Laura Sampietro-Colom

Identifying Bone-Mass-Related Risk Factors for Fracture to Guide Bone Densitometry Measurements: A Systematic Review of the Literature

Abstract: Available evidence suggests that fracture prediction with bone densitometry may improve when used on people at high risk of osteoporotic fractures. The objectives of this literature review were: (1) to identify risk factors for fracture that are associated with the development of a low bone mass for both men and women; (2) to describe and assess the relationship between these factors and the risk of fracture; and (3) to classify them according to the strength of their association with fracture incidence. Studies were identified from MEDLINE (1982–1997), HealthSTAR (1975–1997) and The Cochrane Library (1997) databases. Pre-stated inclusion criteria (original analytic studies assessing risk factors for osteoporotic fractures in men and women) and methodologic quality were assessed by two independent investigators. Information on the study design and analysis, characteristics of participants, exposure (risk factor) and outcome measures (relative risk and odds ratios for fracture incidence), control for potential confounding factors and risk estimates was extracted using a standardized protocol. Qualitative and meta-analytic techniques were used for data synthesis. As a result, risk factors were classified into three groups according to their strength of association with fracture: high risk (RR≥2), moderate risk (1<RR<2) and no risk or protective (RR≤1). Of approximately 80 risk factors identified from 94 cohort and 72 case-control studies, 15% were classified in the high-risk group, including low body weight, loss of weight, physical inactivity, the consumption of corticosteroids or anticonvulsants, primary hyperparathyroidism, diabetes mellitus type I, anorexia nervosa, gastrectomy, pernicious anemia, and aging (>70–80 years). Eighteen percent and 8% of risk factors were classified in the moderate and no risk group respectively, whereas 60% showed either a lack of scientific evidence confirming their association with fracture or contradictory results. An efficient strategy for bone densitometry provision may thus be its selective use in those individuals who present with several strong or moderate risk factors for fracture related to bone mass loss.

SUMMARY REPORT OF THE ECHTA/ECAHI PROJECT

Health technology assessment (HTA) seeks to inform health policy makers by using the best scientific evidence on the medical, social, economic, and ethical implications of investments in health care. Technology is broadly defined to include the drugs, devices, medical, and surgical procedures used in health care, as well as measures for prevention and rehabilitation of disease, and the organizational and support systems in which health care is provided.

Wide Social Participation in Prioritizing Patients on Waiting Lists for Joint Replacement: A Conjoint Analysis

Objective. The aim was to develop a priority scoring system for patients on waiting lists for joint replacement based on a wide social participation, and to analyze the differences among participants. Methods. Conjoint analysis. Focus groups in combination with a nominal technique were employed to identify the priority criteria (N=36). A rank-ordered logit model was then applied for scoring estimations. Participants (N=860) represented: consultants, allied-health professionals, patients and their relatives, and the general population of Catalonia. Results. Clinical and social criteria were selected, and their relative importance (over 100 points) was: pain (33), difficulty in doing activities of daily living (21), disease severity (18), limitations on ability to work (10), having someone to look after the patient (9), being a caregiver (6), and recovery probability (4). Estimated criteria coefficients had the expected positive sign and all were statistically significant (P < 0.001). There were differences between groups; pain was rated higher by patients/relatives, and difficulty in doing activities was rated lower by patients/relatives and the general public. Most interaction terms for these criteria and groups were significant (P < 0.001). Consultants and allied-health professionals had the most similar prioritization pattern (r=0.97). Conclusion. Both clinical and social criteria are considered for prioritization of joint replacement surgery from a wide social perspective. The preference among professional and social groups varies and this might impact the result of patient prioritization. A wide social participation for obtaining adequate prioritizing systems for patients on waiting lists is desirable.

