Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

Systematic review on abdominal aortic aneurysm screening cost-efficiency and methodological quality assessment.

INTRODUCTION: Abdominal aortic aneurysm (AAA) is a silent, progressive disease that can lead to death. It is easily diagnosed with noninvasive methods and its routine treatment has excellent results. This creates an optimal situation for population screening programs. The aim of this paper was to assess results and methodological quality of cost-utility studies on screening versus no screening scenarios for AAA to assess future establishment of new AAA screening programs. EVIDENCE ACQUISITON: A systematic review of efficiency (cost-effectiveness and cost-utility) studies was performed, finally selecting cost-utility studies on AAA screening versus no screening. Papers were selected that dealt with efficiency of screening for AAA according to PICOTS framework and the methodological quality assessed according to the economic evaluation analyses described by Drummond and Caro. Two independent reviewers were involved in the procedure. EVIDENCE SYNTHESIS: Research retrieved 88 studies. From those, 26 showed cost-effectiveness and cost-utility results. Finally, 10 studies had cost-utility results and suited criteria (published in the last 10 years; time-horizon: 10 years or more) for exhaustive analysis. All publications, except one, showed adequate incremental cost-utility ratios according to different national perspectives. Methodological assessment showed some quality limitations, but the majority of items analyzed were favorably answered after applying the questionnaires. CONCLUSIONS: Confirmation of the cost-utility results in this revision at a national/regional level should be the basis for the implantation of new national screening programs worldwide. The methodological evaluation applied in this revision is crucial for the corresponding future piggy-back trials to assess routine application of national AAA screening programs.

[Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact]. / Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad.

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio.

Cost-Effectiveness of the Screening for the Primary Prevention of Fragility Hip Fracture in Spain Using FRAX®.

To assess the cost-effectiveness of the primary prevention of fragility hip fractures through opportunistic risk-based screening using FRAX® among women aged 70 to 89 years, and the subsequent treatment with alendronate in women at high-risk, from the Spanish national health system perspective. We performed a discrete-event simulation model. Women were categorized in low, intermediate and high-risk of fragility hip fracture through screening based on the FRAX® risk assessment tool score (Spanish version). Low-risk women received lifestyle recommendations whereas the high-risk group was assigned to alendronate treatment. For women at intermediate-risk, treatment decision was based on a recalculated score considering bone mineral density (BMD). The cost-effectiveness analysis tested six scenarios defined by different FRAX® cut-off values assessing the incremental costs per averted fracture in 20 years. Deterministic sensitivity analysis was performed. We included a random sample of 5146 women obtained from a Spanish cohort of women referred for BMD. The most cost-effective intervention had an Incremental Cost-effectiveness Ratio (ICER) of 57,390 € per averted hip fracture and consisted of using the FRAX® score without BMD and treating women with a score higher than 5%. The ICER exceeded the acceptability threshold of 25,000 € in all the scenarios. Sensitivity analysis based on time to fracture, treatment efficacy, adherence to treatment and cost of dependence resulted in ICERs ranging from 39,216 € to 254,400 €. An ICER of 24,970 € was obtained when alendronate cost was reduced to 1.13 € per month. The use of FRAX® as screening tool followed by alendronate treatment is not cost-effective in senior women in Spain. Other primary preventions strategies are advisable.

Availability of specific tools to assess patient reported outcomes in hip arthroplasty in Spain. Identifying the best candidates to incorporate in an arthroplasty register. A systematic review and standardized assessment.

