Alicia Granados

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.

The importance of process variables analysis in the assessment of long-term oxygen therapy by concentrator

The aim of the present study was to evaluate process variables and intermediate outcomes involved in long-term oxygen therapy (LTOT) by concentrator with the purpose of identifying which of those factors would be the most influential in the final health outcome of the therapy. A cross-sectional survey was carried out on a random sample of 111 patients receiving LTOT by concentrator in Catalonia (Spain). Patients were interviewed and assessed at home by a trained physician, and the variables collected were arterial oxygen saturation, performance of the concentrators, and patient compliance. Sixty-two patients participated in the study. Overall, LTOT was appropriately prescribed in 36 patients, of whom only 29 were able to correct their level of hypoxaemia. Patient compliance with treatment was considered adequate in 19 of those 29 patients. Thus, only 19 of 62 patients (31%) fulfilled those criteria needed to achieve the expected clinical benefits. Strategies for improving the effectiveness of medical interventions or technologies ought to consider those factors of the therapeutic process which might influence the expected health outcomes in a specific health-care context.

Scoring system has better discriminative value than Helicobacter pylori testing in patients with dyspepsia in a setting with high prevalence of infection

Objective To prospectively assess the accuracy of a scoring system to predict organic diseases in dyspeptic patients in an area of South Europe, and to compare it with that of Helicobacter pylori testing in patients with dyspepsia in an environment with high prevalence of H. pylori infection. Methods Symptoms and demographic data were recorded in 501 consecutive dyspeptic patients referred to an outpatient gastroenterology clinic. A simple scoring system was constructed from the predictive factors obtained in a multi‐variate logistic regression analysis. Overall predictive accuracy was assessed with the c statistic. The model was validated using bootstrap techniques. The accuracy of clinical judgement and H. pylori testing to predict endoscopic diagnosis was also assessed. Results Organic dyspepsia (peptic ulcer, oesophagitis or malignancies) was diagnosed in 45% of the patients. The test for H. pylori was positive in 68%, and 29% of infected patients had an ulcer. The organic dyspepsia predictive model had an accuracy of 0.79, which decreased to 0.77 after validation adjustment. The predictive accuracies for clinical judgement and H. pylori testing were 0.69 and 0.61, respectively. The addition of H. pylori testing to the scoring system resulted in a minor improvement of the predictive accuracy. Conclusion In an environment with a high rate of H. pylori infection and a low prevalence of peptic ulcer among infected patients, a scoring system has higher predictive accuracy for the diagnosis of organic disease than H. pylori testing. Moreover, in this setting, H. pylori testing adds a minimum value to the predictive capability of the scoring system.

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.

HEALTH TECHNOLOGY ASSESSMENT IN SPAIN

The Spanish Constitution of 1978 established a healthcare system available to everyone and free at the point of service. The General Health Law of 1986 also established the framework for a National Health System (NHS). The Constitution and the law form the regulatory framework for the devolution of healthcare services to the Autonomous Regions. All the 17 Autonomous Regions have complete power regarding public health and planning. However, responsibilities on healthcare financing, organization, provision, and management have devolved to only seven Autonomous Regions. Financial support for health services comes mostly from taxes. Global budgets are a mechanism used by hospitals to control the acquisition of medium and low health technology. Major capital investments for health technology are controlled by the central government in 10 Autonomous Regions (population coverage of 38%) and by the Regional Health Services in the seven remaining Autonomous Regions. In 1995 a regulation for basing the introduction of new procedures and medical equipment on the assessment of safety, efficacy, and efficiency was issued. Health technology assessment (HTA) has a long history in Spain, beginning with the Advisory Board on High Technology in the government of Catalonia in 1984. This board evolved into the Catalan Agency for HTA (CAHTA) in 1994. The Basque Country established a unit for HTA in 1992 (Osteba) and the Andalusian government created an agency in 1996 (AETSA). A national agency for HTA (AETS) was established in 1994. These different programs coordinate their work and together act as an Advisory Committee of the Interregional Council of the NHS.

