Long-term cost-effectiveness analysis of sacral neuromodulation in the treatment of severe faecal incontinence.

AIM: The aim of this study was to evaluate the long-term cost-effectiveness of sacral neuromodulation in the treatment of severe faecal incontinence as compared with symptomatic management. METHODS: In the public health field, a micro-costing evaluation method was conducted from the perspectives of the health system and the society. The incremental cost-effectiveness ratio was used as a decision index, and we considered various scenarios to evaluate the impact of the cost of symptomatic management and percutaneous nerve evaluation success rate in its calculation. Clinical data were retrieved from a consecutive cohort of 93 patients with severe faecal incontinence undergoing sacral neuromodulation after a failure of conservative (pharmacological and biofeedback) and/or surgical (sphincteroplasty) first-line treatments were considered. RESULTS: The long-term incremental cost-effectiveness ratio comparing sacral neuromodulation versus symptomatic management was 14347€/QALY and 28523€/QALY from the societal and health service provider's perspectives, respectively. If the definitive pulse generator implant success rate was 100%, incremental cost-effectiveness would correspond to 6831€/QALY and 16761€/QALY, respectively. CONCLUSIONS: Sacral neuromodulation may be considered a cost-effective technique in the long-term treatment of severe faecal incontinence from the societal and health care sector perspectives. Improving patient selection and determining the predictive outcome factors for successful sacral neuromodulation in the treatment of faecal incontinence would improve cost-effectiveness.

Tailoring integrated care services for high-risk patients with multiple chronic conditions: a risk stratification approach using cluster analysis.

BACKGROUND: The purpose of this study was to produce a risk stratification within a population of high-risk patients with multiple chronic conditions who are currently treated under a case management program and to explore the existence of different risk subgroups. Different care strategies were then suggested for healthcare reform according to the characteristics of each subgroup. METHODS: All high-risk multimorbid patients from a case management program in the Navarra region of Spain were included in the study (n = 885). A 1-year mortality risk score was estimated for each patient by logistic regression. The population was then divided into subgroups according to the patients' estimated risk scores. We used cluster analysis to produce the stratification with Ward's linkage hierarchical algorithm. The characteristics of the resulting subgroups were analyzed, and post hoc pairwise tests were performed. RESULTS: Three distinct risk strata were found, containing 45, 38 and 17% of patients. Age increased from cluster to cluster, and functional status, clinical severity, nursing needs and nutritional values deteriorated. Patients in cluster 1 had lower renal deterioration values, and patients in cluster 3 had higher rates of pressure skin ulcers, higher rates of cerebrovascular disease and dementia, and lower prevalence rates of chronic obstructive pulmonary disease. CONCLUSIONS: This study demonstrates the existence of distinct subgroups within a population of high-risk patients with multiple chronic conditions. Current case management integrated care programs use a uniform treatment strategy for patients who have diverse needs. Alternative treatment strategies should be considered to fit the needs of each patient subgroup.

Valuing health using EQ-5D: The impact of chronic diseases on the stock of health.

Chronic diseases strongly affect individuals' health status. In aggregate terms, this impact is reflected by the stock of health, which measures the amount of health of a population in a given period of time. The objectives of this study were to measure the relative burden of chronic illnesses by assessing health-related quality of life using the EQ-5D-5L instrument, to rank diseases according to their associations with the stock of health, and to calculate the stock of health of the Spanish population and the amount of health loss attributable to each chronic disease from a social perspective. Data were gathered from the Spanish Health Survey (ENSE 2011-2012, N = 20,587). A population weighted least squares model was used. Chronic diseases represent 19.19% of the stock of health losses in Spain compared with a country free from those diseases. In Spain, the stock of health in 2011 was 31.86 million units on the visual analog scale. The diseases with the strongest impact in terms of loss of stock of health at the individual level were mental illness and embolism, stroke, or cerebral hemorrhage. Collectively, the diseases with the largest impact included osteoarthritis, arthritis, or rheumatism; chronic back pain; and high blood pressure.

Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial.