PURPOSE: 1) To systematically review the available scientific literature regarding specific instruments developed and/or tested in a Spanish population, to assess these PROMs in hip arthroplasty; 2) to carry out a standardized assessment of their measurement properties; and 3) to identify the best tools for use in Spain in an arthroplasty registry context. METHODS: A systematic review of PubMed/MEDLINE and EMBASE and CINHAL was done. Furthermore, a standardized assessment of the questionnaires identified using the Evaluating the Measurement of Patient-Reported Outcomes (EMPRO) tool was performed. All developments, validation and studies aiming to assess the measurement properties of PROMs in hip arthroplasty in the Spanish population were included. Data from the questionnaires on metric properties was taken into account to identify the best candidates for inclusion in a register. RESULTS: A total of 853 documents were found. After screening title and abstract, 13 full text documents were reviewed and 8 questionnaires adapted and validated to assess some of the aspects of hip arthroplasty in the Spanish population were identified. After the EMPRO assessment, 4 questionnaires showed suitable properties (WOMAC, OAKHQOL, mini-OAKHQOL and PFH). CONCLUSIONS: In Spain, there are a few suitable hip-specific questionnaires currently available to assess PROMs in hip arthroplasty surgery. Some of the more widely used questionnaires, like the OHS and HOOS, have not been validated in the Spanish population until now. Identified tools are suitable for use in a clinical context, however their use in an arthroplasty register is more questionable due to the lack of validation studies of the widely used tools in other registers.

The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).

Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.

Toward a Strategy to Involve Patients in Health Technology Assessment in Spain.

OBJECTIVES: The aim of this study was to develop a feasible and effective strategy to involve patients in the Spanish Network of Agencies of Health Technology Assessment (RedETS). METHODS: The framework for patient involvement (PI) in the assessment activities and processes of RedETS were developed through a research project that included: (i) a systematic search of the international literature describing a strategy and/or a methodology linking health technology assessment (HTA) and PI; (ii) a qualitative study through interviews with RedETS members to analyze the perceptions of PI among HTA managers in the Spanish context; (iii) a Delphi consultation with three large platforms of patients, carers and consumer organizations in Spain about their perspectives of PI; (iv) a consensus process with the members of the RedETS Governing Council to define the final strategy. RESULTS: Three main themes were identified in the literature and Web site review: (i) PI methods for the different HTA phases; (ii) Participant definition and selection; (iii) Resources needed. A three-step implementation strategy was proposed: (i) short-term actions: piloting and testing patient participation in HTA and building patients' capacity; (ii) medium-term actions: broadening the participation of patients, and building internal capacity; (iii) long-term actions: consolidating and mainstreaming patient involvement CONCLUSIONS: Patient participation can be incorporated into almost all the HTA phases and products with greater or lesser degrees of difficulty. However, a progressive implementation strategy is suggested for a feasible PI process.

mHealth Assessment: Conceptualization of a Global Framework.

BACKGROUND: The mass availability and use of mobile health (mHealth) technologies offers the potential for these technologies to support or substitute medical advice. However, it is worrisome that most assessment initiatives are still not able to successfully evaluate all aspects of mHealth solutions. As a result, multiple strategies to assess mHealth solutions are being proposed by medical regulatory bodies and similar organizations. OBJECTIVE: We aim to offer a collective description of a universally applicable description of mHealth assessment initiatives, given their current and, as we see it, potential impact. In doing so, we recommend a common foundation for the development or update of assessment initiatives by addressing the multistakeholder issues that mHealth technology adds to the traditional medical environment. METHODS: Organized by the Mobile World Capital Barcelona Foundation, we represent a workgroup consisting of patient associations, developers, and health authority representatives, including medical practitioners, within Europe. Contributions from each group's diverse competencies has allowed us to create an overview of the complex yet similar approaches to mHealth evaluation that are being developed today, including common gaps in concepts and perspectives. In response, we summarize commonalities of existing initiatives and exemplify additional characteristics that we believe will strengthen and unify these efforts. RESULTS: As opposed to a universal standard or protocol in evaluating mHealth solutions, assessment frameworks should respect the needs and capacity of each medical system or country. Therefore, we expect that the medical system will specify the content, resources, and workflow of assessment protocols in order to ensure a sustainable plan for mHealth solutions within their respective countries. CONCLUSIONS: A common framework for all mHealth initiatives around the world will be useful in order to assess whatever mHealth solution is desirable in different areas, adapting it to the specifics of each context, to bridge the gap between health authorities, patients, and mHealth developers. We aim to foster a more trusting and collaborative environment to safeguard the well-being of patients and citizens while encouraging innovation of technology and policy.