DEVELOPMENT AND TEST OF A DECISION SUPPORT TOOL FOR HOSPITAL HEALTH TECHNOLOGY ASSESSMENT

OBJECTIVE To develop and test a decision-support tool for prioritizing new competing Health Technologies (HTs) after their assessment using the mini-HTA approach. METHODS A two layer value/risk tool was developed based on the mini-HTA. The first layer included 12 mini-HTA variables classified in two dimensions, namely value (safety, clinical benefit, patient impact, cost-effectiveness, quality of the evidence, innovativeness) and risk (staff, space and process of care impacts, incremental costs, net cost, investment effort). Weights given to these variables were obtained from a survey among decision-makers (at National/Regional level and hospital settings). A second layer included results from mini-HTA (scored as higher, equal or lower), which compares the performance of the new HT (in terms of the abovementioned 12 variables) with the available comparator. An algorithm combining the first (weights) and second (scores) layers was developed to obtain an overall score for each HT, which was then plotted in a value/risk matrix. The tool was tested using results from the mini-HTAs for three new HTs (Surgical Robot, Platelet Rich Plasma, Deep Brain Stimulation). RESULTS No significant differences among decision-makers were observed as regards the weights given to the 12 variables, therefore, the median aggregate weights from decision-makers were introduced in the first layer. The dot plot resulting from the mini-HTA presented good power to visually discriminate between the assessed HTs. CONCLUSION The decision-support tool developed here makes possible a robust and straightforward comparison of different competing HTs. This facilitates hospital decision-makers deliberations on the prioritization of competing investments under fixed budgets.

The Effectiveness of Bone Density Measurement and Associated Treatments for Prevention of Fractures: An International Collaborative Review

This review assesses the evidence regarding the effectiveness of bone density measurement (BDM) screening and related interventions--hormone replacement therapy (HRT) and intranasal salmon calcitonin (SCT[N])--in menopausal women to prevent fractures in later life. Data sources included systematic reviews of evidence and relevant primary studies identified through literature searches on MEDLINE and EMBASE. Study selection included trials of BDM screening programs, prospective studies examining the predictive value of BDM, randomized controlled trials, cohort studies, and case-control studies of HRT and SCT (N). The evidence was evaluated using a classification system incorporating study design and quality. Outcomes were measured in terms of relative risk of fracture for a 1 SD decrease in bone mineral density below the age-adjusted mean, relative risks or odds ratios for fractures associated with treatments, and proportion of hip fractures potentially prevented by BDM screening linked to treatments. Fair evidence from prospective cohort studies suggests that BDM can predict the risk of fractures, but not with high accuracy. Fair evidence from low-quality randomized controlled trials and observational studies suggests that HRT and SCT(N) are efficacious in preventing fractures. Good evidence supports the efficacy of these treatments in preserving bone mass, but there is fair evidence that the effect wears off after cessation of therapy. There is little evidence on the impact of screening menopausal women with BDM in association with HRT or SCT(N) treatment. Estimates based on combining existing evidence regarding the predictive value of BDM and efficacy of HRT suggests that 1-7% of hip fractures might be prevented.

EXECUTIVE SUMMARY OF THE ECHTA/ECAHI PROJECT

Health technology is an indispensable part of any nations healthcare system. During the past 50 years, all member states that comprise the European Union have increased their technological base for health care, both in terms of knowledge and by investments in equipment, devices, and pharmaceuticals. Generally, this process has gone well. However, several problems have emerged related to the acquisition, diffusion, and use of modern health technology. Concerns have been also raised about the effectiveness and efficiency of already established procedures in health care.

Hospital managers’ need for information in decision-making – An interview study in nine European countries

Assessments of new health technologies in Europe are often made at the hospital level. However, the guidelines for health technology assessment (HTA), e.g. the EUnetHTA Core Model, are produced by national HTA organizations and focus on decision-making at the national level. This paper describes the results of an interview study with European hospital managers about their need for information when deciding about investments in new treatments. The study is part of the AdHopHTA project. Face-to-face, structured interviews were conducted with 53 hospital managers from nine European countries. The hospital managers identified the clinical, economic, safety and organizational aspects of new treatments as being the most relevant for decision-making. With regard to economic aspects, the hospital managers typically had a narrower focus on budget impact and reimbursement. In addition to the information included in traditional HTAs, hospital managers sometimes needed information on the political and strategic aspects of new treatments, in particular the relationship between the treatment and the strategic goals of the hospital. If further studies are able to verify our results, guidelines for hospital-based HTA should be altered to reflect the information needs of hospital managers when deciding about investments in new treatments.