Technology assessment in Catalonia : integrating economic appraisal

A brief description of the evolution and role of the Catalan Office for Health Technology Assessment (COHTA) into the framework of the Catalan Health Care Service are presented. Methodological approaches used by COHTA range from synthesis of scientific evidence to the collection of primary data. Regarding the integration of economic appraisal into technology assessment, the main approaches are the following: integration into clinical trials funded by the COHTA and in the reimbursement policies of the Catalan Health Service. COHTA participates in the process of purchasing medical technologies, especially expensive ones, and in the establishment of reimbursement policies of medical technologies. The particular characteristics of COHTA as a regional agency for Technology Assessment and its position into the framework of the Department of Health are discussed. Among the advantages of this position are the knowledge of the relevant questions for policy makers and the potential influence in the process. Among the disadvantages are the possibility of losing autonomy. Regional agencies that are closely related to the regional health services could provide a better understanding of the real problems in clinical practice and in the utilization of health technologies.

International collaboration in health technology assessment: a study of technologies used in management of osteoporosis

A collaborative study was undertaken by members of the International Network of Agencies for Health Technology Assessment (INAHTA). The evidence of the effectiveness of bone density measurement and selected treatments in preventing fractures in later life was reviewed. There was fair evidence that bone density measurement can predict risk of fractures and that hormone replacement therapy and intranasal salmon calcitonin preserve bone mass and decrease the risk of fractures. However, it was estimated that only 1-7% of hip fractures would be prevented if these technologies were used in a screening program for menopausal women. Results of the assessment were endorsed by 13 INAHTA members, disseminated widely and provided input to policy and further work in this area. The project demonstrated the feasibility of international collaborative health technology assessment.

Anticipating the consequences for the primary therapy of breast cancer after introducing screening : A more global picture for health care policy making

A breast cancer screening program mainly aims at reducing mortality. However, it also has an effect, often not assessed, on the utilization of health care resources that is relevant to health care policy making. Using a simulation model, this paper forecasts the impact of introducing a breast cancer screening program on the utilization of resources for the primary therapy of breast cancer. The most important consequences from a health care point of view will be an increased use of breast-conserving therapy and an increased need for postoperative radiotherapy; there will also be a higher number of women diagnosed with noninvasive breast cancer. The results of this study could provide support for health care decision making by showing the consequences of policy decisions on the introduction of screening programs for health care utilization.

Complex decisions about an uncomplicated therapy: reimbursement for long-term oxygen therapy in Catalonia (Spain)

Therapies used in the management of chronic diseases cause specific problems regarding reimbursement policy. Oxygen therapy is an example of such treatments that receive little attention from health care policy makers, due to their low cost to the health care budget and to their little importance from a social point of view. In this paper, we analyze the problems posed by this therapy in the Catalan health care system, as an example of the several aspects implied in the reimbursement of such kind of therapies. A technology assessment of this therapy was carried out showing that a change in the reimbursement of long-term home oxygen therapy (LTOT) was needed. Slow diffusion of new oxygen delivery modalities and over-prescription of LTOT were among the problems observed. The new system proposed is presented, and some preliminary results and consequences of the role of technology assessment in health care policy-making are discussed.

International Master's Program in health technology assessment and management: Assessment of the first edition (2001-2003)

BACKGROUND Despite a clear call for greater input from health technology assessment (HTA) in the areas of clinical practice and policy making, there are currently very few formal training programs. The objectives of our Consortium were to (i) develop a masters level program in HTA, (ii) test its content with a group of Canadian and European students, and (iii) evaluate the Programs strengths and weaknesses. OBJECTIVES This study presents the results of our evaluation of the first edition of the Masters Program (2001--2003). METHODS The evaluation relied on (i) a self-administered student questionnaire for each course (n = 142), (ii) interviews with students (n = 10), and (iii) interviews with internship supervisors (n = 5). RESULTS A vast majority of students were satisfied with the course content and particularly appreciated the exercises and materials presented in an intensive format. However, they needed more systematic feedback from faculty members and recommended increasing the methodology content. The six key characteristics of the program are (i) flexible format adapted to the needs of skilled professionals, (ii) continuous interaction between HTA users and producers, (iii) international academic and professional collaboration, (iv) partnership with HTA agencies, (v) global approach to evidence-based methods and practices, and (vi) multidisciplinary approach. CONCLUSIONS Despite the numerous organizational barriers inherent to creating an international program and several areas for improvement in the Program itself, the Ulysses Project was successful in attaining its objectives. Because there is a growing need for human resources with special training in HTA, further efforts need to be devoted to strengthening the international research capacity in HTA.