[Development of a Conceptual Framework for the Assessment of Chronic Care in the Spanish National Health System]. / Desarrollo de un marco conceptual para la evaluación de la atención a la cronicidad en el sistema nacional de salud.

The aim was to develop a conceptual framework for the assessment of new healthcare initiatives on chronic diseases within the Spanish National Health System. A comprehensive literature review between 2002 and 2013, including systematic reviews, meta-analysis, and reports with evaluation frameworks and/or assessment of initiatives was carried out; integrated care initiatives established in Catalonia were studied and described; and semistructured interviews with key stakeholders were performed. The scope and conceptual framework were defined by using the brainstorming approach.Of 910 abstracts identified, a total of 116 studies were included. They referred to several conceptual frameworks and/or assessment indicators at a national and international level. An overall of 24 established chronic care initiatives were identified (9 integrated care initiatives); 10 in-depth interviews were carried out. The proposed conceptual framework envisages: 1)the target population according to complexity levels; 2)an evaluation approach of the structure, processes, and outcomes considering the health status achieved, the recovery process and the maintenance of health; and 3)the dimensions or attributes to be assessed. The proposed conceptual framework will be helpful has been useful to develop indicators and implement them with a community-based and result-oriented approach and a territorial or population-based perspective within the Spanish Health System. This will be essential to know which are the most effective strategies, what are the key elements that determine greater success and what are the groups of patients who can most benefit.

El objetivo del trabajo fue desarrollar un marco conceptual para la evaluación de nuevos programas de gestión clínica y asistencial de carácter integrado en el Sistema Nacional de Salud para la atención a las personas con enfermedades crónicas. Se realizó una revisión exhaustiva de la literatura entre 2002-2013 incluyendo revisiones sistemáticas, metaanálisis e informes con modelos de evaluación y/o evaluaciones de programas. Se estudiaron y describieron programas locales de atención a la cronicidad implementados en Cataluña y se realizaron entrevistas semiestructuradas con expertos clave en el ámbito catalán. El alcance y el marco conceptual se definieron mediante la técnica del brainstorming. De 910 resúmenes identificados, se incluyeron 116 documentos que se referían a marcos conceptuales e indicadores de evaluación a nivel español e internacional. Se identificaron 24 programas de atención a la cronicidad (9 de carácter integrado). El marco conceptual propuesto contempló: 1) la población diana según niveles de complejidad; 2) un enfoque de evaluación de la estructura, procesos y resultados teniendo en cuenta el estado de salud conseguido, el proceso de recuperación y mantenimiento de la salud; y 3) las dimensiones o atributos que se deben evaluar. El marco conceptual propuesto permite desarrollar indicadores e implementarlos con un enfoque comunitario, orientados a los resultados y tener una visión territorial o poblacional, que será imprescindible para saber cuál es la estrategia más efectiva, cuáles son los elementos que determinan un mayor éxito y cuáles son los grupos de pacientes que más se pueden beneficiar.

Variability in home mechanical ventilation prescription.

INTRODUCTION: Few studies have analyzed the prevalence and accessibility of home mechanical ventilation (HMV). The aim of this study was to characterize the prevalence of HMV and variability in prescriptions from administrative data. METHODS: Prescribing rates of HMV in the 37 healthcare sectors of the Catalan Health Service were compared from billing data from 2008 to 2011. Crude accumulated activity rates (per 100,000 population) were calculated using systematic component of variation (SCV) and empirical Bayes (EB) methods. Standardized activity ratios (SAR) were described using a map of healthcare sectors. RESULTS: A crude rate of 23 HMV prescriptions per 100,000 population was observed. Rates increase with age and have increased by 39%. Statistics measuring variation not due to chance show a high variation in women (CSV=0.20 and EB=0.30) and in men (CSV=0.21 and EB=0.40), and were constant over time. In a multilevel Poisson model, hospitals with a chest unit were associated with a greater number of cases (beta=0.68, P<.0001). CONCLUSIONS: High variability in prescribing HMV can be explained, in part, by the attitude of professionals towards treatment and accessibility to specialist centers with a chest unit. Analysis of administrative data and variability mapping help identify unexplained variations and, in the absence of systematic records, are a feasible way of tracking treatment.