BACKGROUND: Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction. METHODS: A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Maïa® prosthesis. Patients, 18 years old and older, with a clinical diagnosis of unilateral or bilateral TMC OA who fulfill the trial's eligibility criteria will be invited to participate. The diagnosis will be made by experienced hand surgeons based on symptoms, clinical history, physical examination, and complementary imaging tests. A total of 106 patients who provide informed consent will be randomly assigned to treatment with APL arthroplasty and prosthetic replacement with Maïa® prosthesis. The participants will complete different questionnaires including EuroQuol 5D-5L (EQ-5D-5L), the Quick DASH, and the Patient Rated Wrist Evaluation (PRWE) at baseline, at 6 weeks, and 3, 6, 12, 24, 36, 48, and 60 months after surgical treatment. The participants will undergo physical examination, range of motion assessment, and strength measure every appointment. The trial's primary outcome variable is the change in the visual analog scale (VAS) from baseline to 12 months. A long-term follow-up analysis will be performed every year for 5 years to assess chronic changes and prosthesis survival rate. The costs will be calculated from the provider's and society perspective using direct and indirect medical costs. DISCUSSION: This is the first randomized study that investigates the effectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Maïa prosthesis. We expect the findings from this trial to lead to new insights into the surgical approach to TMC OA. TRIAL REGISTRATION: ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.

Cost-Utility Analysis of Prostatic Artery Embolization for Treatment of Lower Urinary Tract Symptoms.

PURPOSE: To perform a post hoc cost-utility analysis of a randomized controlled clinical trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP) in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: We conducted a cost-utility analysis over a 5-year period to compare PAE versus TURP from a Spanish National Health System perspective. Data were collected from a randomized clinical trial performed at a single institution. Effectiveness was measured as quality-adjusted life years (QALYs), and an incremental cost-effectiveness ratio (ICER) was derived from the cost and QALY values associated with these treatments. Further sensitivity analysis was performed to account for the impact of reintervention on the cost-effectiveness of both procedures. RESULTS: At the 1-year follow-up, PAE resulted in mean cost per patient of €2904.68 and outcome of 0.975 QALYs per treatment. In comparison, TURP had cost €3846.72 per patient and its outcome was 0.953 QALYs per treatment. At 5 years, the cost for PAE and TURP were €4117.13 and €4297.58, and the mean QALY outcome was 4.572 and 4.487, respectively. Analysis revealed an ICER of €2121.15 saved per QALY gained when comparing PAE to TURP at long-term follow-up. Reintervention rate for PAE and TURP was 12% and 0%, respectively. CONCLUSIONS: Compared to TURP, in short term, PAE could be considered a cost-effective strategy within the Spanish healthcare system for patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia. However, in long term, the superiority is less apparent due to higher reintervention rates.

Epilepsy-Related Direct Medical and Direct Non-Medical Cost in Adult Patients Living with Epilepsy at a Tertiary Neurology Center in Rwanda.

Objective: Up to one in four patients living with epilepsy (PwE) mentions financial constraints as a reason for loss to follow-up at the Ndera tertiary neuropsychiatry hospital. Therefore, we evaluated the annual direct medical cost (DMC) and direct non-medical cost (DnMC) of epilepsy and calculated costs assuming different follow-up frequency. Materials and Methods: DMC data were obtained from a descriptive retrospective study of medical records, pharmacy dispensation and hospital logs of PwE, following their initial consultation in 2018 and who adhered to the normal clinical practice of monthly consultations for one year. DnMC data were collected through structured interviews of PwE in a cross-sectional cohort in August 2020. DnMC included biomedical care costs (eg, transportation, hospitality) and non-biomedical costs (traditional healer visits). We report weighted means for total costs, health insurance costs, and out-of-pocket costs (OoP). Results: Mean annual total cost was 389.4 US$, of which 226.2 US$ was covered by the Rwandan Health Insurance co-payment for DMC and 163.2 US$ was OoP paid by patients. Mean weighted annual DMC (n = 55) was 248.9 US$. Mean weighted annual DMC for medical consultations and antiseizure medication accounted for 30.7 US$ and 161.7 US$, respectively. Based on structured interviews (n = 69), mean weighted annual DnMC for biomedical care was 73.0 US$. Mean DnMC for traditional healer care was 67.6 US$. Weighted annual total OoP was 163.2 US$ or 20% of the GDP per capita. OoP consisted of 14% DMC co-payment, 45% biomedical DnMC, and 41% traditional healer DnMC. Conclusion: Epilepsy-related costs at a tertiary center are an important economic burden for PwE and Rwandan Health Insurance. Biomedical and traditional healer DnMC constitute 86% of total OoP. Future prospective studies should evaluate outcomes and costs of reduced visit frequency, indirect costs, and costs of comorbidities.

