consistency (Cronbach's α = 0.928) were observed. The minimal clinically important difference (MCID) was 7.0 points, and the minimum detectable change (MDC) was 5.5 points. The effect size for moderate improvement in perceived HRQL was 0.73, similar to that of WOMAC dimensions and higher than the EQ-5D-5 L. CONCLUSIONS: The Spanish-adapted version of the OHS is a useful, acceptable tool for the assessment of perceived HRQL in patients with hip OA, and has psychometric properties similar to those of the WOMAC that allow for discriminating both a patient's condition at a given moment and changes that can occur over time.

On the Estimation of the Cost-Effectiveness Threshold: Why, What, How?

BACKGROUND: Many health care systems claim to incorporate the cost-effectiveness criterion in their investment decisions. Information on the system's willingness to pay per effectiveness unit, normally measured as quality-adjusted life-years (QALYs), however, is not available in most countries. This is partly because of the controversy that remains around the use of a cost-effectiveness threshold, about what the threshold ought to represent, and about the appropriate methodology to arrive at a threshold value. OBJECTIVES: The aim of this article was to identify and critically appraise the conceptual perspectives and methodologies used to date to estimate the cost-effectiveness threshold. METHODS: We provided an in-depth discussion of different conceptual views and undertook a systematic review of empirical analyses. Identified studies were categorized into the two main conceptual perspectives that argue that the threshold should reflect 1) the value that society places on a QALY and 2) the opportunity cost of investment to the system given budget constraints. RESULTS: These studies showed different underpinning assumptions, strengths, and limitations, which are highlighted and discussed. Furthermore, this review allowed us to compare the cost-effectiveness threshold estimates derived from different types of studies. We found that thresholds based on society's valuation of a QALY are generally larger than thresholds resulting from estimating the opportunity cost to the health care system. CONCLUSIONS: This implies that some interventions with positive social net benefits, as informed by individuals' preferences, might not be an appropriate use of resources under fixed budget constraints.

The Minnesota living with heart failure questionnaire: comparison of different factor structures.

BACKGROUND: The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is one of the most widely used health-related quality of life questionnaires for patients with heart failure (HF). It provides scores for two dimensions, physical and emotional, and a total score. However, there are some concerns about its factor structure and alternatives have been proposed, some including a third factor representing a social dimension. The objectives of the present study were to analyze the internal structure of the MLHFQ and the unidimensionality of the total score, and to compare the different factor structures proposed. METHODS: The MLHFQ was given to 2565 patients with HF. The structural validity of the questionnaire was assessed by confirmatory factor analysis (CFA), and Rasch analysis. These two approaches were also applied to the alternative structures proposed. RESULTS: The CFA results for the hypothesized model of two latent factors and the Rasch analysis confirmed the adequacy of the physical and emotional scales. Rasch analysis for the total score showed only two problematic items. The results of the CFA for other two-factor structures proposed were not better than the results for the original structure. The Rasch analyses applied to the different social factors yielded the best results for Munyombwe's social dimension, composed of six items. CONCLUSIONS: Our results support the validity of using the MLHFQ physical, emotional and total scores in patients with HF, for clinical practice and research. In addition, they confirmed the existence of a third factor, and we recommend the use of Munyombwe's social factor.

A prospective study of the association of patient expectations with changes in health-related quality of life outcomes, following total joint replacement.