[Estimating the burden of disease due to permanent disability in Spain during the period 2009-2012]. / Estimación de la carga de enfermedad por incapacidad laboral permanente en España durante el período 2009-2012.

BACKGROUND: Permanent disability (PD) is a major social and economic burden. The aim of this study was to determine the burden of disease due to PD. METHODS: Using data from the Continuous Working Life Sample (CWLS) -a random sample consisting of 4% of the active members affiliated to the Social Security (SS) System in Spain (1.1 million members) which data come from administrative registries from the SS- the diagnosis of PD (2009-2012) was established from the information on the temporary sickness absence (TSA) episodes from 2009. The diagnoses were imputed if two criteria were fulfilled: long duration of TSA and short period of time between the TSA episode and PD. The burden of disease was estimated for cases with an established diagnosis of PD by using the potential years of working life lost (PYWLL), estimated as the difference between the legal retirement age (65 years) and the age at the start of a PD. RESULTS: In the CWLS, 163,135 (13.6%9 individuals suffered a TSA episode in 2009, out of which 4,738 were granted a PD pension in the period of 2009-2012. The diagnosis was established for 3,073 (64.9%) cases. A large percentage of PD was produced by musculoskeletal (27.4%) and mental disorders (11.6%), likewise these diagnoses produced more PYWLL due to a PD: 11,086 (26.5%) and 7,052 (16.9%), respectively. Mental disorders produced PD at younger ages (median= 49 years of age). CONCLUSION: Mental and musculoskeletal disorders represent a major burden of disease produced by PD and measured by PYWLL. The diagnoses of PD should become available in order to estimate with more accuracy the PYWLL produced by PD and specific diagnoses.

[The value of using administrative data in public health research: the Continuous Working Life Sample]. / La utilidad del uso de datos administrativos en la investigación de salud pública: la Muestra continua de vidas laborales.

The use of administrative data is common practice in public health research. The present field note describes the Continuous Working Life Sample (CWLS) and its use in health research. The CWLS is built on records generated by all contacts with the social security system (work contracts, disability, etc.), plus tax data (monetary gains, income, etc.) and census data (level of education, country of birth, etc.), but does not allow individuals to be identified. The CWLS was started in 2004 with 4% (1.1 million persons) of the total population who were either contributors to or beneficiaries of the social security system. The information on the individuals in the CWLS is updated annually and lost individuals are replaced. This continuous design allows the construction of a cohort with information on working life and financial status and evaluation of their relationship with work disability. Future connection with clinical records would enable analysis of other health-related outcomes.

Developing a universal tool for the prioritization of patients waiting for elective surgery.

The objective was to elaborate a priority scoring system for patients on waiting lists for elective surgery to be implemented in the Catalan public health system. This tool should ideally be universal (for all patients and across the entire region) with common criteria and weights (for all surgical procedures), simple and user-friendly. A tool based on a point-count linear scale ranging from 0 (lowest priority) to 100 (highest priority) was developed. Patients are scored in three major dimensions: clinical and functional impairment, expected benefit, and social role, which include 8 criteria (with their weights): disease severity (23%), pain (or other main symptoms) (14%), rate of disease progression (15%), difficulty in doing activities of daily life (14%), probability and degree of improvement (12%), being dependent with no caregiver (5%), limitation to care for one's dependents (if that be the case) (8%), and limitations in the ability to work, study or seek for employment (9%). As in previous studies developed in Canada, New Zealand and Catalonia, the tool obtained is mainly based on severity and need. The success of this tool depends very much on implementation mechanisms. Furthermore, prior to implementation, a definition of specificities in the selected criteria for the most frequent surgical procedures is advised.