Priorización de pacientes en lista de espera para cirugía de cataratas: diferencias en las preferencias entre ciudadanos

Objetivos: Estimar y comparar las preferencias de los ciudadanos sobre la priorizacion de pacientes en lista de espera para cirugia de cataratas. Metodo: Analisis de conjunto. Identificacion y seleccion de criterios de priorizacion: 4 grupos focales/nominales de poblacion general, pacientes/familiares, profesionales relacionados, y especialistas de Catalunya (n = 36). Estimacion de las preferencias (puntuaciones de los criterios): entrevista a una muestra representativa de los 4 grupos (n = 771) y aplicacion del modelo del rank-ordered logit. Las diferencias se estudiaron mediante analisis separado por grupo y su comparacion. Resultados: Los criterios seleccionados y su importancia relativa fueron: incapacidad visual (45%), limitacion de las actividades (15%), limitacion para trabajar (14%), tener alguna persona que le cuide (11%), ser cuidador (8%) y probabilidad de recuperacion (7%). Existieron diferencias entre grupos en la puntuacion de los criterios. La poblacion general y los pacientes/familiares valoraron mas la incapacidad visual que los otros grupos (p 0,9), la ordenacion final de estos en la lista de espera podia variar hasta 27 posiciones al aplicar las preferencias obtenidas de un grupo o de otro. Conclusiones: Se considero relevantes los criterios clinicos y los sociales. La existencia de diferencias sobre como deberian priorizarse los pacientes en espera recomienda tener en cuenta las preferencias de todas las partes afectadas.

El producto de la atención primaria definido por profesionales y usuarios

Objetivo: Definir los componentes del producto de la atencion primaria de salud (APS) a partir de las opiniones de profesionales y usuarios, para establecer indicadores de evaluacion. Metodos: Estudio con metodologia cualitativa, con tecnicas grupales: grupo nominal (profesionales) y grupos focales (usuarios). Ambito de realizacion: APS de Catalunya. Se realizaron 7 grupos: a) medicos de familia y pediatras; b) enfermeras y trabajadoras sociales; c) personal de la unidad de admision y atencion al usuario; d) otros medicos especialistas; e) usuarios, y f) gestores, farmaceuticos y farmacologos y tecnicos de salud. Los participantes respondieron a la pregunta: «Respecto a los servicios que deberia ofrecer la APS, ?cuales son los aspectos que se deberian valorar?». Se realizo un analisis de contenido. Los datos textuales se descompusieron en unidades, posteriormente agrupadas en categorias, siguiendo el criterio de analogia. Se tuvo en cuenta el contexto de interpretacion del equipo investigador. Resultados: Profesionales y usuarios identifican 4 dimensiones del producto de la APS, coincidentes con sus atributos basicos: a) accesibilidad a los servicios; b) coordinacion y continuidad del equipo de APS con otros niveles asistenciales; c) relacion entre profesionales y usuarios, y d) calidad cientifico-tecnica de los equipos de atencion primaria y cartera de servicios. Equidad, satisfaccion y eficiencia aparecen en los discursos como ejes transversales de todos los componentes del producto identificados. Conclusion: Hay una gran coincidencia en la definicion del producto entre profesionales y usuarios. La relacion profesional-paciente aparece como un elemento clave en todos los grupos. Estas 4 dimensiones deberian formar parte de la evaluacion de los equipos de APS.

History of health technology assessment: Spain.

OBJECTIVES The aim of this study was to describe the characteristics of the introduction and diffusion of health technology assessment (HTA) in Spain. METHODS A survey to summarize the evolution of HTA was sent to representatives of different HTA initiatives in Spain. RESULTS HTA was introduced in the late 1980s. The main factors were the trend to an increase in healthcare expenditure, concerns regarding efficiency in providing health care, as well as in the level of rationality introducing high technology. Spain has direct (i.e., regulation) and indirect (i.e., payment systems, evidence-based programs, HTA) mechanisms to control health technologies. A recent high priority regulation has established the need of HTA to decide the introduction of a new health technology in the lists of public healthcare coverage, although similar regulations existed in the past and were scarcely implemented. HTA initiatives started at the regional government level. Its introduction followed a progressive pattern among regions. In the beginning, resources were scarce and expertise limited, with work done at intramural level. With time, expertise increase, and promotion of commissioned work was implemented. HTA knowledge transfer in the healthcare system has been carried out through courses, publications, and commissioned research. Currently, there are seven HTA units/agencies, which coordinate their work. CONCLUSIONS HTA in Spain is in its maturity. Facing the unavoidable change of health care environment over time, HTA is also evolving and, currently, there is a trend to broaden the areas of influence of HTA by devolving capacity to hospitals and applying principles to very early phases of health technology development, under the umbrella of regional HTA units/agencies. However, there are two main challenges ahead. One is to have a real impact at the highest level of healthcare policy coordination among Spanish regions, which is done at the Central Ministry of Health. The other is to avoid the influence of political waves in the level of recognition of HTA at the policy decision-making level and to have an adequate and stable funding of HTA initiatives.