BACKGROUND: Patient expectations regarding surgery may be related to outcomes in total joint replacement (TJR). The aim of this study was to determine the association of patient expectations with health related quality of life (HRQoL) outcomes measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short Form 12 (SF-12) and satisfaction with current symptoms measured on a 4-point Likert scale, one year after surgery, adjusting for Body Mass Index (BMI), age, gender, joint, education, previous intervention and baseline scores. METHODS: Consecutive patients preparing for TJR of the knee or hip due to primary osteoarthritis (OA) in 15 hospitals in Spain were recruited for the study. Patients completed questionnaires before surgery and 12 months afterwards: five questions about expectations before surgery; an item to measure satisfaction; two HRQoL instruments-WOMAC and SF-12; as well as questions about sociodemographic information. To determine the association of patient expectations at baseline, with changes in HRQoL 12 months after surgery and with satisfaction, general linear models and logistic regression analysis were performed. RESULTS: A total of 892 patients took part in the study. Patients who had higher pain relief or ability to walk expectations improved more in HRQoL at 12 months. Moreover, patients with high daily activity expectations were more satisfied. CONCLUSIONS: Patients with higher baseline expectations for TJR, improved more in HRQoL at one year and had more likelihood to be satisfied than patients with lower expectations, adjusted for BMI, age, gender, joint, education, previous intervention and HRQoL baseline scores.

A study protocol of a comparative mixed study of the T-Control catheter.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterization by a multifactorial approach. The general purpose of this study is to determine the effectiveness, comfort, and experience of the patient catheterized with T-Control® compared with patients with a conventional Foley catheter. Study Design: This trial is a mixed-method study comprising a two-arm, pilot comparative study with random allocation to T-Control catheter or traditional Foley catheter in patients with long-term catheterization and a study with qualitative methodology, through discussion groups. Endpoints: The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) will be analysed as primary endpoints. As secondary endpoints, the following will be analysed: magnitude and rate of infections (symptomatic and asymptomatic); days free of infection; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterization's healthcare resources; and level of satisfaction and workload of health professionals. Patients and Methods: Eligible patients are male and female adults aged ≥18 years, who require a change of long-term bladder catheter. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 4 weeks later, plus the time until the discussion groups take place.

Effectiveness of the T-Control catheter: A study protocol.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach. The general purpose of this study is to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the Foley-type catheter in patients with Acute Urine Retention (AUR). Study design: This is a pragmatic, open, multicentre, controlled clinical trial with random allocation to the T-Control catheter or a conventional Foley-type catheter in patients with AUR. Endpoints: The magnitude of infections will be analysed as a primary endpoint. While as secondary endpoint, the following will be analysed: rate of symptomatic and asymptomatic infections; days free of infection; quality of life-related to self-perceived health; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterisation's healthcare resources; level of satisfaction and workload of health professionals and acceptability of the T-Control device as well as the patient experience. Patients and methods: Eligible patients are male adults aged ≥50 years, with AUR and with an indication of bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 2 weeks later, plus 2 weeks after this time when the patient will be called for an in-depth interview.

[Cost-effectiveness of universal childhood vaccination against hepatitis A in Spain: a dynamic approach]. / Coste-efectividad de la vacunación universal infantil frente a la hepatitis A en España: un enfoque dinámico.

OBJECTIVE: To evaluate the cost-effectiveness of infant universal vaccination against hepatitis A in Spain. METHOD: Using a dynamic model and decision tree model, a cost-effectiveness analysis was performed to compare three vaccination strategies against hepatitis A: non-vaccination strategy versus universal childhood vaccination of hepatitis A with one or two doses. The perspective of the study was that of the National Health System (NHS) and a lifetime horizon was considered. Both costs and effects were discounted at 3% per year. Health outcomes were measured in terms of quality adjusted life years (QALY) and the cost-effectiveness measure used was the incremental cost-effectiveness ratio (ICER). In addition, deterministic sensitivity analysis by scenarios was performed. RESULTS: In the particular case of Spain, with low endemicity for hepatitis A, the difference in health outcomes between vaccination strategies (with 1 or 2 doses) and non-vaccination are practically non-existent, terms of QALY. In addition, the ICER obtained is high, exceeding the limits of willingness to pay from Spain (€22,000-25,000/QALY). The deterministic sensitivity analysis showed that the results are sensitive to the variations of the key parameters, although in no case the vaccination strategies are cost-effective. CONCLUSIONS: Universal infant vaccination strategy against hepatitis A would not be a cost-effective option from the NHS perspective in Spain.