[Development of indicators to evaluate colorectal cancer prevention programs in the high-risk population: the experience of a high-risk colorectal cancer clinic]. / Desarrollo de indicadores para evaluar los programas de prevención del cáncer colorrectal en la población de riesgo alto. La experiencia de la Clínica de Alto Riesgo.

BACKGROUND/OBJECTIVE: In 2006, the High-Risk Colorectal Cancer (CRC) Clinic was set up in Barcelona, a new healthcare model aimed at individuals and/or patients with an increased risk of developing CRC. The aim of this study was to develop a set of indicators to evaluate CRC prevention programs in the high-risk population and to implement them in the CRC to confirm their feasibility and validity in identifying areas for improvement. METHODS: A literature search was performed and consensus techniques were applied with experts linked to the prevention programs in the distinct autonomous regions in Spain to propose a conceptual model for the evaluation and indicators. Users' opinions were introduced through focus groups for the proposed set of indicators. All experts participating in the consensus meetings and Delphi study evaluated the importance of each indicator (from 1 to 10) and their degree of agreement (agree strongly, agree with modifications, or eliminate this indicator). Expert consensus was considered to have been reached when 80% strongly agreed or agreed with the inclusion of the indicator. In the implementation phase, we included users (with advanced colorectal adenocarcinoma, polyposis syndrome, CRC or a familial history of CRC) attending the program. Information was obtained from computerized medical histories and clinical documentation. In addition, health professionals linked to the program were surveyed. To calculate each indicator, its formula was computed and the indicator was then compared with a standard previously agreed on by the experts in the first phase. RESULTS: Expert consensus was reached in 30 indicators. In the implementation phase, 21 feasible indicators that showed the greatest simplicity and validity in identifying areas for improvement were calculated. Of these, two measured aspects related to accessibility, seven measured patient-centered care, five measured continuity of care, one measured patient safety and four evaluated clinical effectiveness. Overall, eight of the 17 indicators achieved the previously agreed standard of quality of care. CONCLUSIONS: The robustness and importance of the proposed set of indicators is supported by the wide participation of experts from distinct specialties and the adequate agreement reached. The present study serves to identify areas for improvement in the program. Periodic measurement of these indicators will allow the changes produced in this program and their utility to be evaluated and will aid assessment of other CRC prevention programs in the high-risk population.

[Health technology assessment in public health interventions: is prevention better than cure?]. / La evaluación de tecnologías sanitarias en intervenciones de salud pública: más vale prevenir que curar?

Medical activities are increasingly performed with preventive purposes, as part of community programs for secondary prevention but also as part of many clinical activities. However, there are few evaluations of preventive and health promotion activities and, in general, these evaluations only assess aspects of efficacy/effectiveness with little consideration of cost and cost-effectiveness and even less of the ethical, legal, social or organizational consequences. Given the growing interest in evaluation of these interventions from different perspectives, health technology assessment (HTA) has emerged as a multidisciplinary analysis strategy with distinct methodological approaches that may be useful to health administrations and policy-makers for decision making at different levels (micro, meso and macro). This manuscript discusses the characteristics and differential aspects related to assessment of preventive and health promotion activities. This type of evaluation poses constraints, limitations and challenges that should be considered during the process of HTA. In the case of public health there are additional challenges, because the evidence must satisfy a diverse audience, including public health professionals, clinicians, politicians, managers, economists and consumers. The challenge is even greater when evaluating complex, integrated community interventions in which local and contextual aspects are of tremendous importance. In addition, assessment of ethical issues is of the utmost importance since these issues comprise the origin of health services and the target populations are usually healthy.

Comparison of 3 systems for assigning priority to patients on waiting lists for cataract extraction.

