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.

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.

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).

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.

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.

[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.