The cost of generalized anxiety disorder in primary care settings: results of the ANCORA study.

To assess the cost of illness of generalized anxiety disorder (GAD) in a primary healthcare setting in Spain. A cross-sectional, retrospective study was conducted. The sample comprised patients diagnosed with GAD according to ICD-10 criteria and a control group. Healthcare/non-healthcare resource utilization was recorded retrospectively for the 12 months prior to the study visit. Costs were estimated from a societal perspective. Two models have been produced to study the variables that influence the cost of the illness both, without and with controls. The study enrolled 456 patients [76.8 % women, 49.2 (17.0) years] with GAD and 74 controls without GAD [42.5 % women, 47.9 (16.7) years]. 67.8 % of subjects were on combination therapy (antidepressant + anxiolytic); 6 % were using 2 or more drugs to treat anxiety; and 23.4 % were on monotherapy. Total annual average costs were higher in the GAD group (€7,739 vs. €2,609), with mean costs attributable to GAD of €5,139 (healthcare costs: €1,329, indirect costs: 75 % of total cost, approximately). Age and health status measured by Hamilton Anxiety Rating Scale and clinical global impression were related to costs. The improvements in quality of life measured by EQ-5D index are associated to lower cost. GAD treated in Spanish primary healthcare settings generated considerable healthcare costs and, particularly, loss-of-productivity costs.

Multisystem chronic illness prognostication in non-oncologic integrated care.

OBJECTIVES: To develop a mortality-predictive model for correct identification of patients with non-cancer multiple chronic conditions who would benefit from palliative care, recognise predictive indicators of death and provide with tools for individual risk score calculation. DESIGN: Retrospective observational study with multivariate logistic regression models. PARTICIPANTS: All patients with high-risk multiple chronic conditions incorporated into an integrated care strategy that fulfil two conditions: (1) they belong to the top 5% of the programme's risk pyramid according to the adjusted morbidity groups stratification tool and (2) they suffer simultaneously at least three selected chronic non-cancer pathologies (n=591). MAIN OUTCOME MEASURE: 1 year mortality since patient inclusion in the programme. RESULTS: Among study participants, 201 (34%) died within the 1 year follow-up. Variables found to be independently associated to 1 year mortality were the Barthel Scale (p<0.001), creatinine value (p=0.032), existence of pressure ulcers (p=0.029) and patient global status (p<0.001). The area under the curve (AUC) for our model was 0.751, which was validated using bootstrapping (AUC=0.751) and k-fold cross-validation (10 folds; AUC=0.744). The Hosmer-Lemeshow test (p=0.761) showed good calibration. CONCLUSIONS: This study develops and validates a mortality prediction model that will guide transitions of care to non-cancer palliative care services. The model determines prognostic indicators of death and provides tools for the estimation of individual death risk scores for each patient. We present a nomogram, a graphical risk calculation instrument, that favours a practical and easy use of the model within clinical practices.

Economic burden of long-term treatment of severe fecal incontinence.