OBJECTIVE: As the demand for cataract surgery grows, patients in some health care systems are assigned to a waiting list. Several explicit priority tools have been developed. We compared 3 of these: the IRYSS-Cataract Priority Score (ICPS), Catalan Agency for Health Technology Assessment and Research cataract priority system (CCPS), and Western Canada Waiting List project for cataract surgery (WCWL). DESIGN: Prospective cohort study. PARTICIPANTS: A total of 1723 consecutive patients awaiting cataract surgery at 5 hospitals. METHODS: The ICPS, CCPS, and WCWL were applied to these patients after the collection of data. The 3 prioritization systems were compared using correlation methods, 95% limits of agreement, and the kappa coefficient. RESULTS: Means and standard deviations for the different prioritization systems were 60.9 (22.2) for the ICPS, 35.7 (20.4) for the CCPS, and 25.7 (21.5) for the WCWL. Pearson's correlation coefficients were 0.56 between the ICPS and the CCPS, 0.62 between the WCWL and CCPS, and 0.71 between the ICPS and WCWL. The kappa value among them ranged from 0.13 to 0.40, and the intraclass correlation coefficients ranged from 0.31 to 0.55. CONCLUSIONS: These 3 prioritization tools showed acceptable correlations but assigned significantly different point scores to similar scenarios. This may have consequences when using these tools for managing a waiting list for cataract extraction.

Potential for 2 priority systems to be used as appropriateness of indication tools for cataract surgery.

OBJECTIVE: To test 2 systems developed to prioritize patients on waiting lists for cataract surgery, the Western Canadian Waiting List (WCWL), and the Catalan Agency for Health Technology Assessment and Research Cataract Priority System (CCPS), as tools for judging the appropriateness of the intervention. DESIGN: Cross-sectional study with follow-up. PARTICIPANTS: A total of 1723 prospective patients awaiting cataract extraction in 5 hospitals were included in the study. METHODS: Priority scores using the WCWL and the CCPS systems were calculated and compared with visual acuity (VA) and visual function, measured by the Visual Function-14 index, before and after surgery. The sensitivity of each priority system to different groups was evaluated using a validated appropriateness of indications tool for cataract extraction. One-way analysis of variance and the Jonckheere-Terpstra test were used to detect differences in group scores. Spearman correlation coefficients were also examined. RESULTS: The WCWL and CCPS systems produced different mean values according to the preoperative levels of VA and visual function (p < 0.0001). Neither system showed a significant difference in mean scores based on gains in VA and visual function. Both systems produced different mean scores according to the different groups of appropriateness set by the appropriateness of indications tool for cataract (p < 0.0001). CONCLUSIONS: Given that appropriateness tools should correlate with outcomes, we recommend using neither the WCWL nor the CCPS for appropriateness purposes. Incorporating new criteria into these systems may improve the correlation with important outcomes and their adequacy for use as appropriateness tools.

Systems to support health technology assessment (HTA) in member states of the European union with limited institutionalization of HTA.

OBJECTIVES: The aim of this study was to support health technology assessment (HTA) capacity building in Member States of the European Union with limited experience or without institutionalized HTA. The main output is a Handbook on HTA Capacity Building. METHODS: The methods used were worldwide surveys of (i) HTA organizations, (ii) information management units, and (iii) HTA educational programs. The results of two surveys (i & ii) were combined with expert opinion to produce the Handbook on HTA Capacity Building. RESULTS: Survey of HTA organizations (n = 41, response rate 35 percent). Most of the organizations were established by the government (61 percent), and all were not-for-profit. Working on HTA (80.5 percent) and doing research (63.4 percent) were the main lines of activity. Survey on information management units (n = 23, response rate 23 percent). Most (74.2 percent) of the responding HTA agencies reported having personnel dedicated to HTA information services. Survey on HTA educational programs (n = 48, response rate 60 percent). In total, nine Master of Science (MSc) programs were identified (three MSc in HTA and six MSc in HTA-related areas). Handbook on HTA Capacity Building. A group of twenty experts from thirteen countries developed the handbook. It consists of nine chapters focusing on HTA institutional development (structural setup, work processes, and visibility). CONCLUSIONS: Setting up organizational structures and establishing effective HTA programs that guide key policy decisions is a challenging task. There are no standard models or pathways. "One size fits all" is not a useful principle because of the wide systemic and cultural differences between countries. The Handbook on HTA Capacity Building includes approaches for overall institutional development, especially in formulating objectives, setting up structures, and defining work processes.