INTRODUCTION: Find out the long-term economic cost associated with the treatment of severe fecal incontinence by SNS versus symptomatic conservative treatment and definitive colostomy. METHODS: Detailed descriptive study of the costs of the healthcare process (interventions, consultations, devices, complementary tests, hospitalization, etc.) of 3 treatment alternatives for fecal incontinence using analytical accounting tools of the Health Service based on clinical activity data. The frequency of use of health resources or the quantity of products dispensed in pharmacies (medication, diapers, ostomy material, etc.) was estimated in each case. Costs derived from adverse situations were included. Patients with severe fecal incontinence, defined by a score greater than 9 on the Wexner severity scale, in whom first-line treatments had failed, were included. Data from a consecutive cohort of 93 patients who underwent an SNS between 2002 and 2016 were used; patients who underwent definitive colostomy (n=2); parastomal hernia (n=3); and colostomy stenosis (n=1). RESULTS: The mean cumulative cost in 10 years per patient in each alternative was: € 10,972.9 symptomatic treatment (62% diapers); € 17,351.57 SNS (95.83% interventions; 81.6% devices); € 25,858.54 definitive colostomy (70.4% ostomy material and accessories). CONCLUSIONS: Management of severe fecal incontinence implies a great burden in economic terms. The colostomy is the alternative that generates the most direct cost, followed by SNS and symptomatic treatment.

Prostatic Artery Embolization Versus Transurethral Resection of the Prostate: A Post Hoc Cost Analysis of a Randomized Controlled Clinical Trial.

PURPOSE: To perform a post hoc analysis of patient-incurred costs in a randomized controlled clinical trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP). MATERIALS AND METHODS: Patients older than 60 years with indication of TURP were randomized to PAE or TURP procedure. After intervention and hospital discharge, patients were follow-up during 12 months The associated patient costs were categorized according to the study period: pre-intervention, intervention, hospitalization, and follow-up. Several items for both groups were analyzed within each study period. RESULTS: The mean total costs per patient were lower for PAE (€ 3,192.87) than for TURP (€ 3,974.57), with this difference of € 781.70 being significant (p = 0.026). For most evaluated items, the mean costs were significantly higher for TURP. No significant differences were observed in the mean costs of PAE (€ 1,468.00) and TURP (€ 1,684.25) procedures (p = 0.061). However, the histopathology analysis, recovery room stay, and intraoperative laboratory analysis increased the interventional costs for TURP (€ 1,999.70) compared with PAE (€ 1,468.00) (p < 0.001). No cost differences were observed between PAE (€ 725.26) and TURP (€ 556.22) during the 12 months of follow-up (p = 0.605). None of patients required a repeat intervention during the study period. CONCLUSIONS: Considering the short-term follow-up, PAE was associated with significantly lower costs compared with TURP. Future investigations in the context of routine clinical practice should be aimed at comparing the long-term effectiveness of both procedures and determining their cost-effectiveness. LEVEL OF EVIDENCE: Level 1 (a-c).

Economic burden of long-term treatment of severe fecal incontinence. / Impacto económico del tratamiento a largo plazo de la incontinencia fecal grave.

INTRODUCTION: Find out the long-term economic cost associated with the treatment of severe fecal incontinence by SNS versus symptomatic conservative treatment and definitive colostomy. METHODS: Detailed descriptive study of the costs of the healthcare process (interventions, consultations, devices, complementary tests, hospitalization, etc.) of 3 treatment alternatives for fecal incontinence using analytical accounting tools of the Health Service based on clinical activity data. The frequency of use of health resources or the quantity of products dispensed in pharmacies (medication, diapers, ostomy material, etc.) was estimated in each case. Costs derived from adverse situations were included. Patients with severe fecal incontinence, defined by a score greater than 9 on the Wexner severity scale, in whom first-line treatments had failed, were included. Data from a consecutive cohort of 93 patients who underwent an SNS between 2002 and 2016 were used; patients who underwent definitive colostomy (n=2); parastomal hernia (n=3), and colostomy stenosis (n=1). RESULTS: The mean cumulative cost in 10 years per patient in each alternative was: € 10,972.9 symptomatic treatment (62% diapers); € 17,351.57 SNS (95.83% interventions; 81.6% devices); € 25,858.54 definitive colostomy (70.4% ostomy material and accessories). CONCLUSIONS: Management of severe fecal incontinence implies a great burden in economic terms. The colostomy is the alternative that generates the most direct cost, followed by SNS and symptomatic treatment.

Real-World Budget Impact of the Adoption of Insulin Glargine Biosimilars in Primary Care in England (2015-2018).

BACKGROUND: Lantus, the reference insulin glargine used for the treatment of diabetes, lost its patent protection in 2014, opening the market to biosimilar competitors. OBJECTIVE: First, to analyze the adoption rates of insulin glargine biosimilars in primary care in England and estimate the savings realized and missed, since an insulin glargine biosimilar was first used, and second, to assess potential variations in adoption rates across Clinical Commissioning Groups (CCGs). RESEARCH DESIGN AND METHODS: Data sets capturing information on all insulin glargine items prescribed by all general practitioners up to December 2018 were used. Total costs of insulin glargine and uptake rates of biosimilars were calculated. The real-world budget impact was estimated assuming the cost of reference insulin glargine for all items and comparing the total costs in this scenario with the total costs in the real world. The missed savings were estimated assuming the cost of biosimilars for all insulin glargine items. Choropleth maps were generated to assess potential variations in uptake across CCGs. RESULTS: Insulin glargine biosimilars generated savings of £900,000 between October 2015 (time of first prescription) and December 2018. The missed savings amounted to £25.6 million in this period, indicating that only 3.42% of the potential savings were achieved. The analyses demonstrated a large level of variation in the uptake of insulin glargine biosimilars across CCGs, with market shares ranging from 0 to 53.3% (December 2018). CONCLUSIONS: These results may encourage decision makers in England to promote the use of best-value treatments in primary care and to reevaluate variation across CCGs.

Inequalities in prescription rates of anti-osteoporosis drugs in primary care in England: A practice-level prescribing data analysis in 2013-2018.

OBJECTIVE: To investigate potential variations in prescription rates of anti-osteoporosis drugs at the general practitioner (GP) practice level in England, analysing associations of prescription rates with key demographic and socio-economic variables, and its evolution over time. METHODS: A retrospective database analysis was conducted using prescription data from all GP practices in England between April 2013 and September 2018. Potential associations between prescription rates and other variables (sex, age, ethnicity, rural-urban classification and income deprivation) were analysed using mixed-effects Poisson regressions and concentration indices. RESULTS: Alendronic acid was the most frequently prescribed anti-osteoporosis drug. Exploratory and regression analyses showed the association between GP prescriptions and the characteristics of the population they serve. Income deprivation had a statistically significant and negative effect on prescription levels of alendronic acid, denosumab, ibandronic acid and risedronate sodium. Since 2013, denosumab prescriptions exhibited a steep surge in the least income-deprived areas, compared with a modest rise in the most income-deprived areas. Concentration indices indicated a disproportionate concentration of denosumab and, to a lesser extent, ibandronic acid prescriptions among the least income-deprived. The analyses demonstrated that different prescribing behaviours may exist across GPs according to the Clinical Commissioning Group (CCG) to which they belong. CONCLUSIONS: Variation in the prescription of anti-osteoporosis drugs exists across GPs and CCGs in England, this being more prominent for certain drugs (e.g. denosumab) compared with others (e.g. alendronic acid). Inequalities exist in English primary healthcare and we advocate our findings could support the efforts of decision-makers towards a more equitable system.

Cost-effectiveness of a collaborative care program for managing major depression and chronic musculoskeletal pain in primary care: Economic evaluation alongside a randomized controlled trial.

BACKGROUND: We designed a collaborative care program for the integrated management of chronic musculoskeletal pain and depression, which frequently coexist in primary care patients. The aim of this study was to evaluate the cost-effectiveness of this program compared with care as usual. METHODS: We performed a cost-effectiveness analysis alongside a randomized clinical trial. Results were monitored over a 12-month period. The primary outcome was the incremental cost-effectiveness ratio (ICER). We performed cost-effectiveness analyses from the perspectives of the healthcare system and society using an intention-to-treat approach with imputation of missing values. RESULTS: We evaluated 328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline. From the healthcare system perspective, the mean incremental cost was €234 (p = .17) and the mean incremental effectiveness was 0.009 QALYs (p = .66), resulting in an ICER of €23,989/QALY. Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY. These estimates were associated with a high degree of uncertainty illustrated on the cost-effectiveness plane. CONCLUSIONS: Contrary to our expectations, the collaborative care program had no significant effects on health status, and although the additional costs of implementing the program compared with care as usual were not high, we were unable to demonstrate a favorable cost-effectiveness ratio, largely due to the high degree of uncertainty surrounding the estimates.

Cancer Clinical Trials: Treatment Costs Associated With a Spanish National Health System Institution.

BACKGROUND: Clinical trials should be part of routine health care. There is a common perception that enrolling patients into clinical trials results in additional costs. We conducted a retrospective cost analysis to compare medical costs attributable to participation in cancer treatment trials versus standard of care in a single Spanish institution. METHODS: Patients recruited into cancer clinical trials between 2014 and 2016 were selected. Each research protocol was reviewed to identify trial-associated medical procedures and costs, as well as the equivalent care had the patient not been entered in the trial. Treatment cost difference was the difference between the cost of the clinical trial and that of the standard of care. RESULTS: A total of 68 adult patients were treated in 20 different clinical trials. The overall cost treatment of the patients included in the trials was 79% lower in comparison to the standard of care. However, the load of medical procedures was 32% higher. The average treatment cost per patient and protocol ranged from an excess of €8193 to a saving of €59,770. CONCLUSIONS: There is a wide range of difference in treatment costs for cancer clinical trial participants versus standard of care. Commercial trial protocols were associated with larger savings compared with the noncommercial ones, even though these may involve excess treatment costs. Overall, clinical trials provide not only the best context for progress of clinical research and health care but also creates opportunities for reducing cancer care costs.

[Economic tools to prioritize patients on the waiting list: discrete choice experiments]. / Instrumentos económicos para la priorización de pacientes en lista de espera: la aplicación de modelos de elección discreta.

OBJECTIVES: To identify which clinical and social characteristics should be used to prioritize patients on the waiting list for elective surgical procedures. METHODS: A discrete choice experiment (DCE) was conducted using a representative sample of the general population in Navarre (Spain). The sample was selected through simple random sampling by age and sex quotas, stratified by the areas and municipalities of residence of the population aged more than 18 years old. Data were analyzed using Bayesian methods. RESULTS: The relative weights of attributes show that the most important attributes when prioritizing patients were the disease, the cost of the intervention, and waiting time. As expected, severity of illness was the most important attribute and, contrary to prior expectations, improvements in health were considered less important. These findings show that prioritization according to waiting time alone may not take into account other issues considered important by the general public. CONCLUSIONS: Patients should not be prioritized according to waiting time only. An interesting finding that should be analyzed in future is that cost was considered an important prioritization criterion. This study provides a further example of the potential of DCE in health economics. If its limitations are borne in mind, this tool may be useful to develop prioritization scoring systems for patients on waiting lists.

Cost-effectiveness analysis of a collaborative care programme for depression in primary care.

BACKGROUND: Collaborative care programmes lead to better outcomes in the management of depression. A programme of this nature has demonstrated its effectiveness in primary care in Spain. Our objective was to evaluate the cost-effectiveness of this programme compared to usual care. METHODS: A bottom-up cost-effectiveness analysis was conducted within a randomized controlled trial (2007-2010). The intervention consisted of a collaborative care programme with clinical, educational and organizational procedures. Outcomes were monitored over a 12 months period. Primary outcomes were incremental cost-effectiveness ratios (ICER): mean differences in costs divided by quality-adjusted life years (QALY) and mean differences in costs divided by depression-free days (DFD). Analyses were performed from a healthcare system perspective (considering healthcare costs) and from a society perspective (including healthcare costs plus loss of productivity costs). RESULTS: Three hundred and thirty-eight adult patients with major depression were assessed at baseline. Only patients with complete data were included in the primary analysis (166 in the intervention group and 126 in the control group). From a healthcare perspective, the average incremental cost of the programme compared to usual care was €182.53 (p<0.001). Incremental effectiveness was 0.045 QALY (p=0.017) and 40.09 DFD (p=0.011). ICERs were €4,056/QALY and €4.55/DFD. These estimates and their uncertainty are graphically represented in the cost-effectiveness plane. LIMITATIONS: The amount of 13.6% of patients with incomplete data may have introduced a bias. Available data about non-healthcare costs were limited, although they may represent most of the total cost of depression. CONCLUSIONS: The intervention yields better outcomes than usual care with a modest increase in costs, resulting in favourable ICERs. This supports the recommendation for its implementation.

Cost-effectiveness analysis of the surgical treatment of female urinary incontinence using slings and meshes.

OBJECTIVE: To determine the cost-utility and cost-effectiveness of the surgical treatment of female urinary incontinence using suburethral slings and prolapse meshes compared with therapeutic abstention. STUDY DESIGN: An economic analysis was performed on 69 women receiving surgical treatment for urinary incontinence using suburethral slings and prolapse meshes. To calculate the procedure's cost-effectiveness, an incremental analysis up to one year was performed using the incremental cost-effectiveness ratio (ICER). The costs were calculated using a cost-by-process model. Answers to the health-related quality of life questionnaires EQ-5D (generic) and International Consultation Incontinence Questionnaire Short-form (specific) were collected before the operation and as well as one month and one year post-operation to calculate the utility, using quality-adjusted life years (QALY), and the effectiveness, respectively. To complete the economic evaluation, we derived confidence ellipses and acceptability curves. The analysis was conducted for the entire sample and also for each type of urinary incontinence. RESULTS: In total, 45 women presented with stress incontinence, 15 with mixed incontinence and 9 with incontinence associated with prolapse. The average cost per patient at one year post-operation was 1220 €. The QALY achieved at one year was 0.046. The results reveal an ICER at one year of 26,288 €/QALY, which is below the cost-effectiveness threshold considered acceptable, and this value was lower for stress incontinence (21,191 €/QALY). The cost-effectiveness was 106.5 €/International Consultation Incontinence Questionnaire Short-form unit. CONCLUSION: Surgery for female urinary incontinence using slings is cost-effective compared with abstention in our public health environment.

Measuring health-related quality of life in drug clinical trials: is it given due importance?

AIM OF THE REVIEW: Efficacy estimations of drug clinical trials have been based on clinical measurements and survival rates. However, advances in psychometric techniques have allowed to incorporate a new dimension based on quality of life. Questionnaires aimed at measuring patients' health status outlook, now enable us to quantify the loss of quality of life caused by disease and the improvement that can be achieved by pharmacological treatments. The Aim of this study is to make a quantitative evaluation of the use of health related quality of life (HRQL) measures in drug clinical trials. METHODS: A systematic review was performed, in duplicate, of the five journals with highest contribution to the ACP Journal Club, i.e. New England Journal of Medicine, JAMA, The Lancet, Annals of Internal Medicine and the British Medical Journal. HRQL measures were evaluated in published articles referring to drug clinical trials. RESULTS: We identified 193 articles that reported the results of clinical trials, of which 28 included QOL measures as secondary end points and two as primary end points: in total, these comprised 16% of the articles analysed. Discussion Without considering the relevance of HRQL measures as a tool in the allocation of resources, it should be included as a health outcome dimension in drug clinical trials. The absence of this evaluation in studies about chronic diseases that affects patients' daily life activities would not be justified. CONCLUSIONS: HRQL measures are not used on a regular basis in drug clinical trials that are reported in the relevant literature. Systematic incorporation of QOL measures into clinical trials would make it possible to measure the benefit obtained from drug treatments taking into account the patients' perceptions. Moreover, it would encourage the development of prospective cost-effectiveness studies with patient recorded data in the context of clinical trials. Our findings have a direct impact on practice. Being conscious of the low use of HRQL in clinical trials, it could contribute to increase the demand for these measures by health care professionals. The manuscript is also a useful tool to identify where basic concepts about HRQL measures can be found.